HER-2 positive breast cancer
Conditions
Interventions
The observation group of HER-2 positive breast cancer patients with down-regulation of HER-2 expression after receiving neoadjuvant chemotherapy:None
The observation group of HER-2 positive breast cancer with stable HER-2 expression after receiving neoadjuvant chemotherapy:None
The observation group of HER-2 positive breast cancer patients who achieved pCR after receiving neoadjuvant chemotherapy:None
Sponsors
The First Affiliated Hospital of Chongqing Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1.Female patients aged between 18 and 80 years old; 2.Pathological confirmation of primary invasive ductal carcinoma through hollow core needle biopsy; 3. Initial immunohistochemistry (IHC) or fluorescence in situ hybridization (FISH) confirmed HER2 positivity (IHC 3+or IHC 2+/FISH amplification); 4.Preoperative neoadjuvant chemotherapy (NACT) combined with anti-HER2 targeted therapy (single or double target) for foot therapy; 5.Receive standardized surgical treatment after surgery and obtain clear pathological evaluation of residual tumors; 6.Have paired data on HER2 expression status before (puncture) and after (surgery) treatment; 7.Clinical pathological data, laboratory test reports, and survival follow-up data are complete;
Exclusion criteria
Exclusion criteria: 1.breast cancer patients whose initial diagnosis is stage IV (distant metastasis); 2.Patients with inflammatory breast cancer or bilateral primary breast cancer; 3.Patients with a history of other malignant tumors or concomitant serious systemic diseases who cannot tolerate treatment; 4. Those who have not completed the established neoadjuvant therapy cycle before surgery, or have changed treatment plans during the treatment period due to non disease progression; 5. Key clinical variables (such as hormone receptor status, postoperative pathological grading, etc.) are missing or lost to follow-up during the follow-up process.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Area under the receiver operating characteristic curve for predicting stable HER2 evolution pattern after neoadjuvant therapy; | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical net benefit of the prediction model;Area under the receiver operating characteristic curve in the external validation cohort; | — |
Countries
China
Contacts
Public ContactLiu Shengchun
The First Affiliated Hospital of Chongqing Medical University
Outcome results
None listed