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This study is planned to include 40 patients with HER2-negative advanced breast cancer to receive fluzoparib combined with chidamide or fluzoparib combined with camrelizumab to observe and evaluate the efficacy and safety of fluzoparib combined with camrelizumab or chidamide in the treatment of HRD-positive HER2-negative advanced breast cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| fluzoparib+chidamide | Experimental | Fluzoparib: 150 mg twice daily (morning and evening) for 21 consecutive days as a cycle until disease progression or intolerance. Chidamide: It is recommended to take 20 mg (4 tablets) twice a week, with an interval of no less than 3 days between doses (such as Monday and Thursday, Tuesday and Friday, Wednesday and Saturday, etc.), for 30 minutes. Until disease progression or intolerable to patient. |
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| fluzoparib+camrelizumab | Experimental | Fluzoparib: 150 mg twice daily (morning and evening) for 21 consecutive days as a cycle until disease progression or intolerance. Camrelizumab: 200 mg IV drip over approximately 30 minutes (no less than 20 minutes and no more than 60 minutes) on Day 1 of each 3-week treatment cycle until disease progression or intolerance. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| fluzoparib+chidamide | Drug | Arms A will be treated with fluzoparib in combination with cedaramide |
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| Measure | Description | Time Frame |
|---|---|---|
| ORR(objective response rate) | through study completion, an average of 6 months | At the end of Cycle 1 (each cycle is 28 days) |
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Inclusion Criteria:
histologically confirmed initial stage IV breast cancer or recurrent metastatic breast cancer; advanced treatment stage received at least 1 line of chemotherapy but no more than 2 lines of chemotherapy; hormone receptor-positive patients received at least one endocrine therapy in advanced treatment stage, or the investigator judged that they were not suitable for endocrine therapy; and patients with hormone receptor-positive advanced breast cancer who progressed within 2 years of adjuvant endocrine therapy.
histologically confirmed invasive HER2-negative breast cancer (specific definition: HER20-1 + or HER2 2 + by immunohistochemistry but negative or no amplification by FISH or CISH, following the 2018 version of the ASCO-CAPHER2 guidelines for negative interpretation);
central confirmation of HRD positivity, known germline BRCA and/or systemic BRCA mutation status is allowed to be preferred.
age 18-70 years
According to RECIST 1.1, at least one measurable lesion is present;
ECOG score: 0-2; expected survival more than 12 weeks;
Previous treatment with immune checkpoint inhibitors, PARP inhibitors and HDAC inhibitors (including chidamine, romidepsin, vorinostat, benirestat, parastat, etc.);
All acute toxicities caused by previous anti-tumor treatment return to the level specified in the inclusion/exclusion criteria (except alopecia and other toxicities that are considered by the investigator to pose no safety risk to the subjects);
Female subjects of childbearing potential need to use a medically recognized contraceptive measure during the study treatment and at least 3 months after the last use of the study drug;
Patients with known hormone receptor status;
Main organ function is basically normal, and meet the following conditions:
The subject voluntarily joined the study and signed the informed consent form.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chunfang Hao | Contact | 18622223686 | haochf@163.com | |
| SILU WANG | Contact | 18559171530 | wangsiluaaron@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tianjin Medical University Cancer Institute and Hospital | Recruiting | Tianjin | Tianjin Municipality | China |
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| fluzoparib+camrelizumab | Drug | Arms B will be treated with fluzoparib in combination with camrelizumab |
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