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Trial of Chemotherapy and Avastin as Treatment for Women With Breast Cancer at High Risk for Relapse

NCT00462865 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2019-04-09

Study results available
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Summary

Women with breast cancer who are not eligible for breast conserving surgery or who have node-involvement are sometimes treated with chemotherapy up front, in hopes of allowing for a woman to keep her breast and decreasing the size of the excision for her breast cancer. While current research has shown that survival is the same whether women are treated with chemotherapy first or surgery first for breast cancer, the investigators do not yet know how to treat women with persistent breast cancer after she has received primary chemotherapy. This study looks at the use of a combination regimen of two agents (gemcitabine and capecitabine), both of which are active in breast cancer, and using Avastin to see if this regimen can be given to women treated with primary chemotherapy and then surgery, considered to be at high risk of relapse.

Conditions

Interventions

DRUG

Gemcitabine and Capecitabine and Avastin

avastin administered concurrently with chemotherapy (gemcitabine + capecitabine) for six cycles followed by single agent avastin to complete one year of treatment. Radiation therapy (if planned) will take place after adjuvant chemotherapy completes.

Sponsors & Collaborators

  • Women and Infants Hospital of Rhode Island

    collaborator OTHER

  • Rhode Island Hospital

    collaborator OTHER

  • The Miriam Hospital

    collaborator OTHER

  • Memorial Hospital of Rhode Island

    collaborator OTHER

  • University of New Mexico Cancer Center

    collaborator OTHER

  • Brown University

    lead OTHER

Principal Investigators

  • Bachir Sakr, MD · Women & Infants' Hospital of Rhode Island

  • William Sikov, MD · Lifespan Hospitals

  • Melanie Royce, MD · University of New Mexico Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-11-30
Primary Completion
2012-03-31
Completion
2014-01-31

Countries

  • United States

Study Locations

More Related Trials

Entities

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 NCT00462865 on ClinicalTrials.gov