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 study is designed to compare the clinical benefit following treatment with letrozole in combination with PD-0332991 versus letrozole in combination with placebo in postmenopausal women with ER(+)/HER2(-) advanced breast cancer who have not received prior systemic anti cancer therapies for their advanced/metastatic disease.

Stanford is not currently accepting new patients for this trial. You may want to check clinicaltrials.gov to see if other locations are recruiting.

Investigator(s):

Intervention(s):

  • drug : PD-0332991
  • drug : Letrozole
  • drug : Placebo
  • drug : Letrozole

Phase: Phase 3

Eligibility

Ages Eligible For Study:

18 Years - N/A

Inclusion Criteria

- Adult women with locoregionally recurrent or metastatic disease not amenable to curative therapy. - Confirmed diagnosis of ER positive breast cancer - No prior systemic anti-cancer therapy for advanced ER+ disease. - Postmenopausal women - Measurable disease as per Response Evaluation Criterion in Solid Tumors [RECIST] or bone-only disease - Eastern Cooperative Oncology Group [ECOG] 0-2 - Adequate organ and marrow function - Patient must agree to provide tumor tissue

External Links

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Contact information

Primary Contact:

Annabel Castaneda 650-498-7977

Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305

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