OncoMatch/Clinical Trials/NCT07016399
Neoadjuvant Darolutamide Alone or in Combination With Standard Therapy for Stage II-IIIA, AR+, TNBC
Is NCT07016399 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments for anatomic stage ii breast cancer ajcc v8.
Treatment: Carboplatin · Cyclophosphamide · Darolutamide · Doxorubicin · Epirubicin · Paclitaxel · Pembrolizumab — 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 stopping them from spreading. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Darolutamide is in a class of medications called androgen receptor inhibitors. It works by blocking the effects of androgen (a male reproductive hormone) to stop the growth and spread of tumor cells. Giving darolutamide in combination with standard therapy before surgery may make the tumor smaller and may reduce the amount of normal tissue that needs to be removed.
Check if I qualifyExtracted eligibility criteria
Cancer type
Breast Carcinoma
Triple-Negative Breast Cancer
Biomarker criteria
Required: ESR1 low expression (<10% staining by IHC) (<10% staining by IHC)
<10% staining for estrogen receptor (ER) by immunohistochemistry (IHC)
Required: PR (PGR) low expression (<10% staining by IHC) (<10% staining by IHC)
<10% staining for progesterone receptor (PR) by immunohistochemistry (IHC)
Required: HER2 (ERBB2) negative by FISH (negative by FISH)
HER2 negative by fluorescence in situ hybridization (FISH)
Required: AR overexpression (≥80% staining by IHC) (≥80% staining by IHC)
AR positive: defined as ≥ 80% staining for AR by IHC
Disease stage
Required: Stage II, IIIA
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Lab requirements
Blood counts
ANC ≥ 1500/µL; platelets ≥ 100,000/µL; hemoglobin ≥ 9.0 g/dL or ≥ 5.6 mmol/L
Kidney function
eGFR ≥ 60 mL/min (Cockcroft-Gault or institutional standard)
Liver function
Total bilirubin ≤ 1.5x ULN, or direct bilirubin ≤ ULN for participants with total bilirubin > 1.5x ULN; AST and ALT ≤ 2.5x ULN
ANC ≥ 1500/µL; platelets ≥ 100,000/µL; hemoglobin ≥ 9.0 g/dL or ≥ 5.6 mmol/L; eGFR ≥ 60 mL/min; Total bilirubin ≤ 1.5x ULN, or direct bilirubin ≤ ULN for participants with total bilirubin > 1.5x ULN; AST and ALT ≤ 2.5x ULN; Calcium ≤ 11.5 mg/dL or ≤ 2.9 mmol/L
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Vanderbilt University/Ingram Cancer Center · Nashville, Tennessee
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify