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
The Mission of NSABP Foundation, Inc. is to design and conduct practice changing cancer research, including clinical trials and laboratory studies in the medical, surgical and prevention settings in order to improve the survival outcome and quality of life of patients with breast and colorectal cancer, and to disseminate the results of NSABP collaborative research to benefit the world-wide community.
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