CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 280 enrolled
Drug / intervention
Cyclophosphamide +5 moredrug
Likely dose
Not stated in 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/NCT00513292
NCT00513292Phase 3Completed

A Randomized Phase III Trial Comparing a Neoadjuvant Regimen of FEC-75 Followed by Paclitaxel Plus Trastuzumab With a Neoadjuvant Regimen of Paclitaxel Plus Trastuzumab Followed by FEC-75 Plus Trastuzumab in Patients With HER-2 Positive Operable Breast Cancer

National Cancer Institute (NCI)·interventional·Posted Aug 8, 2007·Updated Jan 23, 2019

In Brief

A Phase 3 clinical trial evaluating Cyclophosphamide, Epirubicin Hydrochloride, and 4 other interventions for HER2/Neu Positive and 4 related conditions. Completed, enrolled 280 participants across 115 sites in 2 countries.

Detailed Summary

This randomized phase III trial is studying giving fluorouracil together with epirubicin and cyclophosphamide followed by paclitaxel and trastuzumab to see how well it works compared with giving paclitaxel together with trastuzumab followed by fluorouracil, epirubicin, cyclophosphamide, and trastuzumab in treating women with palpable breast cancer that can be removed by surgery. Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as trastuzumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. It is not yet known whether it is more effective to give combination chemotherapy before or after treatment with paclitaxel plus trastuzumab.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesPuerto Rico, United States
Collaborators--

Timeline

Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedAug 8, 2007
Enrollment StartJul 1, 2007
Primary CompletionJun 1, 2012
Study CompletionFeb 21, 2013
TodayJul 2, 2026
Enrollment to primary: 4.9 yearsPosted 18.9 years ago

Interventions

Cyclophosphamidedrug

Given IV

Epirubicin Hydrochloridedrug

Given IV

Laboratory Biomarker Analysisother

Correlative studies

Paclitaxeldrug

Given IV

Therapeutic Conventional Surgeryprocedure

Undergo surgery

Trastuzumabbiological

Given IV