Study Of Sunitinib In Combination With Docetaxel Vs Docetaxel In Patients With Advanced Breast Cancer (SUN 1064)

Pfizer

Status and phase: Completed; Phase 3

Conditions: Breast Neoplasms

Treatments: Drug: Taxotere; Drug: Sunitinib malate

Study type: Interventional

Funder types: Industry

Identifiers

NCT00393939

A6181064

Details and patient eligibility

About

This is a phase 3 randomized trial evaluating the anti-tumor activity and safety of sunitinib combined with docetaxel versus docetaxel, administered as first-line treatment, in patients with unresectable locally recurrent or metastatic breast cancer.

Enrollment: 594 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Breast cancer with evidence of unresectable locally recurrent, or metastatic disease
• Her-2 negative tumors

Exclusion criteria

• Patients for whom docetaxel is contraindicated
• Clinical presentation of inflammatory carcinoma with no other measurable disease

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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594 participants in 2 patient groups

A

Experimental group

Treatment:

Drug: Sunitinib malate

B

Active Comparator group

Treatment:

Drug: Taxotere