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.
The tumor stage must be in accordance with the 8th edition of the AJCC standard, being stage II-III for the initial diagnosis;
Pre-menopausal or perimenopausal patients (if this is the case, combined with OFS, which includes bilateral oophorectomy or GnRHa drugs), or post-menopausal patients;
All patients must have been pathologically confirmed as HR+/HER2 receptor positive. The estrogen receptor (ER) is positive (>10%), the progesterone receptor (PR) is positive (>1%), and the HER2 receptor is positive. Follow the 2018 ASCO-CAP HER2 positive interpretation guideline standards. The immunohistochemistry (IHC) score is 3+ or 2+ and the in situ hybridization (ISH) test is positive (ISH amplification rate ≥ 2.0);
Age 18-75 years (inclusive of 18 and 75), female;
Has received any form of anti-tumor treatment (chemotherapy, radiotherapy, molecular targeted therapy, endocrine therapy, etc.);
Is concurrently receiving other anti-tumor drug treatments;
Stage IV breast cancer;
Breast cancer without pathological tissue diagnosis;
Single group
Trastuzumab and Pertuzumab Combination with Palbociclib and Exemestane
DrugNeoadjuvant 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)
bpCR，breast physiological complex response
After the primary tumor was removed, microscopic examination of the breast revealed no invasive tumor cells (ypT0/is)
The proportion of patients with Miller & Payne classification (MP classification) at grades 4 to 5
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.
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).
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