Study Of SU011248 In Combination With Docetaxel In Patients With Metastatic Breast Cancer

Pfizer

Status and phase: Completed; Phase 1

Conditions: Breast Neoplasms

Treatments: Drug: Taxotere; Drug: Sunitinib (Sutent)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00291577

A6181100

Details and patient eligibility

About

This study is to evaluate the safety of SU011248 (Sunitinib/Sutent) in combination with docetaxel in patients with metastatic or locally recurrent breast cancer who have not received chemotherapy treatment in the advanced disease setting.

Enrollment: 22 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Breast cancer with evidence of unresectable, locally recurrent or metastatic disease
• Candidate for treatment with docetaxel

Exclusion criteria

• Prior chemotherapy in the advanced disease setting
• Inflammatory breast cancer
• HER2 positive disease

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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22 participants in 1 patient group

1

Experimental group

Treatment:

Drug: Sunitinib (Sutent)

Drug: Taxotere