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Bevacizumab and Combination Chemotherapy in Patients With Lymph Node Positive Breast Cancer

NCT00119262 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 226

Last updated 2014-05-15

Study results available
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Summary

This phase II trial is studying how well giving bevacizumab together with combination chemotherapy works in treating patients who have undergone surgery for breast cancer that has spread to the lymph nodes. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving bevacizumab together with more than one chemotherapy drug (combination chemotherapy), may be a better way to block tumor growth.

Conditions

  • Male Breast Cancer
  • Stage II Breast Cancer
  • Stage IIIA Breast Cancer
  • Stage IIIB Breast Cancer

Interventions

DRUG

doxorubicin hydrochloride

Given IV

DRUG

cyclophosphamide

Given IV

BIOLOGICAL

bevacizumab

Given IV

DRUG

paclitaxel

Given IV

BIOLOGICAL

filgrastim

Given SC

BIOLOGICAL

pegfilgrastim

Given SC

RADIATION

radiation therapy

Undergo radiation therapy

DRUG

tamoxifen citrate

Given orally

DRUG

aromatase inhibition therapy

Receive aromatase inhibition therapy

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    lead NIH

Principal Investigators

  • Kathy Miller · Eastern Cooperative Oncology Group

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-10-31
Primary Completion
2009-08-31
Completion
2009-09-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

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 NCT00119262 on ClinicalTrials.gov