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:T7de,Grade group 5 (GG5) prostate cancer (PCa) carries a less favorable prognosis after standard-of-care (SOC) therapy, necessitating novel therapeutic approaches. High-dose rate brachytherapy (HDRBT) and androgen deprivation therapy (ADT) may modulate immune response in GG5 PCa, particularly in tumors with increased immune content. This study evaluated whether the addition of nivolumab to SOC was associated with improved disease control in patients with high-volume GG5 PCa, including those with oligometastatic disease. In this non-randomized phase II trial, 31 patients with localized or oligometastatic GG5 PCa and >30% positive biopsy cores were evaluated between September 2018 and April 2021. Patients received four doses of nivolumab (240 mg every 2 weeks) beginning 4 weeks prior to HDRBT, alongside ADT, HDRBT, and external beam radiation. The primary endpoint was to evaluate whether the 2-year freedom from biochemical recurrence (FFBR) rate would exceed a prespecified historical control rate of 75%. Among the 31 patients, the median follow-up was 38.8 months (IQR 31.0-46.5 months). The addition of nivolumab to SOC RT with ADT was associated with a 2-year FFBR rate of 90.3% (95% CI 74.3% to 98.0%) (median FFBR not reached), exceeding the prespecified historical control rate of 75% (one-sided p value from binomial test=0.024). Definitive and probable nivolumab-related toxicity included 6.3% acute grade 2 and 6.3% acute grade 3 adverse events (AEs), with no grade 4+ AEs observed. A higher Decipher immunosuppression score at diagnosis correlated with early pathologic response (p=0.005) and was independently associated with time to metastatic failure (p=0.044). Nivolumab combined with SOC was associated with encouraging FFBR in this high-risk GG5 PCa population and may represent a promising therapeutic intensification strategy. The Decipher immunosuppression score may serve as a predictive biomarker for response. These findings warrant further investigation in randomized trials.32:Ta2c, Background Grade group 5 (GG5) prostate cancer (PCa) carries a less favorable prognosis after standard-of-care (SOC) therapy, necessitating novel therapeutic approaches. High-dose rate brachytherapy (HDRBT) and androgen deprivation therapy (ADT) may modulate immune response in GG5 PCa, particularly in tumors with increased immune content. This study evaluated whether the addition of nivolumab to SOC was associated with improved disease control in patients with high-volume GG5 PCa, including those with oligometastatic disease. Methods In this non-randomized phase II trial, 31 patients with localized or oligometastatic GG5 PCa and >30% positive biopsy cores were evaluated between September 2018 and April 2021. Patients received four doses of nivolumab (240 mg every 2 weeks) beginning 4 weeks prior to HDRBT, alongside ADT, HDRBT, and external beam radiation. The primary endpoint was to evaluate whether the 2-year freedom from biochemical recurrence (FFBR) rate would exceed a prespecified historical control rate of 75%. Results Among the 31 patients, the median follow-up was 38.8 months (IQR 31.0–46.5 months). The addition of nivolumab to SOC RT with ADT was associated with a 2-year FFBR rate of 90.3% (95% CI 74.3% to 98.0%) (median FFBR not reached), exceeding the prespecified historical control rate of 75% (one-sided p value from binomial test=0.024). Definitive and probable nivolumab-related toxicity included 6.3% acute grade 2 and 6.3% acute grade 3 adverse events (AEs), with no grade 4+ AEs observed. A higher Decipher immunosuppression score at diagnosis correlated with early pathologic response (p=0.005) and was independently associated with time to metastatic failure (p=0.044). Conclusions Nivolumab combined with SOC was associated with encouraging FFBR in this high-risk GG5 PCa population and may represent a promising therapeutic intensification strategy. The Decipher immunosuppression score may serve as a predictive biomarker for response. These findings warrant further investigation in randomized trials. 