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A Clinical Trial Comparing the Combination of TC Plus Bevacizumab to TC Alone and to TAC for Women With Node-Positive or High-Risk Node-Negative, HER2-Negative Breast Cancer

NCT00887536 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1613

Last updated 2022-04-20

No results posted yet for this study

Summary

The main purpose of this study is to learn if adding bevacizumab to standard treatment with chemotherapy (docetaxel, doxorubicin, and cyclophosphamide) for early stage HER2-negative breast cancer will prevent breast cancer from returning. A second purpose of this study is to learn if adding bevacizumab to treatment with chemotherapy will help women with HER2-negative breast cancer live longer. The researchers also want to learn about the side effects of the combination of drugs used in this study.

Conditions

Interventions

DRUG

bevacizumab

bevacizumab 15 mg/kg IV every 21 days for 6 cycles followed by bevacizumab 15 mg/kg IV every 21 days until 1 year following the first dose of bevacizumab

DRUG

docetaxel

docetaxel 75 mg/m2 IV every 21 days for 6 cycles

DRUG

doxorubicin

doxorubicin 50 mg/m2 IV every 21 days for 6 cycles

DRUG

cyclophosphamide

Group 1: cyclophosphamide 500 mg/m2 IV every 21 days for 6 cycles Group 2 and 3: cyclophosphamide 600 mg/m2 IV every 21 days for 6 cycles

DRUG

pegfilgrastim

pegfilgrastim 6 mg subcutaneous (SC) Day 2 every 21 days for 6 cycles \[filgrastim (Neupogen®) 5 mcg/kg Days 2-10 may be given in lieu of pegfilgrastim (Neulasta®), but pegfilgrastim is preferred.\]

Sponsors & Collaborators

  • Genentech, Inc.

    collaborator INDUSTRY

  • US Oncology Research

    collaborator INDUSTRY

  • NSABP Foundation Inc

    lead NETWORK

Principal Investigators

  • Norman Wolmark, MD · NSABP Foundation Inc

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2009-05-31
Primary Completion
2018-02-28
Completion
2018-02-28

Countries

  • United States
  • Ireland

Study Locations

More Related Trials

Entities

Drugs
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 NCT00887536 on ClinicalTrials.gov