Efficacy And Safety Of Sunitinib In Women With Advanced Breast Cancer

Pfizer

Status and phase: Completed; Phase 2

Conditions: Breast Neoplasms

Treatments: Drug: sunitinib

Study type: Interventional

Funder types: Industry

Identifiers

NCT00471276

A6181068

Details and patient eligibility

About

Patients with advanced breast cancer to receive sunitinib (Sutent) once daily until disease progression.

Enrollment: 83 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Histologically or cytologically proven diagnosis of breast cancer
• Metastatic or locally recurrent disease that is, in the opinion of the investigator, not amenable to resection or radiation therapy
• Patients with at least one measurable lesion as per RECIST

Exclusion criteria

• Inflammatory breast cancer
• Prior treatment with VEGF inhibitors (unless in adjuvant setting at least 12 months ago)

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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83 participants in 1 patient group

1

Experimental group

Treatment:

Drug: sunitinib