Abemaciclib and Bicalutamide for Metastatic Breast Cancer
This study is testing a combination of two drugs, Abemaciclib and Bicalutamide, for people with metastatic breast cancer that is androgen receptor-positive and HER2-negative. The study aims to find the safest and most effective dose of Abemaciclib when given with Bicalutamide. Researchers will also look at how well this combination works to stop cancer growth and how safe it is overall. You may be eligible if you are between 18 and 90 years old, male or female, and have this specific type of breast cancer. The study plans to enroll about 42 participants.
- Study design
- This is an open-label (meaning you and your doctors will know what treatment you are receiving) Phase 1B/2 study. It plans to enroll about 42 participants to test the drug combination.
- What's involved
- You will take Abemaciclib orally twice daily and Bicalutamide orally daily, both for 28-day cycles. Treatment continues until your disease progresses.
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary goal of determining the best dose and side effects will be measured at 12 weeks. You will be treated until your disease progresses.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT05095207
Abemaciclib in Combination With Bicalutamide for Androgen Receptor-positive, HER2-negative Metastatic Breast Cancer
Recruiting
PHASE1Ages 18–90InterventionalTreatmentIcahn School of Medicine at Mount SinaiInvestigator-initiated
~42 participants
Updated 2026-04-13 on ClinicalTrials.gov
What's tested:AbemaciclibBicalutamide
At a glance
Recruiting sites
3 of 3 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
The Dose-Limiting Toxicity (DLT) and Recommended Phase II Dose (RP2D)
Measured over 12 weeks
Conditions
Where it's being run
3 sites across 1 statesNew York3
Study leadership
- Amy Tiersten, MD · PRINCIPAL_INVESTIGATOR · Icahn School of Medicine at Mount Sinai
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
Provision of signed and dated, written informed consent prior to any study specific procedures, sampling and analyses
If a patient declines to participate in any voluntary exploratory research and/or genetic component of the study, there will be no penalty or loss of benefit to the patient and he/she will not be excluded from other aspects of the study
Women aged at least 18 years
The patient has a biopsy-confirmed diagnosis of recurrent, unresectable, locally advanced, or metastatic HER2neu-negative breast cancer (including bone-only metastatic disease) o The patient must have had biopsy confirmation of a metastatic site (with appropriate ER/PR/HER2neu IHC staining)
The patient has AR+ breast cancer (defined as \> or equal to 1% staining on immunohistochemistry of metastatic breast cancer specimen)
Eastern Cooperative Oncology Group (ECOG) performance status 0-2 with no deterioration over the previous 2 weeks and minimum life expectancy of 12 weeks
If the patient has ER+ or PR+ (\>1% on IHC) metastatic breast cancer:
prior CDK4/6 inhibitor exposure allowed (abemaciclib. palbociclib, or ribociclib)
no more than 2 prior line of cytotoxic chemotherapy in the metastatic setting allowed
If the patient has ER-,PR-, HER2- metastatic breast cancer ("triple-negative"):
Patients who received chemotherapy must have recovered (Common Terminology Criteria for Adverse Events \[CTCAE\] Grade ≤1) from the acute effects of chemotherapy except for residual alopecia or Grade 2 peripheral neuropathy prior to randomization. A washout period of at least 21 days is required between last chemotherapy dose and randomization (provided the patient did not receive radiotherapy).
Patients who received radiotherapy must have completed and fully recovered from the acute effects of radiotherapy. A washout period of at least 14 days is required between end of radiotherapy and randomization.
Post-menopausal status or receiving ovarian ablation with a GnRH agonist such as goserelin or leuprolide. Postmenopausal status is defined by any one of the following criteria:
Prior bilateral oophorectomy.
Age ≥ 60 years.
Age \< 60 and amenorrhea for 12 or more months (in the absence of chemotherapy, tamoxifen, or ovarian suppression) and FSH, LH, and estradiol in the postmenopausal range per local normal.
Has not undergone a hysterectomy or bilateral oophorectomy; or
Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months).
