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The study is designed to explore the clinical benefit following treatment with tucidinosta in combination with metronomic capecitabine and endocrine therapy in patients with hormone receptor-positive, Her2-negative advanced breast cancer who have received CDK4/6 Inhibitor treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tucidinostat+Metronomic Capecitabine+Endocrine Therapy | Experimental | This arm is divided into two groups. The main difference of this two groups lies in the selection of endocrine therapy. One is supposed to choose aromatase inhibitor, and the other is fulvestrant. The principle of making choice is based on the history of endocrine drug use. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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) |
| 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, and ≤75 years old, female; 2. Histologically confirmed HR positive and HER2 negative postmenopausal metastatic breast cancer patients [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, HR positve is defined as ER or PR ≥1%;]; 3. After the failure of previous CDK4/6 inhibitor therapy; 4.Receive one line of chemotherapy at most; 5.Premenopausal women need to take effective measures to suppress ovarian function, such as drug suppression, oophorectomy; 6.ECOG score 0-1; 7. According to RECIST1.1 criteria, at least there is one measurable lesion or simple bone metastasis; 8. The main organ and bone marrow function levels meet the following requirements:
9. Expected survival time ≥ 3 months; 10. Voluntary participation study, signed written informed consent.
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 |
|---|---|---|---|---|---|---|
| Shusen Wang | Recruiting | Guangzhou | Gangdong | China |
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| Capecitabine | Drug | 500mg orally three times a day (continuously) |
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| Endocrine Therapy | Drug | Anastrozole, 1mg, orally once daily or Letrozole, 2.5mg, orally once daily or Exemestane , 25mg, orally once daily or fulvestrant 500 mg each time, intramuscularly, injected on the 1st day and 15th day of the 1st cycle, and on the 1st day for subsequent cycle( 4 weeks for one cycle) |
|
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| 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 |
|---|---|
| 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 |
|---|---|
| C547816 | N-(2-amino-5-fluorobenzyl)-4-(N-(pyridine-3-acrylyl)aminomethyl)benzamide |
| D000069287 | Capecitabine |
| D000077384 | Anastrozole |
| D000077289 | Letrozole |
| C056516 | exemestane |
| D000077267 | Fulvestrant |
| 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 |
| D009570 | Nitriles |
| D009930 | Organic Chemicals |
| D014230 | Triazoles |
| D001393 | Azoles |
| D004958 | Estradiol |
| D004963 | Estrenes |
| D004962 | Estranes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D045166 | Estradiol Congeners |
| D012739 | Gonadal Steroid Hormones |
| D042341 | Gonadal Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
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