A 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

Protocol: 
AAAO8357
Phase: 
III

A 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

This study is being done to look at the effects, good and bad, of the investigational drug, palbociclib, on you and your breast cancer when it is given in combination with endocrine therapy. Palbociclib is considered to be investigational (still being researched) because it has not yet been approved by health authorities for the treatment of any disease, including breast cancer.

Are you Eligible? (Inclusion Criteria)

To be eligible for this study, patients must:
- be at least 18 years old when diagnosed with breast cancer
- be otherwise healthy and have not concurrent infections
- have hormone receptor (estrogen receptor and/or progesterone receptor)
positive breast cancer
- have been treated with chemotherapy before surgery
- be a woman who has breast cancer still present at the time of surgery

Specialty Area(s)

Trial Location

Herbert Irving Comprehensive Cancer Center
161 Fort Washington Ave.
Herbert Irving Pavilion
New York, NY 10032
United States