OncoMatch/Clinical Trials/NCT06365788
Bicalutamide and Abemaciclib in Inoperable or Metastatic Androgen Receptor-positive Triple-negative Breast Cancer
Is NCT06365788 recruiting? Yes, currently enrolling (Jun 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 overexpression (≥1% of cells staining on IHC)
AR+ assessed locally and defined as ≥1% of cells staining on IHC of last recurrent/metastatic breast cancer specimen
Required: ESR1 expression ≤10% of cells by IHC (≤10% of cells by IHC)
positive IHC for ER and/or PR in ≤10% of cells
Required: PR (PGR) expression ≤10% of cells by IHC (≤10% of cells by IHC)
positive IHC for ER and/or PR in ≤10% of cells
Required: HER2 (ERBB2) negative per ASCO/CAP-guidelines (negative per ASCO/CAP-guidelines)
negative for HER2 per ASCO/CAP-guidelines
Allowed: BRCA1 pathogenic germline variant
Patients with known germline BRCA1/2 pathogenic variants should have received previous treatment with PARP inhibitors in the early/locally advanced or metastatic setting, unless contraindicated.
Allowed: BRCA2 pathogenic germline variant
Patients with known germline BRCA1/2 pathogenic variants should have received previous treatment with PARP inhibitors in the early/locally advanced or metastatic setting, unless contraindicated.
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Demographics
Prior therapy
Must have received: cytostatic chemotherapy — advanced
must have had prior treatment with at least 1 prior cytostatic regimen in advanced setting unless treatment with a cytostatic regimen is contraindicated as judged by Investigator
Must have received: endocrine therapy — advanced
Patients with 1-10% cells with positive IHC for ER in the last recurrent/metastatic site must be treated with at least one line of endocrine therapy in advanced setting
Must have received: PARP inhibitor — early/locally advanced or metastatic
Patients with known germline BRCA1/2 pathogenic variants should have received previous treatment with PARP inhibitors in the early/locally advanced or metastatic setting, unless contraindicated.
Cannot have received: abemaciclib (abemaciclib)
Any prior exposure to abemaciclib
Cannot have received: anti-androgen therapy (bicalutamide, abiraterone, enzalutamide)
Any prior exposure to anti-androgen therapy (bicalutamide, abiraterone, and/or enzalutamide)
Cannot have received: CDK4/6 inhibitor (palbociclib, ribociclib)
Exception: allowed if at least 6 months have elapsed between last administration and start of study treatment
Prior treatment with palbociclib or ribociclib is allowed, provided at least 6 months have elapsed between last administration and start of study treatment
Lab requirements
Blood counts
ANC < 1.5 x 10^9/L; platelets < 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 (exceptions for Gilbert's syndrome)
Cardiac function
QTc > 470 msec; clinically important ECG abnormalities; LVEF below lower limit of normal; uncontrolled hypotension (SBP <90mmHg and/or DBP <50mmHg); recent major cardiac events
Inadequate bone marrow reserve or organ function as demonstrated by any of the following laboratory values: ... See full criteria for details
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 abemaciclib, anti-androgen therapy, CDK4/6 inhibitor disqualifies patients from enrollment.
Does this trial require AR?
Yes, AR overexpression is a required biomarker for enrollment.
Does this trial require ESR1?
Yes, ESR1 expression ≤10% of cells by IHC is a required biomarker for enrollment.
Does this trial require PGR?
Yes, PGR expression ≤10% of cells by IHC 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.
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