A Study Of Sunitinib In Combination With Capecitabine Compared With Capecitabine In Patients With Breast Cancer

Pfizer

Status and phase: Completed; Phase 3

Conditions: Breast Neoplasms

Treatments: Drug: Sunitinib + Capecitabine; Drug: Capecitabine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00435409

A6181099

Details and patient eligibility

About

The treatment received with sunitinib plus capecitabine could delay tumor growth longer than with treatment with capecitabine alone.

Enrollment: 442 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Locally advanced or metastatic disease that can be measured. Patients with bone-only disease are also allowed to enter the study.
• Previous treatment with an anthracycline and a taxane in any setting
• Progression on first or second line regimen or adjuvant regimen if disease free interval less than 12 months

Exclusion criteria

• History of inflammatory carcinoma if there is no other measurable disease
• More than 2 chemotherapy agents in the advanced disease setting
• Brain metastases

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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442 participants in 2 patient groups

A

Experimental group

Treatment:

Drug: Sunitinib + Capecitabine

B

Active Comparator group

Treatment:

Drug: Capecitabine