1. To explore the predictive value of ctDNA in HER2 positive breast cancer neoadjuvant therapy population; 2. To evaluate the prognostic value of ctDNA in HER2 positive breast cancer neoadjuvant therapy population.
Women with breast cancer diagnosed clinically and pathologically, aged 18-75 years;
ECOG performance score is 0-1;
Histologically confirmed as early or locally advanced invasive breast cancer: the diameter of the primary tumor is more than 2 cm, and HER2 is positive (confirmed by IHC or FISH).
The patient did not receive any treatment for breast cancer before enrollment;
Patients with known metastatic or stage IV breast cancer;
There are other untreated malignant tumors other than breast cancer;
Patients with one or more serious systemic diseases that, in the eyes of researchers, can impair their ability to complete research;
According to the researchers' assessment, there may be other factors that could force the subjects to terminate the study midway, such as suffering from other serious illnesses (including mental illnesses) that require concurrent treatment, severe abnormal laboratory test values, family or social factors, which may affect the safety of the subjects or the collection of experimental data.
This study plans to enroll 50 women patients with HER2 positive early (T2-3, N0-1, M0)/local late (T2-3, N2-3, M0 or T4a-c, Nany, M0) breast cancer, who can accept new adjuvant treatment, voluntarily sign the informed consent form, timely and sufficiently obtain tumor tissue and peripheral blood samples for testing, and are willing to cooperate with follow-up.
Cohort
Prospective
ctDNA-MRD
Diagnostic testThis study is an observational non intervention study that only tests peripheral blood samples from different treatment nodes of the subjects, without interfering with the normal clinical diagnosis and treatment process of the patients.
Postoperative pathological pCR rate
Postoperative pathological pCR rate of HER-2 positive breast cancer patients after completing neoadjuvant therapy and undergoing surgical resection
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