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A Randomized Phase 3 Study Of Docetaxel In Combination With Sunitinib Versus Docetaxel In The First-Line Treatment Of Advanced Breast Cancer Patients


Phase 3
18 Years
N/A
Not Enrolling
Female
Breast Neoplasms

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Trial Information

A Randomized Phase 3 Study Of Docetaxel In Combination With Sunitinib Versus Docetaxel In The First-Line Treatment Of Advanced Breast Cancer Patients


Inclusion Criteria:



- Breast cancer with evidence of unresectable locally recurrent, or metastatic disease

- Her-2 negative tumors

Exclusion Criteria:

- Patients for whom docetaxel is contraindicated

- Clinical presentation of inflammatory carcinoma with no other measurable disease

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 (PFS)

Outcome Description:

PFS defined as time from date of randomization to date of the first documentation of objective tumor progression or death due to any cause, whichever occurred first. PFS calculated as (Months) = (first event date minus randomization date plus 1) divided by 30.4.

Outcome Time Frame:

Baseline up to Month 33

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:

A6181064

NCT ID:

NCT00393939

Start Date:

February 2007

Completion Date:

July 2011

Related Keywords:

  • Breast Neoplasms
  • advanced breast cancer
  • sunitinib
  • docetaxel
  • Phase 3
  • Breast Neoplasms
  • Neoplasms

Name

Location

Pfizer Investigational SiteBlendora, California  91740
Pfizer Investigational SiteHouston, Texas  77030
Pfizer Investigational SiteShreveport, Louisiana  71103