Study Of SU011248 Versus Chemotherapy For Patients With Previously Treated Triple Receptor Negative Breast Cancer

Pfizer

Status and phase: Completed; Phase 2

Conditions: Breast Neoplasms

Treatments: Drug: SU011248; Drug: Chemotherapy

Study type: Interventional

Funder types: Industry

Identifiers

NCT00246571

A6181077

Details and patient eligibility

About

The purpose of this study is to compare progression free survival for SU011248 [sutent (sunitinib malate)] versus standard of care therapy in patients with previously treated, advanced, triple receptor negative (ER, PR, HER2) locally recurrent or metastatic breast cancer.

Enrollment: 217 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Recurrent or metastatic breast cancer
• Estrogen receptor (ER), progestin receptor (PR) and HER2/neu receptor (HER2) negative status
• Prior treatment with an anthracycline and a taxane in the adjuvant or advanced disease setting
• Relapse following adjuvant chemotherapy within 6 months of last treatment and/or received one or two chemotherapy regimens for advanced disease

Exclusion criteria

• More than two chemotherapy regimens for advanced disease
• Uncontrolled/symptomatic spread of cancer to the brain

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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217 participants in 2 patient groups

A

Experimental group

Treatment:

Drug: SU011248

B

Active Comparator group

Treatment:

Drug: Chemotherapy