Comparison of Two Regimens of Liposomal Doxorubicin in Treating Women With Metastatic Breast Cancer

Phase 2

Completed

• Conditions: Breast Cancer

• Registration Number: NCT00005980
• Lead Sponsor: European Organisation for Research and Treatment of Cancer - EORTC

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known which regimen of liposomal doxorubicin is more effective for metastatic breast cancer.

PURPOSE: Randomized phase II trial to compare the effectiveness of two regimens of liposomal doxorubicin in treating women who have metastatic breast cancer.

Detailed Description

OBJECTIVES:

* Determine the response rate in women with metastatic breast cancer treated with two different dose schedules of doxorubicin HCL liposome.

* Assess the side effects of these treatment regimens in this patient population.

* Determine the duration of response in these patients treated with these regimens.

* Assess the concentration of doxorubicin in tumor tissue in patients with easily accessible metastases.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating center, performance status (0-1 vs 2), visceral disease (yes vs no), available lesions for biopsy (yes vs no), prior adjuvant anthracyclines (yes vs no), and prior chemotherapy for advanced disease (yes vs no). Patients are randomized to one of two treatment arms.

* Arm I: Patients receive doxorubicin HCL liposome IV over 1 hour every 6 weeks.

* Arm II: Patients receive doxorubicin HCL liposome IV over 1 hour every 4 weeks. Treatment continues for at least 36 weeks in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months.

PROJECTED ACCRUAL: A total of 64-100 patients (32-50 per treatment arm) will be accrued for this study.

Study Timeline

• Study Start: 2000-04
• Study First Submitted: 2000-07-05
• Primary Completion: 2002-07
• Study First Submitted QC: 2003-01-26
• Study First Posted: 2003-01-27
• Status Verified: 2012-07
• Last Update Submitted: 2012-07-17
• Last Update Posted: 2012-07-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 116

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (14)

Ludwig Boltzmann - Institute for Applied Cancer Research; 🇦🇹 Vienna, Austria

University of Ioannina; 🇬🇷 Ioannina, Greece

Clinique De Genolier; 🇨🇭 Genolier, Switzerland

Centre Henri Becquerel; 🇫🇷 Rouen, France

Centre Jean Perrin; 🇫🇷 Clermont-Ferrand, France

Institut Bergonie; 🇫🇷 Bordeaux, France

Rabin Medical Center - Beilinson Campus; 🇮🇱 Petah-Tikva, Israel

Institut Curie - Section Medicale; 🇫🇷 Paris, France

Mario Negri Institute for Pharmacological Research; 🇮🇹 Milano (Milan), Italy

Hospital Universitario 12 de Octubre; 🇪🇸 Madrid, Spain

Academisch Ziekenhuis Groningen; 🇳🇱 Groningen, Netherlands

University Medical Center Nijmegen; 🇳🇱 Nijmegen, Netherlands

Istituti Fisioterapici Ospitalieri - Roma; 🇮🇹 Rome, Italy

Royal Marsden NHS Trust; 🇬🇧 London, England, United Kingdom