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).
Single group
Abemaciclib
Drug150 mg tablet orally twice daily
Bicalutamide
Drug150 mg tablet orally once daily
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.
Number of participants with (serious) adverse events, death and clinical abnormalities per Common Terminology Criteria for Adverse Events (CTCAE) v5.0
Based on clinically relevant changes from baseline for vital signs and laboratory findings. CTCAE v5.0 uses a range of grades from 1 to 5: grade 1 = mild; grade 2 = moderate; grade 3 = severe; grade 4 = life-threatening; grade 5 = death
HRQoL change from baseline as measured by EORTC QLQ-C30
The European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaires Core-30 item (QLQ-C30) is a self-assessed, health related, quality of life questionnaire. The scale measures quality of life on a 5-component scale including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The possible scores for question 1 to 28 are: 1 = not at all; 2 = a little; 3 = quite a bit; 4 = very much. A lower score means a worse outcome. The possible scores for question 29 and 30 are between 1 and 7 with 1 = very poor and 7 = excellent. A higher score means a better outcome.
Number of participants with disease control at 16 weeks in subgroup with androgen receptor (AR) positivity on immunohistochemistry (IHC) in ≥10% of cells.
Disease control rate (DCR) at 16 weeks for treatment with abemaciclib in combination with bicalutamide in the subgroup with positive AR IHC in ≥10% of cells. 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.
Number of participants with disease control at 16 weeks in subgroups A, B, C and D separate
Disease control rate (DCR) at 16 weeks for treatment with abemaciclib in combination with bicalutamide in subgroups A, B, C and D separate. 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.
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Universitaire Ziekenhuizen KU Leuven
Lead sponsor
Kom Op Tegen Kanker
Collaborator
Eli Lilly and Company
Collaborator
Teva Pharma
Collaborator
