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| Name | Class |
|---|---|
| University Hospital of Crete | OTHER |
The combination of docetaxel+epirubicin is highly effective and well tolerated as first line treatment in patients with metastatic breast cancer (MBC). Capecitabine is an active drug in women with MBC pretreated with taxane and anthracycline. Docetaxel increases the intracellular levels of thymidilate phosphorylase and thus is synergistic with capecitabine. The combination of docetaxel plus capecitabine is highly active and superior to docetaxel monotherapy in women with MBC pretreated with an anthracycline
This trial will compare the efficacy of docetaxel plus epirubicin versus docetaxel plus capecitabine combinations as first line treatment in women with MBC
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | DF |
|
| 2 | Experimental | DC |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Docetaxel | Drug | Docetaxel at the dose of 75mg/m2 IV on day 1 every 3 weeks for 6 consecutive cycles |
|
| Measure | Description | Time Frame |
|---|---|---|
| Compare the time to tumor progression between the two treatment arms | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | 1 year | |
| Toxicity profile between the two treatment arms | 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dimitris Mavrudis, MD | University Hospital of Crete, Dep of Medical Oncology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital of Heraklion | Heraklion | Crete | 71110 | Greece | ||
| University General Hospital of Alexandroupolis, Dep of Medical Oncology |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34037241 | Derived | Hoon SN, Lau PK, White AM, Bulsara MK, Banks PD, Redfern AD. Capecitabine for hormone receptor-positive versus hormone receptor-negative breast cancer. Cochrane Database Syst Rev. 2021 May 26;5(5):CD011220. doi: 10.1002/14651858.CD011220.pub2. |
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| Capecitabine | Drug | Capecitabine 950 mg/m2 orally twice a day on days 1-14 every 3 weeks for 6 consecutive cycles |
|
|
| Epirubicin | Drug | Epirubicin at the dose of 75mg/m2 IV on day 1 every 3 weeks for 6 consecutive cycles |
|
|
| Docetaxel | Drug | Docetaxel at the dose of 75mg/m2 IV on day 1 every 3 weeks for 6 consecutive cycles |
|
|
| 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 Piraias | Piraeus | Greece |
| "Theagenion" Anticancer Hospital of Thessaloniki, 2nd Dep of Medical Oncology | Thessaloniki | Greece |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D000077143 | Docetaxel |
| D000069287 | Capecitabine |
| D015251 | Epirubicin |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D005472 | Fluorouracil |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D004317 | Doxorubicin |
| D003630 | Daunorubicin |
| D018943 | Anthracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D011083 | Polycyclic Compounds |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
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