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

Stopped early · Phase 3

Conditions studied: Breast Neoplasms, Neoplasm Metastasis

In brief

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.

Key facts

Study ID

NCT00083993

Run by

Wyeth is now a wholly owned subsidiary of Pfizer

People needed

1236

Starts

2004-05-01

Expected to finish

2006-10-01

Last updated by the study team

2011-11-08

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Women aged greater than 18 years.
• Postmenopausal subjects
• Confirmed diagnosis of locally advanced (not amenable to curative surgery and/or radiation) or metastatic breast cancer (Stage 3B or 4 respectively, by American Joint Committee on Cancer Criteria)

You may not qualify if…

• Extensive visceral disease
• Subjects with bone as the only site of disease
• Prior radiation therapy to the site of measurable disease for subjects with a solitary measurable lesion

Where it is running

• Study site — Huntsville, Alabama, United States
• Study site — Tucson, Arizona, United States
• Study site — Jonesboro, Arkansas, United States
• Study site — Burbank, California, United States
• Study site — Campbell, California, United States
• Study site — Fountain Valley, California, United States
• Study site — Gilroy, California, United States
• Study site — Glendora, California, United States
• Study site — Modesto, California, United States
• Study site — Montebello, California, United States
• Study site — Pomona, California, United States
• Study site — Poway, California, United States
• Study site — Sacramento, California, United States
• Study site — San Diego, California, United States
• Study site — Santa Rosa, California, United States
• Study site — Soquel, California, United States
• Study site — Vista, California, United States
• Study site — Lakewood, Colorado, United States
• Study site — Norwalk, Connecticut, United States
• Study site — Washington D.C., District of Columbia, United States
• Study site — Boca Raton, Florida, United States
• Study site — Fort Lauderdale, Florida, United States
• Study site — Hollywood, Florida, United States
• Study site — Jacksonville, Florida, United States
• Study site — Hoover, Alabama, United States

Full record on ClinicalTrials.gov

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