Myocet Plus Endoxan for Older Patients With Breast Cancer

• Status: Terminated
• Trial end date: 2015-05-01
• Target enrollment: 0
• Participant gender: Female

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hellenic Oncology Research Group
• Treatments: Cyclophosphamide; Doxorubicin; Liposomal doxorubicin

Criteria

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