2f:I[703058,["/_next/static/immutable/chunks/3bhq_5eh1d760.js","/_next/static/immutable/chunks/1855-ogyi8eh4.js","/_next/static/immutable/chunks/2pfsjpn6k6zlg.js","/_next/static/immutable/chunks/26c7v3_3uwnwu.js","/_next/static/immutable/chunks/25a3ozcrvi1ff.js","/_next/static/immutable/chunks/2r4wx50nvjh_4.js","/_next/static/immutable/chunks/23fsw06hsi5b1.js","/_next/static/immutable/chunks/06_yt270h41rg.js","/_next/static/immutable/chunks/3ezsiz-7shkna.js","/_next/static/immutable/chunks/20x2y96ldu5wx.js","/_next/static/immutable/chunks/2lxntcm3pd1_h.js","/_next/static/immutable/chunks/00dgco8irq3jw.js","/_next/static/immutable/chunks/00nwe-kq0rboc.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:T635,To provide guidance on the recommended management of cancer in pregnant patients. A multidisciplinary Expert Panel convened and conducted a systematic review of the literature. The systematic review identified 450 eligible studies. Much of the evidence consisted of observational data, case series, and case reports. Management of cancer during pregnancy should be grounded in a values-based informed-consent process outlining maternal and fetal risks and anticipated benefits. Diagnostic evaluation should follow the as low as reasonably achievable (ALARA) principle, with timing of diagnostic studies individualized based on urgency of cancer detection, potential dangers of delay, and the balance of risks to both the pregnant patient and her embryo or fetus. Due to significant risk of harm to the developing embryo and/or fetus, systemic therapy should be deferred until the second trimester. Methotrexate, hormonal therapies, human epidermal growth factor receptor 2-targeted agents, vascular endothelial growth factor and poly (ADP-ribose) polymerase inhibitors, antibody-drug conjugates, and all cellular therapies are contraindicated during pregnancy, regardless of gestational age. For patients who wish to continue their pregnancy, delivery should be planned at or after 37 weeks, with the final chemotherapy dose scheduled 2-4 weeks before birth. Referral to psychosocial support services is essential to address emotional and practical challenges, reduce distress, and support shared decision making.Additional information is available at www.asco.org/survivorship-guidelines.34:T11ae, ASCO Guidelines provide recommendations with comprehensive review and analyses of the relevant literature for each recommendation, following the guideline development process as outlined in the

ASCO Guidelines Methodology Manual

. ASCO Guidelines follow the ASCO Conflict of Interest Policy for Clinical Practice Guidelines . Clinical Practice Guidelines and other guidance (“Guidance”) provided by ASCO is not a comprehensive or definitive guide to treatment options. It is intended for voluntary use by clinicians and should be used in conjunction with independent professional judgment. Guidance may not be applicable to all patients, interventions, diseases or stages of diseases. Guidance is based on review and analysis of relevant literature, and is not intended as a statement of the standard of care. ASCO does not endorse third-party drugs, devices, services, or therapies and assumes no responsibility for any harm arising from or related to the use of this information. See complete disclaimer in Appendix 1 and Appendix 2 (online only) for more. PURPOSE To provide guidance on the recommended management of cancer in pregnant patients. METHODS A multidisciplinary Expert Panel convened and conducted a systematic review of the literature. RESULTS The systematic review identified 450 eligible studies. Much of the evidence consisted of observational data, case series, and case reports. RECOMMENDATIONS Management of cancer during pregnancy should be grounded in a values-based informed-consent process outlining maternal and fetal risks and anticipated benefits. Diagnostic evaluation should follow the as low as reasonably achievable (ALARA) principle, with timing of diagnostic studies individualized based on urgency of cancer detection, potential dangers of delay, and the balance of risks to both the pregnant patient and her embryo or fetus. Due to significant risk of harm to the developing embryo and/or fetus, systemic therapy should be deferred until the second trimester. Methotrexate, hormonal therapies, human epidermal growth factor receptor 2–targeted agents, vascular endothelial growth factor and poly (ADP-ribose) polymerase inhibitors, antibody-drug conjugates, and all cellular therapies are contraindicated during pregnancy, regardless of gestational age. For patients who wish to continue their pregnancy, delivery should be planned at or after 37 weeks, with the final chemotherapy dose scheduled 2-4 weeks before birth. Referral to psychosocial support services is essential to address emotional and practical challenges, reduce distress, and support shared decision making. Additional information is available at www.asco.org/survivorship-guidelines . 