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A Phase II Randomized Study Evaluating the Biological and Clinical Effects of the Combination of Palbociclib with Letrozole as Neoadjuvant Therapy in Post-Menopausal Women with Estrogen-Receptor Positive Primary Breast Cancer

Protocol Chair: Shannon Puhalla, MD

Protocol Officer: Samuel Jacobs, MD

Primary Objective: To determine the clinical response by ultrasound according to ECOG criteria after

14 weeks of therapy with letrozole with or without palbociclib.To compare the changes in the proliferation marker Ki67 (% positive tumor cells) as tested by immunohistochemistry (IHC) from baseline and following 14 weeks of treatment with letrozole with or without palbociclib.

Patient Population: Postmenopausal women with estrogen-receptor positive, HER2-negative, invasive breast cancer suitable for neoadjuvant therapy with letrozole

Target Accrual: 306 patients

Status: Closed to accrual

ClinicalTrials.gov Identifier: NCT02296801