ARV-471 + Palbociclib for Breast Cancer
(mBC Trial)
Trial Summary
What is the purpose of this trial?
This trial is testing a new drug called ARV-471 alone and with palbociclib in patients with advanced breast cancer who have tried other treatments. ARV-471 breaks down proteins that help cancer grow, and palbociclib stops cancer cells from multiplying.
Eligibility Criteria
This trial is for postmenopausal women with ER+/HER2- advanced breast cancer who've had prior hormonal therapy and chemotherapy. They must have measurable disease, be over 18, willing to undergo biopsies, and can't have more than two prior chemo regimens for advanced disease or symptomatic brain metastases.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive ARV-471 alone or in combination with palbociclib in 28-day cycles to assess safety, tolerability, and anti-tumor activity
Follow-up
Participants are monitored for safety and effectiveness after treatment
Open-label extension (optional)
Participants may opt into continuation of treatment long-term
Treatment Details
Interventions
- ARV-471
- Palbociclib (IBRANCE®)
ARV-471 is already approved in United States for the following indications:
- None approved; under investigation for ER+/HER2- metastatic breast cancer
Find a Clinic Near You
Who Is Running the Clinical Trial?
Arvinas Inc.
Lead Sponsor
Arvinas Estrogen Receptor, Inc.
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