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

This phase II trial compares the effect of adding darolutamide to standard therapy versus standard therapy alone before surgery for the treatment of patients with stage II-IIIA androgen receptor positive triple-negative breast carcinoma. Standard therapy before surgery for triple-negative breast cancer typically consists of a combination of chemotherapy and immunotherapy drugs. Chemotherapy drugs, such as carboplatin, paclitaxel, doxorubicin and cyclophosphamide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stoppin

Trial Details

NCT ID
NCT07016399
Phase
PHASE2
Sponsor
Vandana Abramson
Status
RECRUITING
Cancer Type
Triple Negative (TNBC) Breast Cancer
Interventions
  • Biospecimen Collection
  • Breast Biopsy Procedure
  • Carboplatin
  • Cyclophosphamide
  • Darolutamide
  • Doxorubicin
Locations (sample)
  • Nashville, Tennessee, United States|36.16589,-86.78444

Key Eligibility Criteria

  • Signed and dated written informed consent as well as the ability to understand and the willingness to sign written consent prior to study registration
  • Male or female ≥ 18 years of age on the day of signing informed consent
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Histologically confirmed newly diagnosed breast cancer with the following requirements:

For full eligibility, visit ClinicalTrials.gov.

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