Adjuvant Palbociclib in Elderly Patients With Breast Cancer

The primary objective of this trial is to assess the efficacy of the combination of at least 5 year endocrine therapy and 2 year‐palbociclib as adjuvant systemic treatment instead of adjuvant chemotherapy followed by endocrine therapy in older patients with stage II‐III ER+/HER2‐ early breast cancer. This is a two‐arm open‐label multi‐center randomized (2:1) non‐comparative phase II study in elderly patients with stage II/III, ER+, HER2‐ early breast cancer for whom treatment with chemotherapy is indicated. Patients will be randomized with a 2:1 allocation rate to the following treatment arm: ‐ experimental palbociclib arm: Standard adjuvant endocrine therapy for a duration of at least 5 years + palbociclib for a total duration of up to 2 years. ‐ control chemotherapy arm: adjuvant chemotherapy (4 cycles of docetaxel/doxorubicin/epirubicin‐cyclophosphamide; or of weekly paclitaxel D1, D8, and D15 q3w if a 3 weekly schedule is not desired), followed by standard adjuvant endocrine therapy for a duration of at least 5 years. The primary endpoint of the study is the 3‐year D‐RFI rate in the experimental arm.