NSABP FB-13
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NSABP FB-13

An Assessment of the Biological and Clinical Effects of Palbociclib (PD 0332991) with Ovarian Suppression and Letrozole in the Neoadjuvant Treatment of Patients with Premenopausal Estrogen-Receptor Positive/HER2-Negative Primary Breast Cancer

Protocol Chair: Shannon Puhalla, MD

Protocol Officer: Amy Sing, MD

Primary Objective: To determine complete cell cycle arrest (CCCA) as indicated by a Ki67 < 2.7% at 6 weeks as determined centrally at a CAP/CLIA certified laboratory.

Patient Population: Premenopausal patients with estrogen-receptor (ER) positive, HER2-negative, early invasive breast cancer.

Target Accrual: 76 patients

Status: Recruiting participants

ClinicalTrials.gov Identifier:NCT03628066