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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


Phase 2
18 Years
N/A
Not Enrolling
Female
Breast Cancer

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Trial Information

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


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.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Progression Free Survival

Outcome Time Frame:

3 years

Safety Issue:

No

Principal Investigator

Pfizer CT.gov Call Center

Investigator Role:

Study Director

Investigator Affiliation:

Pfizer

Authority:

United States: Food and Drug Administration

Study ID:

A4021008

NCT ID:

NCT00678626

Start Date:

April 2009

Completion Date:

September 2011

Related Keywords:

  • Breast Cancer
  • Key words: Docetaxel; breast cancer; breast diseases; breast neoplasms; antineoplastic agents; neoplasms;HER-2 negative; Stage IIIB or IV breast cancer.
  • Breast Neoplasms

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