2f:I[703058,["/_next/static/immutable/chunks/3bhq_5eh1d760.js","/_next/static/immutable/chunks/2iy5wruuedsh6.js","/_next/static/immutable/chunks/2pfsjpn6k6zlg.js","/_next/static/immutable/chunks/26c7v3_3uwnwu.js","/_next/static/immutable/chunks/00yc7rcvua6a7.js","/_next/static/immutable/chunks/37ktb71aq3480.js","/_next/static/immutable/chunks/2d50b-7eu4558.js","/_next/static/immutable/chunks/06_yt270h41rg.js","/_next/static/immutable/chunks/2d6noqpp6ehas.js","/_next/static/immutable/chunks/1sx186c93bpzg.js","/_next/static/immutable/chunks/3dc-1n866s65i.js","/_next/static/immutable/chunks/20x2y96ldu5wx.js","/_next/static/immutable/chunks/2w1bvggzb0ga8.js","/_next/static/immutable/chunks/2051ffx3xzio9.js"],"PaperListPageClient"] 30:T8f4,PHERGain-2 is a multicenter, single-arm, phase II study evaluating a pathologic complete response (pCR)-guided de-escalation strategy to omit chemotherapy in selected patients with HER2-positive early breast cancer (EBC). Eligible patients were adults, treatment-naive, centrally confirmed HER2-positive (immunohistochemistry 3+), node-negative EBC, with tumors 5-30 mm by magnetic resonance imaging. Patients received eight cycles of neoadjuvant trastuzumab-pertuzumab (HP) (600 mg H + 1200 mg P loading dose, followed by 600 mg H + 600 mg P maintenance dose) every 3 weeks. Patients with hormone receptor (HR)-positive tumors also received endocrine therapy. After surgery, patients received 10 cycles of adjuvant therapy guided by the pathological response: HP for patients with pCR (ypT0/is ypN0) (cohort A), trastuzumab emtansine (T-DM1; 3.6 mg/kg) for patients with residual invasive breast tumors and/or ypN0(i+/mol+), ypN1mi (cohort B), and optional chemotherapy followed by T-DM1 for patients with ypN1-3 (cohort C). Co-primary endpoints were 1-year health-related quality of life (HRQoL) decline (based on the European Organisation for Research and Treatment of Cancer Core Quality of Life questionnaire) and 3-year recurrence-free interval (based on the Standardized Definitions for Efficacy End Points). Key secondary endpoints included overall and HR-specific pCR rates and safety. From August 2021 to March 2024, 396 patients initiated neoadjuvant treatment, 391 (98.7%) underwent surgery. A total of 236 patients (59.6%) achieved pCR (cohort A). Among those with residual disease, 148 (37.8%) entered cohort B and 7 (1.8%) cohort C. One year after initiation of neoadjuvant treatment, ≥10% decline rate in global HRQoL was 42.8% [95% confidence interval (CI) 36.9% to 48.8%]; 37.3% (95% CI 30.1% to 44.9%) in patients with pCR and 51.9% (95% CI 41.9% to 61.7%) in those with residual disease. Treatment-related adverse events occurred in 86.6% of patients (5.6% grade ≥3). Serious adverse events occurred in 6.1% of patients. One death (0.3%) due to pneumonitis was attributed to T-DM1. PHERGain-2 shows meaningful HRQoL preservation, expected HP/T-DM1 toxicity, and an outstanding pCR rate comparable with standard chemotherapy plus HP regimens in this patient population.31:Tae9,Globally, 968 350 new cases and 659 853 deaths from gastric cancer were reported in 2022. In the US, 30 300 new cases and 10 780 deaths were estimated in 2025. Gastric cancer is more common in men, and the median age at diagnosis is 68 years. Most gastric cancers (>90%) are adenocarcinomas. Worldwide, 85% of cases arise from the stomach body or antrum and 15% from the cardia. In the US, more than 90% of patients diagnosed with gastric cancer present with symptoms such as weight loss and abdominal pain. At presentation, approximately 13% have localized disease (limited to the stomach), 15% to 25% have locally advanced disease, defined as a tumor that has spread to regional lymph nodes, and 35% to 65% have metastatic disease. Helicobacter pylori infection is a treatable risk factor associated with 90% of gastric body and antrum cancers globally. Additional modifiable risk factors include smoking, alcohol, obesity, and salt intake. In countries with high incidence such as Japan and Korea, routine endoscopic screening beginning at age 40 years is associated with improved survival. Diagnosis is made by endoscopic biopsy. Patients with localized gastric cancer are treated with surgical resection and have a 5-year relative survival rate of 75% with treatment. Patients with more advanced-stage disease should receive gastrectomy, perioperative chemotherapy with 5-fluorouracil, oxaliplatin, and docetaxel and immunotherapy (durvalumab). Metastatic or unresectable disease may be treated with chemotherapy, immunotherapy, and/or targeted therapy depending on biomarkers, including programmed cell death ligand 1 (PD-L1), human epidermal growth factor receptor 2 (ERBB2; formerly HER2 or HER2/neu), and claudin-18, isoform 2 (CLDN18.2). For PD-L1-expressing gastric cancer, adding immune checkpoint inhibitors, such as nivolumab and pembrolizumab, is associated with an additional 3 months of survival when compared with chemotherapy alone. For gastric cancers overexpressing the ERBB2 or CLDN18.2 proteins, the addition of trastuzumab or zolbetuximab, respectively, is associated with an additional 3 to 4 months' survival. Early supportive care focusing on symptom management and on nutritional and psychosocial support is associated with 3 months of survival benefit. Less than 10% of patients with metastatic gastric cancer survive more than 5 years. Approximately 30 300 new cases of gastric cancer are diagnosed annually in the US. Localized gastric cancer is treated with gastrectomy, and locally advanced disease is treated with surgery and chemoimmunotherapy. For patients with unresectable or metastatic gastric cancer, chemotherapy with immune checkpoint inhibitors and targeted therapies such as trastuzumab or zolbetuximab improves survival by several months.32:Te7b, Importance Globally, 968 350 new cases and 659 853 deaths from gastric cancer were reported in 2022. In the US, 30 300 new cases and 10 780 deaths were estimated in 2025. Observations Gastric cancer is more common in men, and the median age at diagnosis is 68 years. Most gastric cancers (&gt;90%) are adenocarcinomas. Worldwide, 85% of cases arise from the stomach body or antrum and 15% from the cardia. In the US, more than 90% of patients diagnosed with gastric cancer present with symptoms such as weight loss and abdominal pain. At presentation, approximately 13% have localized disease (limited to the stomach), 15% to 25% have locally advanced disease, defined as a tumor that has spread to regional lymph nodes, and 35% to 65% have metastatic disease. Helicobacter pylori infection is a treatable risk factor associated with 90% of gastric body and antrum cancers globally. Additional modifiable risk factors include smoking, alcohol, obesity, and salt intake. In countries with high incidence such as Japan and Korea, routine endoscopic screening beginning at age 40 years is associated with improved survival. Diagnosis is made by endoscopic biopsy. Patients with localized gastric cancer are treated with surgical resection and have a 5-year relative survival rate of 75% with treatment. Patients with more advanced-stage disease should receive gastrectomy, perioperative chemotherapy with 5-fluorouracil, oxaliplatin, and docetaxel and immunotherapy (durvalumab). Metastatic or unresectable disease may be treated with chemotherapy, immunotherapy, and/or targeted therapy depending on biomarkers, including programmed cell death ligand 1 (PD-L1), human epidermal growth factor receptor 2 ( ERBB2 ; formerly HER2 or HER2/neu ), and claudin-18, isoform 2 (CLDN18.2). For PD-L1–expressing gastric cancer, adding immune checkpoint inhibitors, such as nivolumab and pembrolizumab, is associated with an additional 3 months of survival when compared with chemotherapy alone. For gastric cancers overexpressing the ERBB2 or CLDN18.2 proteins, the addition of trastuzumab or zolbetuximab, respectively, is associated with an additional 3 to 4 months’ survival. Early supportive care focusing on symptom management and on nutritional and psychosocial support is associated with 3 months of survival benefit. Less than 10% of patients with metastatic gastric cancer survive more than 5 years. Conclusions and Relevance Approximately 30 300 new cases of gastric cancer are diagnosed annually in the US. Localized gastric cancer is treated with gastrectomy, and locally advanced disease is treated with surgery and chemoimmunotherapy. For patients with unresectable or metastatic gastric cancer, chemotherapy with immune checkpoint inhibitors and targeted therapies such as trastuzumab or zolbetuximab improves survival by several months. 