Study Evaluating Temsirolimus (CCI-779) In Breast Neoplasms

NCT00062751 | Completed Phase 2 Results

• 2 other identifiers: 3066A1-204B1771005
• Study Type: interventional
• Target: 108
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

breast; neoplasms

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With Objective Response (OR)

  OR measured as Complete response (CR) or Partial response (PR) confirmed by assessments performed no less than 4 weeks after the criteria for the response are first met. CR=disappearance of all target and non-target lesions with normalization of tumor marker level; PR=at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, referencing the screening sum LD. Target lesions=all measurable lesions up to 5 lesions per organ (10 lesions in total), representative of all involved organs, if possible; recorded and measured at screening. Non-target lesions=all other lesions.

  Baseline, every 4 cycles (1 cycle is defined as a 14 day duration) up to Cycle 25, then every 6 cycles until disease progression

Secondary Outcomes (11)

• Percentage of Participants With Best Overall Response (Clinical Benefit)

  Baseline, every 4 cycles (1 cycle is defined as a 14 day duration) up to Cycle 25, then every 6 cycles until disease progression)

• Time to Disease Progression

  Baseline, every 4 cycles (1 cycle is defined as a 14 day duration) up to Cycle 25, then every 6 cycles until disease progression)

• Time to Treatment Failure

  Baseline until Progressive disease, death, or discontinuation of study treatment

• Percentage of Participants Exhibiting Freedom From Progression

  Baseline, 8 weeks, 6 months, 12 months, and 24 months

• Duration of Response

  Baseline, every 4 cycles (1 cycle is defined as a 14 day duration) up to Cycle 25, then every 6 cycles until disease progression)

Study Arms (3)

A

EXPERIMENTAL

Drug: Letrozole / Temsirolimus (CCI-779)

B

EXPERIMENTAL

Drug: Letrozole / Temsirolimus (CCI-779)

C

ACTIVE COMPARATOR

Drug: Letrozole

Interventions

Letrozole / Temsirolimus (CCI-779) DRUG

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

A

Letrozole DRUG

Letrozole 2.5 mg daily

Also known as: Letrozole alone

C

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Wyeth is now a wholly owned subsidiary of Pfizer: lead
• Pfizer: collaborator

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Breast Neoplasms; Neoplasms

Interventions

Letrozole; temsirolimus

Condition Hierarchy (Ancestors)

Neoplasms by Site; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Nitriles; Organic Chemicals; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Limitations and Caveats

Clinical development of oral temsirolimus for treatment of locally advanced or metastatic breast cancer was terminated by Wyeth based on the results of a phase 3 clinical study with the combination temsirolimus and letrozole.

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.govCallCenter@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: June 12, 2003
• First Posted: June 13, 2003
• Study Start: December 1, 2002
• Primary Completion: April 1, 2005
• Study Completion: October 1, 2009
• Last Updated: April 15, 2011
• Results First Posted: November 25, 2010

Record last verified: 2011-04