NCT00712881

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 126 (actual)
• Sponsor: Cephalon, Inc. · Industry
• Sex: Female
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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

• Breast Cancer

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2008-10-13
• Primary completion: 2015-09-17
• Completion: 2015-09-17
• First posted: 2008-07-10
• Last updated: 2024-02-23
• Results posted: 2024-02-23

Locations

22 sites across 6 countries: Austria, Belgium, France, Germany, Italy, Spain