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Preoperative Dose-dense Doxorubicin and Cyclophosphamide Followed by Paclitaxel With Bevacizumab in Operable Breast Cancer

NCT00546156 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 104

Last updated 2021-05-18

Study results available
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Summary

Dose dense chemotherapy, which is the term for Adriamycin and Cyclophosphamide (AC) followed by Taxol chemotherapy given every two weeks, is the standard chemotherapy for the treatment of ER+ or PR+ breast cancer. In this trial, the standard chemotherapy is being combined with bevacizumab. Bevacizumab is an antibody which works differently from the way other chemotherapy drugs work. Bevacizumab slows or stops cell growth in cancerous tumors by decreasing the blood supply to the tumors by binding to a substance found on cancer cells called VEGF (vascular endothelial growth factor). Bevacizumab is approved by the FDA for the treatment of colorectal cancer and lung cancer. However, it is not approved for the treatment of breast cancer. Another goal of this research is to determine whether we can develop a way to identify tumors that will respond well to this study treatment.

Conditions

Interventions

DRUG

Doxorubicin

Standard chemotherapy regimen

DRUG

Cyclophosphamide

Standard chemotherapy regimen

DRUG

Paclitaxel

Standard chemotherapy regimen

DRUG

Bevacizumab

One intravenous dose given followed 2 weeks later with standard chemotherapy drugs and bevacizumab given intravenously in 8 two-week cycles.

Sponsors & Collaborators

  • Genentech, Inc.

    collaborator INDUSTRY

  • Massachusetts General Hospital

    collaborator OTHER

  • Brigham and Women's Hospital

    collaborator OTHER

  • New Hampshire Oncology-Hematology PA

    collaborator UNKNOWN

  • Ian E. Krop, MD, PhD

    lead OTHER

Principal Investigators

  • Ian Krop, MD, PhD · Dana-Farber Cancer Institute

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-10-31
Primary Completion
2011-10-31
Completion
2012-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00546156 on ClinicalTrials.gov