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This study was a prospective, single-arm, open-label phase II clinical trial conducted at National cancer center in China.
Metronomic chemotherapy is a relatively low-dose, high-frequency, continuous application of cytotoxic agents. Phase I/II VICTOR-1 studies have shown that the dual oral beat combination of vincristine and capecitabine is highly active and well tolerated in patients with locally advanced or metastatic breast cancer. The long-term efficacy of oral two-metronomic agents (vinorelbine and capecitabine) in Chinese advanced HER-2 negative breast cancer patients stays unclear. The current study was designed to explore the efficacy of oral two-metronomic agents (vinorelbine and capecitabine) in advanced HER-2 negative patient China.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study group | Experimental | The eligible patients were enrolled to receive oral metronomic vinorelbine 40 mg on day 1, day 3, day 5 every week (Monday, Wednesday, and Friday) and capecitabine 500mg three times daily (tid) after meals every 3 weeks. Until disease progression or unacceptable toxicity occurred, or the patient refused medication, vinorelbine and capecitabine were administered continuously without drug-free periods over 21-day cycles. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| oral vinorelbine and capecitabine | Drug | The eligible patients were enrolled to receive oral metronomic vinorelbine 40 mg on day 1, day 3, day 5 every week (Monday, Wednesday, and Friday) and capecitabine 500mg three times daily (tid) after meals every 3 weeks. Until disease progression or unacceptable toxicity occurred, or the patient refused medication, vinorelbine and capecitabine were administered continuously without drug-free periods over 21-day cycles. |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free Survival | 1-year progression-free survival (PFS1). Evidence of local recurrence, distant metastasis, or death from any cause within 1 year counted as events in the time-to-event Kaplan-Meier analysis of progression-free survival. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions | At 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Confirmed Response, Defined as a Partial Response (PR) or Better | Confirmed response will be evaluated using all cycles. The proportion of successes will be estimated by the number of successes divided by the total number of evaluable patients. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR Confirmed response will be evaluated using all cycles. The proportion of successes will be estimated by the number of successes divided by the total number of evaluable patients. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Qiao Li, Dr. | Contact | +8615910573527 | 87788819 | liqiaopumc@qq.com |
| Yue Chai, Dr. | Contact | 13350804092 | cy972628990@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Binghe Xu | National Cancer Center/National Clinical Research Center for Cancer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital | Recruiting | Beijing | Beijing Municipality | 00 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37402471 | Derived | Chai Y, Liu J, Jiang M, He M, Wang Z, Ma F, Wang J, Yuan P, Luo Y, Xu B, Li Q. A phase II study of a doublet metronomic chemotherapy regimen consisting of oral vinorelbine and capecitabine in Chinese women with HER2-negative metastatic breast cancer. Thorac Cancer. 2023 Aug;14(23):2259-2268. doi: 10.1111/1759-7714.15011. Epub 2023 Jul 4. |
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Individual anonymized participant data will not be shared.
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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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This study was a prospective, single-arm, open-label phase II clinical trial conducted at National cancer center in China. The eligible patients were enrolled to receive oral metronomic vinorelbine 40 mg on day 1, day 3, day 5 every week (Monday, Wednesday, and Friday) and capecitabine 500mg three times daily (tid) after meals every 3 weeks. Until disease progression or unacceptable toxicity occurred, or the patient refused medication, vinorelbine and capecitabine were administered continuously without drug-free periods over 21-day cycles.
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Open Label
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|
|
| Up to 1 year |
| 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 |