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A single-site 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 ≥Second-line Therapy
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Capecitabine | Experimental | Capecitabine by mouth twice per day for 14 days, per 21 days as a cycle, until disease progress or toxicity can not be tolerated.Capecitabine starting dose was the dose used at the end of the combined chemotherapy regimen,eg:1000mg per BSA. |
|
| endocrine therapy | Experimental | endocrine therapy will been given as a sequential treatment in Metastatic breast cancer patients who are got benefit in capecitabine-base chemotherapy.The medicine will be confirmed by the patient's past-treatment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Capecitabine | Drug | Capecitabine will been given as a sequential treatment who are got benefit in capecitabine-base chemotherapy. |
|
| 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 |
| overall survival |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiao-jia Wang, PHD,MD | Contact | 86 13906500190 | wxiaojia0803@163.com | |
| Ya-bing Zheng, MD | Contact | 13858065353 | zhengyabing@sina.com |
| Name | Affiliation | Role |
|---|---|---|
| Xiao-jia Wang, PHD,MD | Zhejiang Cance Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhejiang Cancer Hospital | Recruiting | Hangzhou | Zhejiang | 310022 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 1922236 | Background | Muss HB, Case LD, Richards F 2nd, White DR, Cooper MR, Cruz JM, Powell BL, Spurr CL, Capizzi RL. Interrupted versus continuous chemotherapy in patients with metastatic breast cancer. The Piedmont Oncology Association. N Engl J Med. 1991 Nov 7;325(19):1342-8. doi: 10.1056/NEJM199111073251904. |
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| endocrine therapy | Drug | endocrine therapy will been given as a sequential treatment who are got benefit in capecitabine-base chemotherapy.Endocrine therapy is determined by the doctor, including any kind of letrozole, anastrozole, exemestane, fulvestrant, tamoxifen, toremifene, combined with or without drugs or surgery in the inhibition of ovarian function. |
|
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 | 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 |
| Quality of life(QOL)（1） | change from enrolling to progression disease or death according EORTC QLQ-C30 | 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 |
| Quality of life(QOL)（2） | change from enrolling to progression disease or death according 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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