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Study Evaluating CCI-779 and Letrozole in Post-menopausal Women With Breast Cancer

NCT00083993 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1236

Last updated 2011-11-08

No results posted yet for this study

Summary

In this clinical research study, postmenopausal subjects with metastatic breast cancer will be given either the combination of temsirolimus (CCI-779) and letrozole or a placebo and letrozole in first-line hormonal treatment. The primary endpoint of this study is to determine overall progression free survival.

Individual subjects will participate in the active treatment phase of the study until disease progression or withdrawal of consent, provided that test article is being tolerated. All subjects will be asked to participate in the long-term follow-up phase of the study, which includes follow-up every 3 months until disease progression (for subjects who withdraw for reasons other than documented progressive disease) or until any new cancer treatment is received, and for survival. The estimated duration of study participation is 34 months.

Conditions

  • Breast Neoplasms
  • Neoplasm Metastasis

Interventions

DRUG

Temsirolimus (CCI-779) for 34 months

DRUG

Letrozole for 34 months

Sponsors & Collaborators

  • Wyeth is now a wholly owned subsidiary of Pfizer

    lead INDUSTRY

Principal Investigators

  • Medical Monitor · Wyeth is now a wholly owned subsidiary of Pfizer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-05-31
Primary Completion
2006-10-31
Completion
2006-10-31

Countries

  • United States
  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00083993 on ClinicalTrials.gov