This study has as goal to evaluate the use of abemaciclib and bicalutamide in androgen receptor positive metastatic triple negative breast cancer.
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
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).
Universitaire Ziekenhuizen KU Leuven
Lead sponsor
Kom Op Tegen Kanker
Collaborator
Eli Lilly and Company
Collaborator
Teva Pharma
Collaborator