# Neoadjuvant Darolutamide Alone or in Combination With Standard Therapy for Stage II-IIIA, AR+, TNBC

Source: https://onco.cc/trials/nct07016399/  
OnCo record `nct07016399` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

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.

## Fields

- Kind: Trial
- Status: recruiting
- Last checked: 2026-09-24
- Tags: ctgov-ingest; tnbc-deep-dive
- Registry id: 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

## Sources

- ClinicalTrials.gov NCT07016399: https://clinicaltrials.gov/study/NCT07016399

## Connected records

- cancers: [Early triple-negative breast cancer](https://onco.cc/cancers/tnbc-early/)
- technologies: [Cytotoxic chemotherapy](https://onco.cc/technologies/cytotoxic-chemotherapy/), [Immune checkpoint inhibitors](https://onco.cc/technologies/checkpoint-inhibitor/), [Platinum agents](https://onco.cc/technologies/platinum/)
- drugs: [Carboplatin](https://onco.cc/drugs/carboplatin/), [Cyclophosphamide](https://onco.cc/drugs/cyclophosphamide/), [Darolutamide](https://onco.cc/drugs/darolutamide/), [Doxorubicin](https://onco.cc/drugs/doxorubicin/), [Epirubicin](https://onco.cc/drugs/epirubicin/), [Paclitaxel / nab-paclitaxel](https://onco.cc/drugs/paclitaxel/), [Pembrolizumab](https://onco.cc/drugs/pembrolizumab/)
- terms: [Triple-negative breast cancer trials open today (registry snapshot and UK sites)](https://onco.cc/terms/tnbc-trials-open-today/)

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JSON: https://onco.cc/api/v1/entities/nct07016399.json