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 No
NSABP-FND-FB-13
Principal Investigator
Lubna Chaudhary
Phase
II
Summary
The main purpose of this study is to look at the safety and effectiveness of the combination of palbociclib and letrozole and ovarian suppression for premenopausal patients who have ER positive/HER2-negative breast cancer that has not yet been treated. Letrozole is a type of endocrine therapy called an aromatase inhibitor (AI) and is standard treatment for post-menopausal women with ER-positive/HER2-negative breast cancer. Letrozole is considered investigational by Health Canada in this study because it has not been approved for the treatment of breast cancer in premenopausal women. Palbociclib is a targeted therapy for ER-positive/HER2-negative breast cancer. A targeted therapy stops cancer cells from growing by targeting and blocking the proteins that help cancer cells to grow. Palbociclib is approved by the U.S. Food and Drug Administration (FDA) for use in combination with letrozole to treat advanced and metastatic breast cancer. Palbociclib is considered investigational in this study because it is not approved by the FDA or Health Canada for use in early breast cancer. Goserelin is a type of therapy which is used to suppress (stop) production of sex hormones (testosterone and estrogen). In this study goserelin is being administered to reduce the amount of estrogen to shut down (suppress) ovarian function in women diagnosed with breast cancer before the time of menopause. This study is being done for the following reasons. The purpose of the study is to determine the effects of letrozole and palbociclib with ovarian suppression on the protein markers associated with ER-positive/HER2-negative breast cancer in premenopausal women. The second purpose of the study is to determine how breast cancer in premenopausal women responds to letrozole with palbociclib with ovarian suppression following 24 weeks of study therapy. • The study includes special research tests using samples from your blood and tumor tissue that are not part of regular cancer care. These required research samples will be explained to you in more detail later in this consent.
Description
Effect of Palbociclib with Ovarian Suppression and Letrozole in Neoadjuvant Treatment of Breast Cancer
Participating Institutions
Froedtert Hospital
Status
OPEN TO ACCRUAL
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