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To explore the efficacy and safety of Chidamide combined with endocrine for maintenance therapy after first-line chemotherapy for HR+/HER2- breast cancer
o explore the efficacy and safety of Chidamide combined with endocrine drug maintenance after first-line chemotherapy in the treatment of advanced untreated breast cancer; To explore the efficacy and safety of Chidamidecombined with endocrine drugs after first-line chemotherapy in the treatment of advanced first-line non-chemotherapeutic breast cancer after failure of CDK4/6 inhibitors
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort A in advanced stages of first-line ± endocrine therapy without CDK4/6 inhibitors | Experimental | Chidamide tablets, specification 5mg/ tablet. Administration method: Oral, 30mg/ time, twice a week; Endocrine drugs: (TAM, AI, fluvestran, etc.) According to patients' previous endocrine treatment, different endocrine drugs were selected according to researchers' judgment, and the dosage was used according to the instructions; OFS drugs (for premenopausal patients only). |
|
| Late-stage first-line ± endocrine therapy with CDK4/6 inhibitors in cohort B | Experimental | Chidamide tablets, specification 5mg/ tablet. Administration method: Oral, 30mg/ time, twice a week; Endocrine drugs: (TAM, AI, fluvestran, etc.) According to patients' previous endocrine treatment, different endocrine drugs were selected according to researchers' judgment, and the dosage was used according to the instructions; OFS drugs (for premenopausal patients only). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Chidamide | Drug | Chidamide+ exemestane/Fulvestrant/Letrozole/Anastrozole/Tamoxifen |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival | PFS is defined as the time from the date of treatment to the first date of disease | 2 year |
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate | Treatment response are defined as complete response (CR), partial response (PR), stable disease (SD) and progression disease (PD) according to Response Evaluation Criteria in Solid Tumor (RECISIT criteria, version 1.1). The percentage of patients who achieved CR and PR was defined as objective response rate (ORR) | 2 year |
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Inclusion Criteria:
9.Always all the acute toxic reaction caused by antineoplastic therapy in screening before easing to 0 and 1 level (according to the NCI CTCAE 5.0 judgment; Hair loss, other than toxicity that the investigator believes does not pose a safety risk to the subject); 10. Functions: bone marrow neutrophils absolute acuity 1.5 x 109 / L, platelet acuity 100 x 109 / L, 90 g/L or higher hemoglobin; 11. Liver and kidney function: TBIL acuities were 1.5 x ULN; ALT and AST≤2.5 x ULN; In case of liver metastasis, ALT and AST≤ 5×ULN; BUN and Cr≤1.5×ULN and creatinine clearance ≥50 ml/min; 12.Voluntary participation in the clinical trials, signed written informed consent.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Li Zhang | Contact | 13920003358 | doctor3399@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Li Zhang | Tianjin Cancer Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 天津市肿瘤医院 | Recruiting | Tianjin | China |
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| ID | Term |
|---|---|
| C547816 | N-(2-amino-5-fluorobenzyl)-4-(N-(pyridine-3-acrylyl)aminomethyl)benzamide |
| C056516 | exemestane |
| D000077267 | Fulvestrant |
| D000077289 | Letrozole |
| D000077384 | Anastrozole |
| D013629 | Tamoxifen |
| ID | Term |
|---|---|
| D004958 | Estradiol |
| D004963 | Estrenes |
| D004962 | Estranes |
| D013256 | Steroids |
| D000072473 |
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|
| Disease control rate | his means that in all patients with a tumor who receive a certain treatment, the tumor shrinks or stays stable, and stays that way for a certain amount of time | 2 year |
| Clinical Benefit Rate (CBR) | CBR is defined as the rate of patients who achieved complete response, partial response, and stable disease for >= 24 weeks as the best response of treatment. | 2 year |
| Overall Survival (OS) | OS defined as the time from the first study treatment administration to death from any cause | 2 year |
| Adverse events (AE) | The level of the adverse event (AE) is analyzed according to the Common Terminology Criteria for Adverse Event (CTCAE) (version 5.0). | 2 year |
| 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 |
| D009570 | Nitriles |
| D009930 | Organic Chemicals |
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D013267 | Stilbenes |
| D001597 | Benzylidene Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |