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| Sponsor: | Wyeth is now a wholly owned subsidiary of Pfizer |
|---|---|
| Information provided by: | Wyeth is now a wholly owned subsidiary of Pfizer |
| ClinicalTrials.gov Identifier: | NCT00083993 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Breast Neoplasms Neoplasm Metastasis |
Drug: Temsirolimus (CCI-779) for 34 months Drug: Letrozole for 34 months |
Phase III |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
| Official Title: | A Phase 3 Randomized, Placebo-Controlled, Double-Blind Study of Oral CCI-779 Administered in Combination With Letrozole vs. Letrozole Alone as First Line Hormonal Therapy in Postmenopausal Women With Locally Advanced or Metastatic Breast Cancer |
| Estimated Enrollment: | 1236 |
| Study Start Date: | May 2004 |
| Study Completion Date: | October 2006 |
| Primary Completion Date: | October 2006 (Final data collection date for primary outcome measure) |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
Show 129 Study Locations| Study Director: | Medical Monitor | Wyeth is now a wholly owned subsidiary of Pfizer |
More Information
| ClinicalTrials.gov Identifier: | NCT00083993 History of Changes |
| Other Study ID Numbers: | 3066A1-303 |
| Study First Received: | June 4, 2004 |
| Last Updated: | November 7, 2011 |
| Health Authority: | United States: Food and Drug Administration |
|
Breast Cancer |
|
Breast Neoplasms Neoplasms Neoplasm Metastasis Neoplasms by Site Breast Diseases Skin Diseases Neoplastic Processes Pathologic Processes Sirolimus Everolimus Letrozole Antibiotics, Antineoplastic |
Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Antifungal Agents Anti-Infective Agents Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Anti-Bacterial Agents Aromatase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
