Study Of Sunitinib With Capecitabine In Breast Cancer

Pfizer

Status and phase: Completed; Phase 2

Conditions: Advanced/Metastatic Breast Cancer

Treatments: Drug: Sunitinib; Drug: Capecitabine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00662025

A6181163

Details and patient eligibility

About

To evaluate efficacy, safety and pharmacokinetics of sunitinib plus Capecitabine in Japanese patients with advanced/metastatic breast cancer.

Enrollment: 63 patients

Sex: Female

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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 disease.
• 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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63 participants in 1 patient group

1

Experimental group

Treatment:

Drug: Capecitabine

Drug: Sunitinib