Neoadjuvant Therapy for Early Triple-Negative Breast Cancer: A Response-Guided Approach Using Iparomlimab and Tuvonralimab Injection in Combination With Chemotherapy
Iparomlimab and Tuvonralimab Injection (QL1706) is a bifunctional combination antibody targeting both programmed cell death protein 1 (PD-1) and cytotoxic T-lymphocyte antigen 4 (CTLA-4). This is a prospective clinical study that plans to enroll screened, eligible early-stage breast-cancer patients to receive neoadjuvant QL1706 plus chemotherapy (four cycles of TP ± four cycles of AC). After the four TP cycles, imaging and core biopsy will be performed. Patients who achieve radiologic complete response will proceed directly to surgery; those who do not will receive four additional AC cycles before surgery. A key feature is the incorporation of an response-guided neoadjuvant therapy（RGN）model to identify sensitive patients who can forgo anthracyclines, thereby reducing long-term cardiotoxicity.
• Voluntarily join this study, sign the informed consent form, and demonstrate good compliance;
• Age: 18-75 years old (at the time of signing the informed consent form);
• ECOG PS score: 0-1; expected survival time exceeding 6 months;
• Patients with primary breast cancer confirmed by histopathological or cytological examination;
• Primary tumor diameter \> 2 cm as measured by local standard assessment methods;
• Judged by the investigator to meet the American Joint Committee on Cancer (AJCC) 8th edition breast cancer TNM staging criteria as cT2-cT4, cN0-cN3, cM0, with locally advanced or early-stage, unilateral, and histologically confirmed invasive breast cancer;
• According to the latest ASCO/CAP guideline definitions, histopathologically confirmed early-stage triple-negative invasive breast carcinoma meeting all of the following criteria:Tumors are triple-negative on pathological subtyping, defined as: ER-negative: IHC ≤10%; PR-negative: IHC ≤10%; HER2-negative: IHC 0/1+, or IHC 2+ with negative ISH.
• At least one measurable lesion according to RECIST 1.1;
• The patient agrees to undergo breast cancer resection surgery when meeting the surgical criteria after neoadjuvant therapy;
• PD-L1 expression status is known;
• Major organ functions are in good condition;
• Female subjects of childbearing potential must have a negative serum pregnancy test within 3 days prior to the first dose. If a female subject of childbearing potential engages in sexual activity with a non-sterilized male partner, the subject must use acceptable and effective contraception from screening onward and agree to continue these precautions until 12 months after the last dose of the study drug; periodic abstinence and rhythm methods are not acceptable contraceptive methods.
• The subject is willing to provide core needle biopsy tissue samples for research analysis.