Phase II Bevacizumab + Tax In Advanced Breast Cancer

Summary

RATIONALE: Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies, such as bevacizumab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or deliver cancer-killing substances to them. Combining chemotherapy with monoclonal antibody therapy may kill more tumor cells.

PURPOSE: This randomized phase II trial is to see if docetaxel with or without bevacizumab followed by surgery, radiation therapy, and combination chemotherapy works better in treating patients who have stage III or stage IV breast cancer.

Conditions

• Breast Cancer

Interventions

BIOLOGICAL

bevacizumab

Patients receive bevacizumab IV over 60 minutes once every 2 weeks on weeks 1-8.

DRUG

cyclophosphamide

Approximately 4 weeks after the completion of radiotherapy, patients receive cyclophosphamide IV over 30-60 minutes on day 1. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.

DRUG

docetaxel

Patients receive docetaxel IV over 1 hour once weekly on weeks 1-6.

DRUG

doxorubicin hydrochloride

Approximately 4 weeks after the completion of radiotherapy, patients receive doxorubicin IV over 5 minutes. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.

PROCEDURE

adjuvant therapy

After the second course, patients with stable or responsive disease undergo modified radical mastectomy or breast-conserving surgery. Three to six weeks after surgery, patients undergo radiotherapy 5 days a week for 7 weeks. Approximately 4 weeks after the completion of radiotherapy, patients receive doxorubicin IV over 5 minutes and cyclophosphamide IV over 30-60 minutes on day 1. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.

PROCEDURE

conventional surgery

After the second course, patients with stable or responsive disease undergo modified radical mastectomy or breast-conserving surgery.

PROCEDURE

neoadjuvant therapy

Arm I: Patients receive docetaxel IV over 1 hour once weekly on weeks 1-6 and bevacizumab IV over 60 minutes once every 2 weeks on weeks 1-8. Arm II: Patients receive docetaxel as in arm I. Treatment in both arms repeats every 8 weeks for 2 courses in the absence of disease progression or unacceptable toxicity.

RADIATION

radiation therapy

Three to six weeks after surgery, patients undergo radiotherapy 5 days a week for 7 weeks.

Sponsors & Collaborators

• National Cancer Institute (NCI)

  collaborator NIH

• Case Comprehensive Cancer Center

  lead OTHER

Principal Investigators

• Paula Silverman, MD · Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2001-11-30

Primary Completion

2005-12-31

Completion

2010-08-31

Countries

• United States

Study Locations