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The goal of this observational study is to learn about the effects of metronomic chemotherapy in advanced breast cancer patients. The main question it aims to answer is:
How effective is metronomic chemotherapy in advanced breast cancer? Specific benefit groups of metronomic chemotherapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| metronomic chemotherapy | Patients with advanced breast cancer who received metronomic chemotherapy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cyclophosphamide , methotrexate , vinorelbine ,capecitabine | Drug | The drugs used in metronomic chemotherapy are cyclophosphamide (CTX), methotrexate (M), vinorelbine (VNR), and capecitabine |
| Measure | Description | Time Frame |
|---|---|---|
| Progression free survival | Time from randomization to the first documentation of objective tumor progression or to death due to any cause without documented progression | Baseline up to approximately 20 months |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival | Time from randomization to date of death due to any cause | Baseline until death (up to approximately 40 months) |
| Objective Response Rate | Objective response is defined as a complete response (CR) or partial response (PR) according to RECIST v.1.1. recorded from randomization until disease progression or death due to any cause. |
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Inclusion Criteria:
Exclusion Criteria:
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Advanced breast cancer taking metronomic chemotherapy
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| Name | Affiliation | Role |
|---|---|---|
| Shusen Wang, MD | Sun Yat-sen University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shusen Wang | Guangzhou | Gangdong | China |
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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 |
|---|---|
| D003520 | Cyclophosphamide |
| D008727 | Methotrexate |
| ID | Term |
|---|---|
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
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| Baseline up to approximately 20 months |
| Disease Control Rate | Disease control is defined as complete response (CR), partial response (PR), or stable disease (SD) >24 weeks according to the RECIST version 1.1 recorded in the time period between randomization and disease progression or death to any cause. | Baseline up to approximately 20 months |
| D017437 |
| Skin and Connective Tissue Diseases |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| D000630 | Aminopterin |
| D011622 | Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |