RecruitingPhase 2

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

Belgium53 participantsStarted 2024-04-08

Plain-language summary

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

Who can participate

Age range18 Years

SexFEMALE

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Inclusion criteria

✓. 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

Exclusion criteria

✕. 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, 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)

What they're measuring

Number of participants with disease control at 16 weeks

Timeframe: Week 16

Trial details

NCT IDNCT06365788

SponsorUniversitaire Ziekenhuizen KU Leuven

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-12

Contact for this trial

Patrick Neven, MD, PhD

+3216344750 patrick.neven@uzleuven.be

View on ClinicalTrials.gov More Triple Negative Breast Neoplasms trials