Exclusion
Treatment with any of the following:
Major surgery (excluding placement of vascular access) within 4 weeks of the first dose of study treatment
Spinal cord compression, leptomeningeal carcinomatosis, or brain metastases - unless asymptomatic, treated and stable and not requiring steroids for at least 2 weeks prior to start of study treatment
Concurrent use of endocrine therapy (tamoxifen, anastrozole, letrozole, exemestane, oral contraceptive pills)
As judged by the investigator, any evidence of severe or uncontrolled systemic diseases, including active bleeding diatheses, or active infection including hepatitis B, hepatitis C and human immunodeficiency virus (HIV). Screening for chronic conditions is not required.
Any of the following cardiac criteria:
Prior history of DVT/PE or embolic stroke, unless currently on therapeutic anticoagulation
Inadequate bone marrow reserve or organ function as demonstrated by any of the following laboratory values:
Liver disease such as cirrhosis, chronic active hepatitis, or chronic persistent hepatitis. Patients who are hepatitis B Core antibody IgG positive are allowed to participate if taking and compliant with daily oral hepatitis B prophylactic medications
The patient has serious and/or uncontrolled preexisting medical condition(s) that, in the judgment of the investigator, would preclude participation in this study (for example, interstitial lung disease, severe dyspnea at rest or requiring oxygen therapy, severe renal impairment \[e.g. estimated creatinine clearance \<30ml/min\], history of major surgical resection involving the stomach or small bowel, or preexisting Crohn's disease or ulcerative colitis or a preexisting chronic condition resulting in baseline Grade 2 or higher diarrhea).
Severely impaired lung function as defined as spirometry and DLCO that is 50% of the normal predicted value and/or 02 saturation that is 89% or less at rest on room air
Uncontrolled diabetes as defined by fasting serum glucose \>1.5 x ULN
Refractory nausea and vomiting, chronic gastrointestinal diseases, inability to swallow the formulated product, or previous significant bowel resection that would preclude adequate absorption abemaciclib or bicalutamide
Patients with an active bleeding diathesis
The patient has active systemic bacterial infection (requiring intravenous \[IV\] antibiotics at time of initiating study treatment), fungal infection, or detectable viral infection (such as known human immunodeficiency virus positivity or with known active hepatitis B or C \[for example, hepatitis B surface antigen positive\]. Screening is not required for enrollment.
History of hypersensitivity or allergic reaction to abemaciclib or bicalutamide, or drugs with a similar chemical structure or class
Judgment by the investigator that the patient should not participate in the study if the patient is unlikely to comply with study procedures, restrictions and requirements
Co-administration with CYP3A4 inducers (e.g., phenytoin, rifampin, carbamazepine, St John's Wort, bosentan, efavirenz, etravirine, modafinil, and nafcillin), CYP3A4 inhibitors (e.g., clarithromycin, indinavir, itraconazole, ketoconazole, lopinavir/ritonavir, nefazodone, nelfinavir, posaconazole, ritonavir, saquinavir, telaprevir, telithromycin, verapamil, and voriconazole), and CYP3A4 substrates (e.g., alfentanil, cyclosporine, dihydroergotamine, ergotamine, everolimus, fentanyl, pimozide, quinidine, sirolimus and tacrolimus). See Appendix C for complete list.
Other malignancies within the past 3 years except for adequately treated carcinoma of the cervix or basal or squamous cell carcinomas of the skin.
Female patients who are pregnant or breast feeding/lactating, or adults of reproductive potential who are not using effective birth control methods. If barrier contraceptives are being used, these must be continued throughout the trial by both sexes. Hormonal contraceptives are not acceptable as a method of contraception.
What this trial measures
- The Dose-Limiting Toxicity (DLT) and Recommended Phase II Dose (RP2D)12 weeks
For the Phase 1 portion of the trial Bayesian optimal interval (BOIN) design is being used. a minimum of 3 and a maximum of 12 patients enrolled to determine the dose-limiting toxicity (DLT) and will be the recommended phase II dose (RP2D). • A DLT will be defined as: * Grade 3 or 4 non-hematologic toxicity * Grade 3 neutropenia lasting greater than 21 days * Grade 3 or 4 neutropenia with neutropenic fever * Grade 4 hematologic toxicity events experienced within the first 4 weeks (1 cycle) of study treatment. These will be assessed via National Cancer Institute Common Terminology Criteria for Adverse Events \[NCI CTCAE\] v.5.0 toxicity criteria. The DLT period will be the first cycle (28 days) of therapy.