Study Evaluating CCI-779 and Letrozole in Post-Menopausal Women With Breast Cancer - Full Text View

Sponsored by:	Wyeth
Information provided by:	Wyeth
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

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

Drug Information available for: Letrozole CCI 779

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
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

Further study details as provided by Wyeth:

Primary Outcome Measures:

To determine overall progression free survival.

Secondary Outcome Measures:

To determine safety, survival, health outcomes, prognostic markers and pharmacogenomics analysis.

Estimated Enrollment:	1236
Study Start Date:	May 2004

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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)

Exclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00083993

Show 129 Study Locations

Sponsors and Collaborators

Wyeth

Investigators

Study Director:

Medical Monitor

Wyeth

More Information

Study ID Numbers:	3066A1-303
Study First Received:	June 4, 2004
Last Updated:	October 5, 2006
ClinicalTrials.gov Identifier:	NCT00083993
Health Authority:	United States: Food and Drug Administration

Keywords provided by Wyeth:

Breast Cancer

Study placed in the following topic categories:

Skin Diseases
Neoplasm Metastasis
Breast Neoplasms

Letrozole
Menopause
Breast Diseases

Additional relevant MeSH terms:

Neoplastic Processes
Neoplasms
Pathologic Processes
Neoplasms by Site
Molecular Mechanisms of Pharmacological Action

Antineoplastic Agents
Therapeutic Uses
Enzyme Inhibitors
Aromatase Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009