ABCSG 49 / POLAR
Status: Treatment Phase & Follow-up
A phase III open-label, multicenter, randomized trial of adjuvant palbociclib in combination with endocrine therapy versus endocrine therapy alone for patients with hormone receptor positive / HER2-negative resected isolated locoregional recurrence of breast cancer
| Coordinating Investigator Austria: | Gabriel Rinnerthaler (Graz) |
| Start of study: | 08/2019 (global) 11/2020 (national) |
| Sample size: | 400 (global), 50 (national) |
| Sponsor (Österreich): | ETOP IBCSG Partners Foundation |
Description and status:
The ABCSG 49 / POLAR study examines adjuvant palbociclib treatment combined with endocrine therapy versus endocrine therapy alone, for patients with HR-positive/HER2-negative resected isolated locoregional recurrence of breast cancer. The trial is sponsored by ETOP IBCSG Partners Foundation and started with the ”First Patient In“ in Switzerland in August 2019. Globally, a total of 45 sites are participating in countries such as Italy, Spain, Switzerland, Hungary, France as well as three sites in Austria. In order to enroll 400 patients worldwide, the recruitment phase lasted until December 2024, with 19 patients coming from Austrian sites. The treatment phase will last 3 years.
It is commonly known that adjuvant chemotherapy and endocrine therapy can reduce the recurrence of breast cancer in patients with primary breast cancer. However, so far only limited data is available serving as a basis for recommendations on the systemic treatment of locoregional recurrence. In view of the documented activity and safety of palbociclib in the first-line treatment of metastatic HR-positive/HER2-negative breast cancer, there is interest in whether the benefits of CDK4/6 inhibition may translate into the adjuvant setting prolonging invasive disease-free survival (iDFS) which is the purpose of the POLAR trial.
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