33:T6c3,Based on the results from SOLTI-PATRICIA trial (NCT02448420) cohorts A/B, a direct comparison with standard-of-care treatments is needed to evaluate the efficacy and safety of palbociclib, trastuzumab and endocrine therapy (ET) in PAM50-luminal A/B pretreated patients. SOLTI-PATRICIA cohort C is a randomised, multicentre, prospective, open-label, phase II study. Pretreated patients with HER2-positive, HR-positive, and PAM50-Luminal A/B ABC were randomised 1:1 to receive either i) the triplet regimen or ii) trastuzumab-based treatment of physician's choice (TPC). Patients allocated in the TPC arm were eligible for re-randomization upon disease progression, if the inclusion criteria were still met. The primary endpoint was investigator-assessed progression-free survival (PFS) per RECIST 1.1. 264 participants were pre-screened between August 2019-2023, and 73 patients were randomised (including seven re-randomisations). In the TPC arm: 48.5% were treated with trastuzumab plus chemotherapy, 39.4% with T-DM1 and 12.1 % with trastuzumab plus ET. The triplet was associated with a significantly better PFS compared to TPC (stratified hazard ratio=0.52 [95% CI 0.29-0.95]; two-sided p=0.03). PFS rates after 24 months were 24.0% with the triplet and 4.3% in the TPC arm. The overall response rate was 18.9% (95% CI 8.6-35.7) and 7.1% (95% CI 1.2-25.0), respectively. In the triplet arm, grade ≥3 adverse events occurred in 61.5% of patients, with neutropenia being the most frequent (53.9%). No permanent discontinuations due to toxicity were observed. Combining palbociclib, trastuzumab, and ET was safe and improved significantly PFS, compared to TPC in previously treated HER2-positive, PAM50 luminal A/B ABC patients.34:T9dc,Abstract Purpose: Based on the results from SOLTI-PATRICIA trial (NCT02448420) cohorts A/B, a direct comparison with standard-of-care treatments is needed to evaluate the efficacy and safety of palbociclib, trastuzumab, and endocrine therapy (ET) in PAM50 luminal A/B pretreated patients. Patients and Methods: SOLTI-PATRICIA cohort C is a randomized, multicenter, prospective, open-label, phase II study. Pretreated patients with HER2-positive, hormone receptor–positive, and PAM50 luminal A/B advanced breast cancer were randomized 1:1 to receive either i) the triplet regimen or ii) trastuzumab-based treatment of physician’s choice (TPC). Patients allocated in the TPC arm were eligible for re-randomization upon disease progression, if the inclusion criteria were still met. The primary endpoint was investigator-assessed progression-free survival (PFS) per RECIST version 1.1. Results: A total of 264 participants were prescreened from August 2019 to 2023, and 73 patients were randomly assigned (including seven re-randomizations). In the TPC arm, 48.5% were treated with trastuzumab plus chemotherapy, 39.4% with trastuzumab emtansine, and 12.1% with trastuzumab plus ET. The triplet was associated with a significantly better PFS compared with TPC [stratified hazard ratio = 0.52; 95% confidence interval (CI), 0.29–0.95; two-sided P = 0.03]. PFS rates after 24 months were 24.0% with the triplet and 4.3% in the TPC arm. The overall response rate was 18.9% (95% CI, 8.6–35.7) and 7.1% (95% CI, 1.2–25.0), respectively. In the triplet arm, grade ≥3 adverse events occurred in 61.5% of patients, with neutropenia being the most frequent (53.9%). No permanent discontinuations due to toxicity were observed. Conclusions: Combining palbociclib, trastuzumab, and ET was safe and significantly improved PFS, compared with TPC, in previously treated patients with HER2-positive, PAM50 luminal A/B advanced breast cancer. 25:[[["$","script","0",{"type":"application/ld+json","dangerouslySetInnerHTML":{"__html":"{\"@context\":\"https://schema.org\",\"@type\":\"CollectionPage\",\"name\":\"trastuzumab: generic Research & Clinical Takeaways\",\"description\":\"Explore peer-reviewed papers on trastuzumab (generic). Clinician-written summaries and actionable practice insights. 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Biomarker-guided strategies (ctDNA, functional imaging) are identified as priorities for future investigation rather than established practice.","practice_takeaway":"For most patients with stage II HER2-positive breast cancer, carboplatin can be dropped from neoadjuvant therapy (moving from TCHP to THP-based regimens) without sacrificing pCR rates. For high-risk patients, T-DXd now has FDA approval in both the neoadjuvant and postneoadjuvant settings and should be considered in treatment planning."}},{"doi":"10.1001/jamaoncol.2026.3128","pmid":"42658505","title":"Cancer Biologics Utilization After Biosimilar Entry and Financial Implications For Payers and Patients","journal_title":"JAMA Oncology","journal_issn":"2374-2437","published_at":"2026-08-27T00:00:00.000Z","url":"https://pmc.ncbi.nlm.nih.gov/articles/PMC13522996/","source_score":43,"is_retracted":false,"is_open_access":true,"raw_metadata":{"pubmed":true,"crossref":true,"unpaywall":true},"created_at":"2026-09-02T06:22:18.628Z","updated_at":"2026-09-02T06:22:18.628Z","tags":[{"paper_doi":"10.1001/jamaoncol.2026.3128","tag_type":"age_group","value":"adult","value_numeric":null},{"paper_doi":"10.1001/jamaoncol.2026.3128","tag_type":"brand","value":"Avastin","value_numeric":null},{"paper_doi":"10.1001/jamaoncol.2026.3128","tag_type":"brand","value":"Herceptin","value_numeric":null},{"paper_doi":"10.1001/jamaoncol.2026.3128","tag_type":"brand","value":"Rituxan","value_numeric":null},{"paper_doi":"10.1001/jamaoncol.2026.3128","tag_type":"category","value":"Oncology","value_numeric":null},{"paper_doi":"10.1001/jamaoncol.2026.3128","tag_type":"condition","value":"Breast Cancer","value_numeric":null},{"paper_doi":"10.1001/jamaoncol.2026.3128","tag_type":"condition","value":"Colorectal Cancer","value_numeric":null},{"paper_doi":"10.1001/jamaoncol.2026.3128","tag_type":"condition","value":"Lymphoma","value_numeric":null},{"paper_doi":"10.1001/jamaoncol.2026.3128","tag_type":"generic","value":"bevacizumab","value_numeric":null},{"paper_doi":"10.1001/jamaoncol.2026.3128","tag_type":"generic","value":"rituximab","value_numeric":null},{"paper_doi":"10.1001/jamaoncol.2026.3128","tag_type":"generic","value":"trastuzumab","value_numeric":null},{"paper_doi":"10.1001/jamaoncol.2026.3128","tag_type":"impact_flag","value":"practice_changing","value_numeric":null},{"paper_doi":"10.1001/jamaoncol.2026.3128","tag_type":"level_of_evidence","value":"3","value_numeric":null},{"paper_doi":"10.1001/jamaoncol.2026.3128","tag_type":"modality","value":"Biosimilar","value_numeric":null},{"paper_doi":"10.1001/jamaoncol.2026.3128","tag_type":"modality","value":"Monoclonal Antibody","value_numeric":null},{"paper_doi":"10.1001/jamaoncol.2026.3128","tag_type":"sample_size","value":"n=14655","value_numeric":14655},{"paper_doi":"10.1001/jamaoncol.2026.3128","tag_type":"sex","value":"mixed","value_numeric":null},{"paper_doi":"10.1001/jamaoncol.2026.3128","tag_type":"study_design","value":"Retrospective Cohort Study","value_numeric":null},{"paper_doi":"10.1001/jamaoncol.2026.3128","tag_type":"warning","value":"Brand name tags (Avastin, Rituxan, Herceptin) refer to the originator reference products studied; biosimilar brand names are not individually specified in the abstract.","value_numeric":null},{"paper_doi":"10.1001/jamaoncol.2026.3128","tag_type":"warning","value":"Pooled analysis across three biologics (bevacizumab, rituximab, trastuzumab) with different biosimilar entry dates may mask drug-specific trends.","value_numeric":null},{"paper_doi":"10.1001/jamaoncol.2026.3128","tag_type":"warning","value":"The