Myocet Plus Endoxan for Older Patients With Breast Cancer

Hellenic Oncology Research Group

Status and phase

Terminated

Phase 2

Conditions

Breast Cancer

Treatments

Drug: Cyclophosphamide

Drug: Liposomal-encapsulated doxorubicin

Study type

Interventional

Funder types

Other

Identifiers

NCT01120171

CT/08.32

Details and patient eligibility

About

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

Full 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

Enrollment

64 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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