NCT01120171

Myocet Plus Endoxan for Older Patients With Breast Cancer

Liposome-encapsulated Doxorubicin (Myocet) Plus Cyclophosphamide as First or Second Line Therapy for Older Patients With Metastatic Breast Cancer

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 64 (actual)
• Sponsor: Hellenic Oncology Research Group · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study will evaluate the efficacy, safety and effect on quality of life of liposomal-encapsulated doxorubicin in combination with cyclophosphamide as first or second line treatment of older patients (≥ 70 years old) with metastatic breast cancer. The efficacy of the combination will be correlated with the functional status of patients according to the comprehensive geriatric assessment

Detailed description

Elderly individuals make up a large part of the breast cancer population. When treated with chemotherapy for metastatic disease they derive similar benefits to their younger counterparts. Anthracyclines are associated with a cumulative dose-dependent cardiomyopathy with increased rate in patients over the age of 70. Liposomal-encapsulated doxorubicin improves the therapeutic index of doxorubicin by reducing significantly the cardiotoxicity and grade 4 neutropenia and provides comparable antitumor efficacy, when used in combination with cyclophosphamide as first-line therapy for metastatic breast cancer

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	Cyclophosphamide	Cyclophosphamide (IV) 600 mg/m2 on day 1. Treatment repeats every 21 days. Primary prophylaxis with pegfilgrastim (6 mg) administered 24 hours after chemotherapy. Therapy will continue until maximum response,or unacceptable toxicity.
DRUG	Liposomal-encapsulated doxorubicin	Liposomal-encapsulated doxorubicin (IV) 50 mg/m2 on day 1. Treatment repeats every 21 days. Primary prophylaxis with pegfilgrastim (6 mg) administered 24 hours after chemotherapy. Therapy will continue until maximum response or unacceptable toxicity.

Timeline

• Start date: 2009-09-01
• Primary completion: 2015-05-01
• Completion: 2015-05-01
• First posted: 2010-05-10
• Last updated: 2015-10-07

Locations

11 sites across 1 country: Greece