OHSU

IRB #

IRB00009239

Title

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

Principal Investigator

Stephen Chui

Study Purpose

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.

Medical Condition(s)

Breast Cancer

Eligibility Criteria

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

Age Range

18 - 100

Healthy Volunteers Needed

No

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.

Minors Included

No

Contact

Knight Clinical Trials Information Line
503-494-1080

Sponsor

Pfizer, Inc.

Recruitment End

12/31/2015

Compensation Provided

No


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