33:T711, Taletrectinib is a next-generation, CNS-active, selective ROS1 tyrosine kinase inhibitor (TKI) with activity against the ROS1 G2032R resistance mutation. Initial data from the TRUST-I study (ClinicalTrials.gov identifier: NCT04395677 ) demonstrated high response rates and intracranial (IC) activity, with promising durability, in Chinese patients with advanced ROS1 + non–small cell lung cancer (NSCLC). With longer follow-up, taletrectinib continued to demonstrate high and durable response rates in both TKI-naïve and crizotinib-pretreated patients, including IC activity and promising overall survival (OS). Among 103 TKI-naïve patients who started taletrectinib at 600 mg once daily (median follow-up, 51.0 months), the objective response rate (ORR) was 90.3% (95% CI, 82.9 to 95.3), the median duration of response (DOR) and median progression-free survival (PFS) exceeded 4 years (49.7 months and 49.6 months, respectively), and median OS was not reached. Among 66 crizotinib-pretreated patients (median follow-up, 45.2 months), the ORR was 51.5%, the median DOR was 13.2 months, the median PFS was 7.6 months, and the median OS was 25.6 months. The safety profile remained consistent with prior reports, and no new safety signals were identified. Overall, taletrectinib demonstrated durable long-term efficacy and a manageable safety profile in patients with advanced ROS1 + NSCLC. 25:[[["$","script","0",{"type":"application/ld+json","dangerouslySetInnerHTML":{"__html":"{\"@context\":\"https://schema.org\",\"@type\":\"CollectionPage\",\"name\":\"Single-Arm Phase II Trial: study design Research & Clinical Takeaways\",\"description\":\"Explore peer-reviewed papers on Single-Arm Phase II Trial (study design). Clinician-written summaries and actionable practice insights. 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The RVS group (n=42) achieved 2-year DFS of 90% (95% CI, 77%–96%) with 100% laryngeal preservation in laryngeal/hypopharyngeal cancers, while the SVS group (n=5) had 2-year DFS of only 20% (95% CI, 0.8%–58%). Grade 3 AEs occurred in 16% (NAICT-related) and 15% (surgery-related); no grade 4–5 AEs were recorded.","limitations":"- Single-arm phase II design with no randomized comparator limits causal inference.\n- Small SVS subgroup (n=5) makes outcomes in poor responders highly uncertain.\n- Restricted to HPV-negative LA-HNSCC, limiting generalizability to HPV-positive disease.","practice_takeaway":"For HPV-negative LA-HNSCC patients who achieve ≥50% tumor regression after neoadjuvant immunochemotherapy, response-adapted reduced-volume surgery appears feasible and yields high laryngeal preservation rates with manageable toxicity. These results should be considered hypothesis-generating; phase III validation is needed before adopting this de-escalation approach."}},{"doi":"10.1016/j.ygyno.2026.07.017","pmid":"42574969","title":"A phase II study of androgen receptor inhibition by darolutamide in combination with leuprolide acetate and exemestane in recurrent adult-type ovarian granulosa cell tumor","journal_title":"Gynecologic Oncology","journal_issn":"0090-8258","published_at":"2026-08-10T00:00:00.000Z","url":"https://doi.org/10.1016/j.ygyno.2026.07.017","source_score":2,"is_retracted":false,"is_open_access":false,"raw_metadata":{"pubmed":true,"crossref":true,"unpaywall":true},"created_at":"2026-08-21T06:28:10.620Z","updated_at":"2026-08-21T06:28:10.620Z","tags":[{"paper_doi":"10.1016/j.ygyno.2026.07.017","tag_type":"age_group","value":"adult","value_numeric":null},{"paper_doi":"10.1016/j.ygyno.2026.07.017","tag_type":"brand","value":"Nubeqa","value_numeric":null},{"paper_doi":"10.1016/j.ygyno.2026.07.017","tag_type":"category","value":"Obstetrics & Gynecology","value_numeric":null},{"paper_doi":"10.1016/j.ygyno.2026.07.017","tag_type":"condition","value":"Adult-Type Ovarian Granulosa Cell Tumor","value_numeric":null},{"paper_doi":"10.1016/j.ygyno.2026.07.017","tag_type":"condition","value":"Recurrent Ovarian Cancer","value_numeric":null},{"paper_doi":"10.1016/j.ygyno.2026.07.017","tag_type":"generic","value":"darolutamide","value_numeric":null},{"paper_doi":"10.1016/j.ygyno.2026.07.017","tag_type":"generic","value":"exemestane","value_numeric":null},{"paper_doi":"10.1016/j.ygyno.2026.07.017","tag_type":"generic","value":"leuprolide