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Breast CancerPhase 1/2NCT05095207

Abemaciclib in Combination With Bicalutamide for Androgen Receptor-positive, HER2-negative Metastatic Breast Cancer

A Phase 1/2 study testing Abemaciclib and Bicalutamide in people with Breast Cancer and Metastasis, run by Icahn School of Medicine at Mount Sinai at 3 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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 Read more about this study

Who is it for?
Ages 18 to 90 yearsHealthy volunteers can take part
Conditions the study is for
Breast Cancer, Metastasis
What is being tested?
Abemaciclib and Bicalutamide
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
42 participants
Where
3 sitesUnited States
Study dates
20 Sep 2021to Jun 2028
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 90 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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)
  • o The patient has measurable or evaluable disease as evidenced on pre-treatment baseline CT chest, abdomen, and pelvis with bone scan OR PET/CT
  • The patient has AR+ breast cancer (defined as > or equal to 1% staining on immunohistochemistry of metastatic breast cancer specimen)
Show all 27Show fewer
  • 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:
  • o patient must have had 1 prior line of endocrine therapy in the metastatic setting
  • 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"):
  • o The patient may have had up to 4 prior lines of chemotherapy in the metastatic setting and at least 1 prior line of chemotherapy in the metastatic setting
  • 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.
  • If the patient does not meet criteria for postmenopausal status but is receiving ovarian ablation therapy with a gonadotropin-releasing hormone (GnRH) agonist such as goserelin or leuprolide, the patient is eligible for the study, provided that the GnRH agonist is started at least 2 weeks prior to C1D1 of study therapy.
  • Negative serum pregnancy test within 7 days prior to starting treatment
  • Women of child-bearing potential and men must agree to use a highly effective method of contraception prior to study entry, for the duration of study participation, and for 3 weeks following completion of therapy. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately, as cases of pregnancy that occur during maternal exposures to abemaciclib should be reported. If a patient or spouse/partner is determined to be pregnant following abemaciclib initiation, she must discontinue treatment immediately. Data on fetal outcome and breast-feeding are to be collected for regulatory reporting and drug safety evaluation.
  • Note: Recommended methods of birth control are: The consistent use of an intrauterine device (IUD), Double barrier methods (Diaphragm with spermicidal gel or condoms with contraceptive foam), Sexual abstinence (no sexual intercourse) or Sterilization.
  • Men must agree to use a condom and not father a child or donate sperm for the duration of the study and for 90 days after completion of therapy.
  • A female of child-bearing potential is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:
  • 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).

Who cannot join

  • Treatment with any of the following:
  • Any investigational agents or study drugs from a previous clinical study within 28 days of the first dose of study treatment
  • Any other chemotherapy, immunotherapy or anticancer agents within 21 days of the first dose of study treatment
  • Any prior exposure to anti-androgen therapy (bicalutamide, abiraterone, and/or enzalutamide)
  • 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
Show all 39Show fewer
  • 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:
  • Mean resting corrected QT interval (QTc) > 470 msec obtained from 3 consecutive electrocardiograms (ECGs)
  • Any clinically important abnormalities in rhythm, conduction or morphology of resting ECG (e.g., complete left bundle branch block, third degree heart block)
  • Any factors that increase the risk of QTc prolongation or risk of arrhythmic events such as heart failure, abnormalities in serum electrolytes, congenital long QT syndrome, family history of long QT syndrome or unexplained sudden death under 40 years of age or any concomitant medication known to prolong the QT interval
  • Personal history of syncope of cardiovascular etiology, ventricular arrhythmia (of pathologic origin including, but not limited to, ventricular tachycardia and ventricular fibrillation), or sudden cardiac arrest.
  • Experience of any of the following procedures or conditions in the preceding 6 months: coronary artery bypass graft, angioplasty, vascular stent, myocardial infarction, angina pectoris, congestive heart failure NYHA Grade 2 or greater
  • Uncontrolled hypotension - Systolic BP <90mmHg and/or diastolic BP <50mmHg
  • Left ventricular ejection fraction (LVEF) below lower limit of normal for site
  • 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:
  • Absolute neutrophil count < 1.5 x 109/L
  • Platelet count < 100 x 109/L
  • Hemoglobin < 8 g/L (Patients may receive erythrocyte transfusions to achieve this hemoglobin level at the discretion of the investigator. Initial treatment must not begin earlier than the day after the erythrocyte transfusion.)
  • Alanine aminotransferase > 3 times the upper limit of normal (ULN)
  • Aspartate aminotransferase > 3 times ULN
  • Total bilirubin > 1.5 times ULN (patients with Gilbert's syndrome with a total bilirubin ≤2.0 times ULN and direct bilirubin within normal limits are permitted)
  • Creatinine >1.5 times ULN concurrent with creatinine clearance < 50 ml/min (measured or calculated by Cockcroft and Gault equation); confirmation of creatinine clearance is only required when creatinine is > 1.5 times ULN
  • Proteinuria 3+ on dipstick analysis or >500mg/24 hours
  • Sodium or potassium outside normal reference range for site
  • 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.

