Palbociclib for HR Positive / HER2-negative Isolated Locoregional Recurrence of Breast Cancer
Status:
Recruiting
Trial end date:
2026-11-01
Target enrollment:
Participant gender:
Summary
POLAR is a phase III clinical trial, which will test the safety and efficacy of an
investigational combination of drugs to learn whether the combination of drugs works for a
specific cancer. Palbociclib (Ibrance®) is the name of the investigational agent, which is
assessed together with standard anti-hormone therapy in this study. Palbociclib is used to
treat patients with hormone receptor-positive / HER2-negative breast cancer which has spread
beyond the original tumor and/or to other organs.
During this study, anti-hormone therapy will consist of either a selective estrogen receptor
modulator (such as tamoxifen) or an aromatase inhibitor (anastrozole, letrozole, exemestane)
or fulvestrant (Faslodex®). Premenopausal women and men may also receive a drug called an
LHRH (luteinizing hormone-releasing hormone) agonist by injection.
It is standard of care for people with hormone receptor positive breast cancer to take
anti-hormone therapy. The study doctor will determine the type of standard anti-hormone
therapy that will be given during this trial.
The purpose of the POLAR study is to compare the effect of using 3 years of palbociclib in
combination with standard anti-hormone therapy with standard anti-hormone therapy alone and
to evaluate the time until the breast cancer returns, if it does return.