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


Phase 3
18 Years
N/A
Not Enrolling
Female
Breast Neoplasms, Neoplasm Metastasis

Thank you

Trial Information

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


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Outcome Measure:

To determine overall progression free survival.

Principal Investigator

Medical Monitor

Investigator Role:

Study Director

Investigator Affiliation:

Wyeth is now a wholly owned subsidiary of Pfizer

Authority:

United States: Food and Drug Administration

Study ID:

3066A1-303

NCT ID:

NCT00083993

Start Date:

May 2004

Completion Date:

October 2006

Related Keywords:

  • Breast Neoplasms
  • Neoplasm Metastasis
  • Breast Cancer
  • Breast Neoplasms
  • Neoplasms
  • Neoplasm Metastasis

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