AG-013736 In Combination With Docetaxel Versus Docetaxel Alone For Patients With Metastatic Breast Cancer

Pfizer

Status and phase: Completed; Phase 2; Phase 1

Conditions: Breast Neoplasms

Treatments: Drug: Docetaxel; Drug: AG-013736 (axitinib); Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00076024

A4061010

Details and patient eligibility

About

The primary purpose of the study is to determine the time to progression of the combination of study drug (AG-013736) and docetaxel versus docetaxel alone in patients who have not received prior chemotherapy for metastatic breast cancer. The secondary purpose of the study is to determine the dose of study drug that can be given with docetaxel administered on an every 3 week schedule.

Enrollment: 174 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Female patients with histologically/cytologically proven metastatic breast carcinoma (stage IV, or recurrent with local or regional spread or distant metastatic disease)
• Adequate bone marrow, liver, and renal function

Exclusion criteria

• Adjuvant chemotherapy given in the past 12 months
• Uncontrolled brain metastases

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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174 participants in 2 patient groups

Docetaxel + Placebo

Other group

Description:

Docetaxel + Placebo

Treatment:

Drug: Docetaxel

Drug: Docetaxel

Drug: Placebo

Docetaxel + AG-013736

Experimental group

Description:

Docetaxel + AG-013736

Treatment:

Drug: Docetaxel

Drug: AG-013736 (axitinib)

Drug: Docetaxel