acetate","value_numeric":null},{"paper_doi":"10.1016/j.ygyno.2026.07.017","tag_type":"impact_flag","value":"limited_evidence","value_numeric":null},{"paper_doi":"10.1016/j.ygyno.2026.07.017","tag_type":"level_of_evidence","value":"3","value_numeric":null},{"paper_doi":"10.1016/j.ygyno.2026.07.017","tag_type":"modality","value":"Androgen Receptor Inhibitor","value_numeric":null},{"paper_doi":"10.1016/j.ygyno.2026.07.017","tag_type":"modality","value":"Aromatase Inhibitor","value_numeric":null},{"paper_doi":"10.1016/j.ygyno.2026.07.017","tag_type":"modality","value":"GnRH Agonist","value_numeric":null},{"paper_doi":"10.1016/j.ygyno.2026.07.017","tag_type":"sample_size","value":"n=17","value_numeric":17},{"paper_doi":"10.1016/j.ygyno.2026.07.017","tag_type":"sex","value":"female","value_numeric":null},{"paper_doi":"10.1016/j.ygyno.2026.07.017","tag_type":"study_design","value":"Single-Arm Phase II Trial","value_numeric":null},{"paper_doi":"10.1016/j.ygyno.2026.07.017","tag_type":"warning","value":"Brand name 'Nubeqa' tagged for darolutamide based on known proprietary name; not explicitly mentioned in the paper.","value_numeric":null},{"paper_doi":"10.1016/j.ygyno.2026.07.017","tag_type":"warning","value":"Only 16 of 17 enrolled patients were evaluable; the basis for excluding one patient is not detailed in the abstract.","value_numeric":null},{"paper_doi":"10.1016/j.ygyno.2026.07.017","tag_type":"warning","value":"The trial used Simon's Optimal two-stage design but closed after stage 1 due to failure to meet the prespecified ORR threshold; the exact threshold is not stated in the available text.","value_numeric":null}],"summaries":{"what_studied":"This single-arm Phase II trial evaluated darolutamide (600 mg BID), exemestane (25 mg daily), and leuprolide acetate (7.5 mg IM monthly) in 17 patients with recurrent adult-type ovarian granulosa cell tumor (AGCT) who had previously progressed on an aromatase inhibitor; accrual ran January–April 2024.","key_result":"Of 16 evaluable patients, ORR was 6.25% (1 partial response); 62.5% had stable disease and 31.25% had progressive disease. Median PFS was 8.5 months (95% CI: 3.1–12.0 months); median OS was not reached. No grade 4 or 5 adverse events were attributed to treatment. The trial did not advance to stage 2.","limitations":"- Very small sample size (n=16 evaluable) limits generalizability.\n- Single-arm design with no comparator group makes it difficult to attribute PFS benefit to treatment.\n- Accrual was completed in just 3 months, raising questions about patient selection at participating sites.","practice_takeaway":"This triplet hormonal regimen did not meet its prespecified ORR threshold in AI-pretreated recurrent AGCT and cannot be recommended as a standard approach. However, the disease control rate (62.5% stable disease) and 8.5-month median PFS may still inform future combination strategies for this rare tumor."}},{"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. Eligibility was limited to node‑negative tumors 5–30 mm, which may restrict generalizability.","practice_takeaway":"In selected node‑negative HER2‑positive early breast cancer, a chemo‑free neoadjuvant HP approach with response‑adapted adjuvant HP/T‑DM1 yielded a high pCR rate (59.6%) with expected toxicity and modest HRQoL decline, lower in those achieving pCR. Note one T‑DM1–related death and await 3‑year outcomes before broad adoption."}},{"doi":"10.1136/jitc-2025-013906","pmid":"42082271","title":"Phase II trial of combination radiation, hormone, and immunotherapy in grade group 5 prostate cancer","journal_title":"Journal for ImmunoTherapy of Cancer","journal_issn":"2051-1426","published_at":"2026-05-05T00:00:00.000Z","url":"https://doi.org/10.1136/jitc-2025-013906","source_score":30,"is_retracted":false,"is_open_access":true,"raw_metadata":{"ooir":{"day":"2026-05-05","doi":"10.1136/jitc-2025-013906","days":"14","issn":"2051-1426","rank":"9","field":"Clinical Medicine","score":"30","category":"Immunology","categories":["Immunology"],"_categories":["Immunology"]},"pubmed":{"doi":"10.1136/jitc-2025-013906","title":"Phase II trial of combination radiation, hormone, and