This study is a prospective, multicenter, single-arm, exploratory study. A total of 90 patients with early/later-stage triple-positive breast cancer who were scheduled to receive neoadjuvant therapy were recruited. They received neoadjuvant treatment with trastuzumab, pertuzumab, palbociclib, and exemestane in combination. The aim of this study is to evaluate the efficacy and safety of the neoadjuvant treatment regimen of trastuzumab-pertuzumab combined with palbociclib and exemestane in triple-positive breast cancer.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
90
Neoadjuvant treatment regimen: QL1701 (Trastuzumab for Injection): First dose 8mg/kg, then 6mg/kg, every 3 weeks, for a total of 6 cycles; QL1209 (Pertuzumab Injection): First dose 840mg, then 420mg, every 3 weeks, for a total of 6 cycles; Palbociclib: 125mg/day, days 1-21, every 4 weeks, for a total of 5 cycles; Exemestane: 25mg/day, every 4 weeks, for a total of 5 cycles.
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)
Time frame: From the time of enrollment to one month after the surgery
bpCR,breast physiological complex response
After the primary tumor was removed, microscopic examination of the breast revealed no invasive tumor cells (ypT0/is)
Time frame: From the time of enrollment to one month after the surgery
The proportion of patients with Miller & Payne classification (MP classification) at grades 4 to 5
Time frame: From the time of enrollment to one month after the surgery
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.
Time frame: baseline,1year,up to 2year
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).
Time frame: 6-12 months
OS,Overall Survival
Refers to the period from the start of medication use until death occurs due to any cause.
Time frame: baseline,1year,up to 2year
adverse event
Collect all adverse events that occurred in all subjects from the signing of the informed consent to 28 days after the cessation of medication, including clinical symptoms and abnormal vital signs, as well as abnormalities in laboratory tests. Record the clinical manifestations, severity, occurrence time, duration, treatment methods, prognosis, and determine the correlation between these events and the test drug.
Time frame: up to 2year
PRO
Outcome indicators reported by the patients,Score using the Chinese version of the EORTC Quality of Life Questionnaire Core 30 (QLQ-C30, V3.0)
Time frame: through study completion, an average of 1 year
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