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| Name | Class |
|---|---|
| University Hospital of Crete | OTHER |
The combination of vinorelbine and gemcitabine seems to be an important part of the chemotherapy regimens used in metastatic breast cancer patients following treatment failure with the combination of a taxane and an anthracycline. Capecitabine rescue monotherapy in metastatic breast cancer patients following treatment failure with the combination of a taxane and an anthracycline, also seems to be an important part of the chemotherapy regimens used in metastatic breast cancer patients. Whether the combination of vinorelbine and gemcitabine or capecitabine administration is preferable is not yet known, especially in patients with metastatic disease.
This trial will compare the efficacy of combination treatment with Vinorelbine and Gemcitabine versus Capecitabine monotherapy in metastatic breast cancer patients following treatment failure with the combination of a taxane and an anthracycline.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | Vinorelbine/Gemcitabine (VG) |
|
| 2 | Active Comparator | Capecitabine (Cap) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gemcitabine | Drug | Gemcitabine at the dose of 1000 mg/m2 intravenously (IV) every 2 weeks for 12 consecutive cycles |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time to tumor progression between the two treatment arms | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | 1 year |
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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, Dept. 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 |
|---|---|
| D000093542 | Gemcitabine |
| D000069287 | Capecitabine |
| D000077235 | Vinorelbine |
| ID | Term |
|---|---|
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
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| Capecitabine | Drug | Capecitabine at the dose of 1250 mg/m2 twice daily orally (os), from day 1 to day 14, every 3 weeks for 6 consecutive cycles |
|
|
| Vinorelbine | Drug | Vinorelbine at the dose of 25 mg/m2 IV on day 1 every 2 weeks for 12 consecutive cycles |
|
|
| Alexandroupoli |
| Greece |
| "IASO" General Hospital of Athens, 1st Dept. of Medical Oncology | Athens | Greece |
| "Laikon" General Hospital, Medical Oncology Unit, Propedeutic Dept. of Internal Medicine | Athens | Greece |
| "Marika Iliadis" Hospital of Athens, Dept. 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, Dept. of Medical Oncology | Larissa | Greece |
| "Metaxa's" Anticancer Hospital of Piraeus, 1st Dept. of Medical Oncology | Piraeus | Greece |
| "Theagenion" Anticancer Hospital of Thessaloniki, 2nd Dept. of Medical Oncology | Thessaloniki | Greece |
| D017437 |
| Skin and Connective Tissue Diseases |
| D011743 |
| Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D005472 | Fluorouracil |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D014748 | Vinca Alkaloids |
| D046948 | Secologanin Tryptamine Alkaloids |
| D026121 | Indole Alkaloids |
| D000470 | Alkaloids |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D054836 | Indolizidines |
| D007212 | Indolizines |