Official Title: PALbociclib rechallenge in horMone receptor-posItive/HER2-negative Advanced breast cancer – PALMIRA.
International, multicenter, randomized, open-label, phase II clinical trial to evaluate the efficacy and safety of continuation of palbociclib in combination with second-line endocrine therapy in hormone receptor-positive/HER2-negative advanced breast cancer patients who have achieved clinical benefit during first-line palbociclib-based treatment.
The primary goal is to compare the efficacy, defined as Progression-Free Survival (PFS), of continuation of palbociclib treatment combined with second-line endocrine therapy (fulvestrant or letrozole) versus endocrine therapy alone in pre- and post-menopausal women with HR-positive/HER2-negative Advanced Breast Cancer (ABC).
In addition, to explore potential molecular markers of sensitivity and/or resistance for the combination and endocrine therapy alone.
PALMIRA at clinicaltrials.gov