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Therapy With Bevacizumab (BEV), Doxorubicin, and Cyclophosphamide Followed by BEV, Docetaxel, and Capecitabine Before Surgery Followed by BEV Alone After Surgery for Women With Locally Advanced Breast Cancer

NCT00365417 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2021-04-13

Study results available
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Summary

Bevacizumab is an angiogenesis inhibitor which means it works to stop blood vessel formation in tumors. Without new blood vessels, the growth of a tumor is slowed. Chemotherapy drugs kill cancer cells more directly. This study will evaluate:

* How bevacizumab, given with chemotherapy before surgery, and then bevacizumab given alone after surgery, will affect locally advanced breast tumors
* Side effects from adding bevacizumab to chemotherapy
* Whether adding bevacizumab to chemotherapy for breast cancer will affect the heart
* If receiving bevacizumab will have any effect on how patients recover from surgery
* Side effects of the combinations of drugs used in this study

Conditions

Interventions

DRUG

Bevacizumab

15 mg/kg IV every 21 days x 4 cycles, then after clinical response assessment, 15 mg/kg IV every 21 days x 2 cycles, then following surgery, 15 mg/kg every 21 days x 10 cycles

DRUG

Doxorubicin

60 mg/m\^2 IV every 21 days x 4 cycles

DRUG

Cyclophosphamide

600 mg/m\^2 IV every 21 days x 4 cycles

DRUG

Capecitabine

Following clinical response assessment, 650 mg/m\^2 twice a day (orally), days 1-14 every 21 days x 4 cycles

DRUG

Docetaxel

Following clinical response assessment, 75 mg/m\^2 IV every 21 days x 4 cycles

Sponsors & Collaborators

  • Genentech, Inc.

    collaborator INDUSTRY

  • Hoffmann-La Roche

    collaborator INDUSTRY

  • International Drug Development Institute

    collaborator OTHER

  • NSABP Foundation Inc

    lead NETWORK

Principal Investigators

  • Norman Wolmark, MD · NSABP Foundation Inc

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-08-31
Primary Completion
2008-02-29
Completion
2009-11-30

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases
Companies

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 NCT00365417 on ClinicalTrials.gov