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

A Multicenter Randomized Phase II Study of Second Line Chemotherapy With Epirubicin( Farmorubicin) Versus the Pegylated Liposomal Doxorubicin in Advanced Breast Cancer Patients

Status

Terminated

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00431795

Enrollment

100

Registered

2007-02-06

Start date

2003-06-30

Completion date

2012-06-30

Last updated

2013-02-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Keywords

Advanced breast cancer, Pegylated liposomal doxorubicin, Epirubicin

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

Interventions

DRUGPegylated liposomal doxorubicin (Caelyx)

Pegylated liposomal Doxorubicin (Caelyx) at the dose of 50mg/m\^2 IV every 4 weeks for 6 consecutive cycles

DRUGEpirubicin

Epirubicin (Farmorubicin) at the dose of 90mg/m\^2 IV every 3 weeks for 6 consecutive cycles

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 75 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Assessment of antitumor efficacy by objective tumor response rates	Objective responses confirmed by CT or MRI (on 3rd and 6th cy)

Secondary

Measure	Time frame
Toxicity profile and tolerance between the two treatment arms	Toxicity assessment of each chemotherapy cycle
Time to progression	1 year
Overall survival	1 year

Countries

Greece

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026