paper is dated 2026; some referenced biosimilar entry timelines and pricing data may not yet be familiar to clinicians current as of mid-2026.","value_numeric":null}],"summaries":{"what_studied":"This retrospective cohort study examined market dynamics and financial implications of biosimilar entry for bevacizumab, rituximab, and trastuzumab among 14,655 patients in commercial and Medicare Part B insurance, using claims data from July 2019 to December 2024.","key_result":"Biosimilar-only use (59.4% of patients) was associated with $3,820 lower mean monthly payer costs and $39.50 lower mean monthly out-of-pocket costs vs. reference product-only use; reference product average sales price fell 3.8% annually and market share dropped ~30–31.5% per year after biosimilar entry.","limitations":"Retrospective claims-based design limits causal inference; data restricted to commercially insured and Medicare Part B patients, excluding Medicaid and uninsured; biosimilar entry timing differed across the three agents, complicating pooled trend analysis.","practice_takeaway":"Biosimilars for bevacizumab, rituximab, and trastuzumab meaningfully reduce costs for both payers and patients without evidence of compromised access. Clinicians and health systems should favor biosimilar initiation as the default to maximize affordability benefits."}},{"doi":"10.1093/jnci/djag256","pmid":"42530873","title":"A multicenter, phase I/II trial of anastrozole, palbociclib, trastuzumab, and pertuzumab in hormone receptor (HR)-positive, HER2-positive metastatic breast cancer (ASPIRE)","journal_title":"JNCI: Journal of the National Cancer Institute","journal_issn":"0027-8874","published_at":"2026-07-30T00:00:00.000Z","url":"https://doi.org/10.1093/jnci/djag256","source_score":14,"is_retracted":false,"is_open_access":false,"raw_metadata":{"pubmed":true,"crossref":true,"unpaywall":true},"created_at":"2026-08-11T13:26:21.632Z","updated_at":"2026-08-11T13:26:21.632Z","tags":[{"paper_doi":"10.1093/jnci/djag256","tag_type":"age_group","value":"adult","value_numeric":null},{"paper_doi":"10.1093/jnci/djag256","tag_type":"brand","value":"Arimidex","value_numeric":null},{"paper_doi":"10.1093/jnci/djag256","tag_type":"brand","value":"Herceptin","value_numeric":null},{"paper_doi":"10.1093/jnci/djag256","tag_type":"brand","value":"Ibrance","value_numeric":null},{"paper_doi":"10.1093/jnci/djag256","tag_type":"brand","value":"Perjeta","value_numeric":null},{"paper_doi":"10.1093/jnci/djag256","tag_type":"category","value":"Oncology","value_numeric":null},{"paper_doi":"10.1093/jnci/djag256","tag_type":"condition","value":"HR-Positive HER2-Positive Breast Cancer","value_numeric":null},{"paper_doi":"10.1093/jnci/djag256","tag_type":"condition","value":"Metastatic Breast Cancer","value_numeric":null},{"paper_doi":"10.1093/jnci/djag256","tag_type":"generic","value":"anastrozole","value_numeric":null},{"paper_doi":"10.1093/jnci/djag256","tag_type":"generic","value":"palbociclib","value_numeric":null},{"paper_doi":"10.1093/jnci/djag256","tag_type":"generic","value":"pertuzumab","value_numeric":null},{"paper_doi":"10.1093/jnci/djag256","tag_type":"generic","value":"trastuzumab","value_numeric":null},{"paper_doi":"10.1093/jnci/djag256","tag_type":"impact_flag","value":"limited_evidence","value_numeric":null},{"paper_doi":"10.1093/jnci/djag256","tag_type":"level_of_evidence","value":"3","value_numeric":null},{"paper_doi":"10.1093/jnci/djag256","tag_type":"modality","value":"Aromatase Inhibitor","value_numeric":null},{"paper_doi":"10.1093/jnci/djag256","tag_type":"modality","value":"CDK4/6 Inhibitor","value_numeric":null},{"paper_doi":"10.1093/jnci/djag256","tag_type":"modality","value":"HER2-Targeted Therapy","value_numeric":null},{"paper_doi":"10.1093/jnci/djag256","tag_type":"sample_size","value":"n=29","value_numeric":29},{"paper_doi":"10.1093/jnci/djag256","tag_type":"sex","value":"female","value_numeric":null},{"paper_doi":"10.1093/jnci/djag256","tag_type":"study_design","value":"Phase I/II Trial","value_numeric":null},{"paper_doi":"10.1093/jnci/djag256","tag_type":"warning","value":"Median OS was not reached, so OS benefit cannot be fully assessed from available follow-up data.","value_numeric":null},{"paper_doi":"10.1093/jnci/djag256","tag_type":"warning","value":"Phase I/II single-arm design (no randomized comparator); level of evidence assigned as 3 reflects non-randomized controlled trial status.","value_numeric":null},{"paper_doi":"10.1093/jnci/djag256","tag_type":"warning","value":"Sample size is very small (n=29 response-evaluable); efficacy estimates should be interpreted with caution.","value_numeric":null},{"paper_doi":"10.1093/jnci/djag256","tag_type":"warning","value":"Sex not explicitly reported in the abstract, but assumed female given the breast cancer population — clinicians should verify in the full paper.","value_numeric":null}],"summaries":{"what_studied":"The ASPIRE trial evaluated frontline anastrozole + palbociclib + trastuzumab + pertuzumab in previously untreated HR-positive, HER2-positive metastatic breast cancer (MBC) in a multicenter Phase I/II design; Phase I used 3+3 dose escalation and Phase II used an optimal Simon two-stage design.","key_result":"Palbociclib MTD was 125 mg (no dose-limiting toxicities at 100 mg or 125 mg). In 29 response-evaluable patients, 6-month clinical benefit rate was 97% (n=28; 95% CI: 82–99%), median PFS was 24.9 months (95% CI: 17.2–44.8), and median OS was not reached at 39.4 months follow-up. Grade 3–4 treatment-related adverse events occurred in 62% of patients (n=18), mostly hematologic.","limitations":"Single-arm trial without a randomized comparator limits causal inference. Very small sample size (n=29 response-evaluable) reduces precision of efficacy estimates. Hormone receptor and HER2 subgroup results cannot be generalized without confirmatory randomized data.","practice_takeaway":"This chemotherapy-free regimen of anastrozole + palbociclib + trastuzumab + pertuzumab showed high clinical benefit (97%) and durable PFS (~25 months) in HR+/HER2+ MBC, but remains investigational pending randomized trial confirmation. Monitor closely for hematologic toxicity, which drove most grade 3–4 adverse events."}},{"doi":"10.1001/jamaoncol.2026.2023","pmid":"42348190","title":"Neoadjuvant Paclitaxel, Trastuzumab, and Pertuzumab for Stage II to III,\n ERBB2\n -Positive Breast Cancer","journal_title":"JAMA Oncology","journal_issn":"2374-2437","published_at":"2026-06-25T00:00:00.000Z","url":"https://pmc.ncbi.nlm.nih.gov/articles/PMC13306490/","source_score":19,"is_retracted":false,"is_open_access":true,"raw_metadata":{"pubmed":true,"crossref":true,"unpaywall":true},"created_at":"2026-07-03T13:38:39.935Z","updated_at":"2026-07-03T13:38:39.935Z","tags":[{"paper_doi":"10.1001/jamaoncol.2026.2023","tag_type":"age_group","value":"adult","value_numeric":null},{"paper_doi":"10.1001/jamaoncol.2026.2023","tag_type":"brand","value":"Herceptin","value_numeric":null},{"paper_doi":"10.1001/jamaoncol.2026.2023","tag_type":"brand","value":"Perjeta","value_numeric":null},{"paper_doi":"10.1001/jamaoncol.2026.2023","tag_type":"category","value":"Oncology","value_numeric":null},{"paper_doi":"10.1001/jamaoncol.2026.2023","tag_type":"condition","value":"HER2-Positive Breast Cancer","value_numeric":null},{"paper_doi":"10.1001/jamaoncol.2026.2023","tag_type":"generic","value":"paclitaxel","value_numeric":null},{"paper_doi":"10.1001/jamaoncol.2026.2023","tag_type":"generic","value":"pertuzumab","value_numeric":null},{"paper_doi":"10.1001/jamaoncol.2026.2023","tag_type":"generic","value":"trastuzumab","value_numeric":null},{"paper_doi":"10.1001/jamaoncol.2026.2023","tag_type":"impact_flag","value":"confirms_prior","value_numeric":null},{"paper_doi":"10.1001/jamaoncol.2026.2023","tag_type":"level_of_evidence","value":"3","value_numeric":null},{"paper_doi":"10.1001/jamaoncol.2026.2023","tag_type":"modality","value":"HER2-Targeted