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Palbociclib for HR Positive / HER2-negative Isolated Locoregional Recurrence of Breast Cancer (POLAR)
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.
Details
| Lead sponsor | ETOP IBCSG Partners Foundation |
|---|---|
| Phase | PHASE3 |
| Status | ACTIVE_NOT_RECRUITING |
| Enrolment | 405 |
| Start date | Tue Aug 27 2019 00:00:00 GMT+0000 (Coordinated Universal Time) |
| Completion | Mon Jan 01 2029 00:00:00 GMT+0000 (Coordinated Universal Time) |
Conditions
- Breast Cancer Recurrent
Interventions
- Palbociclib 125mg
- Standard endocrine therapy
Countries
Spain, Austria, Hungary, Italy, France, Switzerland