This is a single-center, single-arm, prospective study enrolling 30 patients with stage II-III triple-negative breast cancer. The neoadjuvant regimen consists of QL1706 combined with carboplatin plus albumin-bound paclitaxel (21-day cycles for 4 cycles) followed by QL1706 combined with doxorubicin/epirubicin plus cyclophosphamide (21-day cycles for 4 cycles). The treatment observation period is 1 year, and the primary endpoint is the pathological complete response rate.
Histologically or cytologically confirmed newly diagnosed ER-/HER2- breast cancer. ER and PR with Allred score <3 or <1% positively stained cells in tumor infiltrating components. HER2 negativity defined as 0 or 1+ by FISH or IHC staining per NCCN guidelines;
Clinical stage II or III breast cancer eligible for neoadjuvant chemotherapy (per AJCC 8th edition: at least T2 any N M0, or any T if N+), with treatment goal of complete surgical resection following neoadjuvant therapy;
Tumor size ≥2 cm by clinical or imaging assessment per WHO criteria. Patients with histologically confirmed or clinically palpable lymph nodes are eligible regardless of tumor size;
Treatment-naïve subjects;
History of invasive malignancies within 5 years prior to signing the informed consent form, except for adequately treated basal cell carcinoma, squamous cell skin cancer, or carcinoma in situ of the cervix;
Subjects who have received chemotherapy, immunotherapy, targeted therapy, or radiotherapy within the past 12 months;
Stage IV metastatic breast cancer;
Administration of a vaccine within 30 days before the first dose of the study treatment;
Single group
Immunotherapy combined with chemotherapy
DrugAlbumin-bound paclitaxel: 125 mg/m², day 1 and day 8, 21-day cycle; Carboplatin: AUC = 5, day 1 or AUC = 2-3, day 1 and day 8, 21-day cycle; QL1706: 5 mg/kg, day 1, 21-day cycle; Epirubicin: 90-100 mg/m², day 1, 21-day cycle; or Doxorubicin: 50 mg/m², day 1, 21-day cycle; Cyclophosphamide: 600 mg/m², day 1, 21-day cycle.
Pathologic complete response (pCR) rates
pCR rate (ypT0/Tis ypN0) is defined as the percentage of participants without residual invasive cancer on hematoxylin and eosin evaluation of the complete resected breast specimen and all sampled regional lymph nodes following completion of neoadjuvant systemic therapy by current American Joint Committee on Cancer (AJCC) staging criteria assessed by the local pathologist at the time of definitive surgery.
Objective response rate（ORR）
Percentage of Participants With an Objective Response of CR or PR According to RECIST v1.1
3y-EFS
Percentage of patients who, from the initiation of treatment, remain free of any of the following events within three years: disease progression to unresectable status, local or distant recurrence, development of a second primary malignancy (breast cancer or other cancers), or death from any cause.
Overall survival (OS)
OS is defined as the time from the initiation of treatment to death due to any cause. Participants without documented death at the time of the analysis will be censored at the date of the last follow-up.
Adverse events
AEs will be assessed according to NCI CTCAE v5.0, by grade
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