Therapy","value_numeric":null},{"paper_doi":"10.1001/jamaoncol.2026.2023","tag_type":"modality","value":"Taxane","value_numeric":null},{"paper_doi":"10.1001/jamaoncol.2026.2023","tag_type":"sample_size","value":"n=98","value_numeric":98},{"paper_doi":"10.1001/jamaoncol.2026.2023","tag_type":"sex","value":"mixed","value_numeric":null},{"paper_doi":"10.1001/jamaoncol.2026.2023","tag_type":"study_design","value":"Non-Randomized Clinical Trial (Phase 2, Single-Arm)","value_numeric":null},{"paper_doi":"10.1001/jamaoncol.2026.2023","tag_type":"warning","value":"The ctDNA substudy (n=57) is a subset of the full trial cohort (n=98); findings may not fully represent the overall population. The study does not report what proportion of patients received adjuvant T-DM1 vs. other therapies, which could confound outcome interpretation. The single male patient means sex-based subgroup conclusions are not possible.","value_numeric":null}],"summaries":{"what_studied":"The DAPHNe phase 2 single-arm trial evaluated 5-year outcomes and ultrasensitive ctDNA dynamics in 98 patients with stage II–III ERBB2-positive breast cancer receiving 12 weeks of neoadjuvant paclitaxel, trastuzumab, and pertuzumab (THP), followed by response-guided adjuvant therapy (median follow-up 5.2 years).","key_result":"At 5 years: event-free survival 99%, recurrence-free interval 98%, distant recurrence-free interval 100%, and overall survival 99%. Among 57 patients with ctDNA data, baseline ctDNA was detected in 89.5% (51/57); after neoadjuvant THP, 96.1% (49/51) cleared ctDNA preoperatively. Only one local recurrence occurred across the cohort.","limitations":"Single-arm, non-randomized design with no comparator group limits causal inference. ctDNA substudy included only 57 of 98 patients (tissue/plasma availability required), introducing potential selection bias. Predominantly stage II (92.9%) and mostly female (99%) cohort limits generalizability to stage III or male patients.","practice_takeaway":"Abbreviated 12-week neoadjuvant THP shows excellent 5-year outcomes for early-stage HER2-positive breast cancer, supporting its use as a chemotherapy-sparing option. Near-universal ctDNA clearance after therapy suggests ctDNA-guided de-escalation strategies warrant prospective randomized study."}},{"doi":"10.1016/j.breast.2026.104849","pmid":"42391855","title":"HER2DX genomic assay in HER2-positive early breast cancer treated with trastuzumab and pertuzumab: A correlative analysis from a real-world cohort","journal_title":"The Breast","journal_issn":"0960-9776","published_at":"2026-06-23T00:00:00.000Z","url":"https://doi.org/10.1016/j.breast.2026.104849","source_score":8,"is_retracted":false,"is_open_access":true,"raw_metadata":{"pubmed":true,"crossref":true,"unpaywall":true},"created_at":"2026-07-04T13:26:24.219Z","updated_at":"2026-07-04T13:26:24.219Z","tags":[{"paper_doi":"10.1016/j.breast.2026.104849","tag_type":"age_group","value":"adult","value_numeric":null},{"paper_doi":"10.1016/j.breast.2026.104849","tag_type":"brand","value":"Herceptin","value_numeric":null},{"paper_doi":"10.1016/j.breast.2026.104849","tag_type":"brand","value":"Perjeta","value_numeric":null},{"paper_doi":"10.1016/j.breast.2026.104849","tag_type":"category","value":"Obstetrics & Gynecology","value_numeric":null},{"paper_doi":"10.1016/j.breast.2026.104849","tag_type":"condition","value":"Early Breast Cancer","value_numeric":null},{"paper_doi":"10.1016/j.breast.2026.104849","tag_type":"condition","value":"HER2-Positive Breast Cancer","value_numeric":null},{"paper_doi":"10.1016/j.breast.2026.104849","tag_type":"generic","value":"pertuzumab","value_numeric":null},{"paper_doi":"10.1016/j.breast.2026.104849","tag_type":"generic","value":"trastuzumab","value_numeric":null},{"paper_doi":"10.1016/j.breast.2026.104849","tag_type":"impact_flag","value":"confirms_prior","value_numeric":null},{"paper_doi":"10.1016/j.breast.2026.104849","tag_type":"level_of_evidence","value":"3","value_numeric":null},{"paper_doi":"10.1016/j.breast.2026.104849","tag_type":"modality","value":"Genomic Assay","value_numeric":null},{"paper_doi":"10.1016/j.breast.2026.104849","tag_type":"modality","value":"HER2-Targeted Therapy","value_numeric":null},{"paper_doi":"10.1016/j.breast.2026.104849","tag_type":"sample_size","value":"n=156","value_numeric":156},{"paper_doi":"10.1016/j.breast.2026.104849","tag_type":"sex","value":"female","value_numeric":null},{"paper_doi":"10.1016/j.breast.2026.104849","tag_type":"study_design","value":"Retrospective Cohort Study","value_numeric":null},{"paper_doi":"10.1016/j.breast.2026.104849","tag_type":"warning","value":"HER2DX assay was performed in only 111 of 156 patients (71.2%), which may introduce selection bias in the genomic score analyses.","value_numeric":null},{"paper_doi":"10.1016/j.breast.2026.104849","tag_type":"warning","value":"Median IDFS was not reached; survival estimates should be interpreted with caution given the relatively short follow-up implied.","value_numeric":null},{"paper_doi":"10.1016/j.breast.2026.104849","tag_type":"warning","value":"The HER2DX pCR continuous score was not independently significant in multivariable analysis, suggesting the pCR score's independent predictive value in this real-world cohort is uncertain.","value_numeric":null},{"paper_doi":"10.1016/j.breast.2026.104849","tag_type":"warning","value":"The study is from a single center in Spain, which may limit generalizability to other healthcare settings or populations.","value_numeric":null}],"summaries":{"what_studied":"This retrospective, single-center study evaluated the HER2DX genomic assay in 156 patients with stage I–III HER2-positive early breast cancer treated with dual HER2 blockade (trastuzumab + pertuzumab)-based neoadjuvant therapy between February 2015 and May 2022, examining associations with pathological complete response (pCR) and invasive disease-free survival (IDFS).","key_result":"Overall pCR rate was 51.3% (n=156). Medium-high HER2DX pCR category had significantly higher pCR than the low category (OR 4.83, 95% CI 1.72–14.65; p=0.004). The continuous HER2DX risk score was independently associated with IDFS (HR 2.84, 95% CI 1.24–6.48; p=0.010). Hormone receptor-positive disease was strongly associated with lower pCR (OR 0.25, 95% CI 0.11–0.50; p<0.001) but better IDFS (HR 3.67 for HR-negative vs. HR-positive; p=0.004).","limitations":"- Single-center, retrospective design with modest sample size (n=111 with HER2DX data), limiting generalizability.\n- HER2DX pCR score lost significance in multivariable analysis, suggesting possible confounding or limited independent predictive value in this cohort.\n- Median IDFS was not reached, making long-term survival conclusions preliminary.","practice_takeaway":"The HER2DX risk score may help identify HER2-positive early breast cancer patients at higher risk of recurrence after dual HER2 blockade-based neoadjuvant therapy, supporting its potential role in treatment stratification. Clinicians should note that hormone receptor status remains a key modifier of both pCR and survival outcomes in this setting."}},{"doi":"10.1200/po-26-00001","pmid":"42258781","title":"Integrated Molecular and Clinical Analysis of Thymic Epithelial Tumors","journal_title":"JCO Precision Oncology","journal_issn":"2473-4284","published_at":"2026-06-08T00:00:00.000Z","url":"https://doi.org/10.1200/po-26-00001","source_score":19,"is_retracted":false,"is_open_access":false,"raw_metadata":{"pubmed":true,"crossref":true,"unpaywall":true},"created_at":"2026-06-17T13:29:55.937Z","updated_at":"2026-06-17T13:29:55.937Z","tags":[{"paper_doi":"10.1200/po-26-00001","tag_type":"age_group","value":"adult","value_numeric":null},{"paper_doi":"10.1200/po-26-00001","tag_type":"category","value":"Oncology","value_numeric":null},{"paper_doi":"10.1200/po-26-00001","tag_type":"condition","value":"Thymic Carcinoma","value_numeric":null},{"paper_doi":"10.1200/po-26-00001","tag_type":"condition","value":"Thymic Epithelial Tumor","value_numeric":null},{"paper_doi":"10.1200/po-26-00001","tag_type":"condition","value":"Thymoma","value_numeric":null},{"paper_doi":"10.1200/po-26-00001","tag_type":"generic","value":"enfortumab vedotin","value_numeric":null},{"paper_doi":"10.1200/po-26-00001","tag_type":"generic","value":"pembrolizumab","value_numeric":null},{"paper_doi":"10.1200/po-26-00001","tag_type":"generic","value":"sacituzumab