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Due to poor accrual
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| Name | Class |
|---|---|
| University Hospital of Crete | OTHER |
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
To compare the efficacy of pegylated liposomal doxorubicin versus epirubicin as second line chemotherapy in patient with advanced breast cancer
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Epi |
|
| 2 | Experimental | Cael |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pegylated liposomal doxorubicin (Caelyx) | Drug | Pegylated liposomal Doxorubicin (Caelyx) at the dose of 50mg/m^2 IV every 4 weeks for 6 consecutive cycles |
|
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of antitumor efficacy by objective tumor response rates | Objective responses confirmed by CT or MRI (on 3rd and 6th cy) |
| Measure | Description | Time Frame |
|---|---|---|
| Toxicity profile and tolerance between the two treatment arms | Toxicity assessment of each chemotherapy cycle | |
| Time to progression | 1 year | |
| Overall survival |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dimitris Mavrudis, MD | University Hospital of Crete | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital of Crete | Heraklion | Crete | 71110 | Greece | ||
| University General Hospital of Alexandroupolis, Dep of Medical Oncology |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| C506643 | liposomal doxorubicin |
| D015251 | Epirubicin |
| ID | Term |
|---|---|
| D004317 | Doxorubicin |
| D003630 | Daunorubicin |
| D018943 | Anthracyclines |
| D009279 | Naphthacenes |
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| Epirubicin | Drug | Epirubicin (Farmorubicin) at the dose of 90mg/m^2 IV every 3 weeks for 6 consecutive cycles |
|
|
| 1 year |
| 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 |
| "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 |
| 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 | Greece |
| D017437 |
| Skin and Connective Tissue Diseases |
| D011084 |
| Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |