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Bevacizumab With or Without Cyclophosphamide and Methotrexate: A Pilot Study in Women With Operable Breast Cancer

NCT00121134 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 164

Last updated 2013-12-24

Study results available
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Summary

The purpose of this research study is to study the effects (good and bad) of bevacizumab alone, bevacizumab with low-dose continuous chemotherapy (called metronomic chemotherapy), or bevacizumab with capecitabine, on you and your cancer. The goals of the study will be to:

* Examine the safety of these drugs
* See how easy or difficult it is to be treated with them
* Monitor for any signs of recurrent cancer
* Look at blood markers that might indicate how the treatment is working

Conditions

Interventions

DRUG

Bevacizumab

Group A: Once every 3 weeks for 12 months Group B: Once every 3 weeks for 12 months

DRUG

Cyclophosphamide

Once a day for 6 months

DRUG

Methotrexate

Twice daily for the first two days of every week for 6 months

DRUG

Capecitabine

Capecitabine: 2000 mg/m2 a day, on Days 1-14 of a 21 day cycle, for at total of 6 cycles (18 weeks) Bevacizumab: 15 mg/kg IV day 1 every 3 weeks x 1 year (17 cycles)

Sponsors & Collaborators

Principal Investigators

  • Harold J Burstein, MD, PhD · Dana-Farber Cancer Institute

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-06-30
Primary Completion
2009-05-31
Completion
2011-05-31

Countries

  • United States

Study Locations

More Related Trials

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 NCT00121134 on ClinicalTrials.gov