OncoMatch/Clinical Trials/NCT05095207
Abemaciclib in Combination With Bicalutamide for Androgen Receptor-positive, HER2-negative Metastatic Breast Cancer
Is NCT05095207 recruiting? Yes, currently enrolling (Jun 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
Treatments studied
Targeted therapy
Endocrine / hormonal
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)
Demographics
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 →Frequently asked questions
Is NCT05095207 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior anti-androgen therapy disqualifies patients from enrollment.
Does this trial require AR?
Yes, AR positive is a required biomarker for enrollment.
Does this trial require ERBB2?
Yes, ERBB2 wild-type is a required biomarker for enrollment.
Is there an age limit?
Yes. Patients must be 90 years or younger.
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 qualifyRelated pages