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

This study has been terminated.
(This study was closed to enrollment as of 13 May 2011 due to business reasons. Premature closure was not prompted by any safety or efficacy concerns.)
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00372996
First received: September 5, 2006
Last updated: June 29, 2015
Last verified: June 2015
  Purpose

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


Condition Intervention Phase
Breast Neoplasms
Drug: CP-751,871
Drug: exemestane
Drug: Fulvestrant
Phase 2

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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Progression-Free Survival (PFS) [ Time Frame: Baseline, Day 1 of Cycles 2 and 4 and then Day 1 of every 3rd cycle starting at Cycle 7 up to 60 months ] [ Designated as safety issue: No ]
    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.

  • PFS in Participants With Hemoglobin A1c (HbA1c) Less Than (<) 5.7% at Baseline [ Time Frame: Baseline, Day 1 of Cycles 2 and 4 and then Day 1 of every 3rd cycle starting at Cycle 7 up to 60 months ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Percentage of Participants Achieving Complete Response (CR), Partial Response (PR), or Stable Disease (SD) Maintained for at Least 6 Months [ Time Frame: Baseline, Day 1 of Cycles 2 and 4 and then Day 1 of every 3rd cycle starting at Cycle 7 up to 60 months ] [ Designated as safety issue: No ]
    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.

  • Maximum Plasma Concentration of CP-751,871 [ Time Frame: 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 ] [ Designated as safety issue: No ]
  • Minimum Plasma Concentration of CP-751,871 [ Time Frame: 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 ] [ Designated as safety issue: No ]
  • Area Under the Concentration Time Curve From Time 0 to the Last Time Point With Quantifiable Concentration [ Time Frame: 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 ] [ Designated as safety issue: No ]
  • Number of Participants With Negative Human Anti-Human Antibodies (HAHAs) [ Time Frame: Predose on Day 1 of Cycle 1 and at 150 days post last CP-751,871 infusion ] [ Designated as safety issue: No ]
    Negative human anti-human antibodies were defined as <6.64

  • Percentage of Participants With Circulating Tumor Cells Expressing Insulin-Like Growth Factor 1 Receptor (IGF-IR) [ Time Frame: Predose on Day 1 of Cycle 1 ] [ Designated as safety issue: No ]
  • Percentage of Participants With Serum Markers Relevant to the IGF-1R Pathway [ Time Frame: Predose on Day 1 of Cycles 1 and 4 and at end of treatment prior to beginning salvage therapy ] [ Designated as safety issue: No ]
  • European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire 30 (QLQ-C30) Scores [ Time Frame: Predose on Day 1 of each cycle, at the end of treatment and at follow-up, up to 60 months ] [ Designated as safety issue: No ]
    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.

  • EORTC QLQ Breast Cancer Module (BR23) Scores [ Time Frame: Predose on Day 1, at end of treatment, and at Follow-up, up to 60 months ] [ Designated as safety issue: No ]
    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.


Enrollment: 219
Study Start Date: February 2007
Study Completion Date: June 2014
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
CP-751,871 + exemestane Treatment until progression or toxicity
Drug: CP-751,871
CP-751,871 given at 20 mg/kg IV on day 1 of each 21 day cycle.
Drug: exemestane
Exemestane given at 25 mg orally once a day.
Drug: Fulvestrant
Used for salvage therapy and administered according to the local label and standard clinical practice.
Active Comparator: 2 Drug: exemestane
Exemestane given at 25 mg orally once a day. Treatment until progression or toxicity

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00372996

  Show 63 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00372996     History of Changes
Other Study ID Numbers: A4021004, 2006-005573-21
Study First Received: September 5, 2006
Results First Received: June 3, 2015
Last Updated: June 29, 2015
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Breast Neoplasms
Breast Diseases
Neoplasms
Neoplasms by Site
Skin Diseases
Exemestane
Antineoplastic Agents
Aromatase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on July 27, 2015