35: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.36: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\":\"HER2-Targeted Therapy: modality Research & Clinical Takeaways\",\"description\":\"Explore peer-reviewed papers on HER2-Targeted Therapy (modality). 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":"10.1016/j.breast.2026.104896","pmid":null,"title":"Revisiting HER2-Negative Breast Cancer in the Era of HER2-Low and HER2-Ultralow Expression: Assessment of Interobserver Variability","journal_title":"The Breast","journal_issn":"0960-9776","published_at":"2026-08-18T00:00:00.000Z","url":"https://doi.org/10.1016/j.breast.2026.104896","source_score":1,"is_retracted":false,"is_open_access":true,"raw_metadata":{"pubmed":false,"crossref":true,"unpaywall":true},"created_at":"2026-08-26T06:19:57.280Z","updated_at":"2026-08-26T06:19:57.280Z","tags":[{"paper_doi":"10.1016/j.breast.2026.104896","tag_type":"category","value":"Obstetrics & Gynecology","value_numeric":null},{"paper_doi":"10.1016/j.breast.2026.104896","tag_type":"condition","value":"Breast Cancer","value_numeric":null},{"paper_doi":"10.1016/j.breast.2026.104896","tag_type":"impact_flag","value":"safety_signal","value_numeric":null},{"paper_doi":"10.1016/j.breast.2026.104896","tag_type":"modality","value":"HER2-Targeted Therapy","value_numeric":null},{"paper_doi":"10.1016/j.breast.2026.104896","tag_type":"study_design","value":"Interobserver Variability Study","value_numeric":null},{"paper_doi":"10.1016/j.breast.2026.104896","tag_type":"warning","value":"Only the paper metadata (title, DOI, journal, date) was provided — no abstract, methods, results, or full text were available. Summaries and tags are based solely on the title and known clinical context. Key result and sample size could not be extracted.","value_numeric":null},{"paper_doi":"10.1016/j.breast.2026.104896","tag_type":"warning","value":"Publication date (2026-08-18) is in the future relative to most training data; findings may reflect emerging or provisional classification criteria not yet widely validated.","value_numeric":null},{"paper_doi":"10.1016/j.breast.2026.104896","tag_type":"warning","value":"Study design tag is inferred from the title ('interobserver variability'); the specific methodology (e.g., retrospective review, prospective cohort) is unknown.","value_numeric":null}],"summaries":{"what_studied":"This study reassessed the classification of HER2-negative breast cancer into HER2-low and HER2-ultralow subcategories, evaluating interobserver variability among pathologists in distinguishing these newly defined expression levels.","limitations":"The paper abstract/text provided contains no methodological details, sample size, or quantitative results, limiting extraction of specific findings or outcome data.","practice_takeaway":"Pathologists should be aware that subclassifying HER2-negative tumors into HER2-low and HER2-ultralow categories may carry significant interobserver variability, which could affect patient eligibility for emerging HER2-directed therapies."}},{"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":"10.1016/j.jhep.2026.02.030","pmid":null,"title":"Systemic therapy of biliary tract cancer: The road to personalised strategies","journal_title":"Journal of Hepatology","journal_issn":"0168-8278","published_at":"2026-07-02T00:00:00.000Z","url":"https://doi.org/10.1016/j.jhep.2026.02.030","source_score":11,"is_retracted":false,"is_open_access":false,"raw_metadata":{"pubmed":false,"crossref":true,"unpaywall":true},"created_at":"2026-07-07T13:26:09.823Z","updated_at":"2026-07-07T13:26:09.823Z","tags":[{"paper_doi":"10.1016/j.jhep.2026.02.030","tag_type":"age_group","value":"adult","value_numeric":null},{"paper_doi":"10.1016/j.jhep.2026.02.030","tag_type":"brand","value":"Enhertu","value_numeric":null},{"paper_doi":"10.1016/j.jhep.2026.02.030","tag_type":"brand","value":"Lytgobi","value_numeric":null},{"paper_doi":"10.1016/j.jhep.2026.02.030","tag_type":"brand","value":"Pemazyre","value_numeric":null},{"paper_doi":"10.1016/j.jhep.2026.02.030","tag_type":"brand","value":"Tibsovo","value_numeric":null},{"paper_doi":"10.1016/j.jhep.2026.02.030","tag_type":"category","value":"Gastroenterology & Hepatology","value_numeric":null},{"paper_doi":"10.1016/j.jhep.2026.02.030","tag_type":"condition","value":"Ampullary Cancer","value_numeric":null},{"paper_doi":"10.1016/j.jhep.2026.02.030","tag_type":"condition","value":"Biliary Tract Cancer","value_numeric":null},{"paper_doi":"10.1016/j.jhep.2026.02.030","tag_type":"condition","value":"Cholangiocarcinoma","value_numeric":null},{"paper_doi":"10.1016/j.jhep.2026.02.030","tag_type":"condition","value":"Gallbladder Cancer","value_numeric":null},{"paper_doi":"10.1016/j.jhep.2026.02.030","tag_type":"generic","value":"dabrafenib","value_numeric":null},{"paper_doi":"10.1016/j.jhep.2026.02.030","tag_type":"generic","value":"durvalumab","value_numeric":null},{"paper_doi":"10.1016/j.jhep.2026.02.030","tag_type":"generic","value":"entrectinib","value_numeric":null},{"paper_doi":"10.1016/j.jhep.2026.02.030","tag_type":"generic","value":"futibatinib","value_numeric":null},{"paper_doi":"10.1016/j.jhep.2026.02.030","tag_type":"generic","value":"ivosidenib","value_numeric":null},{"paper_doi":"10.1016/j.jhep.2026.02.030","tag_type":"generic","value":"larotrectinib","value_numeric":null},{"paper_doi":"10.1016/j.jhep.2026.02.030","tag_type":"generic","value":"lirafugratinib","value_numeric":null},{"paper_doi":"10.1016/j.jhep.2026.02.030","tag_type":"generic","value":"neratinib","value_numeric":null},{"paper_doi":"10.1016/j.jhep.2026.02.030","tag_type":"generic","value":"pembrolizumab","value_numeric":null},{"paper_doi":"10.1016/j.jhep.2026.02.030","tag_type":"generic","value":"pemigatinib","value_numeric":null},{"paper_doi":"10.1016/j.jhep.2026.02.030","tag_type":"generic","value":"selpercatinib","value_numeric":null},{"paper_doi":"10.1016/j.jhep.2026.02.030","tag_type":"generic","value":"tinengotinib","value_numeric":null},{"paper_doi":"10.1016/j.jhep.2026.02.030","tag_type":"generic","value":"trametinib","value_numeric":null},{"paper_doi":"10.1016/j.jhep.2026.02.030","tag_type":"generic","value":"trastuzumab deruxtecan","value_numeric":null},{"paper_doi":"10.1016/j.jhep.2026.02.030","tag_type":"generic","value":"tucatinib","value_numeric":null},{"paper_doi":"10.1016/j.jhep.2026.02.030","tag_type":"generic","value":"zanidatamab","value_numeric":null},{"paper_doi":"10.1016/j.jhep.2026.02.030","tag_type":"impact_flag","value":"practice_changing","value_numeric":null},{"paper_doi":"10.1016/j.jhep.2026.02.030","tag_type":"level_of_evidence","value":"5","value_numeric":null},{"paper_doi":"10.1016/j.jhep.2026.02.030","tag_type":"modality","value":"Antibody-Drug Conjugate","value_numeric":null},{"paper_doi":"10.1016/j.jhep.2026.02.030","tag_type":"modality","value":"BRAF/MEK Inhibitor","value_numeric":null},{"paper_doi":"10.1016/j.jhep.2026.02.030","tag_type":"modality","value":"FGFR Inhibitor","value_numeric":null},{"paper_doi":"10.1016/j.jhep.2026.02.030","tag_type":"modality","value":"HER2-Targeted Therapy","value_numeric":null},{"paper_doi":"10.1016/j.jhep.2026.02.030","tag_type":"modality","value":"IDH1 Inhibitor","value_numeric":null},{"paper_doi":"10.1016/j.jhep.2026.02.030","tag_type":"modality","value":"Immune Checkpoint Inhibitor","value_numeric":null},{"paper_doi":"10.1016/j.jhep.2026.02.030","tag_type":"sex","value":"mixed","value_numeric":null},{"paper_doi":"10.1016/j.jhep.2026.02.030","tag_type":"study_design","value":"Narrative Review","value_numeric":null},{"paper_doi":"10.1016/j.jhep.2026.02.030","tag_type":"warning","value":"HER2 IHC scoring in BTC is extrapolated from breast/gastric cancer criteria — no BTC-specific validated system exists, which may affect patient selection in practice.","value_numeric":null},{"paper_doi":"10.1016/j.jhep.2026.02.030","tag_type":"warning","value":"Several referenced trials (FIGHT-302, FOENIX-CCA3) were terminated early due to low accrual; results for some are still pending as of publication date.","value_numeric":null},{"paper_doi":"10.1016/j.jhep.2026.02.030","tag_type":"warning","value":"Some