CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 3,299 enrolled
Drug / intervention
docetaxel, doxorubicin, cyclophosphamide +1 moredrug
Likely dose
docetaxel, doxorubicin, cyclophosphamide 75 mgfrom 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/NCT00312208
NCT00312208Phase 3Completed
CompareCT.gov

A Multicenter Phase III Randomized Trial Comparing Docetaxel in Combination With Doxorubicin and Cyclophosphamide Versus Doxorubicin and Cyclophosphamide Followed by Docetaxel as Adjuvant Treatment of Operable Breast Cancer HER2neu Negative Patients With Positive Axillary Lymph Nodes

Sanofi·interventional·Posted Apr 7, 2006·Updated Dec 30, 2013

In Brief

A Phase 3 clinical trial evaluating docetaxel, doxorubicin, cyclophosphamide and Docetaxel,doxorubicin, cyclophosphamide for Breast Cancer. Completed, enrolled 3,299 participants across 37 sites in 37 countries.

Detailed Summary

Primary objective : * To compare disease-free survival after treatment with docetaxel in combination with doxorubicin and cyclophosphamide to doxorubicin and cyclophosphamide followed by docetaxel in operable adjuvant breast cancer HER2neu negative patients with positive axillary lymph nodes. Secondary objectives : * To compare toxicity and quality of life between the 2 above-mentioned arms. * To evaluate pathologic and molecular markers for predicting efficacy.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Cancer
CountriesArgentina, Australia, Belgium, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, China, Colombia, Croatia, Cyprus, Czechia, Egypt, Estonia, France, Germany, Greece, Hong Kong, Hungary, Ireland, Israel, Lebanon, Mexico, New Zealand, Poland, Portugal, Romania, Russia, Saudi Arabia, Slovenia, South Africa, South Korea, Spain, Taiwan, United States, Uruguay, Venezuela
CollaboratorsCancer International Research Group (CIRG)

Timeline

Phase 3CompletedFinished
20022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedApr 7, 2006
Enrollment StartNov 1, 2001
Primary CompletionOct 1, 2008
Study CompletionOct 1, 2013
TodayJul 2, 2026
Enrollment to primary: 6.9 yearsPosted 20.2 years ago

Interventions

docetaxel, doxorubicin, cyclophosphamidedrug

TAC x 6 : Docetaxel 75 mg/m² as 1 hour IV infusion on day 1 every 3 weeks in combination with doxorubicin 50 mg/m² as an IV bolus and cyclophosphamide 500 mg/m2 as IV on day 1 every 3 weeks. Sequence of administration is as follows: doxorubicin followed by cyclophosphamide followed by docetaxel.

Docetaxel,doxorubicin, cyclophosphamidedrug

AC x 4: Doxorubicin 60 mg/m² as an IV bolus in combination with cyclophosphamide 600 mg/m² as IV followed by docetaxel 100 mg/m² as 1 hour IV infusion on day 1 every 3 weeks for 4 cycles.