Fluzoparib as Adjuvant Treatment in Patients With Germline Homologous Recombination Repair (HRR) Mutated Primary Breast Cancer (Flamenco)

Inclusion criteria

• Female 18-75 years
• ECOG 0-1
• Histologically confirmed invasive carcinoma (regardless of pathological type)
• No gross or microscopic residual tumor after surgical resection
• For triple-negative early breast cancer receiving neoadjuvant therapy (at least 6 cycles of chemotherapy), postoperative pathological assessment of non-pCR is required; for ER and/or PgR-positive and HER2-negative early breast cancer receiving neoadjuvant therapy (at least 6 cycles of chemotherapy or endocrine therapy), postoperative pathological assessment of non-pCR and ypLN + is required; for triple-negative early breast cancer not receiving neoadjuvant therapy, postoperative pathological assessment of ≥ pT2 or ≥ pN1 is required; for ER and/or PgR-positive and HER2-negative early breast cancer not receiving neoadjuvant therapy, postoperative pathological assessment of ≥ 4 positive lymph nodes or 1-3 positive lymph nodes with high-risk factors (tumor diameter ≥ 5 cm, or histological grade 3, or Ki-67 ≥ 30%) is required
• Carrying pathogenic or possibly pathogenic mutations in BARD1/BRIP1/EXO1/FANCM/NBN/PALB2/PARP1/PARP2/POLQ/RAD50/RAD51/RAD51B/RAD51C/RAD51D/RAD52/RAD54L/RE/QL5/RFC1/RPA1/TOP3A/TOP3B/BLM germline genes confirmed by second-generation sequencing or first-generation sanger sequencing

Exclusion criteria

• Bilateral breast cancer or carcinoma in situ DCIS/LCIS;
• Metastases at any site;
• contralateral breast clinical or imaging suspected malignant but not confirmed, need biopsy;
• Treated for advanced disease;
• Patients who have received tamoxifen, raloxifene, or aromatase inhibitors (AIs) to reduce the risk of breast cancer ("chemoprevention") and/or who have previously undergone prophylactic ovariectomy within 2 years;
• Malignant tumor (except skin basal cell carcinoma and cervical carcinoma in situ) within 5 years, including contralateral breast cancer;