A Randomized, Multicenter, Double-Blind Phase 3 Study of PD-0332991 (Oral CDK 4/6 Inhibitor) plus Letrozole versus Placebo plus Letrozole for the Treatment of Postmenopausal Women with ER (+), HER2 (-) Breast Cancer Who Have Not Received Any Prior Systemic Anti-Cancer Treatment for Advanced Disease
The purpose of this study is to compare the effects of PD-0332991 (the study drug) in combination with letrozole with placebo in combination with letrozole to find out which is better for treating advanced breast cancer.
1. Adult women age 18 years or older who are postmenopausal
2. Documented diagnosis of estrogen-receptor positive (ER+) breast cancer
3. Previously untreated with any anti-cancer therapy for recurrent or metastatic ER+ disease
4. Other criteria apply
18 - 100
Healthy Volunteers Needed
Duration of Participation
You may receive the study drug/placebo and letrozole as long as you are benefitting and do not experience unacceptable side effects. After you stop taking the study drugs the study team will contact you by telephone once every six months for life.
Knight Clinical Trials Information Line