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Primary objective of this study is to evaluate the efficacy of gemcitabine and cisplatin as first line therapy in patients with triple-negative MBC. 80 patients will be treated into this study.
Triple-negative breast tumors could contribute to the poor prognosis comparing with luminal A breast cancer.Fewer study has revealed that Cisplatin-based therapy may be effective for this type breast cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| gemcitabine and cisplatin | Experimental | cisplatin and gemcitabine in the management of triple negative metastatic breast cancer |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| gemcitabine and cisplatin | Drug | Cispaltin 25mg/m2,ivgtt,D1, 2, 3 gemcitabine 1000mg/m2,ivgtt,30',D1, 8 repeat every 3 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| PFS (progression free survival) | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| side effects | 6 months | |
| BRCA1 mutation realtionship with efficacy and toxicity analysis | at the end of therapy | |
| pharmacogenetic analysis |
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Inclusion Criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Zhonghua Wang, MD | Fudan University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fudan University Cancer Hospital | Shanghai | Shanghai Municipality | +86200032 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17016441 | Background | Turner NC, Reis-Filho JS, Russell AM, Springall RJ, Ryder K, Steele D, Savage K, Gillett CE, Schmitt FC, Ashworth A, Tutt AN. BRCA1 dysfunction in sporadic basal-like breast cancer. Oncogene. 2007 Mar 29;26(14):2126-32. doi: 10.1038/sj.onc.1210014. Epub 2006 Oct 2. | |
| 24824628 | Derived | Zhang J, Wang Z, Hu X, Wang B, Wang L, Yang W, Liu Y, Liu G, Di G, Hu Z, Wu J, Shao Z. Cisplatin and gemcitabine as the first line therapy in metastatic triple negative breast cancer. Int J Cancer. 2015 Jan 1;136(1):204-11. doi: 10.1002/ijc.28966. Epub 2014 May 23. |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D064726 | Triple Negative Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D000093542 | Gemcitabine |
| D002945 | Cisplatin |
| ID | Term |
|---|---|
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
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| collect blood samples before therapy |
| D017437 |
| Skin and Connective Tissue Diseases |
| D011743 |
| Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |