Actively Recruiting
A Multicenter, Phase IB/II Study of Abemaciclib with Bicalutamide for Androgen Receptor-positive, HER2-negative Metastatic Breast Cancer
Led by Icahn School of Medicine at Mount Sinai · Updated on 2026-04-13
42
Participants Needed
3
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the combination of abemaciclib and bicalutamide in patients with androgen receptor-positive, HER2-negative metastatic breast cancer. This open-label, multicenter Phase IB/II study aims to find the safe and recommended dose of abemaciclib when given with bicalutamide, and to assess how well this treatment works. The study also looks at safety, tolerability, and progression-free survival in patients who often have already received prior endocrine therapies. Participants will receive abemaciclib orally twice daily with dose adjustments based on tolerance, starting at 100 mg and potentially increasing to 150 mg or decreasing to 50 mg. Bicalutamide will be taken orally once daily at 150 mg. Treatment continues until the disease progresses. The study plans to enroll about 54-60 patients over 36 months. During the study, patients will undergo evaluations including CT scans and bone scans or PET/CT to measure disease status. Researchers will monitor dose-limiting toxicities, side effects, and disease control rates over 12 weeks. Participants must meet specific health and laboratory criteria, and will be followed throughout treatment to assess safety and effectiveness of the combination therapy.
CONDITIONS
Brief Title
Abemaciclib in Combination With Bicalutamide for Androgen Receptor-positive, HER2-negative Metastatic Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent before any study procedures
- Women aged at least 18 years
- Biopsy-confirmed recurrent, unresectable, locally advanced, or metastatic HER2-negative breast cancer
- Biopsy confirmation of a metastatic site with appropriate staining
- Measurable or evaluable disease on baseline CT chest, abdomen, pelvis with bone scan or PET/CT
- Androgen receptor-positive breast cancer (≥1% staining on immunohistochemistry)
- ECOG performance status 0-2 with no recent deterioration and life expectancy ≥12 weeks
- For ER+ or PR+ metastatic breast cancer: at least 1 prior endocrine therapy line in metastatic setting
- Prior CDK4/6 inhibitor exposure allowed
- No more than 2 prior lines of cytotoxic chemotherapy in metastatic setting
- For triple-negative metastatic breast cancer: up to 4 prior chemotherapy lines allowed
- Recovery from chemotherapy acute effects (CTCAE grade ≤1) with 21-day washout
- Recovery from radiotherapy acute effects with 14-day washout
- Postmenopausal or receiving ovarian ablation with GnRH agonist started ≥2 weeks before study
- Negative pregnancy test within 7 days prior to treatment
- Use of effective contraception during and 3 weeks after study participation
You will not qualify if you...
- Use of investigational agents or prior study drugs within 28 days before study drug
- Other chemotherapy, immunotherapy, or anticancer agents within 21 days before study drug
- Prior anti-androgen therapy (bicalutamide, abiraterone, enzalutamide)
- Major surgery within 4 weeks before study drug (except vascular access placement)
- Spinal cord compression, leptomeningeal carcinomatosis, or brain metastases unless stable and steroid-free for ≥2 weeks
- Concurrent use of endocrine therapy (tamoxifen, anastrozole, letrozole, exemestane, oral contraceptives)
- Severe or uncontrolled systemic diseases or active infections including hepatitis B, C, HIV
- Cardiac conditions including QTc >470 msec, significant ECG abnormalities, arrhythmia risks, recent major cardiac events
- Prior history of DVT/PE or embolic stroke unless on therapeutic anticoagulation
- Inadequate bone marrow or organ function based on lab values
- Liver disease such as cirrhosis or chronic active hepatitis
- Serious uncontrolled preexisting medical conditions interfering with study participation
- Severely impaired lung function or oxygen saturation ≤89% at rest
- Uncontrolled diabetes with fasting glucose >1.5 x upper limit
- Chronic gastrointestinal conditions affecting drug absorption
- Active bleeding disorders or infections requiring IV antibiotics
- Known hypersensitivity to study drugs or similar compounds
- Use of CYP3A4 inducers, inhibitors, or substrates that may interact with study drugs
- Other malignancies within past 3 years except certain treated skin or cervical cancers
- Pregnant or breastfeeding women, or adults not using effective birth control
- Investigator judgment of inability to comply with study procedures or restrictions
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Until disease progression
Participants receive a combination of Abemaciclib and Bicalutamide orally on a continuous daily dosing schedule until disease progression.
1 baseline visit and regular visits during treatment
Trial Site Locations
Total: 3 locations
1
Mount Sinai Beth Israel
New York, New York, United States, 10003
Actively Recruiting
2
Mount Sinai - West
New York, New York, United States, 10019
Actively Recruiting
3
Dubin breast Center
New York, New York, United States, 10029
Actively Recruiting
Research Team
L
Laura A Fiedler, MPH
E
Esther Kim, CRC
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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