OncoMatch/Clinical Trials/NCT05095207
Abemaciclib in Combination With Bicalutamide for Androgen Receptor-positive, HER2-negative Metastatic Breast Cancer
Is NCT05095207 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies multiple treatments including Abemaciclib and Bicalutamide for breast cancer.
Treatment: Abemaciclib · Bicalutamide — This is an open label multicenter, Phase IB/II Study of Abemaciclib in Combination with Bicalutamide for Androgen Receptor-positive, HER2-negative Metastatic Breast Cancer
Check if I qualifyExtracted eligibility criteria
Cancer type
Breast Carcinoma
Biomarker criteria
Required: AR positive (≥ 1% staining on immunohistochemistry of metastatic breast cancer specimen)
AR+ breast cancer (defined as ≥ or equal to 1% staining on immunohistochemistry of metastatic breast cancer specimen)
Required: HER2 (ERBB2) wild-type
HER2neu-negative breast cancer
Disease stage
Metastatic disease required
recurrent, unresectable, locally advanced, or metastatic HER2neu-negative breast cancer (including bone-only metastatic disease)
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Cannot have received: anti-androgen therapy (bicalutamide, abiraterone, enzalutamide)
Lab requirements
Blood counts
ANC < 1.5 x 10^9/L; Platelet count < 100 x 10^9/L; Hemoglobin < 8 g/L
Kidney function
Creatinine >1.5x ULN concurrent with creatinine clearance < 50 ml/min (measured or calculated by Cockcroft and Gault equation); confirmation of creatinine clearance is only required when creatinine is > 1.5x ULN
Liver function
ALT > 3x ULN, AST > 3x ULN, total bilirubin > 1.5x ULN (Gilbert's syndrome exception: total bilirubin ≤2.0x ULN and direct bilirubin within normal limits permitted)
Cardiac function
Mean resting QTc > 470 msec (3 ECGs); clinically important ECG abnormalities; risk factors for QTc prolongation or arrhythmic events; LVEF below lower limit of normal for site; uncontrolled hypotension (SBP <90mmHg and/or DBP <50mmHg); history of significant cardiac events in preceding 6 months
Inadequate bone marrow reserve or organ function as demonstrated by any of the following laboratory values: ANC < 1.5 x 10^9/L; Platelet count < 100 x 10^9/L; Hemoglobin < 8 g/L; ALT > 3x ULN; AST > 3x ULN; total bilirubin > 1.5x ULN (Gilbert's syndrome exception: total bilirubin ≤2.0x ULN and direct bilirubin within normal limits permitted); Creatinine >1.5x ULN concurrent with creatinine clearance < 50 ml/min; Proteinuria 3+ on dipstick or >500mg/24 hours; Sodium or potassium outside normal reference range for site; Cardiac criteria as listed
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Mount Sinai Beth Israel · New York, New York
- Mount Sinai - West · New York, New York
- Dubin breast Center · New York, New York
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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