This study is a prospective, multicenter, single-arm, exploratory study. 30 patients with locally advanced HR+/HER2- breast cancer who have not received any treatment were recruited to receive apalutamide voraparib combined with chemotherapy for neoadjuvant therapy. This study adopts Simon's two-stage design: in the first stage, 12 patients need to be enrolled. If among these 12 patients, 1 or fewer patients achieve tpCR, the study will be prematurely terminated due to early failure. Otherwise, 18 patients will be enrolled in the second stage. If 7 or more patients achieve tpCR among the 30 patients, the study achieves the expected results, and the drug can be further studied; otherwise, the study fails, and the drug does not need further study. The aim of this study is to evaluate the efficacy and safety of apalutamide voraparib combined with chemotherapy for neoadjuvant therapy in patients with HR+/HER2- breast cancer.
Age ≥ 18 years and ≤ 75 years, regardless of gender;
The primary lesion tissue pathology is confirmed as HR+/HER2- breast cancer, following the 2018 ASCO/CAP breast cancer HER2 testing guidelines and the 2010 ASCO/CAP breast cancer ER/PR testing guidelines for interpretation. HER2-negative is defined as confirmed by the pathology laboratory with an immunohistochemistry (IHC) score of HER2 0/1+ or 2+ and negative in in situ hybridization (ISH), and estrogen receptor positive (ER+) breast cancer with or without progesterone receptor (PgR) expression;
Tumor histological grade 3, or histological grade 2 with the percentage of ER expression level between 1-10%;
According to the American Joint Committee on Cancer (AJCC) 8th edition TNM classification, the clinical stage should be T1c-T2cN1-2 or T3-4cN0-2, M0 stage;
Patients with stage IV metastatic breast cancer or other conditions deemed by the researchers as not achievable through neoadjuvant therapy for radical surgical resection;
Bilateral invasive breast cancer;
Breast cancer patients who have previously received anti-tumor treatments such as chemotherapy, endocrine therapy, or undergone breast surgery (except for the diagnostic biopsy of primary breast cancer);
Patients who participated in other drug clinical trials within 4 weeks prior to enrollment, received major surgical treatment, incisional biopsy, or significant traumatic injury (except for the diagnostic biopsy of primary breast cancer);
Single group
Iparomlimab and Tuvonralimab Injection (QL1706) combined chemotherapy
DrugThe dosage of Iparomlimab and Tuvonralimab Injection is 5mg/kg, administered intravenously, with each treatment cycle lasting every 3 weeks. The chemotherapy regimen is AC-T: epirubicin 100mg/m2, cyclophosphamide 600mg/m2, every 3 weeks for 4 cycles; followed by paclitaxel 80mg/m2, every week for 12 cycles. A total of 8 cycles of neoadjuvant chemotherapy combined with immunotherapy were performed before the surgery. It is recommended that the surgery be conducted within 4 weeks after the completion of neoadjuvant treatment. The postoperative adjuvant treatment can be continued with postoperative adjuvant chemotherapy and the treatment of the etolo combination antibody according to the decision of the researcher and/or the willingness of the subject.
tpCR rate，total physiological complex response
After the resection of the primary tumor, microscopic examination of the breast and the ipsilateral axillary lymph nodes revealed no invasive tumor cells (ypT0/is ypN0)
bpCR，breast physiological complex response
After the primary tumor was removed, microscopic examination of the breast revealed no invasive tumor cells (ypT0/is)
EFS，Event-free survival
The time from the start of medication to the occurrence of any of the following events for the first time: disease progression making surgical treatment impossible, local or distant recurrence, death due to any cause, etc.
ORR，Objective Response Rate
The proportion of patients whose tumor volume has decreased by 30% and has remained stable for more than four weeks is referred to as the sum of complete response (CR) and partial response (PR).
OS，Overall Survival
Refers to the period from the start of medication use until death occurs due to any cause.
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