Know Cancer

or
forgot password

A Phase 2 Efficacy And Safety Study Of SU011248 In Combination With Trastuzumab As Treatment For Metastatic Disease In Patients With Breast Cancer


Phase 2
18 Years
N/A
Not Enrolling
Both
Breast Neoplasms

Thank you

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 SiteBirmingham, Alabama  35205
Pfizer Investigational SiteSpringfield, Illinois  62701-1014
Pfizer Investigational SiteBronx, New York  10461
Pfizer Investigational SiteClearwater, Florida  33761
Pfizer Investigational SiteCarmel, Indiana  46032
Pfizer Investigational SiteLas Vegas, Nevada  89128
Pfizer Investigational SiteShreveport, Louisiana  71103
Pfizer Investigational SiteBristol, Tennessee  37620
Pfizer Investigational SiteOlive Branch, Mississippi  38654
Pfizer Investigational SiteNewark, Delaware  19713