Palbociclib + Bicalutamide for Breast Cancer
Trial Summary
Do I need to stop my current medications to join the trial?
The trial protocol does not specify if you must stop all current medications, but you should avoid medications that strongly affect CYP3A4, as they can interact with palbociclib. It's best to discuss your current medications with the trial team to see if any changes are needed.
What data supports the effectiveness of the drug combination Palbociclib and Bicalutamide for breast cancer?
Palbociclib has been shown to be effective in treating hormone receptor-positive, HER2-negative advanced breast cancer when combined with other drugs like fulvestrant, significantly improving progression-free survival. This suggests that Palbociclib may be beneficial in similar drug combinations for breast cancer treatment.12345
Is the combination of Palbociclib and Bicalutamide safe for humans?
Palbociclib has been studied extensively and is generally considered safe for treating certain types of breast cancer in both men and women, with no new safety concerns identified in recent studies. However, specific safety data for the combination of Palbociclib and Bicalutamide is not available in the provided research.26789
What makes the drug Palbociclib unique for breast cancer treatment?
What is the purpose of this trial?
The purpose of this study is to test the safety and effectiveness of the investigational drug, palbociclib with bicalutamide for the treatment of triple negative, androgen receptor positive breast cancer.
Research Team
Ayca Gucalp, MD
Principal Investigator
Memorial Sloan Kettering Cancer Center
Eligibility Criteria
This trial is for postmenopausal women with AR(+) metastatic breast cancer who haven't been treated with bicalutamide or CDK4/6 inhibitors. Participants must have adequate organ function, not be pregnant, and agree to use contraception. They should have recovered from previous treatments and cannot have active severe illnesses or a history of certain heart conditions.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Phase I Treatment
Dose finding lead-in to establish the recommended phase II doses for the combination of palbociclib and bicalutamide using a standard 3+3 design
Phase II Treatment
Efficacy evaluation of palbociclib and bicalutamide at the recommended phase II dose
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Bicalutamide
- Palbociclib
Bicalutamide is already approved in European Union, United States, Japan, Canada for the following indications:
- Metastatic prostate cancer
- Locally advanced prostate cancer
- Metastatic prostate cancer
- Metastatic prostate cancer
- Locally advanced prostate cancer
- Metastatic prostate cancer
- Locally advanced prostate cancer
Find a Clinic Near You
Who Is Running the Clinical Trial?
Memorial Sloan Kettering Cancer Center
Lead Sponsor
Pfizer
Industry Sponsor
Albert Bourla
Pfizer
Chief Executive Officer since 2019
PhD in Biotechnology of Reproduction, Aristotle University of Thessaloniki
Patrizia Cavazzoni
Pfizer
Chief Medical Officer
MD from McGill University