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

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

Status

Terminated

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00083993

Enrollment

1236

Registered

2004-06-08

Start date

2004-05-31

Completion date

2006-10-31

Last updated

2011-11-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Neoplasms, Neoplasm Metastasis

Keywords

Breast Cancer

Brief summary

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.

Interventions

DRUGTemsirolimus (CCI-779) for 34 months

DRUGLetrozole for 34 months

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
To determine overall progression free survival.	—

Secondary

Measure	Time frame
To determine safety, survival, health outcomes, prognostic markers and pharmacogenomics analysis.	—

Countries

Canada, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026