Trial locations and contacts

3 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Laura A Fiedler, MPH contact

(646) 957-1407

laura.fiedler@mssm.edu

Esther Kim, CRC contact

esther.kim@mssm.edu

United States3 sites, 3 recruiting

  • Mount Sinai Beth Israel

    New York, New York, 10003

    Recruiting

  • Mount Sinai - West

    New York, New York, 10019

    Recruiting

  • Dubin breast Center

    New York, New York, 10029

    Atul G Joshi, MS, 212-824-7320, gargiatul.joshi@mssm.edu

    Amy Tiersten

    Recruiting

Other trials in United States

About this study

Official title: A Multicenter, Phase IB/II Study of Abemaciclib in Combination With Bicalutamide for Androgen Receptor-positive, HER2-negative Metastatic Breast Cancer

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

Read the detailed description

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 About 54-60 patients will be enrolled over the course of 36 months. Patients will be treated until disease progression.

Study regimen is Abemaciclib with Bicalutamide

Primary objective is to determine the dose-limiting toxicity (DLT) and recommended phase II dose for abemaciclib when administered in combination with bicalutamide and to determine the efficacy of the treatment secondary objective is to determine the safety and tolerability along with progression free survival.

Given the suggestive pre-clinical data and the unique properties of abemaciclib, the researchers believe that abemaciclib is an ideal partner for bicalutamide in treatment of AR+ metastatic breast cancer. The study team hypothesize that the combination will demonstrate a further improved clinical benefit rate than either agent alone, including in those patients who have already been treated with prior endocrine therapies. Additionally, the study team believe that the convenience of an all-oral, continuous daily dosing schedule and the favorable side effect profile of both therapies with minimal overlapping or serious toxicities further supports this investigation.

Being tested
Abemaciclib, Bicalutamide
Keywords
Breast Cancer, Androgen Receptor-positive, HER2 negative, Abemaciclib, Bicalutamide
Medical subject headings
Breast Neoplasms, Neoplasm Metastasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AbemaciclibDrug

    100 mg orally twice daily, day 1 to 28. If no toxicity in cycle 1 for the first 3 patients, increase dose to 150mg orally twice daily day 1-28 and enroll 3 patients. If excessive toxicity experienced at 100mg orally twice daily dose, decrease dose to 50mg orally twice daily day 1-28.

  • BicalutamideDrug

    150 mg orally daily, day 1 to 28.

Study groups in NCT05095207
Study groupRoleWhat they receive
Participants with Androgen Receptor-positive, HER2-negative Metastatic Breast CancerExperimentalAbemaciclib in Combination with Bicalutamide
Receives: Drug: Abemaciclib; Drug: Bicalutamide

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The Dose-Limiting Toxicity (DLT) and Recommended Phase II Dose (RP2D)

    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.

    Measured: 12 weeks

Secondary outcomes (2)

  1. Frequency of Adverse Events (AE)

    The frequency and percentage of AE associated with abemaciclib in combination with bicalutamide by the type, severity (as graded by the NCI CTCAE v.5.0), and relationship to study medications.

    Measured: 12 weeks

  2. Disease Control Rate (DCR)

    Disease Control Rate (DCR) is defined as the percentage of patients whose cancer shrinks or remains stable over the duration of the study. This will be measured as the sum of complete response (CR), partial response (PR), and stable disease (SD) for greater than or equal to 24 weeks.

    CR: Disappearance of all target lesions, determined by two separate observations conducted not less than 4 weeks apart. There can be no appearance of new lesions.

    PR: At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. There can be no appearance of new lesions.

    PD: At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started, or the appearance of one or more new lesions.

    SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started

    Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Oct 2021
  2. Study start20 Sep 2021
  3. Primary completionJun 2027 (estimated)
  4. Study completionJun 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
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 RP2D. The 3-9 patients evaluated at the RP2D of the Phase I part of the trial will be enrolled and included in the Phase II part of the trial. If 2 or fewer among 12 patients in the first stage of Phase II have disease control, the trial will stop. However, if at least 3 have disease control in the first stage, then an additional 33 patients will be enrolled in the second stage, for a total of 46 patients. If among the 46 patients, 12 or fewer achieved complete response, partial response or stable disease, the treatment regimen under investigation in this trial will be rejected; or if at least 13 out of the 46 patients respond, the treatment regimen will be considered worthy of further study. The total sample size for Phase I and II portions combined is a minimum of 3 and a maximum of 60.
Masking
None (open label)
Enrolment
42 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05095207
Sponsor's protocol ID
GCO 21-0699
Status last verified
Apr 2026
First submitted
14 Oct 2021
Last updated
13 Apr 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: All of the individual participant data collected during the trial, after deidentification.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Abemaciclib and Bicalutamide in people with Breast Cancer and Metastasis, run by Icahn School of Medicine at Mount Sinai at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 27 inclusion and 39 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Laura A Fiedler, MPH ((646) 957-1407, laura.fiedler@mssm.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The Dose-Limiting Toxicity (DLT) and Recommended Phase II Dose (RP2D) (time frame: 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05095207.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026; AzTrials last refreshed its copy on 26 Oct 2026.

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