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A Phase II Study Of Sunitinib Malate In Combination With Capecitabine In Patients With Advanced Or Metastatic Breast Cancer

Phase 2
20 Years
Not Enrolling
Advanced/Metastatic Breast Cancer

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Trial Information

A Phase II Study Of Sunitinib Malate In Combination With Capecitabine In Patients With Advanced Or Metastatic Breast Cancer

Inclusion Criteria:

- Histologically- or cytologically-proven diagnosis of breast adenocarcinoma that is
not amenable to surgery, radiation, or combined modality therapy with curative intent

- Measurable disease as per RECIST. Measurable lesions that have been previously
irradiated will not be considered target lesions unless increase in size has been
observed following completion of radiation therapy.

- Prior treatment with an anthracycline and a taxane in the neoadjuvant, adjuvant or
metastatic disease settings.

Exclusion Criteria:

- Histology of inflammatory carcinoma with no other measurable disease. Patients with
histology of inflammatory carcinoma are allowed on study if they have measurable

- Brain metastases, spinal cord compression, or carcinomatous meningitis, or
leptomeningeal disease.

- Prior treatment with 5-fluorouracil (5-FU) and 5-FU derivatives such as Furtulon
(5'-DFUR), Futraful/ Sunfural (tegafur), UFT/UFT-E (tegafur/uracil), TS-1
(tegafur/gimeracil/oteracil) or Mifurol (carmofur) in metastatic disease setting

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Number of Participants With Objective Response Based on Data Review Committee's Assessment

Outcome Description:

Number of participants with objective response based on assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors version 1.0 (RECIST). CR is defined as disappearance of all target and non-target lesions. PR is defined as ≥30% decrease in sum of the longest dimensions (LDs) of the target lesions taking as reference the baseline sum LD according to RECIST. Confirmed responses are those that persist on repeat evaluation ≥4 weeks after initial documentation of response.

Outcome Time Frame:

Day 1 of Cycle 2, every 6 weeks after Cycle 2, and at the end of Cycle 8.

Safety Issue:


Principal Investigator

Pfizer Call Center

Investigator Role:

Study Director

Investigator Affiliation:



Japan: Ministry of Health, Labor and Welfare

Study ID:




Start Date:

April 2008

Completion Date:

May 2012

Related Keywords:

  • Advanced/Metastatic Breast Cancer
  • Breast Neoplasms