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| Name | Class |
|---|---|
| 307 Hospital of PLA | OTHER |
| Fudan University | OTHER |
| The Tumor Hospital of Jiangsu Province | OTHER |
| Fujian Province Tumor Hospital |
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A multi-sites study about the efficacy of sequential monotherapy: Capecitabine vs. endocrine therapy, in metastatic breast cancer patients with HR-positive & HER2-negative after capecitabine-base chemotherapy.
capecitabine-base chemotherapy must be first-line chemotherapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Capecitabine | Active Comparator | Capecitabine 1250mg per BSA by mouth twice per day for 14 days, per 21 days as a cycle, until disease progress or toxicity can not be tolerated. |
|
| endocrine therapy | Experimental | endocrine therapy is be gived as a sequential treatment in Metastatic breast cancer patients who are got benefit in chemotreatment,the medcine will be confirmed by the patient's past-treatment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Capecitabine | Drug | Capecitabine is be given as a sequential treatment in Metastatic breast cancer patients who are got benefit in chemo treatment. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival(PFS) | Progression-free survival (PFS) is defined as the time elapsed between enrolling and tumor progression or death from any cause | From date of enrolling until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| clinical benefit rate(CBR) | the response is CR+PR+SD ≥ 24 weeks | From date of enrolling until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| overall survival(OS) | the time elapsed between enrolling and death from any cause | From date of enrolling until the date of death from any cause, assessed up to 3 years |
| Number of participants with Grade 3/4 adverse events |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiaojia - wang, PHD | Contact | 86 13906500190 | wxiaojia0803@163.com | |
| Jian Huang, Doctor | Contact | 86 13588048995 | huang_jian22@aliyun.com |
| Name | Affiliation | Role |
|---|---|---|
| Xiaojia Wang, PHD | Zhejiang Cance Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhejiang Cancer Hospital | Recruiting | Hangzhou | Zhejiang | 310022 | China |
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| OTHER |
| Zhejiang University | OTHER |
| Sir Run Run Shaw Hospital | OTHER |
| Zhejiang Chinese Medical University | OTHER_GOV |
| Hangzhou Cancer Hospital | OTHER |
| Jiangsu Provincial People's Hospital | OTHER |
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| endocrine therapy | Procedure | endocrine therapy is be given as a sequential treatment in Metastatic breast cancer patients who are got benefit in chemo treatment,the medicine will be confirmed by the patient's past-treatment. |
|
Number of Participants with Grade 3/4 Adverse Events
| From date of enrolling until the date of 1 month of stop treatment, assessed up to 3 years |
| QOL | change from enrolling to progression disease or death according EORTC QLQ-C30 and EORTC BR23 | From date of enrolling until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 3 years |
| 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 |
|---|---|
| D000069287 | Capecitabine |
| ID | Term |
|---|---|
| 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 |
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