CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 1,961 enrolled
Drug / intervention
Docetaxel +2 moredrug
Likely dose
Docetaxel 75 mg/m2from record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00493870
NCT00493870Phase 3Completed
CompareCT.gov

Phase III Trial of TC Versus TAC in HER2-Negative Early Stage Breast Cancer Patients

US Oncology Research·interventional·Posted Jun 28, 2007·Updated Mar 2, 2023

In Brief

A Phase 3 clinical trial evaluating Docetaxel, Doxorubicin, and 1 other intervention for Breast Cancer. Completed, enrolled 1,961 participants across 95 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Cancer
CountriesUnited States
CollaboratorsSanofi

Timeline

Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJun 28, 2007
Enrollment StartMay 29, 2007
Primary CompletionMay 31, 2015
Study CompletionMar 30, 2020
TodayJul 2, 2026
Enrollment to primary: 8.0 yearsPosted 19.0 years ago

Interventions

Docetaxeldrug

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

Doxorubicindrug

• 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).

Cyclophosphamidedrug

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