Randomized Phase II Study of Epirubicin vs Caelyx in Pretreated Metastatic Breast Cancer

Breast Cancer Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00431795
• Other study ID #: CT/03.12
• Status: Terminated
• Phase: Phase 2
• First received: February 5, 2007
• Last updated: February 12, 2013
• Start date: June 2003
• Est. completion date: June 2012

Study information

• Verified date: February 2013
• Source: Hellenic Oncology Research Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: Greece: National Organization of Medicines
• Study type: Interventional

Clinical Trial 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

Description:

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 100
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• Pegylated liposomal doxorubicin (Caelyx)
Pegylated liposomal Doxorubicin (Caelyx) at the dose of 50mg/m^2 IV every 4 weeks for 6 consecutive cycles
• Epirubicin
Epirubicin (Farmorubicin) at the dose of 90mg/m^2 IV every 3 weeks for 6 consecutive cycles

Locations

Country	Name	City	State
Greece	University General Hospital of Alexandroupolis, Dep of Medical Oncology	Alexandroupolis
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	"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	University Hospital of Crete	Heraklion	Crete
Greece	State General Hospital of Larissa, Dep of Medical Oncology	Larissa
Greece	"Metaxa's" Anticancer Hospital of Piraeus, 1st Dep of Medical Oncology	Piraeus
Greece	"Theagenion" Anticancer Hospital of Thessaloniki, 2nd Dep of Medical Oncology	Thessaloniki

Sponsors (2)

Lead Sponsor	Collaborator
Hellenic Oncology Research Group	University Hospital of Crete

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment of antitumor efficacy by objective tumor response rates		Objective responses confirmed by CT or MRI (on 3rd and 6th cy)	No
Secondary	Toxicity profile and tolerance between the two treatment arms		Toxicity assessment of each chemotherapy cycle	Yes
Secondary	Time to progression		1 year	No
Secondary	Overall survival		1 year	No