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The objective of this study is to explore and evaluate the efficacy of tucidinostat combined with metronomic capecitabine in the treatment of metastatic triple-negative breast cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tucidinostat and metronomic capecitabine group | Experimental |
| |
| metronomic capecitabine group | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Capecitabine | Drug | 500mg orally three times a day (continuously) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Up to 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Progress-free survival | Time from randomization to the first documentation of objective tumor progression or to death due to any cause | Up to 3 years |
| 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. |
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Inclusion Criteria:
1. ≥18 years old, female; 2. Histologically confirmed triple-negative metastatic breast cancer [HER2 negative is defined as immunohistochemistry(IHC) 0 or IHC 1+, and if the score of IHC is 2+, fluorescence in situ hybridization technology (FISH) test must be negative, subjects with ER ≤ 10% and PR ≤ 10% and those with no benefit from endocrine therapy in the investigator's judgment are allowed to enroll]; 3. Metastatic breast cancer that has failed at first-line taxane therapy; definition of taxane treatment failure: disease progression during rescue therapy, or recurrence and metastasis within 12 months after completion of adjuvant therapy; 4. ECOG score 0-1; 5. According to RECIST1.1 criteria, at least there is one measurable lesion; 6. The main organ and bone marrow function levels meet the following requirements:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Susen Wang, MD | Contact | +86-13926168469 | wangshs@sysucc.org.cn |
| Name | Affiliation | Role |
|---|---|---|
| Susen Wang, MD | Sun Yat-sen University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sun-yat sen university cancer center | Recruiting | Guangzhou | Guangdong | 510060 | China |
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| Tucidinostat | Drug | 20mg each time, orally 30 minutes after dinner, 3 weeks for a cycle, administered on day 1, day 4, day 8, day 11, day 15,and day 18 of each cycle (twice a week, at least 3 days between each administration) |
|
|
| Up to 3 years |
| Overall Survival | Time from randomization to date of death due to any cause. according to the RECIST version 1.1 recorded in the time period between randomization and disease progression or death to any cause. | Up to 3 years |
| ID | Term |
|---|---|
| D064726 | Triple Negative Breast Neoplasms |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| 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 |
| C547816 | N-(2-amino-5-fluorobenzyl)-4-(N-(pyridine-3-acrylyl)aminomethyl)benzamide |
| 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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