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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-003564-72 | EudraCT Number |
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| Name | Class |
|---|---|
| Pierre Fabre Laboratories | INDUSTRY |
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The study hypothesis is that metronomic treatment is more efficient than standard treatment.
Purpose: In an open-label randomized phase II trial, patients with metastatic Human Epidermal Growth Factor Receptor 2-negative breast cancer with normal organ function sant WHO performance status < 3 are randomized to receive either capecitabine (day 1-14) plus vinorelbine oral (day 1 and 8) or capecitabine (day 1-14) plus vinorelbine oral metronomic (3 days a week).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A | Active Comparator | Vinorelbine (Navelbine Oral) 60 mg/m2 day 1 and day 8 Plus Capecitabine (Xeloda) 1000 mg/m2 2 times daily day 1 to 14 in a 3 weekly schedule. |
|
| Arm B | Experimental | Oral Vinorelbine (Navelbine oral) 50 mg 3 times weekly, monday, wednesday and friday plus Capecitabine (Xeloda) 1000 mg/m2 2 times daily day 1-14 in a 3 weekly schedule. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Arm B Vinorelbine (Navelbine oral) Capecitabine (Xeloda) | Drug | Oral Vinorelbine (Navelbine oral) 50 mg 3 times weekly, monday, wednesday and friday plus Capecitabine (Xeloda) 1000 mg/m2 2 times daily day 1-14 in a 3 weekly schedule. |
| Measure | Description | Time Frame |
|---|---|---|
| Primary endpoint is overall response rate i both arms. | Response evaluation at 3rd and 6th cycle by resist criterias. The number of patients that respond to treatment in percent of the total number of patients treated. | up to 60 month |
| Measure | Description | Time Frame |
|---|---|---|
| Time to progression. | Number of days from start of treatment to progression of disease assessed up to 60 months | up to 60 month |
| Overall survival. | Number of days from start of treatment to death assessed up to 60 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Toxicity | Monitoring side effects of treatment assessed up to 60 months. | Side effects of treatment |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sven Tyge Langkjer, MD, PhD | University hospital of Aarhus | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Oncology, Aarhus University Hospital | Aarhus | Aarhus C | 8000 | Denmark |
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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 |
|---|---|
| D000077235 | Vinorelbine |
| D000069287 | Capecitabine |
| ID | Term |
|---|---|
| D014748 | Vinca Alkaloids |
| D046948 | Secologanin Tryptamine Alkaloids |
| D026121 | Indole Alkaloids |
| D000470 | Alkaloids |
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|
| Arm A Vinorelbine (Navelbine oral) Capecitabine (Xeloda) | Drug | Vinorelbine (Navelbine Oral) 60 mg/m2 day 1 and day 8 Plus Capecitabine (Xeloda) 1000 mg/m2 2 times daily day 1 to 14 in a 3 weekly schedule. |
|
|
| up to 60 month |
| D017437 |
| Skin and Connective Tissue Diseases |
| D006571 |
| Heterocyclic Compounds |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D054836 | Indolizidines |
| D007212 | Indolizines |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D005472 | Fluorouracil |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |