Actively Recruiting
Abemaciclib in Combination 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
349 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official 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 18 years or older
- Biopsy-confirmed recurrent, unresectable, locally advanced, or metastatic HER2-negative breast cancer
- Biopsy confirmation of metastatic site with appropriate staining
- Measurable or evaluable disease by baseline scans
- Androgen receptor-positive breast cancer (\u22651% staining on immunohistochemistry)
- ECOG performance status 0 to 2 with no recent deterioration and life expectancy of at least 12 weeks
- For ER+ or PR+ metastatic breast cancer, at least one prior endocrine therapy in metastatic setting
- Prior CDK4/6 inhibitor exposure allowed
- No more than two prior lines of cytotoxic chemotherapy in metastatic setting for ER+/PR+ patients
- For triple-negative metastatic breast cancer, up to four prior chemotherapy lines including at least one
- Recovery from chemotherapy acute effects and appropriate washout periods
- Recovery from radiotherapy acute effects and appropriate washout periods
- Postmenopausal status or ovarian ablation with GnRH agonist started at least two weeks before treatment
- Negative pregnancy test within 7 days prior to treatment start
- Use of effective contraception for women of child-bearing potential and men during and after study treatment
You will not qualify if you...
- Treatment with investigational agents within 28 days before study treatment
- Chemotherapy, immunotherapy, or anticancer agents within 21 days before study treatment
- Prior exposure to anti-androgen therapies (bicalutamide, abiraterone, enzalutamide)
- Major surgery within 4 weeks before study treatment
- Spinal cord compression, leptomeningeal carcinomatosis, or active brain metastases unless stable and asymptomatic
- Concurrent endocrine therapy use
- Severe or uncontrolled systemic diseases or active infections including hepatitis B, C, or HIV
- Cardiac abnormalities including prolonged QTc, arrhythmias, recent major cardiac events, or uncontrolled hypotension
- History of blood clots or embolic stroke unless on therapeutic anticoagulation
- Inadequate bone marrow or organ function based on lab values
- Liver diseases such as cirrhosis or chronic active hepatitis (except compliant hepatitis B patients)
- Serious uncontrolled medical conditions including severe lung function impairment or diabetes
- Gastrointestinal conditions preventing drug absorption
- Active bleeding disorders
- Allergies to study drugs or similar compounds
- Use of CYP3A4 inducers, inhibitors, or substrates that affect drug metabolism
- Other malignancies within past 3 years except treated skin or cervical cancers
- Pregnancy, breastfeeding, or lack of effective contraception in those of reproductive potential
- Investigator judgment of inability to comply with study requirements
AI-Screening
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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
CONTACT
E
Esther Kim, CRC
CONTACT
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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