Study Of SU011248 In Combination With Docetaxel And Trastuzumab In Patients With Advanced Breast Cancer HER-2 Positive

Pfizer

Status and phase: Completed; Phase 1

Conditions: Breast Cancer

Treatments: Drug: Sunitinib; Drug: Taxotere; Drug: Herceptin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00372424

A6181113

Details and patient eligibility

About

This is an exploratory trial evaluating the tolerability and preliminary anti-tumor activity of SU011248 combined with docetaxel and trastuzumab in patients with locally recurrent or metastatic breast cancer over-expressing Her-2, who have not received chemotherapy treatment in the advanced disease setting.

Enrollment: 26 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Breast cancer with evidence of unresectable, locally recurrent, or metastatic disease.
• Tumors over-expressing Her-2
• Candidate for treatment with docetaxel/trastuzumab

Exclusion criteria

• Histology of inflammatory carcinoma
• AST and/or ALT >1.5 x ULN concomitant with ALP >2.5 x ULN

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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26 participants in 1 patient group

1

Experimental group

Description:

Combination of SU011248 (37.5 mg once daily \[Schedule 2/1\]) with docetaxel (75 mg/m2 every 3 weeks) and trastuzumab (therapeutic dose)

Treatment:

Drug: Herceptin

Drug: Taxotere

Drug: Sunitinib