{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,11,7]],"date-time":"2026-11-07T02:07:16Z","timestamp":1794017236755,"version":"4.8.0"},"reference-count":53,"publisher":"American Medical Association (AMA)","issue":"2","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["JAMA Netw Open"],"abstract":"Importance<\/jats:title>Subgroup definitions for possible deescalation of neoadjuvant cancer treatment are urgently needed in clinical practice.<\/jats:p><\/jats:sec>Objective<\/jats:title>To investigate the effect of BRCA1<\/jats:italic> and\/or BRCA2<\/jats:italic> tumor pathogenic variants (tPVs) by comparing 2 deescalated neoadjuvant regimens (nab-paclitaxel plus either carboplatin or gemcitabine) on pathologic complete response (pCR), invasive disease\u2013free survival (IDFS), and overall survival (OS) of patients with early-stage triple-negative breast cancer (TNBC).<\/jats:p><\/jats:sec>Design, Setting, and Participants<\/jats:title>This was a preplanned secondary analysis of a phase 2 prospective randomized clinical trial (ADAPT-TN) conducted by the West German Study Group (WSG) at 45 sites in Germany between June 2013 and February 2015. The trial enrolled patients with noninflammatory early-stage TNBC (clinical tumor size \u22651 cm; estrogen receptor and progesterone receptor expression &amp;lt;1%; and ERBB2<\/jats:italic> negative). DNA samples from pretreatment biopsies were obtained. Genetic analysis was performed between January 2018 and March 2020. Final data analyses took place in September 2023.<\/jats:p><\/jats:sec>Exposure<\/jats:title>Patients were randomized to 12 weeks of treatment with nab-paclitaxel plus either carboplatin or gemcitabine; omission of otherwise mandatory anthracycline-containing chemotherapy was allowed in the case of pCR. tPVs in 20 cancer-associated genes, including BRCA1<\/jats:italic> and BRCA2<\/jats:italic>, were analyzed using a customized gene panel.<\/jats:p><\/jats:sec>Main Outcomes and Measures<\/jats:title>The prevalence of BRCA1<\/jats:italic> and\/or BRCA2<\/jats:italic> tPVs and their effect on pCR rate, IDFS, and OS were evaluated using logistic and Cox proportional hazards regression.<\/jats:p><\/jats:sec>Results<\/jats:title>Of the 307 patients with DNA samples from pretreatment biopsies available, tumor next-generation sequencing analyses were successful for 266 patients. The 266 patients included in this analysis were female, with a median age of 51 years (range, 26-76 years). A total of 162 patients (60.9%) had a clinical tumor size of 2 cm or greater, and 70 (26.3%) had clinical node-positive disease. BRCA1<\/jats:italic> and\/or BRCA2<\/jats:italic> tPVs were detected in 42 patients (15.8%). The highest pCR rate among patients with BRCA1<\/jats:italic> and\/or BRCA2<\/jats:italic> tPVs was seen in the nab-paclitaxel plus carboplatin group (9 of 14 patients [64.3%]) compared with the nab-paclitaxel plus gemcitabine group (10 of 28 [35.7%]) (odds ratio, 3.24 [95% CI, 0.85-12.36]; P<\/jats:italic>\u2009=\u2009.08); the highest numeric 5-year IDFS and OS rates (84.4% and 92.9%, respectively) were seen in the nab-paclitaxel plus carboplatin group.<\/jats:p><\/jats:sec>Conclusions and Relevance<\/jats:title>In this secondary analysis of the WSG-ADAPT-TN randomized clinical trial on tPVs, deescalated nab-paclitaxel plus carboplatin was superior to nab-paclitaxel plus gemcitabine, particularly in patients with BRCA1<\/jats:italic> and\/or BRCA2<\/jats:italic> tPVs. These findings suggest that BRCA1<\/jats:italic> and\/or BRCA2<\/jats:italic> tPV status could be a candidate marker for a deescalation strategy in early-stage TNBC; however, prospective validation of survival outcomes in larger cohorts with differentiation between germline and somatic pathogenic variants is necessary.<\/jats:p><\/jats:sec>Trial Registration<\/jats:title>ClinicalTrials.gov Identifier: NCT01815242<\/jats:ext-link><\/jats:p><\/jats:sec>","DOI":"10.1001\/jamanetworkopen.2024.61639","type":"journal-article","created":{"date-parts":[[2025,2,26]],"date-time":"2025-02-26T16:32:49Z","timestamp":1740587569000},"page":"e2461639","source":"Crossref","is-referenced-by-count":10,"title":["Genetic Alterations, Therapy Response, and Survival Among Patients With Triple-Negative Breast Cancer"],"prefix":"10.1001","volume":"8","author":[{"given":"Lisa","family":"Richters","sequence":"first","affiliation":[{"name":"Center for Familial Breast and Ovarian Cancer, Faculty of Medicine, University Hospital Cologne, Cologne, Germany"},{"name":"Center for Integrated Oncology, Faculty of Medicine, University Hospital Cologne, Cologne, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Oleg","family":"Gluz","sequence":"additional","affiliation":[{"name":"West German Study Group, Moenchengladbach, Germany"},{"name":"Ev. 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