Actively Recruiting
Bicalutamide and Abemaciclib in Inoperable or Metastatic Androgen Receptor-positive Triple-negative Breast Cancer
Led by Universitaire Ziekenhuizen KU Leuven · Updated on 2026-04-01
53
Participants Needed
6
Research Sites
242 weeks
Total Duration
On this page
Sponsors
U
Universitaire Ziekenhuizen KU Leuven
Lead Sponsor
K
Kom Op Tegen Kanker
Collaborating Sponsor
AI-Summary
What this Trial Is About
This study has as goal to evaluate the use of abemaciclib and bicalutamide in androgen receptor positive metastatic triple negative breast cancer.
CONDITIONS
Official Title
Bicalutamide and Abemaciclib in Inoperable or Metastatic Androgen Receptor-positive Triple-negative Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provide signed informed consent before any study procedures
- Female aged 18 years or older
- Biopsy-confirmed recurrent, unresectable, locally advanced, or metastatic androgen receptor positive triple negative breast cancer
- Androgen receptor positive defined as at least 1% of cells staining on immunohistochemistry (IHC) of last recurrent/metastatic biopsy
- Local biopsy confirmation showing ER and/or PR positive in 10% or fewer cells and HER2 negative per guidelines
- Measurable disease or evaluable bone-only disease that is progressing
- ECOG performance status of 0 to 2 with no recent deterioration and minimum life expectancy of 12 weeks
- Prior treatment with at least one cytostatic regimen in advanced setting unless contraindicated
- Patients with known germline BRCA1/2 variants should have received prior PARP inhibitor treatment unless contraindicated
- Prior treatment with palbociclib or ribociclib allowed if at least 6 months have passed since last dose
- Recovery from acute effects of prior anticancer treatments with certain exceptions
- Completed and recovered from radiotherapy with required washout period
- Negative pregnancy test for females of child-bearing potential and agreement to use effective contraception during and after study participation
You will not qualify if you...
- Treatment with experimental therapies within 30 days or 5 half-lives before randomization
- Current enrollment in incompatible medical research
- Chemotherapy, immunotherapy, or anticancer agents within 21 days before study treatment
- Treatment with palbociclib or ribociclib within 6 months before study treatment
- Prior exposure to abemaciclib or anti-androgen therapies
- Major surgery within 4 weeks before study treatment
- Spinal cord compression, leptomeningeal carcinomatosis, or brain metastases unless stable and asymptomatic
- Concurrent use of endocrine therapy
- Serious or uncontrolled medical conditions that may preclude participation
- Severe or uncontrolled systemic diseases or active infections including hepatitis B, C, or HIV
- Significant cardiac abnormalities or recent cardiac events
- Prior history of blood clots or embolic stroke unless on anticoagulation
- Inadequate bone marrow or organ function based on specified laboratory values
- Liver diseases like cirrhosis or chronic hepatitis
- Severely impaired lung function
- Uncontrolled diabetes
- Gastrointestinal conditions affecting drug absorption
- Active bleeding disorders
- Active systemic infections requiring IV antibiotics
- Allergic reactions to study drugs or similar compounds
- Unlikely to comply with study procedures
- Co-administration with strong CYP3A4 inducers or inhibitors
- Other invasive cancers within past 3 years except certain treated skin or cervical cancers
- Pregnant or breastfeeding females or those not using effective birth control
- Hereditary problems with galactose intolerance or related conditions
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 6 locations
1
ZAS Augustinus
Antwerp, Belgium, 2610
Actively Recruiting
2
Antwerp University Hospital
Antwerp, Belgium
Not Yet Recruiting
3
University Hospital Brussels
Brussels, Belgium
Actively Recruiting
4
Ghent University Hospital
Ghent, Belgium
Actively Recruiting
5
Jessa Ziekenhuis
Hasselt, Belgium
Actively Recruiting
6
University Hospitals Leuven
Leuven, Belgium
Actively Recruiting
Research Team
P
Patrick Neven, MD, PhD
CONTACT
K
Kristien Borremans, MD
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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