immunotherapy in grade group 5 prostate cancer.","journal":"Journal for immunotherapy of cancer","methods":"","results":"Among the 31 patients, the median follow-up was 38.8 months (IQR 31.0-46.5 months). The addition of nivolumab to SOC RT with ADT was associated with a 2-year FFBR rate of 90.3% (95% CI 74.3% to 98.0%) (median FFBR not reached), exceeding the prespecified historical control rate of 75% (one-sided p value from binomial test=0.024). Definitive and probable nivolumab-related toxicity included 6.3% acute grade 2 and 6.3% acute grade 3 adverse events (AEs), with no grade 4+ AEs observed. A higher Decipher immunosuppression score at diagnosis correlated with early pathologic response (p=0.005) and was independently associated with time to metastatic failure (p=0.044).","abstract":"$31","keywords":["Biomarker","Genitourinary Cancer","Immunotherapy","Prostate Cancer","Radiotherapy/radioimmunotherapy"],"pubmed_id":"42082271","conclusions":"","publication_date":"2026-05-05T00:00:00"},"crossref":{"DOI":"10.1136/jitc-2025-013906","URL":"https://doi.org/10.1136/jitc-2025-013906","ISSN":["2051-1426"],"link":[{"URL":"https://syndication.highwire.org/content/doi/10.1136/jitc-2025-013906","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"page":"e013906","type":"journal-article","issue":"5","score":1,"title":["Phase II trial of combination radiation, hormone, and immunotherapy in grade group 5 prostate cancer"],"author":[{"given":"John Michael","family":"Bryant","sequence":"first","affiliation":[{"name":"Radiation Oncology, H Lee 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generalizability to non-Asian populations is uncertain.","value_numeric":null},{"paper_doi":"10.1200/jco-26-00434","tag_type":"warning","value":"Taletrectinib does not yet have broad regulatory approval in all markets; clinicians should verify local availability.","value_numeric":null},{"paper_doi":"10.1200/jco-26-00434","tag_type":"warning","value":"The impact flag 'practice_changing' reflects the unprecedented 4+ year median PFS in the TKI-naïve setting, but no head-to-head RCT data are available for direct comparison with other next-generation ROS1 TKIs.","value_numeric":null},{"paper_doi":"10.1200/jco-26-00434","tag_type":"warning","value":"Total sample size of n=169 is inferred by combining the two reported cohorts (103 TKI-naïve + 66 crizotinib-pretreated); the abstract does not explicitly state an overall combined N.","value_numeric":null}],"summaries":{"what_studied":"Long-term efficacy and safety of taletrectinib (600 mg once daily) in Chinese patients with advanced ROS1+ NSCLC, evaluated separately in TKI-naïve (n=103, median follow-up 51.0 months) and crizotinib-pretreated (n=66, median follow-up 45.2 months) cohorts in the phase II TRUST-I study.","key_result":"In TKI-naïve patients, ORR was 90.3%, median DOR and PFS both exceeded 4 years (~49.7 and 49.6 months), and median OS was not reached. In crizotinib-pretreated patients, ORR was 51.5%, median DOR was 13.2 months, median PFS was 7.6 months, and median OS was 25.6 months. No new safety signals were identified.","limitations":"Single-arm phase II design with no comparator arm; study population limited to Chinese patients, which may affect generalizability; OS data remain immature in the TKI-naïve cohort (median not reached).","practice_takeaway":"Taletrectinib offers durable, 4+ year PFS in TKI-naïve ROS1+ NSCLC and meaningful activity after crizotinib failure, including CNS penetration and activity against the G2032R resistance mutation. Clinicians treating ROS1+ NSCLC should consider taletrectinib as a frontline option given its long-term durability data."}}],"initialOffset":5,"fetchConfig":{"kind":"tags","tags":[{"tag_type":"study_design","value":"Single-Arm Phase II Trial"}]},"breadcrumbItems":[{"name":"Home","href":"/"},{"name":"Research Hub","href":"/hub"},{"name":"Study Designs","href":"/hub/tag/study_design"},{"name":"Single-Arm Phase II Trial"}],"hrefConfig":{"basePath":"/hub/papers","webViewQueryParams":{"hub_ctx":"tag","hub_tag_type":"study_design","hub_tag_value":"Single-Arm Phase II Trial"}}}]]

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