Bicalutamide and Abemaciclib in Inoperable or Metastatic Androgen Receptor-positive Triple-negative Breast Cancer

NCT06365788 | Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: S664662022-502272-23-00
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 6

Brief Summary

This study has as goal to evaluate the use of abemaciclib and bicalutamide in androgen receptor positive metastatic triple negative breast cancer.

Conditions

Triple Negative Breast Neoplasms

Keywords

Triple Negative Breast Cancer; Receptors, Androgen

Outcome Measures

Primary Outcomes (1)

• Number of participants with disease control at 16 weeks

  Disease control rate at week 16 in all patients (cohorts A, B, C and D combined) treated at the selected dose level. DCR is defined as the proportion of patients that present with stable disease, partial response or complete response per RECIST 1.1 at 16 weeks after treatment initiation.

  Week 16

Secondary Outcomes (9)

• Number of participants with (serious) adverse events, death and clinical abnormalities per Common Terminology Criteria for Adverse Events (CTCAE) v5.0

  2 years

• HRQoL change from baseline as measured by EORTC QLQ-C30

  2 years

• Number of participants with disease control at 16 weeks in subgroup with androgen receptor (AR) positivity on immunohistochemistry (IHC) in ≥10% of cells.

  Week 16

• Number of participants with disease control at 16 weeks in subgroups A, B, C and D separate

  Week 16

• Number of participants with disease control at 24 weeks

  Week 16

Study Arms (1)

Abemaciclib and bicalutamide

EXPERIMENTAL

Participants receive Abemaciclib 150 mg tablet orally twice daily and Bicalutamide 150 mg orally once daily until disease progression or unacceptable toxicity.

Drug: Abemaciclib; Drug: Bicalutamide

Interventions

Abemaciclib DRUG

150 mg tablet orally twice daily

Also known as: Verzenios

Abemaciclib and bicalutamide

Bicalutamide DRUG

150 mg tablet orally once daily

Also known as: Bicalutamide Teva

Abemaciclib and bicalutamide

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Provision of signed and dated, written informed consent prior to any study specific procedures, sampling and analysis. If a patient declines to participate in any voluntary exploratory research of the study, there will be no loss of benefit to the patient and 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 AR+ TNBC
• AR+ assessed locally and defined as ≥1% of cells staining on IHC of last recurrent/metastatic breast cancer specimen
• Local biopsy confirmation of last recurrent/metastatic site with positive IHC for ER and/or PR in ≤10% of cells and negative for HER2 per ASCO/CAP-guidelines
• Prior invasive (metastatic) breast cancer with positive IHC for ER and/or PR in \>10% of cells is allowed, provided the last biopsy of recurrent/metastatic disease has positive IHC for ER and/or PR in ≤10% of cells
• Prior invasive (metastatic) HER2-positive breast cancer per ASCO/CAP-guidelines is not allowed
• The patient has measurable disease per RECIST 1.1 or evaluable bone-only disease with lytic or mixed component that is progressive as evidenced on pre-treatment baseline imaging
• Eastern Cooperative Oncology Group (ECOG) performance status 0-2 with no deterioration over the previous 2 weeks and minimum life expectancy of 12 weeks
• The patient must have had prior treatment with at least 1 prior cytostatic regimen in advanced setting setting unless treatment with a cytostatic regimen is contraindicated as judged by Investigator. There is no upper limit for prior treatment lines in advanced setting.
• 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.
• Prior treatment with palbociclib or ribociclib is allowed, provided at least 6 months have elapsed between last administration and start of study treatment
• Patients must have recovered (Common Terminology Criteria for Adverse Events \[CTCAE\] Grade ≤1) from the acute effects of prior anticancer treatment except for residual Grade 2 alopecia, anemia or peripheral neuropathy prior to randomization. A washout period of at least 21 days is required between last chemotherapy dose and first dose of study drug (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.
• In females of child-bearing potential, a negative serum or urine pregnancy test within 7 days prior to starting treatment is required. Women of child-bearing potential must agree to use a highly effective method of contraception prior to study entry, for the duration of study participation (in addition to the LHRH-agonist), and for 3 weeks following completion of abemaciclib and for 130 days following completion of bicalutamide.

You may not qualify if:

• Treatment with any of the following:
• a. Any experimental treatment in a clinical trial within the last 30 days or 5 half-lives, whichever is longer, prior to randomization.
• b) Currently enrolled in any other type of medical research (for example: medical device) judged by the sponsor not to be scientifically or medically compatible with this study.
• c. Any other chemotherapy, immunotherapy or anticancer agents within 21 days of the first dose of study treatment d. Treatment with palbociclib or ribociclib within 6 months of the first dose of study treatment e. Any prior exposure to abemaciclib f. 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, stable at baseline imaging and not requiring corticosteroids \>10 mg prednisolone daily (or equivalent) for at least 2 weeks prior to start of study treatment
• Concurrent use of endocrine therapy (tamoxifen, anastrozole, letrozole, exemestane, oral contraceptive pills)
• 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).
• 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 (eg, 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, hypokalemia, 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

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead
• Kom Op Tegen Kanker: collaborator
• Eli Lilly and Company: collaborator
• Teva Pharma: collaborator

Study Sites (6)

ZAS Augustinus

Antwerp, 2610, Belgium

RECRUITING

Antwerp University Hospital

Antwerp, Belgium

NOT YET RECRUITING

University Hospital Brussels

Brussels, Belgium

RECRUITING

Ghent University Hospital

Ghent, Belgium

RECRUITING

Jessa Ziekenhuis

Hasselt, Belgium

RECRUITING

University Hospitals Leuven

Leuven, Belgium

RECRUITING

MeSH Terms

Conditions

Triple Negative Breast Neoplasms; Bulbo-Spinal Atrophy, X-Linked

Interventions

abemaciclib; bicalutamide

Condition Hierarchy (Ancestors)

Breast Neoplasms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Muscular Atrophy, Spinal; Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Motor Neuron Disease; Neuromuscular Diseases; Genetic Diseases, X-Linked; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Patrick Neven, MD, PhD

  Universitaire Ziekenhuizen KU Leuven

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Patrick Neven, MD, PhD

CONTACT

+3216344750; patrick.neven@uzleuven.be

Kristien Borremans, MD

CONTACT

+321647795; kristien.borremans@kuleuven.be

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 11, 2023
• First Posted: April 15, 2024
• Study Start: April 8, 2024
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2028
• Last Updated: April 1, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

BE (6)