govitecan","value_numeric":null},{"paper_doi":"10.1200/po-26-00001","tag_type":"generic","value":"trastuzumab","value_numeric":null},{"paper_doi":"10.1200/po-26-00001","tag_type":"impact_flag","value":"practice_changing","value_numeric":null},{"paper_doi":"10.1200/po-26-00001","tag_type":"level_of_evidence","value":"4","value_numeric":null},{"paper_doi":"10.1200/po-26-00001","tag_type":"modality","value":"Antibody-Drug Conjugate","value_numeric":null},{"paper_doi":"10.1200/po-26-00001","tag_type":"modality","value":"Immune Checkpoint Inhibitor","value_numeric":null},{"paper_doi":"10.1200/po-26-00001","tag_type":"modality","value":"Next-Generation Sequencing","value_numeric":null},{"paper_doi":"10.1200/po-26-00001","tag_type":"sample_size","value":"n=138","value_numeric":138},{"paper_doi":"10.1200/po-26-00001","tag_type":"sex","value":"mixed","value_numeric":null},{"paper_doi":"10.1200/po-26-00001","tag_type":"study_design","value":"Retrospective Molecular Profiling Study","value_numeric":null},{"paper_doi":"10.1200/po-26-00001","tag_type":"warning","value":"Age group tagged as 'adult' based on typical TET epidemiology; the paper does not explicitly report patient age distribution.","value_numeric":null},{"paper_doi":"10.1200/po-26-00001","tag_type":"warning","value":"Generic drug names (e.g., pembrolizumab, trastuzumab) are inferred from therapeutic targets discussed (PD-L1, ERBB2); they are not explicitly named in the abstract.","value_numeric":null},{"paper_doi":"10.1200/po-26-00001","tag_type":"warning","value":"The paper does not specify sex breakdown of participants; 'mixed' is assumed.","value_numeric":null},{"paper_doi":"10.1200/po-26-00001","tag_type":"warning","value":"The study is retrospective and observational; no direct treatment outcomes are reported for the identified molecular targets, so 'practice_changing' flag reflects target identification potential, not proven therapeutic benefit.","value_numeric":null}],"summaries":{"what_studied":"Integrated genomic, transcriptomic, and immune profiling of 138 thymic epithelial tumors (TETs) — 48 thymic carcinomas (TCs) and 90 thymomas — using NGS (592-gene panel or whole-exome sequencing), whole-transcriptome sequencing, dMMR/MSI, PD-L1, and TMB assessment.","key_result":"TP53 was the most mutated gene and its mutations correlated with worse survival. TCs showed enrichment of cell cycle (13.8%), DNA repair (8.0%), and chromatin remodeling (19.6%) alterations, plus CDKN2A/CDKN2B/MTAP deletions. dMMR/MSI-H occurred in 5 cases (mostly TCs), with 80% also TMB-high. TCs overexpressed ERBB2, ERBB3, TACSTD2, NECTIN4, and MSLN — all potentially actionable targets.","limitations":"Retrospective profiling cohort without prospective treatment matching; survival analysis limited by sample size (n=138); immune cell fractions estimated computationally (quanTIseq), not validated by histology.","practice_takeaway":"In thymic carcinoma, consider molecular profiling for actionable targets including ERBB2/3, TACSTD2, NECTIN4, and MSLN, as well as dMMR/MSI-H status (present in ~10% of TCs) to guide immunotherapy eligibility. TP53 mutation may serve as a prognostic marker for worse outcomes across TETs."}},{"doi":"10.1056/nejmoa2517729","pmid":"42202319","title":"Zanidatamab with and without Tislelizumab in HER2-Positive Gastroesophageal Cancer","journal_title":"New England Journal of Medicine","journal_issn":"0028-4793","published_at":"2026-05-27T00:00:00.000Z","url":"https://doi.org/10.1056/nejmoa2517729","source_score":193,"is_retracted":false,"is_open_access":false,"raw_metadata":{"pubmed":true,"crossref":true,"unpaywall":true},"created_at":"2026-06-05T13:26:43.443Z","updated_at":"2026-06-05T13:26:43.443Z","tags":[{"paper_doi":"10.1056/nejmoa2517729","tag_type":"age_group","value":"adult","value_numeric":null},{"paper_doi":"10.1056/nejmoa2517729","tag_type":"category","value":"Medicine, General & Internal","value_numeric":null},{"paper_doi":"10.1056/nejmoa2517729","tag_type":"condition","value":"Gastroesophageal Adenocarcinoma","value_numeric":null},{"paper_doi":"10.1056/nejmoa2517729","tag_type":"condition","value":"HER2-Positive Cancer","value_numeric":null},{"paper_doi":"10.1056/nejmoa2517729","tag_type":"generic","value":"tislelizumab","value_numeric":null},{"paper_doi":"10.1056/nejmoa2517729","tag_type":"generic","value":"trastuzumab","value_numeric":null},{"paper_doi":"10.1056/nejmoa2517729","tag_type":"generic","value":"zanidatamab","value_numeric":null},{"paper_doi":"10.1056/nejmoa2517729","tag_type":"impact_flag","value":"practice_changing","value_numeric":null},{"paper_doi":"10.1056/nejmoa2517729","tag_type":"level_of_evidence","value":"1","value_numeric":null},{"paper_doi":"10.1056/nejmoa2517729","tag_type":"modality","value":"Anti-PD-1 Immunotherapy","value_numeric":null},{"paper_doi":"10.1056/nejmoa2517729","tag_type":"modality","value":"Bispecific Antibody","value_numeric":null},{"paper_doi":"10.1056/nejmoa2517729","tag_type":"modality","value":"HER2-Targeted Therapy","value_numeric":null},{"paper_doi":"10.1056/nejmoa2517729","tag_type":"sample_size","value":"n=914","value_numeric":914},{"paper_doi":"10.1056/nejmoa2517729","tag_type":"sex","value":"mixed","value_numeric":null},{"paper_doi":"10.1056/nejmoa2517729","tag_type":"study_design","value":"Randomized Controlled Trial","value_numeric":null},{"paper_doi":"10.1056/nejmoa2517729","tag_type":"warning","value":"OS benefit for zanidatamab + chemotherapy (without tislelizumab) is based on an interim analysis only (P=0.06); final OS data are not yet available and conclusions in that arm remain preliminary.","value_numeric":null},{"paper_doi":"10.1056/nejmoa2517729","tag_type":"warning","value":"Sex distribution details and subgroup analyses (e.g., by PD-L1 or HER2 IHC score) are not reported in the abstract; clinical heterogeneity in the population cannot be fully assessed from the available text.","value_numeric":null},{"paper_doi":"10.1056/nejmoa2517729","tag_type":"warning","value":"The trial is funded by Jazz Pharmaceuticals, which should be considered when interpreting effect sizes and publication timing.","value_numeric":null}],"summaries":{"what_studied":"Phase 3 open-label RCT (HERIZON-GEA-01) comparing three first-line regimens in 914 patients with previously untreated, centrally confirmed HER2-positive advanced gastroesophageal adenocarcinoma: zanidatamab + tislelizumab + chemotherapy vs. zanidatamab + chemotherapy vs. trastuzumab + chemotherapy (1:1:1), with co-primary endpoints of PFS and OS at median follow-up of 25.9 months.","key_result":"Both zanidatamab arms improved PFS over trastuzumab + chemo (median 12.4 vs. 8.1 months; HR ~0.63–0.65, P<0.001). OS was significantly longer with zanidatamab + tislelizumab + chemo vs. trastuzumab + chemo (26.4 vs. 19.2 months; HR 0.72, 95% CI 0.57–0.90; P=0.004), but the zanidatamab-only arm did not yet reach significance (24.4 vs. 19.2 months; HR 0.80, P=0.06) at this interim analysis.","limitations":"- OS result for zanidatamab + chemo arm is an interim analysis only; final OS data are pending.\n- Open-label design may introduce performance or assessment bias.\n- Grade ≥3 adverse events were notably higher in the triple-therapy arm (83.3%), driven partly by diarrhea (24.8%), which may limit tolerability in some patients.","practice_takeaway":"For HER2-positive advanced gastroesophageal adenocarcinoma, zanidatamab + tislelizumab + chemotherapy significantly improves both PFS and OS over trastuzumab + chemotherapy and may become a new first-line standard. Clinicians should anticipate higher rates of grade ≥3 diarrhea with the triple regimen and counsel patients accordingly."