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
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
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
64
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.
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.
University General Hospital of Alexandroupolis
Alexandroupoli, Greece
"IASO" General Hospital of Athens, 1st Dep of Medical Oncology
Athens, Greece
"Laikon" General Hospital, Medical Oncology Unit, Propedeutic Dep of Internal Medicine
Athens, Greece
Overall Response Rate
Time frame: Objective responses confirmed by CT or MRI every 3 months
Toxicity profile
Time frame: Toxicity assessment every month
Time to Tumor Progression
Time frame: 1-year
Overall Survival
Time frame: 1 year
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"Marika Iliadis" Hospital of Athens, Dep of Medical Oncology
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"Metaxa's" Anticancer Hospital of Piraeus, 1st Dep of Medical Oncology
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401 Military Hospital of Athens
Athens, Greece
Air Forces Military Hospital of Athens
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University Hospital of Crete
Heraklion, Greece
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"Diabalkaniko" hospital, Thessaloniki
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...and 1 more locations