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Palbociclib in HR-Positive/HER2-Normal Early Breast Cancer

Clinical Trial Title: 
Phase III study evaluating palbociclib (PD-0332991), a cyclin-dependent kinase (CDK) 4/6 inhibitor in patients with hormone-receptor-positive, HER2-normal primary breast cancer with high relapse risk after neoadjuvant chemotherapy "PENELOPEB."
Clinical Trial Protocol ID: 
14071602
Clinical Trial Investigator Name: 
Melody A. Cobleigh, MD
Clinical Trial Protocol Description: 

This study tests a drug called palbociclib compared to placebo in pre- and postmenopausal women with HR-positive/HER2-normal early breast cancer at high risk of relapse after showing less than pathological complete response to neoadjuvant taxane-containing chemotherapy.

Clinical Trial Eligibility Criteria: 

In order to participate you must meet the following criteria:

  • Have high-risk primary breast cancer.
  • Have estrogen and/or progesterone positive and HER2 negative.
  • Have received at least 16 weeks of neoadjuvant chemotherapy, including 6 weeks of a taxane-based therapy.
  • Has been less than 16 weeks since the date of final surgery or less than 10 weeks from completing radiotherapy (whichever occurs last).

You will be excluded from the study if any of the following criteria apply to you:

  • Have hemoglobin < 10, ANC < 2.0.
  • Have active inflammatory bowel disease or chronic diarrhea, short bowel syndrome, or any upper gastrointestinal surgery including gastric resection.
  • Have had prior treatment with any CDK4/6 inhibitor.
  • Are a male patient.

This is a partial list of inclusion and exclusion criteria.

Clinical Trial Area: 
Breast Cancer
Contact Phone: 
(312) 942-3732
Contact Name: 
Chrystie Paul, RN, BSN