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

Pfizer

Status and phase: Completed; Phase 1

Conditions: Breast Neoplasms

Treatments: Drug: SU011248; Drug: Paclitaxel

Study type: Interventional

Funder types: Industry

Identifiers

NCT00174434

A6181073

Details and patient eligibility

About

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

Enrollment: 22 patients

Sex: All

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 paclitaxel.

Exclusion criteria

• Prior chemotherapy in the advanced disease setting.
• HER2 positive disease unless previously treated with trastuzumab.

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

A

Experimental group

Treatment:

Drug: Paclitaxel

Drug: SU011248