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Study Evaluating Temsirolimus (CCI-779) In Breast Neoplasms

NCT00062751 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 108

Last updated 2011-04-15

Study results available
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Summary

To evaluate the preliminary activity and pharmacokinetics of 2 separate doses and schedules of orally administered Temsirolimus (CCI-779) given in combination with daily letrozole, compared to letrozole alone, in the treatment of locally advanced or metastatic breast cancer in postmenopausal women. All patients must be appropriate to receive endocrine therapy as treatment for advanced disease.

Conditions

  • Breast Neoplasms

Interventions

DRUG

Letrozole / Temsirolimus (CCI-779)

Letrozole 2.5 mg daily + Temsirolimus (CCI-779) 10 mg daily

DRUG

Letrozole / Temsirolimus (CCI-779)

Letrozole 2.5 mg daily + Temsirolimus (CCI-779) intermittent 30 mg daily for five days every 2 weeks

DRUG

Letrozole

Letrozole 2.5 mg daily

Sponsors & Collaborators

  • Pfizer

    collaborator INDUSTRY

  • Wyeth is now a wholly owned subsidiary of Pfizer

    lead INDUSTRY

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2002-12-31
Primary Completion
2005-04-30
Completion
2009-10-31

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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 NCT00062751 on ClinicalTrials.gov