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The purpose of this study is to determine whether UTD1 Injection in combination with capecitabine is effective in the treatment of advanced metastatic breast cancer using capecitabine as a control.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| UTD1 Injection plus capecitabine | Experimental | UTD1 Injection: 30 mg/m2/day, IV on day 1-day 5 of each 21 day cycle; Capecitabine: 2000 mg/m2/day, oral bid on day 1-day 14 of each 21 day cycle. Number of Cycles: until progression or unacceptable toxicity develops. |
|
| capecitabine | Active Comparator | Capecitabine: 2500 mg/m2/day, oral bid on day 1-day 14 of each 21 day cycle. Number of Cycles: until progression or unacceptable toxicity develops. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| UTD1 Injection plus capecitabine | Drug |
| ||
| Capecitabine |
| Measure | Description | Time Frame |
|---|---|---|
| Progresssion free survival (PFS) | 2.0 years |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival (OS) | 4 years | |
| Objective Response Rate(ORR) | 1.5 years |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| B Xu, doctor | Cancer Institute and Hospital, Chinese Academy of Medical Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cancer Hospital, Chinese Academy of Medical Sciences | Beijing | Beijing Municipality | 100021 | China | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33188874 | Derived | Xu B, Sun T, Zhang Q, Zhang P, Yuan Z, Jiang Z, Wang X, Cui S, Teng Y, Hu XC, Yang J, Pan H, Tong Z, Li H, Yao Q, Wang Y, Yin Y, Sun P, Zheng H, Cheng J, Lu J, Zhang B, Geng C, Liu J, Shen K, Yu S, Li H, Tang L, Qiu R; study group of BG01-1323L. Efficacy of utidelone plus capecitabine versus capecitabine for heavily pretreated, anthracycline- and taxane-refractory metastatic breast cancer: final analysis of overall survival in a phase III randomised controlled trial. Ann Oncol. 2021 Feb;32(2):218-228. doi: 10.1016/j.annonc.2020.10.600. Epub 2020 Nov 11. | |
| 33163394 |
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| Drug |
|
| The Hospital Affiliated To Military Medical Science |
| Beijing |
| Beijing Municipality |
| 100071 |
| China |
| The General Hospital of the People's Liberation Army | Beijing | Beijing Municipality | 100853 | China |
| Sun Yat-sen University Cancer Center | Guangzhou | Guangdong | 510060 | China |
| Harbin Medical University Cancer Hospital | Harbin | Heilongjiang | 150081 | China |
| Henan Cancer Hospital | Zhengzhou | Henan | 450008 | China |
| the First Hospital of China Medical University | Shenyang | Liaoning | 110001 | China |
| Liaoning Cancer Hospital & Institute | Shenyang | Liaoning | 110042 | China |
| Fudan University Shanghai Cancer Center | Shanghai | Shanghai Municipality | 200433 | China |
| Sir Run Run Shaw Hospital | Hangzhou | Zhejiang | 310016 | China |
| Zhejiang Cancer Hospital | Hangzhou | Zhejiang | 310022 | China |
| Derived |
| Xu J, Wang Y, Jiang C, Cao H, Jiang J, Xu B, Sun T. Ganglioside Monosialic Acid Alleviates Peripheral Neuropathy Induced by Utidelone Plus Capecitabine in Metastatic Breast Cancer From a Phase III Clinical Trial. Front Oncol. 2020 Oct 9;10:524223. doi: 10.3389/fonc.2020.524223. eCollection 2020. |
| 28209298 | Derived | Zhang P, Sun T, Zhang Q, Yuan Z, Jiang Z, Wang XJ, Cui S, Teng Y, Hu XC, Yang J, Pan H, Tong Z, Li H, Yao Q, Wang Y, Yin Y, Sun P, Zheng H, Cheng J, Lu J, Zhang B, Geng C, Liu J, Peng R, Yan M, Zhang S, Huang J, Tang L, Qiu R, Xu B; BG01-1323L study group. Utidelone plus capecitabine versus capecitabine alone for heavily pretreated metastatic breast cancer refractory to anthracyclines and taxanes: a multicentre, open-label, superiority, phase 3, randomised controlled trial. Lancet Oncol. 2017 Mar;18(3):371-383. doi: 10.1016/S1470-2045(17)30088-8. Epub 2017 Feb 11. |
| 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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