Study Of CP-751,871 In Combination With Exemestane In Postmenopausal Women With Hormone Receptor Positive Advanced Breast Cancer

Breast Neoplasms Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00372996
• Other study ID #: A4021004
• Secondary ID: 2006-005573-21
• Status: Terminated
• Phase: Phase 2
• First received: September 5, 2006
• Last updated: October 6, 2015
• Start date: February 2007
• Est. completion date: June 2014

Study information

• Verified date: October 2015
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

To test the efficacy of CP-751,871 combined with exemestane in the treatment of postmenopausal patients with hormone positive advanced breast cancer

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 219
• Est. completion date: June 2014
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Postmenopausal women with a diagnosis of hormone receptor positive advanced breast cancer

• HbA1c <5.7%

Exclusion Criteria:

• Previous treatment for advanced disease

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Neoplasms

Intervention

Drug:
• CP-751,871
CP-751,871 given at 20 mg/kg IV on day 1 of each 21 day cycle.
• exemestane
Exemestane given at 25 mg orally once a day.
• exemestane
Exemestane given at 25 mg orally once a day. Treatment until progression or toxicity
• Fulvestrant
Used for salvage therapy and administered according to the local label and standard clinical practice.

Locations

Country	Name	City	State
Argentina	Hospital Italiano Cordoba	Cordoba
Argentina	Breast Clinica de la Mama	La Plata	Buenos Aires
Argentina	Policlinica Privada Site	La Plata	Buenos Aires
Argentina	Policlinica Privada Site La Plata S. A.	La Plata	Buenos Aires
Argentina	Policlinica Privada Site La Plata S.A.	La Plata	Buenos Aires
Argentina	Centro Oncologico	Rosario	Santa Fé
Argentina	Centro Oncologico De Rosario	Rosario	Santa Fe
Argentina	Centro Oncologico Rosario	Rosario	Santa Fe
Argentina	Instituto de Investigaciones Clinicas	Rosario	Santa Fe
Belgium	UZ Gasthuisberg	Leuven
Belgium	UZ Gasthuisberg, Medische Oncologie	Leuven
Belgium	Oncologisch Centrum GZA	Wilrijk
Brazil	Jewish General Hospital	Montreal	QC
Brazil	Centro de Pesquisa em Oncologia - CPO	Porto Alegre
Brazil	Clínica de Oncologia de porto Alegre Sociedade Simples ltda.	Porto Alegre	RS
Brazil	Hospital Sao Lucas da PUCRS	Porto Alegre	RS
Brazil	Hospital Sao Lucas da PUCRS	Porto Alegre	Rio Grande do Sul
Brazil	Instituto Nacional do Cancer	Rio De Janeiro
Brazil	Instituto Nacional DO Cancer - INCA	Rio de Janeiro	RJ
Brazil	Instituto Nacional de Cancer - HCII	Santo Cristo	Rio de Janeiro
Brazil	Hospital Das Clinicas Da Faculdade De Medicina Da Universidade De Sao Paulo Instituto Central	Sao Paulo	SP
Canada	Cross Cancer Institute	Edmonton	Alberta
Canada	Sir Mortimer B. Davis - Jewish General Hospital	Montreal	Quebec
Italy	Dipartimento di Medicina, Divisione di Oncologia Medica, Istituto Europeo di Oncologia	Milano
Italy	Divisione di Oncologia	Napoli
Italy	Uo Oncologia Medica 2 Regione Del Veneto Istituto Oncologico Veneto IRCCS Ospedale Busonera	Padova
Netherlands	VU University Medical Center	Amsterdam
Sweden	Malmö University Hospital	Malmo
United Kingdom	Imperial College Healthcare NHS Trust - Charing Cross Hospital	London
United Kingdom	St Mary's Hospital NHS Trust	London
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	Bringham and Women's Hospital	Boston	Massachusetts
United States	Dana-Farber Cancer Institute	Boston	Massachusetts
United States	Dana-Farber Cancer Institute	Boston	Massachusetts
United States	Dana-Farber Cancer Institute (DFCI)	Boston	Massachusetts
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Alamance Regional Medical Center - Cancer Center	Burlington	North Carolina
United States	Fletcher Allan Health Care	Burlington	Vermont
United States	Fletcher Allen Health Care	Burlington	Vermont
United States	Fletcher Allen Healthcare	Burlington	Vermont
United States	Fletcher Allen Healthcare	Burlington	Vermont
United States	Fletcher Allen Hospital MCHV Campus	Burlington	Vermont
United States	Pharmacist, Investigational Drug Service	Burlington	Vermont
United States	Texas Oncology - PA Collins Building 5th Floor	Dallas	Texas
United States	Florida Cancer Research Institute	Davie	Florida
United States	Duke University Medical Center	Durham	North Carolina
United States	Duke University Medical Center - Morris Cancer Center Clinics	Durham	North Carolina
United States	Duke University Medical Center- Department of Medicine Oncology	Durham	North Carolina
United States	Duke University Medical Center-Duke Cancer Center	Durham	North Carolina
United States	Duke University School Of Medicine	Durham	North Carolina
United States	Baylor College Of Medicine (Bcm)	Houston	Texas
United States	Baylor College of Medicine Breast Center	Houston	Texas
United States	UCSD Medical Center - La Jolla	La Jolla	California
United States	UCSD Moores Cancer Center	La Jolla	California
United States	Bluegrass Hematology/Oncology, PSC	Lexington	Kentucky
United States	Central Baptist Hospital	Lexington	Kentucky
United States	Lexington Oncology Associates	Lexington	Kentucky
United States	University of Minnesota Cancer Center	Minneapolis	Minnesota
United States	University Of Minnesota Medical Center	Minneapolis	Minnesota
United States	University of Minnesota Medical Center-Fairview, Riverside Campus	Minneapolis	Minnesota
United States	Florida Cancer Research Institute	Plantation	Florida
United States	UCSD Medical Center - Hillcrest	San Diego	California
United States	Washington Cancer Institute (WCI) at Washington Hospital Center (WHC)	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Countries where clinical trial is conducted

United States,  Argentina,  Belgium,  Brazil,  Canada,  Italy,  Netherlands,  Sweden,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-Free Survival (PFS)	PFS was calculated from the time of randomization to either progression of disease, death, or treatment discontinuation because of unsatisfactory therapy results (such as global deterioration of health status). Disease progression was defined as 1 or more of the following: radiographic progression (20 percent [%] increase in measurable lesions, appearance of new lesions or unequivocal progression of evaluable lesions as defined by Response Evaluation Criteria in Solid Tumors [RECIST]); occurrence of new pleural/pericardial effusions or ascites confirmed by positive cytology; persistent hypercalcemia requiring more than 2 IV treatments with bisphosphonates; intervention for any cancer-related events (radiations, surgery) or new symptoms related to tumor growth requiring participant discontinuation; development of brain metastasis; or death for any cause. Median PFS was estimated from the Kaplan-Meier curve. 95% confidence interval (CI) is based on the Brookmeyer and Crowley method.	Baseline, Day 1 of Cycles 2 and 4 and then Day 1 of every 3rd cycle starting at Cycle 7 up to 60 months	No
Primary	PFS in Participants With Hemoglobin A1c (HbA1c) Less Than (<) 5.7% at Baseline	PFS was calculated from the time of randomization to either progression of disease, death, or treatment discontinuation because of unsatisfactory therapy results (such as global deterioration of health status). Disease progression was defined as 1 or more of the following: radiographic progression (20% increase in measurable lesions, appearance of new lesions or unequivocal progression of evaluable lesions as defined by RECIST); occurrence of new pleural/pericardial effusions or ascites confirmed by positive cytology; persistent hypercalcemia requiring more than 2 IV treatments with bisphosphonates; intervention for any cancer-related events (radiations, surgery) or new symptoms related to tumor growth requiring participant discontinuation; development of brain metastasis; or death for any cause. Median PFS was estimated from the Kaplan-Meier curve. 95% CI is based on the Brookmeyer and Crowley method.	Baseline, Day 1 of Cycles 2 and 4 and then Day 1 of every 3rd cycle starting at Cycle 7 up to 60 months	No
Secondary	Percentage of Participants Achieving Complete Response (CR), Partial Response (PR), or Stable Disease (SD) Maintained for at Least 6 Months	Objective responses were defined using RECIST as CR: disappearance of all target and nontarget lesions. PR: at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as a reference the baseline sum LD. Nontarget lesions may persist provided there is no unequivocal progression in these lesions. SD: measurements demonstrating neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify as progressive disease (PD) during the first 6 weeks after the start of treatment taking as reference the smallest sum LD since the treatment started. During this time, nontarget lesions may persist provided there is no unequivocal progression in these lesions.	Baseline, Day 1 of Cycles 2 and 4 and then Day 1 of every 3rd cycle starting at Cycle 7 up to 60 months	No
Secondary	Maximum Plasma Concentration of CP-751,871		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	No
Secondary	Minimum Plasma Concentration of CP-751,871		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	No
Secondary	Area Under the Concentration Time Curve From Time 0 to the Last Time Point With Quantifiable Concentration		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	No
Secondary	Number of Participants With Negative Human Anti-Human Antibodies (HAHAs)	Negative human anti-human antibodies were defined as <6.64	Predose on Day 1 of Cycle 1 and at 150 days post last CP-751,871 infusion	No
Secondary	Percentage of Participants With Circulating Tumor Cells Expressing Insulin-Like Growth Factor 1 Receptor (IGF-IR)		Predose on Day 1 of Cycle 1	No
Secondary	Percentage of Participants With Serum Markers Relevant to the IGF-1R Pathway		Predose on Day 1 of Cycles 1 and 4 and at end of treatment prior to beginning salvage therapy	No
Secondary	European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire 30 (QLQ-C30) Scores	EORTC QLQ-C30: included functional scales (physical, role, cognitive, emotional, and social), global health status, symptom scales (fatigue, pain, nausea/vomiting) and single items (dyspnoea, appetite loss, insomnia, constipation/diarrhea and financial difficulties). Most questions used 4 point scale (1 'Not at all' to 4 'Very much'; 2 questions used 7-point scale (1 'very poor' to 7 'Excellent'). Scores averaged, transformed to 0-100 scale; higher score equals (=) better level of functioning or greater degree of symptoms.	Predose on Day 1 of each cycle, at the end of treatment and at follow-up, up to 60 months	No
Secondary	EORTC QLQ Breast Cancer Module (BR23) Scores	EORTC-QLQ-BR23: included functional scales (body image, sexual functioning, sexual enjoyment, and future perspective) and single item symptoms scales (systemic therapy side effects, breast symptoms, arm symptoms, and upset by hair loss). Questions used 4-point Likert scale (1 ‘Not at All’ to 4 ‘Very Much’). Scores averaged and transformed to 0-100 scale. High score for functional scale=high/healthy level of functioning. High score for single item=high level of symptomatology/problems. Change from baseline=Cycle/Day score minus baseline score.	Predose on Day 1, at end of treatment, and at Follow-up, up to 60 months	No

External Links

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