Fluzoparib in Combination With or Without Camrelizumab for Homologous Recombinant Deficiency (HRD) HER2 Negative Advanced Breast Cancer

Inclusion Criteria

• •1. Women ≥18 years old
• •2. Histologically or cytologically confirmed locally advanced or metastatic breast cancer.
• •3. Pathologically documented breast cancer that is HER2-negative for both primary tumor and metastases (if puncture results are available)
• •4. ECOG PS of 0-1.
• •5. For locally advanced or metastatic breast cancer, the tumor tissue HRD score\> 42 is needed (for HRD testing, the recipient must provide a test report from an institution with a qualified testing unit prior to enrollment; if no report is available, the relevant test sample must be provided for confirmation in the central laboratory prior to enrollment).
• •6. Presence of at least 1 measurable lesion based on computed tomography (CT) or magnetic resonance imaging (MRI) per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1).
• •7. If treated with PARP inhibitors or immune checkpoint inhibitors in the (neo) adjuvant phase, a relapse-free interval of more than 1 year after the end of treatment is required.
• •8. Prior treatment with paclitaxel-based chemotherapeutic agents is allowed.
• •9. ≤ 2 lines of prior chemotherapy in the advanced stage.
• •10. For HR+ patients, progression within two years of (neo) adjuvant endocrine therapy is required; patients who have progressed after more than two years of endocrine therapy are required to have received at least first-line endocrine therapy for metastatic disease (including CDK4/6 inhibitors, cidarabine and PI3K inhibitors, etc.).
• •11. ≤ grade 1 (CTCAE v5.0) for all toxicities occurring in relation to prior antitumor therapy. However, patients with any grade of alopecia are allowed to enter the study.
• •12. CNS metastases without symptoms may be enrolled.
• •* If there is no extracranial assessable lesion, intracranial lesions are required to be assessable and suitable for systemic therapy only
• •* If there is an extracranial evaluable lesion, patients with an intracranial lesion that has been stabilized with local therapy may be accepted for enrollment
• •13. Routine blood tests within 1 week prior to enrollment are essentially normal.
• •* White blood cell count (WBC) ≥ 2.5 × 109/L.
• •* Neutrophil count (ANC) ≥ 1.5 × 109/L.
• •* Platelet count (PLT) ≥ 75 × 109/L.
• •* Patients may receive blood transfusions or erythropoietin therapy to meet this criterion.
• •14. Basic normal liver and renal function tests within 1 week prior to enrollment.
• •* Total bilirubin (T BIL) ≤ 1.5 x the upper limit of normal (ULN).
• •* Glutathione transaminase (SGPT/ALT) ≤ 2.5 x ULN (≤ 5 x ULN in patients with liver metastases).
• •* Glutathione aminotransferase (SGOT/AST) ≤ 2.5× ULN (≤ 5× ULN in patients with liver metastases).
• •* creatinine clearance (Ccr) ≥ 60 ml/min.
• •15. Patients subjects of reproductive/childbearing potential must agree to use a highly effective form of contraception or avoid intercourse during and upon completion of the study and after the last dose of treatment medicine for at least 90 days.
• •16. A life expectancy of at least 12 weeks.
• •17. Patients must be able to participate and comply with treatment and follow-up.