Clinical trial NCT00083993: Study Evaluating CCI-779 and Letrozole in Post-menopausal Women With Breast Cancer
Official title: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Breast Neoplasms
Neoplasm Metastasis
Keywords: Breast Cancer
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2004-06-08
Enrollment: 1236
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: To determine overall progression free survival.
Secondary outcomes:
measure: To determine safety, survival, health outcomes, prognostic markers and pharmacogenomics analysis.
Other outcomes:
Locations:
city: Hoover
country: United States
state: Alabama
city: Huntsville
country: United States
state: Alabama
city: Tucson
country: United States
state: Arizona
city: Jonesboro
country: United States
state: Arkansas
city: Burbank
country: United States
state: California
city: Campbell
country: United States
state: California
city: Fountain Valley
country: United States
state: California
city: Gilroy
country: United States
state: California
city: Glendora
country: United States
state: California
city: Modesto
country: United States
state: California
city: Montebello
country: United States
state: California
city: Pomona
country: United States
state: California
city: Poway
country: United States
state: California
city: Sacramento
country: United States
state: California
city: San Diego
country: United States
state: California
city: Santa Rosa
country: United States
state: California
city: Soquel
country: United States
state: California
city: Vista
country: United States
state: California
city: Lakewood
country: United States
state: Colorado
city: Norwalk
country: United States
state: Connecticut
city: Washington
country: United States
state: District of Columbia
city: Boca Raton
country: United States
state: Florida
city: Fort Lauderdale
country: United States
state: Florida
city: Hollywood
country: United States
state: Florida
city: Jacksonville
country: United States
state: Florida
city: Jacksonville
country: United States
state: Florida
city: Lake Worth
country: United States
state: Florida
city: Miami Shores
country: United States
state: Florida
city: New Port Richey
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city: Plantation
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state: Florida
city: Sarasota
country: United States
state: Florida
city: Zephyrhills
country: United States
state: Florida
city: Atlanta
country: United States
state: Georgia
city: Columbus
country: United States
state: Georgia
city: Roswell
country: United States
state: Georgia
city: Thomasville
country: United States
state: Georgia
city: Coeur d'Alene
country: United States
state: Idaho
city: Centralia
country: United States
state: Illinois
city: Skokie
country: United States
state: Illinois
city: Skokie
country: United States
state: Illinois
city: Springfield
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state: Illinois
city: Urbana
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state: Illinois
city: Munster
country: United States
state: Indiana
city: South Bend
country: United States
state: Indiana
city: Lexington
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state: Kentucky
city: Baltimore
country: United States
state: Maryland
city: Baltimore
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state: Maryland
city: Baltimore
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city: Bethesda
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city: Frederick
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city: Towson
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state: Maryland
city: Boston
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state: Massachusetts
city: Boston
country: United States
state: Massachusetts
city: Ann Arbor
country: United States
state: Michigan
city: Detroit
country: United States
state: Michigan
city: Flint
country: United States
state: Michigan
city: Grand Rapids
country: United States
state: Michigan
city: Grand Rapids
country: United States
state: Michigan
city: Minneapolis
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state: Minnesota
city: Hattiesburg
country: United States
state: Mississippi
city: Rolla
country: United States
state: Missouri
city: Great Falls
country: United States
state: Montana
city: Omaha
country: United States
state: Nebraska
city: Carson City
country: United States
state: Nevada
city: Lebanon
country: United States
state: New Hampshire
city: Belleville
country: United States
state: New Jersey
city: Somerset
country: United States
state: New Jersey
city: Albuquerque
country: United States
state: New Mexico
city: Binghamton
country: United States
state: New York
city: East Syracuse
country: United States
state: New York
city: New York
country: United States
state: New York
city: Nyack
country: United States
state: New York
city: Staten Island
country: United States
state: New York
city: Charlotte
country: United States
state: North Carolina
city: Gastonia
country: United States
state: North Carolina
city: Wilmington
country: United States
state: North Carolina
city: Winston-Salem
country: United States
state: North Carolina
city: Bismark
country: United States
state: North Dakota
city: Canton
country: United States
state: Ohio
city: Canton
country: United States
state: Ohio
city: Cincinnati
country: United States
state: Ohio
city: Cincinnati
country: United States
state: Ohio
city: Cleveland
country: United States
state: Ohio
city: Cleveland
country: United States
state: Ohio
city: Columbus
country: United States
state: Ohio
city: Columbus
country: United States
state: Ohio
city: Mayfield Heights
country: United States
state: Ohio
city: Corvallis
country: United States
state: Oregon
city: Portland
country: United States
state: Oregon
city: Harrisburg
country: United States
state: Pennsylvania
city: Hershey
country: United States
state: Pennsylvania
city: Langhorne
country: United States
state: Pennsylvania
city: Philadelphia
country: United States
state: Pennsylvania
city: Pittsburgh
country: United States
state: Pennsylvania
city: Charleston
country: United States
state: South Carolina
city: Columbia
country: United States
state: South Carolina
city: Chattanooga
country: United States
state: Tennessee
city: Nashville
country: United States
state: Tennessee
city: Nashville
country: United States
state: Tennessee
city: Arlington
country: United States
state: Texas
city: Corpus Christi
country: United States
state: Texas
city: Dallas
country: United States
state: Texas
city: Fort Worth
country: United States
state: Texas
city: Irving
country: United States
state: Texas
city: Tyler
country: United States
state: Texas
city: Logan
country: United States
state: Utah
city: Ogden
country: United States
state: Utah
city: Arlington
country: United States
state: Virginia
city: Richmond
country: United States
state: Virginia
city: Woodbridge
country: United States
state: Virginia
city: Seattle
country: United States
state: Washington
city: Morgantown
country: United States
state: West Virginia
city: Calgary
country: Canada
state: Alberta
city: North Vancouver
country: Canada
state: British Columbia
city: Richmond
country: Canada
state: British Columbia
city: Halifax
country: Canada
state: Nova Scotia
city: Barrie
country: Canada
state: Ontario
city: Hamilton
country: Canada
state: Ontario
city: Newmarket
country: Canada
state: Ontario
city: Toronto
country: Canada
state: Ontario
city: Toronto
country: Canada
state: Ontario
city: Toronto
country: Canada
state: Ontario
city: Toronto
country: Canada
state: Ontario
city: Chicoutimi
country: Canada
state: Quebec
city: Fleurimont
country: Canada
state: Quebec
city: Levis
country: Canada
state: Quebec
city: Pointe Claire
country: Canada
state: Quebec
city: Quebec City
country: Canada
state: Quebec
city: Saskatoon
country: Canada
state: Saskatchewan
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Wolff AC, Lazar AA, Bondarenko I, Garin AM, Brincat S, Chow L, Sun Y, Neskovic-Konstantinovic Z, Guimaraes RC, Fumoleau P, Chan A, Hachemi S, Strahs A, Cincotta M, Berkenblit A, Krygowski M, Kang LL, Moore L, Hayes DF. Randomized phase III placebo-controlled trial of letrozole plus oral temsirolimus as first-line endocrine therapy in postmenopausal women with locally advanced or metastatic breast cancer. J Clin Oncol. 2013 Jan 10;31(2):195-202. doi: 10.1200/JCO.2011.38.3331. Epub 2012 Dec 10.