NCT07016399View on ClinicalTrials.gov

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

PHASE2Not yet recruitingINTERVENTIONAL
Enrollment

51

Participants

Timeline

Start Date

September 1, 2025

Primary Completion Date

September 1, 2028

Study Completion Date

October 31, 2033

Conditions
Anatomic Stage II Breast Cancer AJCC v8Anatomic Stage IIIA Breast Cancer AJCC v8Triple-Negative Breast Carcinoma
Interventions
PROCEDURE

Biospecimen Collection

Undergo blood sample collection

PROCEDURE

Breast Biopsy Procedure

Undergo breast biopsies

DRUG

Carboplatin

Given IV

DRUG

Cyclophosphamide

Given IV

DRUG

Darolutamide

Given PO

DRUG

Doxorubicin

Given IV

DRUG

Epirubicin

Given IV

PROCEDURE

Magnetic Resonance Imaging

Undergo MRI

DRUG

Paclitaxel

Given IV

BIOLOGICAL

Pembrolizumab

Given IV

PROCEDURE

Surgical Procedure

Undergo breast surgery

PROCEDURE

Ultrasound Imaging

Undergo US

Trial Locations (1)

37232

Vanderbilt University/Ingram Cancer Center, Nashville

All Listed Sponsors
collaborator

National Cancer Institute (NCI)

NIH

lead

Vandana Abramson

OTHER