}},{"doi":"10.1016/j.annonc.2026.01.013","pmid":"42097893","title":"A chemotherapy-free, pathological response-adapted strategy using trastuzumab–pertuzumab and T-DM1 in HER2-positive early breast cancer: the PHERGain-2 study","journal_title":"Annals of Oncology","journal_issn":"0923-7534","published_at":"2026-05-08T00:00:00.000Z","url":"https://doi.org/10.1016/j.annonc.2026.01.013","source_score":27,"is_retracted":false,"is_open_access":false,"raw_metadata":{"ooir":{"day":"2026-05-08","doi":"10.1016/j.annonc.2026.01.013","days":"7","issn":"0923-7534","rank":"7","field":"Clinical Medicine","score":"27","category":"Oncology","categories":["Oncology"],"_categories":["Oncology"]},"pubmed":{"doi":"10.1016/j.annonc.2026.01.013","title":"A chemotherapy-free, pathological response-adapted strategy using trastuzumab-pertuzumab and T-DM1 in HER2-positive early breast cancer: the PHERGain-2 study.","journal":"Annals of oncology : official journal of the European Society for Medical Oncology","methods":"","results":"From August 2021 to March 2024, 396 patients initiated neoadjuvant treatment, 391 (98.7%) underwent surgery. A total of 236 patients (59.6%) achieved pCR (cohort A). Among those with residual disease, 148 (37.8%) entered cohort B and 7 (1.8%) cohort C. One year after initiation of neoadjuvant treatment, ≥10% decline rate in global HRQoL was 42.8% [95% confidence interval (CI) 36.9% to 48.8%]; 37.3% (95% CI 30.1% to 44.9%) in patients with pCR and 51.9% (95% CI 41.9% to 61.7%) in those with residual disease. Treatment-related adverse events occurred in 86.6% of patients (5.6% grade ≥3). Serious adverse events occurred in 6.1% of patients. One death (0.3%) due to pneumonitis was attributed to T-DM1.","abstract":"$30","keywords":["HER2-positive","de-escalation","early breast cancer","pathological complete response","trastuzumab emtansine (T-DM1)","trastuzumab–pertuzumab"],"pubmed_id":"42097893","conclusions":"","publication_date":"2026-05-08T00:00:00"},"crossref":{"DOI":"10.1016/j.annonc.2026.01.013","URL":"https://doi.org/10.1016/j.annonc.2026.01.013","ISSN":["0923-7534"],"link":[{"URL":"https://api.elsevier.com/content/article/PII:S0923753426000402?httpAccept=text/xml","content-type":"text/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https://api.elsevier.com/content/article/PII:S0923753426000402?httpAccept=text/plain","content-type":"text/plain","content-version":"vor","intended-application":"text-mining"}],"page":null,"type":"journal-article","issue":null,"score":1,"title":["A chemotherapy-free, pathological response-adapted strategy using trastuzumab–pertuzumab and T-DM1 in HER2-positive 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but survival data are pending and the design is single-arm.","value_numeric":null}],"summaries":{"what_studied":"A multicenter, single-arm phase II trial tested a chemotherapy-free, pathologic response–adapted strategy in adults with node-negative, centrally confirmed HER2-positive early breast cancer (5–30 mm). Patients received eight cycles of neoadjuvant trastuzumab–pertuzumab every 3 weeks (plus endocrine therapy if HR+), then adjuvant HP for pCR, T‑DM1 for residual disease, or optional chemotherapy followed by T‑DM1 for ypN1–3; co-primary endpoints were 1‑year HRQoL decline and 3‑year recurrence‑free interval.","key_result":"Pathologic complete response occurred in 236 patients (59.6%). At 1 year, ≥10% decline in global HRQoL was 42.8% overall (37.3% with pCR; 51.9% with residual disease); treatment‑related adverse events occurred in 86.6% (5.6% grade ≥3), serious adverse events in 6.1%, and there was one T‑DM1–attributed death (0.3%).","limitations":"Single-arm design without a comparator. The co‑primary 3‑year recurrence‑free interval has not yet been reported. 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It reports incidence (968,350 new cases and 659,853 deaths worldwide in 2022; 30,300 cases and 10,780 deaths in the US in 2025) and biomarker-driven management.","key_result":"At diagnosis, about 13% have localized, 15%–25% locally advanced, and 35%–65% metastatic disease; resection of localized cancer yields a 5-year relative survival of 75%, while fewer than 10% with metastatic disease live 5 years. In PD-L1–expressing tumors, adding nivolumab or pembrolizumab to chemotherapy adds ~3 months of survival; adding trastuzumab (ERBB2) or zolbetuximab (CLDN18.2) adds 3–4 months; early supportive care adds ~3 months; routine endoscopic screening from age 40 in high-incidence countries is associated with improved survival.","practice_takeaway":"Test for PD-L1, ERBB2, and CLDN18.2 in unresectable or metastatic gastric cancer to select immunotherapy or targeted therapy that can extend survival by several months. Use gastrectomy for localized disease and perioperative 5-fluorouracil/oxaliplatin/docetaxel plus durvalumab for more advanced resectable disease; initiate early supportive care, and in high-incidence regions, employ routine endoscopic screening from age 40."}},{"doi":"10.1200/jco-25-02600","pmid":"41369677","title":"HER2CLIMB-05: A Phase III Study of Tucatinib Versus Placebo in Combination With Trastuzumab and Pertuzumab as First-Line Maintenance Therapy for HER2+ Metastatic Breast Cancer","journal_title":"Journal of Clinical Oncology","journal_issn":"0732-183X","published_at":"2025-12-10T00:00:00.000Z","url":"https://doi.org/10.1200/jco-25-02600","source_score":221,"is_retracted":false,"is_open_access":true,"raw_metadata":{"pubmed":true,"crossref":true,"unpaywall":true},"created_at":"2026-07-05T13:38:51.979Z","updated_at":"2026-07-05T13:38:51.979Z","tags":[{"paper_doi":"10.1200/jco-25-02600","tag_type":"age_group","value":"adult","value_numeric":null},{"paper_doi":"10.1200/jco-25-02600","tag_type":"brand","value":"Herceptin","value_numeric":null},{"paper_doi":"10.1200/jco-25-02600","tag_type":"brand","value":"Perjeta","value_numeric":null},{"paper_doi":"10.1200/jco-25-02600","tag_type":"brand","value":"Tukysa","value_numeric":null},{"paper_doi":"10.1200/jco-25-02600","tag_type":"category","value":"Oncology","value_numeric":null},{"paper_doi":"10.1200/jco-25-02600","tag_type":"condition","value":"Brain Metastases","value_numeric":null},{"paper_doi":"10.1200/jco-25-02600","tag_type":"condition","value":"HER2-Positive Metastatic Breast Cancer","value_numeric":null},{"paper_doi":"10.1200/jco-25-02600","tag_type":"generic","value":"pertuzumab","value_numeric":null},{"paper_doi":"10.1200/jco-25-02600","tag_type":"generic","value":"trastuzumab","value_numeric":null},{"paper_doi":"10.1200/jco-25-02600","tag_type":"generic","value":"tucatinib","value_numeric":null},{"paper_doi":"10.1200/jco-25-02600","tag_type":"impact_flag","value":"practice_changing","value_numeric":null},{"paper_doi":"10.1200/jco-25-02600","tag_type":"level_of_evidence","value":"1","value_numeric":null},{"paper_doi":"10.1200/jco-25-02600","tag_type":"modality","value":"HER2-Targeted Monoclonal Antibody","value_numeric":null},{"paper_doi":"10.1200/jco-25-02600","tag_type":"modality","value":"HER2 Tyrosine Kinase Inhibitor","value_numeric":null},{"paper_doi":"10.1200/jco-25-02600","tag_type":"sample_size","value":"n=654","value_numeric":654},{"paper_doi":"10.1200/jco-25-02600","tag_type":"sex","value":"female","value_numeric":null},{"paper_doi":"10.1200/jco-25-02600","tag_type":"study_design","value":"Randomized Controlled Trial","value_numeric":null},{"paper_doi":"10.1200/jco-25-02600","tag_type":"warning","value":"One grade 5 DILI death occurred in the tucatinib arm but was confounded by multiple hepatotoxic concomitant medications; causality is uncertain.","value_numeric":null},{"paper_doi":"10.1200/jco-25-02600","tag_type":"warning","value":"OS data are immature at primary analysis (only 20.2% of required events observed); the OS HR of 0.539 should be interpreted with caution and is presented for safety context only.","value_numeric":null},{"paper_doi":"10.1200/jco-25-02600","tag_type":"warning","value":"The brand name 'Tukysa' is used for tucatinib; confirm local regulatory approval status for this first-line maintenance indication, as the trial results were published in 2025 and regulatory review may be ongoing.","value_numeric":null},{"paper_doi":"10.1200/jco-25-02600","tag_type":"warning","value":"The control arm median PFS of 16.3 months is shorter than comparator arms in CLEOPATRA, PATINA, and DESTINY-Breast09, which may reflect population differences and limits cross-trial comparisons.","value_numeric":null}],"summaries":{"what_studied":"HER2CLIMB-05 was a randomized, double-blind, phase III trial (n=654) comparing tucatinib 300 mg twice daily plus trastuzumab/pertuzumab versus placebo plus trastuzumab/pertuzumab as first-line maintenance therapy in women with HER2+ metastatic breast cancer who had no progression after 4–8 cycles of induction chemotherapy (trastuzumab, pertuzumab, taxane); 12.4% had baseline brain metastases.","key_result":"Tucatinib significantly improved investigator-assessed PFS: median 24.9 vs. 16.3 months (HR 0.641, 95% CI 0.514–0.799; P<0.0001), a 36% reduction in risk of progression or death. Benefit was consistent across all subgroups including hormone receptor status and brain metastasis presence. OS was immature (51 deaths, 20.2% of required events). Grade ≥3 TEAEs occurred in 42.3% (tucatinib) vs. 24.4% (placebo); 13.5% discontinued tucatinib due to TEAEs, most commonly hepatic events (7.7%).","limitations":"- OS data were immature at primary analysis, so survival benefit remains unconfirmed.