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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00678626
Recruitment Status : Withdrawn
First Posted : May 15, 2008
Last Update Posted : May 4, 2015
Information provided by:

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.

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: CP-751,871 Drug: Docetaxel Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : April 2009
Estimated Primary Completion Date : September 2011
Estimated Study Completion Date : September 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
Drug Information available for: Docetaxel

Arm Intervention/treatment
Experimental: Arm A
combination of CP-751,871 + docetaxel administered
Drug: CP-751,871
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.

Active Comparator: Arm B
Drug: Docetaxel
Docetaxel only is administered every 3 weeks. After progression, administration with CP-751, 871 (20 mg/kg IV) is permitted.

Primary Outcome Measures :
  1. Progression Free Survival [ Time Frame: 3 years ]

Secondary Outcome Measures :
  1. Biomarkers (IGF-1R positive Circulating Tumor Cells; Anti-Drug Antibodies) [ Time Frame: 3 years ]
  2. Overall Response [ Time Frame: 3 years ]
  3. Overall Survival [ Time Frame: 3 years ]
  4. Safety and tolerability [ Time Frame: 3 years ]
  5. Patient Reported Outcomes using the MDASI (MD Anderson Symptom Inventory) questionnaire [ Time Frame: 3 years ]
  6. Pharmacokinetics of CP-751,871 [ Time Frame: 3 years ]
  7. Optional tissue markers of the IGF-1R pathway from tumor tissue obtained [ Time Frame: 3 years ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00678626

Sponsors and Collaborators
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Study Director: Pfizer Call Center Pfizer

Additional Information:
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Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer Inc Identifier: NCT00678626    
Other Study ID Numbers: A4021008
First Posted: May 15, 2008    Key Record Dates
Last Update Posted: May 4, 2015
Last Verified: April 2015
Keywords provided by Pfizer:
Key words: Docetaxel; breast cancer; breast diseases; breast neoplasms; antineoplastic agents; neoplasms;HER-2 negative; Stage IIIB or IV breast cancer.
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Antibodies, Monoclonal
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Physiological Effects of Drugs