OncoMatch/Clinical Trials/NCT06365788
Bicalutamide and Abemaciclib in Inoperable or Metastatic Androgen Receptor-positive Triple-negative Breast Cancer
Is NCT06365788 recruiting? Yes, currently enrolling (Sep 2026). This Phase 2 trial studies multiple treatments including Abemaciclib and Bicalutamide for triple negative breast neoplasms.
Treatment: Abemaciclib · Bicalutamide — This study has as goal to evaluate the use of abemaciclib and bicalutamide in androgen receptor positive metastatic triple negative breast cancer.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Targeted therapy
Endocrine / hormonal
Cancer type
Triple-Negative Breast Cancer
Breast Carcinoma
Biomarker criteria
Required: AR expression (≥1% of cells staining on ihc)
Required: HER2 (ERBB2) wild-type (negative per asco/cap-guidelines)
Required: ESR1 expression (≤10% of cells staining on ihc)
Required: PR (PGR) expression (≤10% of cells staining on ihc)
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Demographics
Prior therapy
Must have received: cytostatic regimen — advanced setting
Cannot have received: cdk4/6 inhibitor (abemaciclib)
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/dl
Kidney function
creatinine >1.5x uln concurrent with creatinine clearance < 50 ml/min; severe renal impairment (e.g. estimated creatinine clearance <30ml/min)
Liver function
alt > 3x uln, ast > 3x uln, total bilirubin > 1.5x uln (gilbert's syndrome exception: ≤2.0x uln and direct bilirubin within normal limits permitted)
Cardiac function
qtc > 470 msec; clinically important ecg abnormalities; history of arrhythmia, syncope, mi, chf nyha ≥2, uncontrolled hypotension, lvef below lower limit of normal
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT06365788 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior cdk4/6 inhibitor, anti-androgen therapy disqualifies patients from enrollment.
Does this trial require AR?
Yes, AR expression is a required biomarker for enrollment.
Does this trial require ERBB2?
Yes, ERBB2 wild-type is a required biomarker for enrollment.
Does this trial require ESR1?
Yes, ESR1 expression is a required biomarker for enrollment.
Is this trial open to male patients?
No. This trial enrolls female patients only.
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