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Combination Therapy With MYOCET® (Doxorubicin HCL Liposome for Injection) in Participants With HER2-Positive Breast Cancer

NCT00712881 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 126

Last updated 2024-02-23

Study results available
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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.

Conditions

Interventions

DRUG

Liposomal doxorubicin hydrochloride

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

DRUG

Cyclophosphamide

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

DRUG

Trastuzumab

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

DRUG

Free doxorubicin hydrochloride

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

DRUG

Docetaxel

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

Sponsors & Collaborators

  • Cephalon, Inc.

    lead INDUSTRY

Principal Investigators

  • Teva Medical Expert · Teva Branded Pharmaceutical Products R&D, Inc.

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
2008-10-13
Primary Completion
2015-09-17
Completion
2015-09-17

Countries

  • Austria
  • Belgium
  • France
  • Germany
  • Italy
  • Spain

Study Locations

More Related Trials

Entities

Drugs
Diseases

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 NCT00712881 on ClinicalTrials.gov