This study is a multicenter, prospective, randomized phase II trial designed to observe and evaluate the efficacy and safety of trastuzumab, pertuzumab, docetaxel combined with QL1706 versus combined with carboplatin as neoadjuvant therapy in patients with operable or locally advanced HER2-positive breast cancer.
This multicenter, randomized phase II trial evaluates the efficacy and safety of neoadjuvant therapy with trastuzumab, pertuzumab, and docetaxel plus QL1706 versus the same regimen plus carboplatin in patients with operable or locally advanced HER2-positive breast cancer. The study will enroll 188 subjects, randomly assigned 1:1 to either the QL1706 combination arm or the carboplatin combination arm, stratified by nodal status and hormone receptor status (\<10% vs ≥10%). Both treatment groups will receive four 3-week cycles of assigned therapy followed by surgical resection and response assessment. Postoperative adjuvant treatment will be administered according to investigator discretion and guideline recommendations.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
188
On Day 1 of each cycle at a dose of 5 mg/kg, IV infusion
On Day 1 of each cycle; 8 mg/kg IV loading dose followed by 6 mg/kg IV every 3 weeks
On Day 1 of each cycle; 840 mg IV loading dose followed by 420 mg IV every 3 weeks
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, China
The First Affiliated Hospital, Sun Yat-sen University (FAH-SYSU)
Guangzhou, Guangdong, China
The Fourth Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
The First Affiliated Hospital of Henan University of Science & Technology
Pathological complete response (pCR) rate using the definition of ypT0/Tis ypN0 (i.e., no invasive residual in breast or nodes; noninvasive breast residuals allowed) at the time of definitive surgery
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 16-18weeks
pCR rate using the definition of ypT0/Tis (i.e., no invasive residual in breast or nodes; noninvasive breast residuals allowed) at the time of definitive surgery
pCR rate (ypT0/Tis) is defined as the percentage of participants without invasive cancer in the breast irrespective of ductal carcinoma in situ or nodal involvement following completion of neoadjuvant systemic therapy by current AJCC staging criteria assessed by the local pathologist at the time of definitive surgery
Time frame: Up to approximately 16-18 weeks
Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1)
ORR is defined as the percentage of participants in the analysis population who achieve confirmed complete response (CR: disappearance of all target lesions) or partial response (PR: at least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1, modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ.
Time frame: Up to approximately 12 weeks
Event Free Survival
EFS is defined as the time from randomization to any of the following events: preoperative disease progression as determined by the investigator according to RECIST v1.1 - any evidence of contralateral in situ disease is not considered disease progression (PD), while all evidence of contralateral invasive disease is considered PD; postoperative disease recurrence (local, regional, distant, or contralateral); death from any cause. (Whichever occurs first)
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On Day 1 of each cycle at a dose of 75 mg/m², IV infusion
On Day 1 of each cycle at a dose of AUC = 4, IV infusion
Luoyang, Henan, China
Nanyang Central Hospital
Nanyang, Henan, China
The West China Second University Hospital of Sichuan University (WCSUH- SCU)
Chengdu, Sichuan, China
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, China
Affiliated Hospital of Jiaxing University
Jiaxing, Zhejiang, China
Time frame: Up to approximately 5 years
Disease-free Survival
DFS is defined as the time from date of surgery (date of no disease) to the first documentation of progressive disease (local, regional, distant, or contralateral) or death.
Time frame: Up to approximately 5 years
Overall survival (OS)
OS is defined as the time from randomization to death due to any cause.
Time frame: Up to approximately 5 years
Breast-conserving surgery rate
Breast-conserving surgery rate is the proportion of patients who underwent breast-conserving surgery among all patients who underwent surgery.
Time frame: Up to approximately 16-18 weeks
Radical resection rate
The proportion of patients who achieved radical resection among all patients.
Time frame: Up to approximately 16-18 weeks