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This is a Open-label study of chidamide in combination with fulvestrant for the treatment of postmenopausal women with hormone receptor positive, Her2 negative, advanced breast cancer who have received no or only one line of endocrine therapy for advanced breast cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| chidamide + fulvestrant | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Chidamide | Drug | chidamide 30mg orally,Biw |
| |
| Fulvestrant |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Response Rate (ORR) | Overall response rate (ORR) is defined as the proportion of patients with the best overall response of complete response (CR) or partial response (PR) according to RECIST 1.1. | Up to approximately 26 months |
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival (PFS) | PFS is defined as the time from the date of randomization to the date of the first documented progression or death due to any cause. | Up to approximately 26 months |
| Overall Survival (OS) |
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Inclusion Criteria:
women aged ≥ 18 years, histologically or cytologically confirmed HR positive (ER expression ≥ 10%, PR positive or negative), HER2 negative breast cancer patients;
before enrollment for unresectable locally advanced or metastatic breast cancer, and at least one measurable lesion or no measurable lesion and bone metastasis alone patients;
For locally advanced or metastatic breast cancer, no previous endocrine therapy or first-line endocrine therapy, and no previous use of CDK4/6 inhibitors. Specifically, it includes the following conditions:
Cohort 1: (neo) recurrence > 12 months after the end of adjuvant endocrine therapy, and without any rescue therapy · newly diagnosed advanced breast cancer without any rescue therapy Cohort 2: (neo) recurrence during or ≤ 12 months after the completion of adjuvant endocrine therapy, and without any rescue therapy · recurrence > 12 months after the completion of adjuvant endocrine therapy, and progression by first-line endocrine therapy · newly diagnosed advanced breast cancer and progression by first-line endocrine rescue therapy
Cohort 1 without previous chemotherapy for advanced breast cancer; Cohort 2 with ≤ 1 previous chemotherapy for advanced breast cancer;
no brain metastasis or asymptomatic brain metastasis;
ECOG score 0-1;
Absolute neutrophil count ≥ 1.5 × 109/L, platelet ≥ 100 × 109/L, hemoglobin ≥ 90 g/L;
Expected survival time ≥ 3 months;
Voluntarily participate in this clinical trial, sign the written informed consent;
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sun Tao, Doctor | Contact | 13940404526 | lnzlrxnsy@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Liangning Tumor Hospital &Institute | Recruiting | Shenyang | Liaoning | 110042 | China |
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| ID | Term |
|---|---|
| C547816 | N-(2-amino-5-fluorobenzyl)-4-(N-(pyridine-3-acrylyl)aminomethyl)benzamide |
| D000077267 | Fulvestrant |
| ID | Term |
|---|---|
| D004958 | Estradiol |
| D004963 | Estrenes |
| D004962 | Estranes |
| D013256 | Steroids |
| D000072473 |
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| Drug |
Fulvestrant 500mg i.m. injections every 28 days (Cycle n Day 1) with 1 additional dose on Day 15 of Cycle 1 |
|
Time from date of randomization to the date of death from any cause.
| Up to approximately 58 months |
| Clinical Benefit Rate (CBR) | Clinical benefit rate (CBR), defined as the proportion of patients with a best overall response of complete response (CR) or partial response (PR) or stable disease (SD) lasting 24 weeks or longer as defined in RECIST 1.1. | Up to approximately 26 months |
| Duration of Response (DOR) | Time from the first documented response (CR or PR) to the first documented progression or death due to underlying cancer as defined in RECIST 1.1. | Up to approximately 26 months |
| 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 |