HR+/HER2+ breast cancer belongs to a special type of tumor with dual-channel signal activation. However, in clinical treatment, the preferred approach is usually the inhibition of the HER2 signaling pathway. Therefore, the non-pCR rate after neoadjuvant therapy is relatively high (about 60%). To optimize the neoadjuvant treatment strategy for HR+/HER2+ breast cancer, increase the pCR rate of neoadjuvant treatment, and improve the prognosis of patients, our research group intends to conduct a prospective clinical and translational study. By observing the clinical efficacy and changes in biomarkers, individualized treatment for HR+/HER2+ breast cancer will be carried out. Patients who respond well to HER2-targeted therapy will be identified early, and for those without early relief, targeted combined dual-channel inhibition therapy with endocrine treatment will be adopted. The effectiveness and safety of the individualized neoadjuvant treatment strategy for HR+/HER2+ breast cancer patients will be evaluated. In addition, this study aims to focus on the neoadjuvant chemotherapy mechanism of HR+/HER2+ breast cancer, and combine the establishment and validation of effective disease models to provide theoretical basis and experimental support for achieving precise treatment and clinical transformation.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
60
For HR+/HER2+ breast cancer patients treated with TCbHP, after 2 cycles of treatment, they were classified according to the therapeutic effect into the effective group and the group without early response. The effective group continued to receive TCbHP treatment for another 4 cycles, while the group without early response changed to the neoadjuvant treatment regimen of trastuzumab dual-target combined with exemestane and palbociclib for 4 cycles. Evaluation methods: Early non-response is defined as the results of the examination after the end of the 2nd cycle of treatment meeting any of the following criteria: 1. MRI, ultrasound: PD/SD of lymph nodes or primary lesion, PR but tumor regression \< 50%; 2. Histological pathological examination:Changes in immunohistochemical molecular typing;The decrease in Ki-67 compared to the baseline is less than 20%;PIK3CA mutation.
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
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
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