HR+/HER2- breast cancer
Conditions
Interventions
Experimental Group:Neoadjuvant chemotherapy + immunotherapy + radiotherapy
Control group:Neoadjuvant chemotherapy + immunotherapy
Sponsors
The First Affiliated Hospital of Wenzhou Medical University
Eligibility
Sex/Gender
Female
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Newly diagnosed, untreated breast cancer; 2.Age: 18 years = 10%); 4.Human epidermal growth factor receptor-2 immunohistochemistry (HER2-IHC) result of 0/1+ or 2+ with negative fluorescence in situ hybridization (FISH) test; 5.Histologically confirmed cell proliferation index (Ki67)>= 20%; 6.Programmed death-ligand 1 combined positive score (PD-L1 CPS) evaluable (i.e., availability of fresh/archived specimens); 7.Good pulmonary function; 8.Adequate hepatic and renal function; 9.Histological grade >= 2; 10.cN0, cT >=3 cm or cN1-3, cT >= 2 cm (cT: clinically assessed maximum diameter of primary tumor; cN: clinically assessed regional lymph node status); 11.Eastern Cooperative Oncology Group Performance Status (ECOG score) 0-1;
Exclusion criteria
Exclusion criteria: 1.Pregnancy; 2.Tumor > 8 cm with skin ulceration; 3.History of thoracic radiotherapy or contraindications to radiotherapy; 4.Active autoimmune disease; 5.Prior use of PD-L1 antibody therapy; 6.De novo breast cancer; 7.There are factors that may significantly increase the risk of lung or cardiac toxicity related to radiotherapy, such as(1) maximum lung depth(MLD) >3.2cm; (2) maximum heart distance(MHD) <2.4cm?
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathological complete response rate, pCR; | — |
Secondary
| Measure | Time frame |
|---|---|
| Event-free survival, EFS;Objective Response Rate, ORR;Incidence of adverse reactions; | — |
Countries
China
Contacts
Public ContactOuchen Wang
The First Affiliated Hospital of Wenzhou Medical University
Outcome results
None listed