Clinical trial NCT00431795: Randomized Phase II Study of Epirubicin vs Caelyx in Pretreated Metastatic Breast Cancer
Official title: A Multicenter Randomized Phase II Study of Second Line Chemotherapy With Epirubicin( Farmorubicin) Versus the Pegylated Liposomal Doxorubicin in Advanced Breast Cancer Patients
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Breast Cancer
Keywords: Advanced breast cancer
Pegylated liposomal doxorubicin
Epirubicin
Lead sponsor: Hellenic Oncology Research Group
Sponsor class: OTHER
Collaborators: name: University Hospital of Crete
First posted: 2007-02-06
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: DOXORUBICIN is recognized as one of the most active drugs for breast cancer, but its clinical utility is limited because of a cumulative dose-dependent cardiac myopathy that can lead to potentially fatal congestive heart failure. Caelyx (pegylated liposomal doxorubicin) was designed to reduce the cardiotoxicity of doxorubicin while preserving its antitumor efficacy

Detailed description: To compare the efficacy of pegylated liposomal doxorubicin versus epirubicin as second line chemotherapy in patient with advanced breast cancer

Eligibility criteria: Inclusion Criteria:

* Age 18-75 years
* Eastern Cooperative Oncology Group (ECOG) performance status 0-2
* Adequate bone marrow function (Absolute neutrophil count \>1000/mm\^3, Platelet count\>100000/mm\^3, Hemoglobin\>9gr/mm\^3)
* Histologically- or cytologically- confirmed breast adenocarcinoma
* No prior anthracycline-based chemotherapy as treatment of advanced breast cancer
* No prior chemotherapy with ≥ 300mg/m2 doxorubicin or ≥ 540mg/m2 epirubicin as adjuvant setting
* At least 4 weeks interval since prior anticancer treatment
* Measurable disease as defined by the presence of at least one measurable lesion(except bone metastases, ascites or pleural effusions)
* Life expectancy \> 3 months
* Written informed consent

Exclusion Criteria:

* Pregnancy or nursing
* Documented history of congestive heart failure (CHF), serious arrhythmia, or myocardial infarction (within 6 months)
* Other invasive malignancy except nonmelanoma skin cancer or acute infection.
* Radiation of measurable disease (except brain metastases)
* Progressive brain metastases according to clinical or radiological criteria.
* Brain metastases without prior radiation therapy

Primary outcomes:
measure: Assessment of antitumor efficacy by objective tumor response rates
timeFrame: Objective responses confirmed by CT or MRI (on 3rd and 6th cy)
Secondary outcomes:
measure: Toxicity profile and tolerance between the two treatment arms
timeFrame: Toxicity assessment of each chemotherapy cycle
measure: Time to progression
timeFrame: 1 year
measure: Overall survival
timeFrame: 1 year
Other outcomes:
Locations:
city: Heraklion
country: Greece
facility: University Hospital of Crete
state: Crete
city: Alexandroupolis
country: Greece
facility: University General Hospital of Alexandroupolis, Dep of Medical Oncology
city: Athens
country: Greece
facility: "IASO" General Hospital of Athens, 1st Dep of Medical Oncology
city: Athens
country: Greece
facility: "Laikon" General Hospital, Medical Oncology Unit, Propedeutic Dep of Internal Medicine
city: Athens
country: Greece
facility: "Marika Iliadis" Hospital of Athens, Dep of Medical Oncology
city: Athens
country: Greece
facility: 401 Military Hospital of Athens
city: Athens
country: Greece
facility: Air Forces Military Hospital of Athens
city: Larissa
country: Greece
facility: State General Hospital of Larissa, Dep of Medical Oncology
city: Piraeus
country: Greece
facility: "Metaxa's" Anticancer Hospital of Piraeus, 1st Dep of Medical Oncology
city: Thessaloniki
country: Greece
facility: "Theagenion" Anticancer Hospital of Thessaloniki, 2nd Dep of Medical Oncology
Study officials:
affiliation: University Hospital of Crete
name: Dimitris Mavrudis, MD
role: PRINCIPAL_INVESTIGATOR
References: