Breast cancer
Conditions
Interventions
Experimental Group:Trastuzumab + oral Chinese herbal granules (Chai Gui Wen Yang Formula)
Control Group:Trastuzumab + oral placebo granules
Sponsors
Shanghai University of Traditional Chinese Medicine Affiliated Longhua Hospital
Eligibility
Sex/Gender
Female
Age
30 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1) Female 2) Age 30-75 years 3) Patients who meet the diagnostic criteria of Western medicine and the criteria of Chinese medicine, and are preoperative breast cancer patients about to receive trastuzumab treatment 4) Patients with LVEF =50% before enrollment and no abnormalities in cardiac enzyme spectrum, BNP, and NT-proBNP 5) Patients with a Karnofsky score of 60 or above 6) Willing to undergo random allocation 7) Voluntarily participating in the clinical trial and signing the informed consent form
Exclusion criteria
Exclusion criteria: 1) Pregnant and breastfeeding women. 2) Individuals with impaired liver and kidney function (ALT, AST, and serum creatinine levels exceeding twice the upper limit of normal or higher). 3) Individuals who have previously received various anti-HER-2 targeted therapies, including trastuzumab. 4) Individuals who are unable to complete this study for various reasons, such as drug allergies. 5) Individuals with a history of other heart conditions, such as organic heart disease, congenital heart disease, cardiomyopathy, etc. 6) Individuals assessed by a cardiologist to have acute heart failure or severe arrhythmias, requiring cardiology-related treatment. 7) Individuals currently taking anti-tumor traditional Chinese medicine (TCM) with overlapping components involved in this trial. 8) Individuals who have already participated in other clinical trials.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cardiotoxicity incidence rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Left ventricular ejection fraction;Left ventricular end-diastolic volume;NYHA;Cardiac enzyme panel;B-type Natriuretic Peptide;N-terminal pro-B-type natriuretic peptide;electrocardiogram;TCM syndrome score;Generalized Anxiety Assessment Scale;Beck Depression Inventory;Breast Cancer Quality of Life Assessment Scale;Breast Cancer Treatment-Related Cardiovascular Toxicity Clinical Assessment Form; | — |
Countries
China
Contacts
Public ContactChen Xinlin
Shanghai University of Traditional Chinese Medicine Affiliated Longhua Hospital
Outcome results
None listed