Open Label Study Of SU011248 In Combination With Trastuzumab For Patients With Metastatic Breast Cancer

Pfizer

Status and phase: Completed; Phase 2

Conditions: Breast Neoplasms

Treatments: Drug: SU011248/Trastuzumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT00243503

A6181067

Details and patient eligibility

About

The current study is to evaluate: Overall response rate for the combination of trastuzumab and SU011248 in metastatic or locally recurrent breast cancer; evaluate safety and tolerability of the combination; measure duration of tumor control and survival; assess patient reported outcomes; assess PK in combination with trastuzumab and compare efficacy and safety.

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• A diagnosis of breast cancer with evidence of 1) unresectable, locally recurrent, or 2) metastatic disease.
• HER2 positive disease (3+ by immunohistochemistry [IHC] or FISH-positive)
• Candidate for treatment with trastuzumab. Prior treatment with trastuzumab and or/ lapatinib in the neoadjuvant, adjuvant or metastatic disease setting is permitted. Treatment with hormone therapy in the adjuvant and/or advanced disease setting is permitted.

Exclusion criteria

• Prior treatment with >1 regimen of cytotoxic therapy in the advanced disease setting. Adjuvant chemotherapy is permitted
• Prior exposure to trastuzumab if the patient had developed severe hypersensitivity reactions.
• Prior treatment on a SU11248 clinical trial.
• Uncontrolled brain metastases.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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60 participants in 1 patient group

A

Experimental group

Treatment:

Drug: SU011248/Trastuzumab