Know Cancer

or
forgot password

A Randomized, Phase 3 Study Of Sunitinib In Combination With Capecitabine Compared With Capecitabine In Patients With Previously Treated Breast Cancer


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

Thank you

Trial Information

A Randomized, Phase 3 Study Of Sunitinib In Combination With Capecitabine Compared With Capecitabine In Patients With Previously Treated Breast Cancer


Inclusion Criteria:



- Locally advanced or metastatic disease that can be measured. Patients with bone-only
disease are also allowed to enter the study.

- Previous treatment with an anthracycline and a taxane in any setting

- Progression on first or second line regimen or adjuvant regimen if disease free
interval less than 12 months

Exclusion Criteria:

- History of inflammatory carcinoma if there is no other measurable disease

- More than 2 chemotherapy agents in the advanced disease setting

- Brain metastases 

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Progression Free Survival (PFS)

Outcome Description:

Defined as the time from the date of randomization to the date of the first documentation of objective tumor progression or death due to any cause, whichever occurs first. If tumor progression data include more than 1 date, the first date will be used. PFS (in months) will be calculated as (first event date minus randomization date plus 1) divided by 30.4.

Outcome Time Frame:

Baseline until disease progression (up to 3 years from first dose)

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:

A6181099

NCT ID:

NCT00435409

Start Date:

February 2007

Completion Date:

June 2011

Related Keywords:

  • Breast Neoplasms
  • Breast Neoplasms
  • Neoplasms

Name

Location

Pfizer Investigational Site Blendora, California  91740
Pfizer Investigational Site Atlanta, Georgia  30342
Pfizer Investigational Site Houston, Texas  77030
Pfizer Investigational Site Richmond, Virginia  23249
Pfizer Investigational Site Federal Way, Washington  98003
Pfizer Investigational Site Clearwater, Florida  33761
Pfizer Investigational Site Carmel, Indiana  46032
Pfizer Investigational Site Westminster, Maryland  21157
Pfizer Investigational Site Columbia, Missouri  65201
Pfizer Investigational Site Santa Fe, New Mexico  87505
Pfizer Investigational Site Asheville, North Carolina  28801
Pfizer Investigational Site Bartlesville, Oklahoma  74006
Pfizer Investigational Site Kingston, Pennsylvania  18704-5535
Pfizer Investigational Site Shreveport, Louisiana  71103
Pfizer Investigational Site Bristol, Tennessee  37620
Pfizer Investigational Site Olive Branch, Mississippi  38654
Pfizer Investigational Site Salt Lake City, Utah  84112
Pfizer Investigational Site Billings, Montana  59101