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

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

Study Overview

• Status: Terminated
• Conditions: Breast Cancer
• Intervention / Treatment: Drug: Cyclophosphamide; Drug: Liposomal-encapsulated doxorubicin

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

• Study Type: Interventional
• Enrollment (Actual): 64
• Phase: Phase 2

Contacts and Locations

Study Locations

• Greece
  • Alexandroupolis, Greece
    • University General Hospital of Alexandroupolis
  • Athens, Greece
    • "Laikon" General Hospital, Medical Oncology Unit, Propedeutic Dep of Internal Medicine
  • Athens, Greece
    • "IASO" General Hospital of Athens, 1st Dep of Medical Oncology
  • Athens, Greece
    • "Marika Iliadis" Hospital of Athens, Dep of Medical Oncology
  • Athens, Greece
    • 401 Military Hospital of Athens
  • Athens, Greece
    • Air Forces Military Hospital of Athens
  • Athens, Greece
    • "Metaxa's" Anticancer Hospital of Piraeus, 1st Dep of Medical Oncology
  • Heraklion, Greece
    • University Hospital of Crete
  • Larissa, Greece
    • State General Hospital of Larissa, Dep of Medical Oncology
  • Thessaloniki, Greece
    • "Diabalkaniko" hospital, Thessaloniki
  • Thessaloniki, Greece
    • : "Theagenion" Anticancer Hospital of Thessaloniki, 2nd Dep of Medical Oncology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Histologically or cytologically confirmed metastatic breast adenocarcinoma
• No more than one prior therapy regimen (other than hormonal therapy) for metastatic breast cancer is acceptable.
• Measurable disease as defined by the presence of at least one measurable lesion (except bone metastases, ascites or pleural effusions)
• Performance status (WHO) 0-2
• Adequate liver (serum bilirubin <1.5 times the upper normal limit, AST and ALT <2.5 times the upper normal limit in the absence of demonstrable liver metastases, or <5 times the upper normal limit in the presence of liver metastases)
• Adequate renal function (serum creatinine <1.5 times the upper normal limit)
• Adequate cardiac function (LVEF within normal limits)
• Adequate bone marrow function (neutrophils ≥ 1.5x 109 /L, and platelets ≥ 100x 109 /L)
• No radiation of measurable disease (except brain metastases)
• No progressive brain metastases according to clinical or radiological criteria
• No brain metastases without prior radiation therapy
• Written informed consent

Exclusion Criteria:

• Active infection
• History of significant cardiac disease (unstable angina, congestive heart failure, myocardial infarction within the previous 6 months, ventricular arrhythmias)
• Prior treatment with an anthracycline-containing regimen (as adjuvant therapy) during the previous 12 months period
• Other invasive malignancy except non-melanoma skin cancer
• Psychiatric illness or social situation that would preclude study compliance
• Pregnant or lactating women

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 1; Cyclofosfamide/Liposomal-encapsulated doxorubicin

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.; Other Names: Endoxan; 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.; Other Names: Myocet

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Overall Response Rate	Objective responses confirmed by CT or MRI every 3 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Time to Tumor Progression	1-year
Overall Survival	1 year
Toxicity profile	Toxicity assessment every month

Collaborators and Investigators

• Sponsor: Hellenic Oncology Research Group

Study record dates

Study Major Dates

• Study Start: September 1, 2009
• Primary Completion (Actual): May 1, 2015
• Study Completion (Actual): May 1, 2015

Study Registration Dates

• First Submitted: May 5, 2010
• First Submitted That Met QC Criteria: May 7, 2010
• First Posted (Estimate): May 10, 2010

Study Record Updates

• Last Update Posted (Estimate): October 7, 2015
• Last Update Submitted That Met QC Criteria: October 6, 2015
• Last Verified: October 1, 2015

More Information

Terms related to this study

• Keywords: Elderly; Breast cancer; Chemotherapy; Cardiotoxicity
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antirheumatic Agents; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Antineoplastic Agents, Alkylating; Alkylating Agents; Myeloablative Agonists; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Antibiotics, Antineoplastic; Cyclophosphamide; Doxorubicin; Liposomal doxorubicin
• Other Study ID Numbers: CT/08.32

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No