Study Evaluating Temsirolimus (CCI-779) In Breast Neoplasms

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

108 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-12-31

Study Completion Date

2009-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

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

NCT00083993

Breast Neoplasms Neoplasm Metastasis

TERMINATED PHASE3

Letrozole in Treating Breast Cancer in Postmenopausal Women With Stage I, II, or III Breast Cancer Previously Treated With Tamoxifen (GIM4)

NCT01064635

Breast Cancer

ACTIVE_NOT_RECRUITING PHASE3

Letrozole or Tamoxifen in Treating Postmenopausal Women With Breast Cancer

NCT00004205

Breast Cancer

COMPLETED PHASE3

Letrozole in Treating Postmenopausal Women With Stage I, II or III Breast Cancer That Can Be Removed by Surgery

NCT00651976

Breast Cancer

TERMINATED EARLY_PHASE1

A Study of Neoadjuvant Letrozole + Taselisib Versus Letrozole + Placebo in Post-Menopausal Women With Breast Cancer (LORELEI)

NCT02273973

Breast Cancer

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Breast Neoplasms

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

A

Group Type EXPERIMENTAL

Letrozole / Temsirolimus (CCI-779)

Intervention Type DRUG

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

B

Group Type EXPERIMENTAL

Letrozole / Temsirolimus (CCI-779)

Intervention Type DRUG

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

C

Group Type ACTIVE_COMPARATOR

Letrozole

Intervention Type DRUG

Letrozole 2.5 mg daily

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Letrozole / Temsirolimus (CCI-779)

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

Intervention Type DRUG

Letrozole / Temsirolimus (CCI-779)

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

Intervention Type DRUG

Letrozole

Letrozole 2.5 mg daily

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Letrozole / Temsirolimus(CCI-779), Torisel Letrozole alone

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Postmenopausal women with histologically confirmed, measurable locally advanced disease or metastatic breast.
* Must be appropriate to receive endocrine therapy as treatment for advanced disease (chemotherapy; prior adjuvant therapy with antiestrogens other than aromatase inhibitors; prior adjuvant or first-line metastatic therapy with tamoxifen or trastuzumab, are permitted).
* Women may either present with de novo advanced or metastatic cancer, or have had tumor progression while receiving adjuvant tamoxifen or at any time after completing adjuvant tamoxifen, or have had tumor progression while receiving first-line metastatic therapy with tamoxifen.

Exclusion Criteria

* Patients having known central nervous system (CNS) metastases.
* Prior therapy with Temsirolimus (CCI-779) or aromatase inhibitors.
* Tamoxifen, or other hormonal therapy, in the metastatic or adjuvant setting within 1 week prior to day 1 of treatment on study.

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No