A Study of AMG 706 or Bevacizumab, in Combination With Paclitaxel Chemotherapy, as Treatment for Breast Cancer

Amgen

Status and phase: Terminated; Phase 2

Conditions: Breast Cancer; Breast Tumors; Locally Recurrent and Metastatic Breast Cancer; Breast Neoplasms

Treatments: Drug: Bevacizumab; Drug: Paclitaxel; Drug: AMG 706; Drug: AMG 706 placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00356681

CIRG/TORI 010

20050225

Details and patient eligibility

About

To determine if treatment with paclitaxel plus AMG 706 is superior to paclitaxel plus AMG 706 placebo in subjects with HER2 negative locally recurrent or metastatic breast cancer. Also to estimate differences between treatment with paclitaxel plus AMG 706 and paclitaxel plus bevacizumab.

Enrollment: 282 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Histologically or cytologically confirmed adenocarcinoma of the breast with locally recurrent or metastatic disease.
• Measurable disease by RECIST guidelines.
• Tumor (primary or metastatic) must be HER2 negative.
• Adequate organ and hematologic function. Exclusion:
• Taxane treatment within 12 months prior to registration.
• Prior chemotherapy for locally recurrent or metastatic breast cancer (prior endocrine therapy is permitted).
• Prior radiation therapy, radiofrequency ablation, percutaneous cryotherapy or hepatic chemoembolization on all sites of measurable disease.
• Current or prior history of central nervous system metastases.
• Peripheral neuropathy ≥ grade 2 (CTCAE v3.0) at registration.
• History of arterial or venous thrombosis within 1 year prior to registration.
• History of bleeding diathesis or bleeding within 14 days of registration.
• Uncontrolled hypertension (systolic >145 mmHg; diastolic >85 mmHg).
• Clinically significant cardiac disease within 12 months of registration.
• Known HIV positive, hepatitis C positive or hepatitis B surface antigen positive.
• Prior treatment with VEGFr targeted therapies.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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282 participants in 3 patient groups, including a placebo group

Arm A Placebo

Placebo Comparator group

Description:

Blinded AMG 706 placebo plus paclitaxel

Treatment:

Drug: Paclitaxel

Drug: AMG 706 placebo

Arm B Experimental

Experimental group

Description:

Blinded AMG 706 plus paclitaxel

Treatment:

Drug: Paclitaxel

Drug: AMG 706

Arm C Comparator

Active Comparator group

Description:

Open-label bevacizumab plus paclitaxel

Treatment:

Drug: Paclitaxel

Drug: Bevacizumab