Pfizer Enrolls HR+, HER2- Advanced Breast Cancer Patients in Palbociclib Expanded Access Program

Pfizer Enrolls HR+, HER2- Advanced Breast Cancer Patients in Palbociclib Expanded Access Program
pfizer breast cancer drugPfizer is preparing to initiate a multi-center, open-label expanded access program (EAP) for an investigational treatment  for post-menopausal women with hormone receptor positive (HR+), human epidermal growth factor receptor 2 negative (HER2-) advanced breast cancer in the United States. The program aims to test the novel cyclin-dependent kinases (CDK) 4/6 inhibitor palbociclib in combination with letrozole, which is already used to treat the condition. The company is seeking to enroll post-menopausal women who are 18 years of age or more and have a proven diagnosis of advanced adenocarcinoma of the breast, including loco regionally recurrent or metastatic disease and ER-positive and/or PR-positive tumor based on local laboratory results, as well as HER2-negative tumor based on local laboratory results. Patients must be appropriate candidates for letrozole therapy and must not have previously participated in a palbociclib trial or received prior treatment with any CDK inhibitor. During the trial, Palbociclib will be administered orally once a day at 125 mg/day for 21 days followed by 7 days off treatment for each 28-day cycle, while Letrozole will be administered orally at 2.5 mg once daily as continuous daily dosing schedule according to product labeling and in compliance with its local prescribing information. “Palbociclib is being evaluated as a potential new treatment for women wit
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