OncoMatch/Clinical Trials/NCT04947189
Seviteronel in Combination With Chemotherapy in Androgen-receptor Positive Metastatic Triple-negative Breast Cancer
Is NCT04947189 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies multiple treatments including Seviteronel-D (Seivteronel in combination with dexamethasone) and Docetaxel for triple negative breast cancer.
Treatment: Seviteronel-D (Seivteronel in combination with dexamethasone) · Docetaxel — To facilitate the clinical testing of seviteronel and dexamethasone (SEVI-D) in combination with docetaxel in androgen receptor (AR) positive triple-negative breast cancer.
Check if I qualifyExtracted eligibility criteria
Cancer type
Triple-Negative Breast Cancer
Breast Carcinoma
Biomarker criteria
Required: AR positive (>0% by IHC or gene classifier)
The tumor must also show androgen receptor positivity (i.e., AR>0%) by IHC or gene classifier (molecular testing).
Required: ESR1 wild-type (<1% by IHC)
triple-negative breast cancer, i.e., HER2-negative by ASCO/GAO Guidelines and <1% expression of estrogen and/or progesterone receptor by IHC.
Required: PR (PGR) wild-type (<1% by IHC)
triple-negative breast cancer, i.e., HER2-negative by ASCO/GAO Guidelines and <1% expression of estrogen and/or progesterone receptor by IHC.
Required: HER2 (ERBB2) wild-type (HER2-negative by ASCO/GAO Guidelines)
triple-negative breast cancer, i.e., HER2-negative by ASCO/GAO Guidelines and <1% expression of estrogen and/or progesterone receptor by IHC.
Disease stage
Metastatic disease required
Measurability of lesion: have at least 1 measurable lesion assessable using standard techniques by RECIST v1.1
Performance status
ECOG 0–1(Restricted strenuous activity)
Lab requirements
Blood counts
Adequate haematologic function within 14 days before the first study treatment on cycle1, day 1
Kidney function
Adequate organ function within 14 days before the first study treatment on cycle1, day 1
Liver function
No clinically significant history of liver disease consistent with Child-Pugh Class B or C, including active viral or other hepatitis, current drug or alcohol abuse, or cirrhosis.
Adequate haematologic and organ function within 14 days before the first study treatment on cycle1, day 1. Known clinically significant history of liver disease consistent with Child-Pugh Class B or C, including active viral or other hepatitis (e.g., positive for hepatitis B surface antigen [HBsAg] or hepatitis C virus [HCV] antibody at screening), current drug or alcohol abuse, or cirrhosis.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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