MedTrace Logo

TAC Versus TC for Adjuvant Breast Cancer

NCT00493870 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1961

Last updated 2023-03-02

Study results available
· View outcomes & findings →

Summary

The purpose of this research study is to find out what effects (good and bad) TC or TAC has on early stage HER2- breast cancer.

Conditions

Interventions

DRUG

Docetaxel

Docetaxel 75 mg/m2 IV over 1 hour on Day 1 followed by cyclophosphamide

DRUG

Doxorubicin

• Doxorubicin 50 mg/m2 IV push over 5-15 minutes via sidearm through a running IV line on Day 1, followed by cyclophosphamide 500 mg/m2 IV over 15-30 minutes on Day 1, followed by docetaxel 75 mg/m2 IV over 1 hour on Day 1. Administer pegfilgrastim 6 mg SC on Day 2 (or filgrastim 5 mcg/kg SC per standard of care).

DRUG

Cyclophosphamide

600 mg/m2 IV over 15-30 minutes on Day 1.

Sponsors & Collaborators

  • Sanofi

    collaborator INDUSTRY

  • US Oncology Research

    lead INDUSTRY

Principal Investigators

  • Joanne L Blum, MD · US Oncology Research

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
2007-05-29
Primary Completion
2015-05-31
Completion
2020-03-30

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 NCT00493870 on ClinicalTrials.gov