Clinical trial NCT00372996: Study Of CP-751,871 In Combination With Exemestane In Postmenopausal Women With Hormone Receptor Positive Advanced Breast Cancer
Official title: A Two-arm Randomized Open Label Phase 2 Study Of Cp-751,871 In Combination With Exemestane Versus Exemestane Alone As First Line Treatment For Postmenopausal Patients With Hormone Receptor Positive Advanced Breast Cancer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Breast Neoplasms
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2006-09-07
Enrollment: 219
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: To test the efficacy of CP-751,871 combined with exemestane in the treatment of postmenopausal patients with hormone positive advanced breast cancer


Eligibility criteria: Inclusion Criteria:

* Postmenopausal women with a diagnosis of hormone receptor positive advanced breast cancer
* HbA1c \<5.7%

Exclusion Criteria:

* Previous treatment for advanced disease

Primary outcomes:
measure: Progression-Free Survival (PFS)
timeFrame: Baseline, Day 1 of Cycles 2 and 4 and then Day 1 of every 3rd cycle starting at Cycle 7 up to 60 months
measure: PFS in Participants With Hemoglobin A1c (HbA1c) Less Than (<) 5.7% at Baseline
timeFrame: Baseline, Day 1 of Cycles 2 and 4 and then Day 1 of every 3rd cycle starting at Cycle 7 up to 60 months
Secondary outcomes:
measure: Percentage of Participants Achieving Complete Response (CR), Partial Response (PR), or Stable Disease (SD) Maintained for at Least 6 Months
timeFrame: Baseline, Day 1 of Cycles 2 and 4 and then Day 1 of every 3rd cycle starting at Cycle 7 up to 60 months
measure: Maximum Plasma Concentration of CP-751,871
timeFrame: Predose on Day 1 at Cycles 1, 2, 4, and 5 and 150 days post last dose of CP-751,871 and for salvage therapy, at Day 1 and 150 days post last dose of CP-751,871
measure: Minimum Plasma Concentration of CP-751,871
timeFrame: Predose on Day 1 at Cycles 1, 2, 4, and 5 and 150 days post last dose of CP-751,871 and for salvage therapy, at Day 1 and 150 days post last dose of CP-751,871
measure: Area Under the Concentration Time Curve From Time 0 to the Last Time Point With Quantifiable Concentration
timeFrame: Predose on Day 1 at Cycles 1, 2, 4, and 5 and 150 days post last dose of CP-751,871 and for salvage therapy, at Day 1 and 150 days post last dose of CP-751,871
measure: Number of Participants With Negative Human Anti-Human Antibodies (HAHAs)
timeFrame: Predose on Day 1 of Cycle 1 and at 150 days post last CP-751,871 infusion
measure: Percentage of Participants With Circulating Tumor Cells Expressing Insulin-Like Growth Factor 1 Receptor (IGF-IR)
timeFrame: Predose on Day 1 of Cycle 1
measure: Percentage of Participants With Serum Markers Relevant to the IGF-1R Pathway
timeFrame: Predose on Day 1 of Cycles 1 and 4 and at end of treatment prior to beginning salvage therapy
measure: European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire 30 (QLQ-C30) Scores
timeFrame: Predose on Day 1 of each cycle, at the end of treatment and at follow-up, up to 60 months
measure: EORTC QLQ Breast Cancer Module (BR23) Scores
timeFrame: Predose on Day 1, at end of treatment, and at Follow-up, up to 60 months
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: UCSD Medical Center - La Jolla
state: California
city: La Jolla
country: United States
facility: UCSD Moores Cancer Center
state: California
city: San Diego
country: United States
facility: UCSD Medical Center - Hillcrest
state: California
city: Washington
country: United States
facility: Washington Cancer Institute (WCI) at Washington Hospital Center (WHC)
state: District of Columbia
city: Davie
country: United States
facility: Florida Cancer Research Institute
state: Florida
city: Plantation
country: United States
facility: Florida Cancer Research Institute
state: Florida
city: Lexington
country: United States
facility: Central Baptist Hospital
state: Kentucky
city: Lexington
country: United States
facility: Lexington Oncology Associates
state: Kentucky
city: Lexington
country: United States
facility: Bluegrass Hematology/Oncology, PSC
state: Kentucky
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Bringham and Women's Hospital
state: Massachusetts
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Boston
country: United States
facility: Dana-Farber Cancer Institute (DFCI)
state: Massachusetts
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
city: Minneapolis
country: United States
facility: University of Minnesota Medical Center-Fairview, Riverside Campus
