Breast cancer
Conditions
Interventions
Control group:Drink placebo water
Control group:Drink AENW
Sponsors
The First Affiliated Hospital of Dalian Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Histopathologically confirmed advanced breast cancer, with HER-2 overexpression (IHC 3+ or IHC 2+/ISH+) or HER-2 low expression (IHC 2+/ISH- or IHC 1+). 2. Participants with advanced breast cancer scheduled to receive trastuzumab deruxtecan treatment, with no restriction on prior treatment lines, and planned to complete at least two cycles of trastuzumab deruxtecan administration. 3. Eastern Cooperative Oncology Group (ECOG) performance status score of = 6 months. 4. Aged >= 18 years and <= 75 years. 5. No language communication barriers, with the ability to accurately understand the content of the questionnaires. 6. Willing to voluntarily participate in the study, able to cooperate with scheduled follow-up visits, and willing to provide written informed consent prior to enrollment.
Exclusion criteria
Exclusion criteria: 1. A history of documented hypersensitivity to trastuzumab deruxtecan or its excipients. 2. Laboratory and examination findings that are not compatible with the requirements for trastuzumab deruxtecan treatment. 3. History of other malignant tumors; severe cardiovascular diseases, active infections, and a large amount of serous cavity effusion, including pleural effusion, peritoneal effusion, and pericardial effusion, require drainage to relieve compression symptoms. 4. Patients with abnormal cardiac function indicators, abnormal renal function indicators, such as BNP > 100 pg/mL, NT-BNP > 300 pg/mL, GFR < 60 mL/min/1.73 m^2, etc. 5. Other research related to weakly alkaline, negatively potential single-molecule highly active water is currently being conducted. 6. There are active autoimmune diseases (such as systemic lupus erythematosus, rheumatoid arthritis) or long-term immunosuppressive therapy is required. 7. Pregnant and lactating female patients, female patients with fertility and positive baseline pregnancy test results, or patients of childbearing age who are unwilling to take effective contraceptive measures throughout the trial period. 8. Any other circumstances in which the researchers consider the study participants unsuitable to participate in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Perceptible adverse reactions; | — |
Secondary
| Measure | