A Single-Arm Phase Ⅱ Study of Fluzoparib Maintenance in Platinum-sensitive Advanced Triple-Negative Breast Cance

Exclusion Criteria

• •1. Known hypersensitivity to fluzoparib or any of its excipients.
• •2. Prior treatment with any PARP inhibitor.
• •3. Use of strong CYP3A4 inhibitors within 14 days or strong CYP3A4 inducers within 28 days before first dose.
• •4. Wash-out interval \<4 weeks from any prior anti-cancer therapy (chemotherapy, radiotherapy, surgery, targeted therapy, immunotherapy) to first dose.
• •5. Planned anti-cancer therapy other than study drug during the trial period.
• •6. Severe bone complications from bone metastases (uncontrolled pain, impending pathological fracture, or spinal cord compression within 6 months or judged likely to occur).
• •7. Symptomatic or untreated brain metastases, leptomeningeal disease, spinal cord compression, or primary CNS tumors. (Stable brain metastases treated ≥28 days prior to first dose, without steroids and with confirmatory imaging showing no hemorrhage, may be allowed at investigator's discretion.)
• •8. Active autoimmune disease requiring systemic therapy within the past 2 years.
• •9. Recovery from major surgery under general anesthesia or severe trauma \<14 days before start of study treatment.
• •10. Active hepatitis B (HBsAg positive and HBV DNA ≥500 IU/mL) or hepatitis C (anti-HCV positive and HCV RNA \>ULN).
• •11. Untreated CNS metastases.
• •12. History of immunodeficiency (including HIV positive), congenital or acquired, or prior solid-organ transplant.
• •13. Other malignancies within 5 years except adequately treated carcinoma in situ or indolent tumors judged by the investigator to have low risk of recurrence.
• •14. Alcohol abuse (\>14 units/week) or drug abuse; inability to stop smoking (\>10 cigarettes/day), nicotine products, grapefruit juice, or excessive caffeine/tea during the study.
• •15. History of non-infectious pneumonitis requiring steroids or current pneumonitis.
• •16. Clinically significant ECG abnormalities, including QTcF \>470 ms in females (QTc calculated with Fredericia's formula).
• •17. Conditions that could impair oral absorption: inability to swallow, active GI disease, bowel obstruction, inflammatory bowel disease, chronic diarrhea, short-bowel syndrome, or major upper-GI surgery (e.g., gastrectomy).
• •18. Active infection or unexplained fever \>38.5 °C on screening or day 1 (tumor fever allowed if investigator judges stable).
• •19. Uncontrolled chronic systemic diseases (severe pulmonary, hepatic, renal, or cardiac).
• •20. Thyroid function abnormalities (TSH, FT3, FT4) deemed clinically significant by the investigator.
• •21. Bleeding diathesis: active peptic ulcer with positive fecal occult blood (FOB ++), melena or hematemesis within 2 months, or any condition predisposing to GI hemorrhage; gastric ulcer-type tumor without resection and judged at high risk of major bleeding; on thrombolytic/anticoagulant therapy that cannot be safely interrupted.
• •22. Urinalysis ≥++ proteinuria confirmed by 24-h urine protein \>1.0 g.
• •23. Arterial or venous thrombo-embolic events (stroke, TIA, DVT, PE) within 6 months before screening.
• •24. Active tuberculosis or acute infection requiring anti-infective therapy.
• •25. Live-vaccine administration within 30 days before planned first dose.
• •26. Additional exclusion: Any severe concomitant condition that, in the investigator's opinion, could compromise patient safety or interfere with study compliance (e.g., uncontrolled diabetes, thyroid disorders, psychiatric illness).