CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 126 enrolled
Drug / intervention
Liposomal doxorubicin hydrochloride +4 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/NCT00712881
NCT00712881Phase 2Completed
CompareCT.gov

Prospective, Open-Label, Randomized Study of Combination Therapy of MYOCET® Plus Cyclophosphamide and Trastuzumab Versus Free Doxorubicin Plus Cyclophosphamide Alone, Each Followed by Docetaxel and Trastuzumab, in Neoadjuvant Setting in Treatment-Naive Patients With HER2-Positive Breast Cancer

Cephalon, Inc.·interventional·Posted Jul 10, 2008·Updated Feb 23, 2024

In Brief

A Phase 2 clinical trial evaluating Liposomal doxorubicin hydrochloride, Cyclophosphamide, and 3 other interventions for Breast Cancer. Completed, enrolled 126 participants across 22 sites in 6 countries.

Detailed Summary

To evaluate the efficacy and safety of treatment with MYOCET® (doxorubicin hydrochloride) in combination with cyclophosphamide and trastuzumab, 4 cycles, followed by docetaxel plus trastuzumab, 4 cycles, in women with stage II or III breast cancer whose tumour overexpresses the human epidermal growth factor receptor 2 (HER2) gene.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Cancer
CountriesAustria, Belgium, France, Germany, Italy, Spain
Collaborators--

Timeline

Phase 2CompletedFinished
2009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJul 10, 2008
Enrollment StartOct 13, 2008
Primary CompletionSep 17, 2015
TodayJul 2, 2026
Enrollment to primary: 6.9 yearsPosted 18.0 years ago

Interventions

Liposomal doxorubicin hydrochloridedrug

Liposomal doxorubicin hydrochloride will be administered per dose and schedule specified in the arm description.

Cyclophosphamidedrug

Cyclophosphamide will be administered per dose and schedule specified in the arm description.

Trastuzumabdrug

Trastuzumab will be administered per dose and schedule specified in the arm description.

Free doxorubicin hydrochloridedrug

Free doxorubicin hydrochloride will be administered per dose and schedule specified in the arm description.

Docetaxeldrug

Docetaxel will be administered per dose and schedule specified in the arm description.