Clinical Trials

Text Size A A

E-Mail to a Friend






secret  Click to Play Audio


SCCA Breast Cancer Clinical Trials

PD-0332991 + Letrozole vs. Letrozole ER+/HER2- Advanced Breast Cancer (UW13012)
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
Status Conditions Phase Study ID
Closed Breast Neoplasms Phase III UW13012
NCT01740427
Summary

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.


Investigator
Jennifer M. Specht, MD
Location    
Seattle Cancer Care Alliance 800-804-8824  
Eligibility Criteria (must meet the following to participate in this study)
  • 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
Exclusions (conditions that would prevent participation in this study)
  • Confirmed diagnosis of HER2 positive disease
  • Patients with advanced, symptomatic, visceral spread that are at risk of life threatening complication in the short term
  • Known uncontrolled or symptomatic CNS metastases
  • Prior (neo)adjuvant treatment with letrozole or anastrozole with DFI ≤ 12-months from completion of treatment.
  • Prior treatment with any CDK 4/6 inhibitor.
Last Updated
September 02, 2014
See this trial at ClinicalTrials.gov
Access protocol and consent forms at Fred Hutchinson Cancer Research Center
Disclaimer: We update this information regularly. However, what you read today may not be completely up to date.

Please remember:
  • Talk to your health care providers first before making decisions about your health care.
  • Whether you are eligible for a research study depends on many things. There are specific requirements to be in research studies. These requirements are different for each study.