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Preoperative Chemotherapy in Triple Negative Invasive Breast Cancer That Can be Removed by Surgery.

NCT00777673 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2013-01-04

No results posted yet for this study

Summary

The purpose of this study is to determine how well this combination of chemotherapy drugs works with bevacizumab in eliminating primary tumor in the breast prior to surgery(pathological complete response or pCR in the breast). Bevacizumab is a drug that works by blocking new blood vessel formation by the tumor cells. Giving chemotherapy and bevacizumab before surgery may allow for lesser amount of breast tissue to be removed. To be able to predict in the future which patients are more likely to get pCR to this drug combination, specialized tests on tumor tissue will be performed.

Conditions

Interventions

DRUG

Bevacizumab, nab-paclitaxel, carboplatin, doxorubicin hydrochloride, cyclophosphamide, PEG-Filgrastim

Eligible patients will receive: * nab-paclitaxel IV on days 1, 8, and 15. Treatment will be repeated every 28 days 28 days for 4 courses. * Carboplatin IV on day 1. Treatment will be repeated every 28 days for 4 courses. * Bevacizumab IV on days 1 and 15. Treatment will be repeated every 28 days for 4 courses. After completion of the above regimen, patients will receive: * Doxorubicin IV on day 1. Treatment will be repeated every 14 days for 4 courses. * Cyclophosphamide IV on day 1. Treatment will be repeated every 14 days for 4 courses. * Bevacizumab IV on day 1. Treatment will be repeated every 14 days for 2 courses. Patients will then proceed with: \- Surgery including axillary staging A minimum of 4 weeks post operatively, patient will receive: \- Bevacizumab IV on days 1 and 15. Treatment will be repeated every 28 days for 8 courses.

Sponsors & Collaborators

  • National Comprehensive Cancer Network

    collaborator NETWORK

  • Celgene Corporation

    collaborator INDUSTRY

  • Genentech, Inc.

    collaborator INDUSTRY

  • University of Tennessee Cancer Institute

    lead OTHER

Principal Investigators

  • Jasgit C. Sachdev, MD · University of Tennessee Cancer Institute

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-10-31
Primary Completion
2013-01-31
Completion
2013-10-31

Countries

  • United States

Study Locations

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Entities

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 NCT00777673 on ClinicalTrials.gov