Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Due to poor accrual
Summary
Brief summary (as posted)
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
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Epirubicin | Drug | Epirubicin | ALIAS |
| Pegylated liposomal doxorubicin (Caelyx) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- 1
- description
- Epi
- interventionNames
- Drug: Epirubicin
- type
- EXPERIMENTAL
- label
- 2
- description
- Cael
- interventionNames
- Drug: Pegylated liposomal doxorubicin (Caelyx)
Primary outcomes (1)
- 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 (3)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available