\n- Less than half of hormone receptor–positive patients received concurrent endocrine therapy, which is recommended standard of care.\n- CNS-PFS analysis was limited by small brain metastasis subgroup size and inconsistent brain imaging frequency between patients with and without baseline brain metastases.","practice_takeaway":"Adding tucatinib to first-line trastuzumab/pertuzumab maintenance extends median PFS by ~8.6 months in HER2+ metastatic breast cancer, including patients with brain metastases. Monitor closely for hepatic toxicity (grade ≥3 ALT elevation in 13.5%) and manage diarrhea proactively, as both are common but generally reversible."}},{"doi":"10.1158/1078-0432.ccr-25-2882","pmid":"41335375","title":"Palbociclib, Trastuzumab, and Endocrine Therapy in Pretreated HER2-Positive and PAM50 Luminal Advanced Breast Cancer: Randomized Phase II, SOLTI-1303 PATRICIA Trial","journal_title":"Clinical Cancer Research","journal_issn":"1078-0432","published_at":"2025-12-03T00:00:00.000Z","url":"https://doi.org/10.1158/1078-0432.ccr-25-2882","source_score":77,"is_retracted":false,"is_open_access":false,"raw_metadata":{"ooir":{"day":"2026-01-08","doi":"10.1158/1078-0432.ccr-25-2882","days":"14","issn":"1078-0432","rank":"10","field":"Clinical Medicine","score":"77","category":"Oncology","categories":["Oncology"],"_categories":["Oncology"]},"pubmed":{"doi":"10.1158/1078-0432.CCR-25-2882","title":"Palbociclib, trastuzumab and endocrine therapy in pretreated HER2-positive and PAM50 luminal advanced breast cancer: randomised phase II, SOLTI-1303 PATRICIA trial.","journal":"Clinical cancer research : an official journal of the American Association for Cancer Research","methods":"","results":"264 participants were pre-screened between August 2019-2023, and 73 patients were randomised (including seven re-randomisations). In the TPC arm: 48.5% were treated with trastuzumab plus chemotherapy, 39.4% with T-DM1 and 12.1 % with trastuzumab plus ET. The triplet was associated with a significantly better PFS compared to TPC (stratified hazard ratio=0.52 [95% CI 0.29-0.95]; two-sided p=0.03). PFS rates after 24 months were 24.0% with the triplet and 4.3% in the TPC arm. The overall response rate was 18.9% (95% CI 8.6-35.7) and 7.1% (95% CI 1.2-25.0), respectively. In the triplet arm, grade ≥3 adverse events occurred in 61.5% of patients, with neutropenia being the most frequent (53.9%). No permanent discontinuations due to toxicity were observed.","abstract":"$33","keywords":[],"pubmed_id":"41335375","conclusions":"","publication_date":"2025-12-03T00:00:00"},"crossref":{"DOI":"10.1158/1078-0432.ccr-25-2882","URL":"https://doi.org/10.1158/1078-0432.ccr-25-2882","ISSN":["1078-0432","1557-3265"],"link":[{"URL":"https://aacrjournals.org/clincancerres/article-pdf/doi/10.1158/1078-0432.CCR-25-2882/3708870/ccr-25-2882.pdf","content-type":"application/pdf","content-version":"am","intended-application":"syndication"},{"URL":"https://aacrjournals.org/clincancerres/article-pdf/doi/10.1158/1078-0432.CCR-25-2882/3723636/ccr-25-2882.pdf","content-type":"application/pdf","content-version":"vor","intended-application":"syndication"},{"URL":"https://aacrjournals.org/clincancerres/article-pdf/doi/10.1158/1078-0432.CCR-25-2882/3723636/ccr-25-2882.pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"page":"OF1-OF10","type":"journal-article","issue":null,"score":1,"title":["Palbociclib, Trastuzumab, and Endocrine Therapy in Pretreated HER2-Positive and PAM50 Luminal Advanced Breast Cancer: Randomized Phase II, SOLTI-1303 PATRICIA Trial"],"author":[{"given":"Eva","family":"Ciruelos","sequence":"first","affiliation":[{"name":"1SOLTI Cancer Research Group, Barcelona, Spain."},{"name":"2Hospital Universitario 12 de Octubre, Instituto de Investigación Sanitaria Hospital 12 de Octubre (imas12), Madrid, Spain."},{"name":"3HM Hospitales, Madrid, Spain."}]},{"given":"Tomás","family":"Pascual","sequence":"additional","affiliation":[{"name":"1SOLTI Cancer Research Group, Barcelona, Spain."},{"name":"4Medical Oncology, Institute of Cancer and Blood Diseases, Hospital Clinic of Barcelona, Barcelona, Spain."},{"name":"5Translational Genomics and Targeted Therapies in Solid Tumors group, August Pi i Sunyer Biomedical Research Institute (IDIBAPS), Barcelona, Spain."},{"name":"6Faculty of Biomedical and Health Sciences, Department of Medicine, Universidad Europea de Madrid, Madrid, Spain."}]},{"given":"Guillermo","family":"Villacampa","sequence":"additional","affiliation":[{"name":"1SOLTI Cancer Research Group, Barcelona, Spain."},{"name":"7Statistics Unit, Vall d’Hebron Institute of Oncology (VHIO), Barcelona, Spain."}]},{"given":"Sonia","family":"Pernas","sequence":"additional","affiliation":[{"name":"1SOLTI Cancer Research Group, Barcelona, Spain."},{"name":"8Medical Oncology Department, Institut Catala d’ Oncologia (ICO)- Institute of Biomedical Research of Bellvitge (IDIBELL), L’Hospitalet del Llobregat, Barcelona, Spain."}]},{"given":"Rodrigo","family":"Sanchez-Bayona","sequence":"additional","affiliation":[{"name":"1SOLTI Cancer Research Group, Barcelona, Spain."},{"name":"2Hospital Universitario 12 de Octubre, Instituto de Investigación Sanitaria Hospital 12 de Octubre (imas12), Madrid, Spain."}]},{"given":"José","family":"Ponce","sequence":"additional","affiliation":[{"name":"9Medical Oncology, Hospital General Universitario Dr. Balmis, Instituto de Investigación Sanitaria y Biomédica de Alicante (ISABIAL), Alicante, Spain."},{"name":"10GEICAM Spanish Breast Cancer Group, Madrid, Spain."}]},{"given":"Blanca","family":"Cantos","sequence":"additional","affiliation":[{"name":"11Hospital Universitario Puerta de Hierro, Madrid, Spain."}]},{"given":"Santiago","family":"Escrivá-de-Romaní","sequence":"additional","affiliation":[{"name":"12Medical Oncology Department, Vall d’Hebron University Hospital, and Breast Cancer Group, Vall d’Hebron Institute of Oncology (VHIO), Barcelona, Spain."}]},{"given":"Antonia","family":"Perelló","sequence":"additional","affiliation":[{"name":"13Medical Oncology Department, Hospital Universitario Son Espases, Palma De Mallorca, Spain."}]},{"given":"Esther","family":"Sanfeliu","sequence":"additional","affiliation":[{"name":"1SOLTI Cancer Research Group, Barcelona, Spain."},{"name":"5Translational Genomics and Targeted Therapies in Solid Tumors group, August Pi i Sunyer Biomedical Research Institute (IDIBAPS), Barcelona, Spain."},{"name":"14Pathology Department, Hospital Clínic de Barcelona, Barcelona, Spain."}]},{"given":"Patricia","family":"Galvan","sequence":"additional","affiliation":[{"name":"5Translational Genomics and Targeted Therapies in Solid Tumors group, August Pi i Sunyer Biomedical Research Institute (IDIBAPS), Barcelona, Spain."}]},{"given":"Alvaro","family":"Montaño","sequence":"additional","affiliation":[{"name":"15Department of Medical Oncology, Hospital Universitario Virgen del Rocío, Sevilla, Spain."}]},{"given":"Eduardo","family":"Martínez","sequence":"additional","affiliation":[{"name":"16Consorcio Hospitalario Provincial de Castellón, Castellón de la Plana, Spain."}]},{"given":"Ana","family":"Lopez","sequence":"additional","affiliation":[{"name":"10GEICAM Spanish Breast Cancer Group, Madrid, Spain."