Advanced HER2 Negative Breast Carcinoma, HRD+Breast Cancer
Conditions
Brief summary
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.
Interventions
DRUGfluzoparib+chidamide
Arms A will be treated with fluzoparib in combination with cedaramide
Arms B will be treated with fluzoparib in combination with camrelizumab
Sponsors
Tianjin Medical University Cancer Institute and Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
1. 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. 2. 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); 3. central confirmation of HRD positivity, known germline BRCA and/or systemic BRCA mutation status is allowed to be preferred. 4. age 18-70 years 5. According to RECIST 1.1, at least one measurable lesion is present; 6. ECOG score: 0-2; expected survival more than 12 weeks; 7. Previous treatment with immune checkpoint inhibitors, PARP inhibitors and HDAC inhibitors (including chidamine, romidepsin, vorinostat, benirestat, parastat, etc.); 8. 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); 9. 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; 10. Patients with known hormone receptor status; 11. Main organ function is basically normal, and meet the following conditions: 1. Blood routine examination criteria need to meet: HB ≥ 90 g/L (14 without blood transfusion); ANC ≥ 1.5 × 109/L; PLT ≥ 75 × 109/L; 2. Biochemical examination need to meet the following criteria: TBIL ≤ 1.5 × ULN (upper limit of normal); ALT and AST ≤ 3 × ULN; if there is liver metastasis, ALT and AST ≤ 5 × ULN; serum Cr ≤ 1 × ULN; 3. cardiac function: LVEF ≥ 50% 12. The subject voluntarily joined the study and signed the informed consent form.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| ORR(objective response rate) | At the end of Cycle 1 (each cycle is 28 days) | through study completion, an average of 6 months |
Countries
China
Contacts
Primary ContactChunfang Hao
Backup ContactSILU WANG
Outcome results
None listed