Neoadjuvant NabPE With or Without Serplulimab for Early-stage Hormone Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative (HR+/HER2-) Breast cancer-an Observational Real-world Study.
The goal of this clinical study is to learn if serplulimab is effective in early HR+/HER2- breast cancer. This trial serves a prospective parallel control cohort for HELEN-018 (NCT). The main questions it aims to answer are: Does serplulimab combined with neoadjuvant chemotherapy improve the pCR rate of early HR+/HER2- breast cancer? What medical problems do participants have when receiving serplulimab? Researchers will compare the effect of serplulimab combined with chemotherapy to the effect of chemotherapy reported in literature. Participants will: Receive serplulimab plus chemotherapy every 3 weeks for 6 cycles; All patients will receive surgery, and the primary end point is a pathological complete response at the time of definitive surgery; After definitive surgery, the participants will receive adjuvant serplulimab every 3 weeks for up to 6 months from the begining of the treatment.
• Age\>=18 years old
• cT2 - cT4d, or cT1c with axillary lymph node metastasis confirmed clinically and pathologically；
• Pathologically proven HR+/HER2- breast cancer:
• defined as:
⁃ positive for ER or PR (IHC nuclear staining \>1%)
⁃ Her-2 negative (IHC 0, 1+ without FISH, or IHC 2+ with no amplification by FISH)；
• Has clinically measurable lesions:Measurable lesions on ultrasound, mammography, or MR (optional) within 1 month before randomization；
• Organ and bone marrow function tests within 1 month before chemotherapy suggest no contraindications to chemotherapy；
• Cardiac ultrasound EF value ≧55%；
• Females of childbearing age, with a negative serum pregnancy test 14 days before randomization;
• ECOG score≤1 point;
• Sign informed consent；