emerging targets (MTAP, MDM2, MET, RAS) are represented only by early-phase or case-series data; these should not be considered standard of care.","value_numeric":null},{"paper_doi":"10.1016/j.jhep.2026.02.030","tag_type":"warning","value":"The paper's DOI suggests a 2026 publication date, which is consistent with today's date; some cited references are also from 2025–2026 and may not yet be widely available.","value_numeric":null},{"paper_doi":"10.1016/j.jhep.2026.02.030","tag_type":"warning","value":"This is a narrative review (not a systematic review or meta-analysis); clinical outcome data cited are from individual trials with varying designs and patient populations.","value_numeric":null}],"summaries":{"what_studied":"This review covers the evolving systemic therapy landscape of biliary tract cancer (BTC), including cholangiocarcinoma, gallbladder cancer, and ampullary cancer, with a focus on chemo-immunotherapy as first-line standard of care and precision oncology strategies targeting FGFR2 fusions, IDH1 mutations, HER2 alterations, and tumour-agnostic biomarkers (BRAF V600E, MSI-H/dMMR, RET/NTRK/NRG1 fusions).","key_result":"Chemo-immunotherapy (CisGem + durvalumab or pembrolizumab) is now first-line standard of care; approved targeted agents include pemigatinib (ORR 37%, mPFS 7.0 mo, mOS 17.5 mo) and futibatinib (ORR 42%, mPFS 9.0 mo, mOS 21.7 mo) for FGFR2 fusion+ iCCA, ivosidenib for IDH1-mutant CCA (mOS 10.3 mo vs. 7.5 mo placebo, crossover-adjusted HR 0.49), and zanidatamab for HER2 IHC3+ BTC (ORR 41.3%, mOS 15.5 mo); lirafugratinib shows promising next-gen FGFR2 selectivity (ORR 47%, mPFS 11.3 mo, mOS 22.8 mo).","limitations":"- All targeted therapy approvals are in previously treated patients only; no first-line phase III targeted therapy trial has completed successfully (three closed early due to low accrual).\n- Biomarker testing is heterogeneous and incompletely standardised, with up to 25% of tissue samples failing NGS; no BTC-specific HER2 IHC scoring system exists.\n- This is a narrative review without systematic methods or meta-analysis; cross-trial comparisons are confounded by differing patient populations and the potential prognostic effect of molecular subtypes.","practice_takeaway":"All patients with advanced BTC should receive hybrid-capture DNA/RNA NGS at diagnosis to identify actionable alterations (FGFR2 fusions, IDH1 mutations, HER2 status, and tumour-agnostic targets) before second-line therapy decisions are made. In the absence of a targetable alteration, CisGem plus durvalumab or pembrolizumab is first-line standard of care; when actionable alterations are found, approved targeted agents should be prioritised over second-line chemotherapy."}},{"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":"10.1056/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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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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ensure values‑based informed consent and referral to psychosocial support.","limitations":"The evidence base is dominated by observational studies, case series, and case reports, limiting certainty; recommendations stem from expert consensus rather than randomized trials.","practice_takeaway":"Counsel pregnant patients with cancer using shared decision making; follow ALARA for diagnostics; delay systemic therapy until the second trimester; avoid the specified contraindicated agents; and coordinate delivery at ≥37 weeks with chemotherapy stopped 2–4 weeks prior, while engaging psychosocial support."}},{"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%). 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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, 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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, 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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":"modality","value":"HER2-Targeted Therapy"}]},"breadcrumbItems":[{"name":"Home","href":"/"},{"name":"Research Hub","href":"/hub"},{"name":"Modalities","href":"/hub/tag/modality"},{"name":"HER2-Targeted Therapy"}],"hrefConfig":{"basePath":"/hub/papers","webViewQueryParams":{"hub_ctx":"tag","hub_tag_type":"modality","hub_tag_value":"HER2-Targeted Therapy"}}}]]

Papers