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Phase 2 Trial Of CP-751,871 And Docetaxel In Advanced Breast Cancer

Primary Purpose

Breast Cancer

Status
Withdrawn
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
CP-751,871
Docetaxel
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring Key words: Docetaxel; breast cancer; breast diseases; breast neoplasms; antineoplastic agents; neoplasms;HER-2 negative; Stage IIIB or IV breast cancer.

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • histologically or cytologically confirmed diagnosis with evidence of either metastatic disease (Stage IV) of locally recurrent disease not amenable to curative resection or radiation therapy (Stage IIIB).
  • Her-2negative breast cancer or unknown Her-2 status.
  • at least 1 measurable lesion as defined by RECIST.
  • ECOG status 0-1
  • adequate bone marrow, hepatic and renal function.
  • left ventricular ejection fraction of greater than or equal to 50%.
  • willingness to discontinue hormonal therapy.

Exclusion Criteria:

  • any previous chemotherapy for advanced disease.
  • prior exposure to taxanes as (neo) adjuvant treatment less than 12 months prior to randomization.
  • symptomatic brain metastases.
  • prior anti-IGF-1R based investigational therapy.
  • peripheral neuropathy greater than grade 2.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Arm A

    Arm B

    Arm Description

    combination of CP-751,871 + docetaxel administered

    chemotherapy

    Outcomes

    Primary Outcome Measures

    Progression Free Survival

    Secondary Outcome Measures

    Biomarkers (IGF-1R positive Circulating Tumor Cells; Anti-Drug Antibodies)
    Overall Response
    Overall Survival
    Safety and tolerability
    Patient Reported Outcomes using the MDASI (MD Anderson Symptom Inventory) questionnaire
    Pharmacokinetics of CP-751,871
    Optional tissue markers of the IGF-1R pathway from tumor tissue obtained

    Full Information

    First Posted
    May 12, 2008
    Last Updated
    April 30, 2015
    Sponsor
    Pfizer
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00678626
    Brief Title
    Phase 2 Trial Of CP-751,871 And Docetaxel In Advanced Breast Cancer
    Official Title
    A Randomized Phase 2, Open-Label Study Of CP-751,871 In Combination With Docetaxel And Docetaxel Alone As A First Line Treatment Of Patients With Advanced Breast Cancer
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2015
    Overall Recruitment Status
    Withdrawn
    Study Start Date
    April 2009 (undefined)
    Primary Completion Date
    September 2011 (Anticipated)
    Study Completion Date
    September 2011 (Anticipated)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Pfizer

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    This study will assess the effectiveness of CP- 751,871 when given in combination with docetaxel to women with the first occurrence of advanced breast cancer disease. The effectiveness will be measured by progression-free survival duration. Patients will be followed for 2 years from the date of randomization.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Breast Cancer
    Keywords
    Key words: Docetaxel; breast cancer; breast diseases; breast neoplasms; antineoplastic agents; neoplasms;HER-2 negative; Stage IIIB or IV breast cancer.

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Arm A
    Arm Type
    Experimental
    Arm Description
    combination of CP-751,871 + docetaxel administered
    Arm Title
    Arm B
    Arm Type
    Active Comparator
    Arm Description
    chemotherapy
    Intervention Type
    Drug
    Intervention Name(s)
    CP-751,871
    Intervention Description
    Docetaxel administered every 3 weeks. CP-751,871 administered every 3 weeks. CP-751,871 administration (20 mg/kg IV) will continue after the docetaxel is stopped.
    Intervention Type
    Drug
    Intervention Name(s)
    Docetaxel
    Intervention Description
    Docetaxel only is administered every 3 weeks. After progression, administration with CP-751, 871 (20 mg/kg IV) is permitted.
    Primary Outcome Measure Information:
    Title
    Progression Free Survival
    Time Frame
    3 years
    Secondary Outcome Measure Information:
    Title
    Biomarkers (IGF-1R positive Circulating Tumor Cells; Anti-Drug Antibodies)
    Time Frame
    3 years
    Title
    Overall Response
    Time Frame
    3 years
    Title
    Overall Survival
    Time Frame
    3 years
    Title
    Safety and tolerability
    Time Frame
    3 years
    Title
    Patient Reported Outcomes using the MDASI (MD Anderson Symptom Inventory) questionnaire
    Time Frame
    3 years
    Title
    Pharmacokinetics of CP-751,871
    Time Frame
    3 years
    Title
    Optional tissue markers of the IGF-1R pathway from tumor tissue obtained
    Time Frame
    3 years

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: histologically or cytologically confirmed diagnosis with evidence of either metastatic disease (Stage IV) of locally recurrent disease not amenable to curative resection or radiation therapy (Stage IIIB). Her-2negative breast cancer or unknown Her-2 status. at least 1 measurable lesion as defined by RECIST. ECOG status 0-1 adequate bone marrow, hepatic and renal function. left ventricular ejection fraction of greater than or equal to 50%. willingness to discontinue hormonal therapy. Exclusion Criteria: any previous chemotherapy for advanced disease. prior exposure to taxanes as (neo) adjuvant treatment less than 12 months prior to randomization. symptomatic brain metastases. prior anti-IGF-1R based investigational therapy. peripheral neuropathy greater than grade 2.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Pfizer CT.gov Call Center
    Organizational Affiliation
    Pfizer
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Links:
    URL
    https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A4021008&StudyName=Phase%202%20Trial%20Of%20CP-751%2C871%20And%20Docetaxel%20In%20Advanced%20Breast%20Cancer
    Description
    To obtain contact information for a study center near you, click here.

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    Phase 2 Trial Of CP-751,871 And Docetaxel In Advanced Breast Cancer

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