breast cancer
Conditions
Interventions
experimental group:Anastrozole
Sponsors
Shenzhen Second Hospital
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: (1) The subjects sign the informed consent; (2) The subjects with unilateral, invasive stage I, II, III postmenopausal breast cancer diagnosed by surgical histopathology without distant metastases; (3) ER / PR-negative and ER-ß1-positive breast cancer diagnosed by immunohistochemistry, that is, the percentage of ER and PR-positive cells is less than 1% and the percentage of ER-ß1-positive tumor cells is more than 10%; (4) The subjects have not previously received neoadjuvant endocrine therapy; (5) The heart ultrasound indicates that the ejection fraction of the heart is within the normal range; (6) Eastern Cooperative Oncology Group (ECOG) scale is lower than 2 points; (7) Female, postmenopausal or sexual hormone levels are in menopause; (8) The patient receives neoadjuvant chemotherapy after the diagnosis of breast cancer (the specific plan is not limited) or the following standard breast cancer surgery: -Standard standardized breast cancer radical mastectomy, radical mastectomy; -Standardized breast preservation surgery for breast cancer, that is, mastectomy or quadrant resection plus standard sentinel lymph node biopsy or axillary lymph node dissection, the margin of the breast-conserving surgery must be negative, and postoperative standardized radiotherapy (completed in standardized adjuvant chemotherapy Rear). (9) Postoperative adjuvant chemotherapy in accordance with the 2019 NCCN guidelines (the specific protocol is not limited), radiotherapy or Herceptin-targeted therapy: postoperative adjuvant chemotherapy (the chemotherapy regimens recommended by the NCCN guidelines in 2019 are all acceptable, specific protocols Unlimited), postoperative adjuvant radiotherapy (all patients undergoing breast-conserving surgery and patients undergoing breast-sparing surgery and axillary lymph node metastasis >= 4), and HER2-positive patients with tumors> 1 cm will receive targeted Herceptin for 1 year. (10) Capable of swallowing pills; (11) The subjects with good organ function and meeting the following indicators without anastrozole contraindication.
Exclusion criteria
Exclusion criteria: (1) The patients who combined with other malignant tumors or have suffered from other malignant tumors in the past 5 years, except for skin basal cell carcinoma or flat cell carcinoma that has been fully treated and controlled, and carcinoma in situ of the cervix; (2) The patients who have received neoadjuvant endocrine therapy after diagnosis; (3) The patients who suffered from severe diseases combined with non-malignant tumors which will affect patient compliance or set patients at risk; (4) The patients who are receiving other antitumor treatments or participating in other clinical trials in the same time; (5) Premenopausal, pregnant or lactating women; (6) The patients who suffer from dementia, mental retardation, or any mental illness that prevents understanding of the informed consent form; (7) The patients who suffer from severe liver dysfunction, Child-Pugh grade C, and / or severe cardiac insufficiency, cardiac function grade III and above; (8) The patients who suffer from arrhythmia or taking anti-arrhythmic drugs; (9) The patients who suffer from excessive dyslipidemia; (10) The patients who are allergic or contraindicated to the aromatase inhibitor anastrozole (severe history of osteoporosis or those with thromboembolic disease, fracture disease).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| DFS;PFS; | — |
Countries
China
Contacts
Public ContactWenjing JIan
Shenzhen Second Hospital
Outcome results
None listed