state: Minnesota
city: Minneapolis
country: United States
facility: University of Minnesota Cancer Center
state: Minnesota
city: Minneapolis
country: United States
facility: University Of Minnesota Medical Center
state: Minnesota
city: Burlington
country: United States
facility: Alamance Regional Medical Center - Cancer Center
state: North Carolina
city: Durham
country: United States
facility: Duke University Medical Center - Morris Cancer Center Clinics
state: North Carolina
city: Durham
country: United States
facility: Duke University Medical Center- Department of Medicine Oncology
state: North Carolina
city: Durham
country: United States
facility: Duke University Medical Center-Duke Cancer Center
state: North Carolina
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Durham
country: United States
facility: Duke University School Of Medicine
state: North Carolina
city: Dallas
country: United States
facility: Texas Oncology - PA Collins Building 5th Floor
state: Texas
city: Houston
country: United States
facility: Baylor College Of Medicine (Bcm)
state: Texas
city: Houston
country: United States
facility: Baylor College of Medicine Breast Center
state: Texas
city: Burlington
country: United States
facility: Fletcher Allen Healthcare
state: Vermont
city: Burlington
country: United States
facility: Fletcher Allen Health Care
state: Vermont
city: Burlington
country: United States
facility: Fletcher Allen Hospital MCHV Campus
state: Vermont
city: Burlington
country: United States
facility: Pharmacist, Investigational Drug Service
state: Vermont
city: Burlington
country: United States
facility: Fletcher Allen Healthcare
state: Vermont
city: Burlington
country: United States
facility: Fletcher Allan Health Care
state: Vermont
city: La Plata
country: Argentina
facility: Policlinica Privada Site La Plata S.A.
state: Buenos Aires
city: La Plata
country: Argentina
facility: Breast Clinica de la Mama
state: Buenos Aires
city: La Plata
country: Argentina
facility: Policlinica Privada Site
state: Buenos Aires
city: La Plata
country: Argentina
facility: Policlinica Privada Site La Plata S. A.
state: Buenos Aires
city: Rosario
country: Argentina
facility: Instituto de Investigaciones Clinicas
state: Santa Fe
city: Rosario
country: Argentina
facility: Centro Oncologico Rosario
state: Santa Fe
city: Rosario
country: Argentina
facility: Centro Oncologico De Rosario
state: Santa Fe
city: Rosario
country: Argentina
facility: Centro Oncologico
state: Santa Fé
city: Cordoba
country: Argentina
facility: Hospital Italiano Cordoba
city: Leuven
country: Belgium
facility: UZ Gasthuisberg, Medische Oncologie
city: Leuven
country: Belgium
facility: UZ Gasthuisberg
city: Wilrijk
country: Belgium
facility: Oncologisch Centrum GZA
city: Montreal
country: Brazil
facility: Jewish General Hospital
state: QC
city: Santo Cristo
country: Brazil
facility: Instituto Nacional de Cancer - HCII
state: Rio de Janeiro
city: Porto Alegre
country: Brazil
facility: Hospital Sao Lucas da PUCRS
state: Rio Grande do Sul
city: Rio de Janeiro
country: Brazil
facility: Instituto Nacional DO Cancer - INCA
state: RJ
city: Porto Alegre
country: Brazil
facility: Clínica de Oncologia de porto Alegre Sociedade Simples ltda.
state: RS
city: Porto Alegre
country: Brazil
facility: Hospital Sao Lucas da PUCRS
state: RS
city: Sao Paulo
country: Brazil
facility: Hospital Das Clinicas Da Faculdade De Medicina Da Universidade De Sao Paulo Instituto Central
state: SP
city: Porto Alegre
country: Brazil
facility: Centro de Pesquisa em Oncologia - CPO
city: Rio De Janeiro
country: Brazil
facility: Instituto Nacional do Cancer
city: Edmonton
country: Canada
facility: Cross Cancer Institute
state: Alberta
city: Montreal
country: Canada
facility: Sir Mortimer B. Davis - Jewish General Hospital
state: Quebec
city: Milano
country: Italy
facility: Dipartimento di Medicina, Divisione di Oncologia Medica, Istituto Europeo di Oncologia
city: Napoli
country: Italy
facility: Divisione di Oncologia
city: Padova
country: Italy
facility: Uo Oncologia Medica 2 Regione Del Veneto Istituto Oncologico Veneto IRCCS Ospedale Busonera
city: Amsterdam
country: Netherlands
facility: VU University Medical Center
city: Malmo
country: Sweden
facility: Malmö University Hospital
city: London
country: United Kingdom
facility: St Mary's Hospital NHS Trust
city: London
country: United Kingdom
facility: Imperial College Healthcare NHS Trust - Charing Cross Hospital
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: