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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Albumin-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.
Time frame: Up to approximately 9 months
Objective response rate(ORR)
Percentage of Participants With an Objective Response of CR or PR According to RECIST v1.1
Time frame: Up to approximately 27-30 weeks
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.
Time frame: Up to approximately 3 years
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.
Time frame: Up to approximately 8 years
Adverse events
AEs will be assessed according to NCI CTCAE v5.0, by grade
Time frame: up to 18 months
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