},{"name":"17Complejo Asistencial Universitario de León, León, Spain."}]},{"given":"Mireia","family":"Mele","sequence":"additional","affiliation":[{"name":"18Medical Oncology, Hospital Universitari Sant Joan de Reus, Reus, Spain."}]},{"given":"Juan","family":"de la Haba","sequence":"additional","affiliation":[{"name":"10GEICAM Spanish Breast Cancer Group, Madrid, Spain."},{"name":"19Medical Oncology Department, Hospital Universitario Reina Sofia, Cordoba, Spain."}]},{"given":"Javier","family":"Cortés","sequence":"additional","affiliation":[{"name":"6Faculty of Biomedical and Health Sciences, Department of Medicine, Universidad Europea de Madrid, Madrid, Spain."},{"name":"20International Breast Cancer Center (IBCC), Pangaea Oncology, Quironsalud Group, Barcelona, Spain."},{"name":"21IOB Madrid, Hospital Beata Maria Ana, Madrid, Spain."}]},{"given":"Antonio","family":"Mulero-Sánchez","sequence":"additional","affiliation":[{"name":"1SOLTI Cancer Research Group, Barcelona, Spain."}]},{"given":"Juan M.","family":"Ferrero-Cafiero","sequence":"additional","affiliation":[{"name":"1SOLTI Cancer Research Group, Barcelona, Spain."}]},{"given":"Mafalda","family":"Oliveira","sequence":"additional","affiliation":[{"name":"1SOLTI Cancer Research Group, Barcelona, Spain."},{"name":"12Medical Oncology Department, Vall d’Hebron University Hospital, and Breast Cancer Group, Vall d’Hebron Institute of Oncology (VHIO), Barcelona, Spain."}]},{"given":"Lorea","family":"Villanueva","sequence":"additional","affiliation":[{"name":"1SOLTI Cancer Research Group, Barcelona, Spain."}]},{"given":"Xavier","family":"Gonzalez","sequence":"additional","affiliation":[{"name":"1SOLTI Cancer Research Group, Barcelona, Spain."},{"name":"22Medical Oncology, IOR - Instituto Oncologico Dr. Rosell, Hospital General de Catalunya, Barcelona, Spain."}]},{"given":"Patricia","family":"Villagrasa","sequence":"additional","affiliation":[{"name":"1SOLTI Cancer Research Group, Barcelona, Spain."},{"name":"23Reveal Genomics, S.L Barcelona, Barcelona, Spain."}]},{"given":"Aleix","family":"Prat","sequence":"additional","affiliation":[{"name":"1SOLTI Cancer Research Group, Barcelona, Spain."},{"name":"4Medical Oncology, Institute of Cancer and Blood Diseases, Hospital Clinic of Barcelona, Barcelona, Spain."},{"name":"5Translational Genomics and Targeted Therapies in Solid Tumors group, August Pi i Sunyer Biomedical Research Institute (IDIBAPS), Barcelona, Spain."},{"name":"23Reveal Genomics, S.L Barcelona, Barcelona, Spain."}]}],"funder":[{"id":[{"id":"10.13039/100004319","id-type":"DOI","asserted-by":"publisher"}],"DOI":"10.13039/100004319","name":"Pfizer","doi-asserted-by":"publisher"}],"issued":{"date-parts":[[2026,1,6]]},"member":"1086","prefix":"10.1158","source":"Crossref","volume":null,"created":{"date-time":"2025-12-03T16:04:32Z","timestamp":1764777872000,"date-parts":[[2025,12,3]]},"indexed":{"date-time":"2026-01-06T16:31:26Z","timestamp":1767717086180,"date-parts":[[2026,1,6]]},"subject":[],"abstract":"$34","language":"en","relation":{},"resource":{"primary":{"URL":"https://aacrjournals.org/clincancerres/article/doi/10.1158/1078-0432.CCR-25-2882/771469/Palbociclib-Trastuzumab-and-Endocrine-Therapy-in"}},"subtitle":[],"deposited":{"date-time":"2026-01-06T16:28:49Z","timestamp":1767716929000,"date-parts":[[2026,1,6]]},"issn-type":[{"type":"print","value":"1078-0432"},{"type":"electronic","value":"1557-3265"}],"published":{"date-parts":[[2026,1,6]]},"publisher":"American Association for Cancer Research (AACR)","reference":null,"short-title":[],"update-policy":"https://doi.org/10.1158/crossmark_policy","content-domain":{"domain":["aacrjournals.org"],"crossmark-restriction":true},"original-title":[],"container-title":["Clinical Cancer Research"],"reference-count":0,"published-online":{"date-time":null,"timestamp":null,"date-parts":[[2026,1,6]]},"references-count":0,"short-container-title":[],"is-referenced-by-count":0},"unpaywall":{"doi":"10.1158/1078-0432.ccr-25-2882","is_oa":false,"title":"Palbociclib, Trastuzumab, and Endocrine Therapy in Pretreated HER2-Positive and PAM50 Luminal Advanced Breast Cancer: Randomized Phase II, SOLTI-1303 PATRICIA Trial","updated":"2026-01-10T04:46:20+00:00","published_date":"2025-12-03","best_oa_location":null}},"created_at":"2026-01-11T11:19:33.869Z","updated_at":"2026-01-17T09:03:27.421Z","tags":[{"paper_doi":"10.1158/1078-0432.ccr-25-2882","tag_type":"category","value":"Oncology","value_numeric":null},{"paper_doi":"10.1158/1078-0432.ccr-25-2882","tag_type":"condition","value":"HER2-Positive Breast Cancer","value_numeric":null},{"paper_doi":"10.1158/1078-0432.ccr-25-2882","tag_type":"generic","value":"palbociclib","value_numeric":null},{"paper_doi":"10.1158/1078-0432.ccr-25-2882","tag_type":"generic","value":"trastuzumab","value_numeric":null},{"paper_doi":"10.1158/1078-0432.ccr-25-2882","tag_type":"impact_flag","value":"limited_evidence","value_numeric":null},{"paper_doi":"10.1158/1078-0432.ccr-25-2882","tag_type":"level_of_evidence","value":"2","value_numeric":null},{"paper_doi":"10.1158/1078-0432.ccr-25-2882","tag_type":"modality","value":"CDK4/6 Inhibitor","value_numeric":null},{"paper_doi":"10.1158/1078-0432.ccr-25-2882","tag_type":"modality","value":"Endocrine Therapy","value_numeric":null},{"paper_doi":"10.1158/1078-0432.ccr-25-2882","tag_type":"modality","value":"HER2-Targeted Therapy","value_numeric":null},{"paper_doi":"10.1158/1078-0432.ccr-25-2882","tag_type":"sample_size","value":"n=73","value_numeric":73},{"paper_doi":"10.1158/1078-0432.ccr-25-2882","tag_type":"study_design","value":"Randomized Controlled Trial","value_numeric":null},{"paper_doi":"10.1158/1078-0432.ccr-25-2882","tag_type":"warning","value":"Comparator arm consisted of heterogeneous regimens (trastuzumab + chemotherapy, T-DM1, or trastuzumab + endocrine therapy).","value_numeric":null},{"paper_doi":"10.1158/1078-0432.ccr-25-2882","tag_type":"warning","value":"Only investigator-assessed PFS is reported; no OS data provided.","value_numeric":null},{"paper_doi":"10.1158/1078-0432.ccr-25-2882","tag_type":"warning","value":"Open-label phase II randomized design with small N and re-randomization in the physician’s choice arm may affect interpretation.","value_numeric":null}],"summaries":{"what_studied":"A multicenter, open-label, randomized phase II trial compared palbociclib + trastuzumab + endocrine therapy with trastuzumab-based treatment of physician’s choice in pretreated HER2-positive, HR-positive, PAM50-luminal A/B advanced breast cancer; the primary endpoint was investigator-assessed PFS per RECIST 1.1. From August 2019–2023, 264 were pre-screened and 73 were randomized (including 7 re-randomizations).","key_result":"The triplet improved PFS versus physician’s choice (HR 0.52, 95% CI 0.29–0.95; p=0.03); 24-month PFS rates were 24.0% with the triplet and 4.3% with physician’s choice. ORR was 18.9% (95% CI 8.6–35.7) for the triplet versus 7.1% (95% CI 1.2–25.0), and in the triplet arm grade ≥3 AEs occurred in 61.5% with neutropenia in 53.9% and no permanent discontinuations due to toxicity.","limitations":"Open-label phase II study with a small randomized sample (n=73) and allowance for re-randomization in the physician’s choice arm. The comparator was heterogeneous (trastuzumab + chemotherapy, T-DM1, or trastuzumab + endocrine therapy), and outcomes were investigator-assessed.","practice_takeaway":"In selected pretreated HR+/HER2+ PAM50-luminal A/B advanced breast cancer, adding palbociclib to trastuzumab and endocrine therapy prolonged PFS versus trastuzumab-based options. Expect frequent neutropenia; monitor counts, noting no permanent discontinuations were reported."}}],"initialOffset":12,"fetchConfig":{"kind":"tags","tags":[{"tag_type":"generic","value":"trastuzumab"}]},"breadcrumbItems":[{"name":"Home","href":"/"},{"name":"Research Hub","href":"/hub"},{"name":"Generics","href":"/hub/tag/generic"},{"name":"trastuzumab"}],"hrefConfig":{"basePath":"/hub/papers","webViewQueryParams":{"hub_ctx":"tag","hub_tag_type":"generic","hub_tag_value":"trastuzumab"}}}]]

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