Study Evaluating CCI-779 in Breast Neoplasms - Full Text View

Sponsored by:	Wyeth
Information provided by:	Wyeth
ClinicalTrials.gov Identifier:	NCT00062751

Purpose

To evaluate the preliminary activity and pharmacokinetics of 2 separate doses and schedules of orally administered 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.

Condition	Intervention	Phase
Breast Neoplasms	Drug: Letrozole / CCI-779	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Phase 2 Randomized Open-Label Study of Letrozole in Combination With Two Dose Levels and Schedules of Oral CCI-779, or Letrozole Alone, in Postmenopausal Women With Locally Advanced or Metastatic Breast Cancer.

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

Drug Information available for: Letrozole CCI 779

U.S. FDA Resources

Further study details as provided by Wyeth:

Primary Outcome Measures:

Preliminary activity (objective response rate) [ Time Frame: Duration of trial ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

pharmacokinetics, clinical benefit, pharmacodynamics [ Time Frame: Duration of trial ] [ Designated as safety issue: No ]

Estimated Enrollment:	109
Study Start Date:	December 2002
Estimated Study Completion Date:	February 2008
Estimated Primary Completion Date:	February 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental	Drug: Letrozole / CCI-779 Letrozole + TEMSR QD 10 mg, Letrozole Alone, Letrozole + TEMSR 30 mg QDx% q2wks
B: Active Comparator	Drug: Letrozole / CCI-779 Letrozole + TEMSR QD 10 mg, Letrozole Alone, Letrozole + TEMSR 30 mg QDx% q2wks
C: Experimental	Drug: Letrozole / CCI-779 Letrozole + TEMSR QD 10 mg, Letrozole Alone, Letrozole + TEMSR 30 mg QDx% q2wks

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Postmenopausal women with histologically confirmed, measurable locally advanced disease
Must be appropriate to receive endocrine therapy as treatment for advanced disease (prior adjuvant therapy with antiestrogens other than aromatase inhibitors is 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 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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00062751

Sponsors and Collaborators

Wyeth

Investigators

Study Director:

Medical Monitor, MD

Wyeth

More Information

No publications provided

Responsible Party:	Wyeth ( Wyeth (Registry Contact: Clinical Trial Registry Specialist) )
Study ID Numbers:	3066A1-204
Study First Received:	June 12, 2003
Last Updated:	December 19, 2007
ClinicalTrials.gov Identifier:	NCT00062751 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Wyeth:

breast
neoplasms

Study placed in the following topic categories:

Skin Diseases
Breast Neoplasms
Letrozole
Aromatase Inhibitors
Breast Diseases

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Molecular Mechanisms of Pharmacological Action
Skin Diseases
Antineoplastic Agents
Therapeutic Uses

Breast Neoplasms
Enzyme Inhibitors
Letrozole
Aromatase Inhibitors
Pharmacologic Actions
Breast Diseases

ClinicalTrials.gov processed this record on September 02, 2009