For the hormone receptor-positive (HR+)/human epidermal growth factor receptor 2-negative (HER2-) subtype of breast cancer, although surgical, radiotherapy, and endocrine treatments have shown better survival, this subtype has a relatively poor response to neoadjuvant chemotherapy and immunotherapy, with an approximately pCR of 20%. The low immunogenicity result in suboptimal pCR and objective response rates for this group. Therefore, there is an urgent need to explore new, highly effective, and low-toxicity treatment strategies to further improve the efficacy of HR+/HER2- breast cancer. Radiotherapy has systemic immune regulatory effects by promoting the release of antigens from tumor cells, enhancing T-cell infiltration, and directly killing tumor cells. Therefore, this study aims to investigate the efficacy and safety of chemotherapy combined with PD-1 inhibitor and different radiotherapy fractionations in the neoadjuvant treatment of HR+/HER2- breast cancer.
1. Histologically or cytologically confirmed HR+/HER2- breast cancer
2. cT1c-2N1-2M0 or cT3N0-2M0（AJCC 7th）
3. ECOG performance status of 0-1;
4. Adequate bone marrow function, defined as: Hb ≥ 9.0 g/dL (90 g/L); ANC ≥ 1,500/mcL (1.5 × 10^9/L); PLT ≥ 100,000/mcL (100 × 10^9/L) and no blood transfusion within 3 weeks or growth factor (G-CSF, EPO) therapy within 2 weeks prior to dosing;
1. Patients with a history of mental illness or those diagnosed with mental disorders at the time of enrollment in the clinical trial.
2. Patients with communication barriers due to confusion, aphasia, intellectual disability, or other reasons that prevent them from responding normally.
3. Poorly controlled tumor-related pain.
4. Patients participating in other clinical studies simultaneously.
Parallel
Chemotherapy+PD-1 inhibitor+8Gy x 3f
DrugRadiotherapy: 8Gy x 3f, once every other day; Chemotherapy: Cycles 1-4: Albumin-bound paclitaxel: 260 mg/m², IV, administered on day 1 of each cycle. Cycles 5-8: Epirubicin: 90-100 mg/m², IV, administered on day 1 of each cycle; Cyclophosphamide: 600 mg/m², IV, administered on day 1 of each cycle; Immunotherapy: PD-1 inhibitor, once every three weeks
Chemotherapy+PD-1 inhibitor+16Gy x 1f
DrugRadiotherapy: 16Gy x 1f; Chemotherapy: Cycles 1-4: Albumin-bound paclitaxel: 260 mg/m², IV, administered on day 1 of each cycle. Cycles 5-8: Epirubicin: 90-100 mg/m², IV, administered on day 1 of each cycle; Cyclophosphamide: 600 mg/m², IV, administered on day 1 of each cycle; Immunotherapy: PD-1 inhibitor, once every three weeks
Chemotherapy+PD-1 inhibitor+2.67Gy x 15f
DrugRadiotherapy: 2.67Gy x 15f; Chemotherapy: Cycles 1-4: Albumin-bound paclitaxel: 260 mg/m², IV, administered on day 1 of each cycle. Cycles 5-8: Epirubicin: 90-100 mg/m², IV, administered on day 1 of each cycle; Cyclophosphamide: 600 mg/m², IV, administered on day 1 of each cycle; Immunotherapy: PD-1 inhibitor, once every three weeks
Chemotherapy+PD-1 inhibitor+0.5Gy x 12-18f
DrugRadiotherapy: 0.5Gy x 12-18f; Chemotherapy: Cycles 1-4: Albumin-bound paclitaxel: 260 mg/m², IV, administered on day 1 of each cycle. Cycles 5-8: Epirubicin: 90-100 mg/m², IV, administered on day 1 of each cycle; Cyclophosphamide: 600 mg/m², IV, administered on day 1 of each cycle; Immunotherapy: PD-1 inhibitor, once every three weeks
pCR
The percentage of patients showing no evidence of invasive cancer cells in the tissue samples after treatment
Ipsilateral breast recurrence or local regional recurrence
The percentage of patients experiencing a recurrence of cancer in the same breast or in the nearby lymph nodes
Overall survival
The time from the start of treatment until the occurrence of death
Distant metastasis-free survival
the time from the start of treatment until the occurrence of distant metastasis
Incidence of Treatment-Emergent Adverse Events
the incidence of adverse events
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Lei Liu
Lead sponsor
West China Hospital
Sponsor institution
This trial is not recruiting at the moment. You can still explore other options:
