APPALACHES (GBG 100)

Patient recruitment is closed.

We are still looking for patients for this study. You are welcome to make a referral to one of our trial centers. We gladly inform you of the nearest trial center by email.

The inclusion and exclusion criteria can be found at the bottom of the page.

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 fulfilling the inclusion criteria will be centrally registered at EORTC after written informed consent has been obtained.
Randomization will be stratified by country, pathological TNM stage (stage II versus stage III) and potential clinical frailty as defined by the G8 geriatric assessment score (>14 versus ≤14). Patients will be randomized with a 2:1 allocation rate to the following treatment arms:

• 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: standard adjuvant chemotherapy, followed by standard adjuvant endocrine therapy for a duration of at least 5 years.

The primary endpoint of the study is the 3-year DRFI rate in the experimental arm.
All patients will be followed-up up to 10 years after randomization or until they experienced a DRFI event.
Because the tolerability of a long-term (two years) treatment with palbociclib in older patients might be an issue, a safety interim analysis will be conducted based on treatment discontinuation rate in the experimental arm.