{"entity":{"id":"nct07016399","kind":"trial","name":"Neoadjuvant Darolutamide Alone or in Combination With Standard Therapy for Stage II-IIIA, AR+, TNBC","aka":[],"tldr":"A phase 2 trial of carboplatin, cyclophosphamide, darolutamide, doxorubicin and other drugs in triple-negative breast cancer, run by Vandana Abramson, now recruiting.","summary":"Neoadjuvant Darolutamide Alone or in Combination With Standard Therapy for Stage II-IIIA, AR+, TNBC is a phase 2, randomised interventional study registered as NCT07016399 by Vandana Abramson, with a registry enrolment figure of 51 participants, started 2025-09-09 and due to reach its primary completion in 2028-09-01. Interventions recorded: Biospecimen Collection; Breast Biopsy Procedure; Carboplatin; Cyclophosphamide; Darolutamide; Doxorubicin; Epirubicin; Magnetic Resonance Imaging; Paclitaxel; Pembrolizumab; Surgical Procedure; Ultrasound Imaging. Conditions listed: Anatomic Stage II Breast Cancer AJCC v8; Anatomic Stage IIIA Breast Cancer AJCC v8; Triple-Negative Breast Carcinoma. Triple-negative eligibility wording from the registry: \"* Malignancies other than TNBC within 5 years prior to randomization, with the exception of those with a negligible risk of metastases or death and treated with expected curative outcome (such as adequately treated carcinoma in situ of the cervix or basal or squamous cell skin cancer)\". Sites: United States. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07016399","url":"https://clinicaltrials.gov/study/NCT07016399"}],"tags":["ctgov-ingest","tnbc-deep-dive"],"related":[],"cancers":["tnbc-early"],"sections":[],"technologies":["checkpoint-inhibitor","cytotoxic-chemotherapy","platinum"],"targets":[],"drugs":["carboplatin","cyclophosphamide","darolutamide","doxorubicin","epirubicin","paclitaxel","pembrolizumab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07016399","phase":"2","setting":"A Phase II Neoadjuvant Clinical Trial of the Androgen Receptor Inhibitor Darolutamide in Early-Stage Androgen Receptor Positive (AR+) Triple-Negative Breast Cancer","sponsor":"Vandana Abramson","enrolled":51,"enrolledBasis":"registry","outcomes":[]},"route":"/trials/nct07016399/","neighbours":{"cancer":[{"id":"tnbc-early","kind":"cancer","name":"Early triple-negative breast cancer","route":"/cancers/tnbc-early/"}],"technology":[{"id":"cytotoxic-chemotherapy","kind":"technology","name":"Cytotoxic chemotherapy","route":"/technologies/cytotoxic-chemotherapy/"},{"id":"checkpoint-inhibitor","kind":"technology","name":"Immune checkpoint inhibitors","route":"/technologies/checkpoint-inhibitor/"},{"id":"platinum","kind":"technology","name":"Platinum agents","route":"/technologies/platinum/"}],"drug":[{"id":"carboplatin","kind":"drug","name":"Carboplatin","route":"/drugs/carboplatin/"},{"id":"cyclophosphamide","kind":"drug","name":"Cyclophosphamide","route":"/drugs/cyclophosphamide/"},{"id":"darolutamide","kind":"drug","name":"Darolutamide","route":"/drugs/darolutamide/"},{"id":"doxorubicin","kind":"drug","name":"Doxorubicin","route":"/drugs/doxorubicin/"},{"id":"epirubicin","kind":"drug","name":"Epirubicin","route":"/drugs/epirubicin/"},{"id":"paclitaxel","kind":"drug","name":"Paclitaxel / nab-paclitaxel","route":"/drugs/paclitaxel/"},{"id":"pembrolizumab","kind":"drug","name":"Pembrolizumab","route":"/drugs/pembrolizumab/"}],"term":[{"id":"tnbc-trials-open-today","kind":"term","name":"Triple-negative breast cancer trials open today (registry snapshot and UK sites)","route":"/terms/tnbc-trials-open-today/"}]}}