A Phase 2 Efficacy And Safety Study Of SU011248 In Combination With Trastuzumab As Treatment For Metastatic Disease In Patients With Breast Cancer
18 Years
N/A
Both
Breast Neoplasms
Trial Information
A Phase 2 Efficacy And Safety Study Of SU011248 In Combination With Trastuzumab As Treatment For Metastatic Disease In Patients With Breast Cancer
Inclusion Criteria:
- A diagnosis of breast cancer with evidence of 1) unresectable, locally recurrent, or
2) metastatic disease.
- HER2 positive disease (3+ by immunohistochemistry [IHC] or FISH-positive)
- Candidate for treatment with trastuzumab. Prior treatment with trastuzumab and or/
lapatinib in the neoadjuvant, adjuvant or metastatic disease setting is permitted.
Treatment with hormone therapy in the adjuvant and/or advanced disease setting is
permitted.
Exclusion Criteria:
- Prior treatment with >1 regimen of cytotoxic therapy in the advanced disease setting.
Adjuvant chemotherapy is permitted
- Prior exposure to trastuzumab if the patient had developed severe hypersensitivity
reactions.
- Prior treatment on a SU11248 clinical trial.
- Uncontrolled brain metastases.
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Percentage of Participants With Overall Confirmed Objective Disease Response
Outcome Description:
Objective disease response =participants with confirmed complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). A CR was defined as the disappearance of all target and non-target lesions. A PR was defined as a > = 30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions associated to a non-progressive disease response for the non target lesions.
Outcome Time Frame:
From start of treatment through 18 months
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:
A6181067
NCT ID:
NCT00243503
Start Date:
February 2006
Completion Date:
July 2010
Related Keywords:
- Breast Neoplasms
- Breast Cancer Metastatic
- Breast Neoplasms
- Neoplasms
Name | Location |
|---|---|
| Pfizer Investigational Site | Birmingham, Alabama 35205 |
| Pfizer Investigational Site | Springfield, Illinois 62701-1014 |
| Pfizer Investigational Site | Bronx, New York 10461 |
| Pfizer Investigational Site | Clearwater, Florida 33761 |
| Pfizer Investigational Site | Carmel, Indiana 46032 |
| Pfizer Investigational Site | Las Vegas, Nevada 89128 |
| Pfizer Investigational Site | Shreveport, Louisiana 71103 |
| Pfizer Investigational Site | Bristol, Tennessee 37620 |
| Pfizer Investigational Site | Olive Branch, Mississippi 38654 |
| Pfizer Investigational Site | Newark, Delaware 19713 |
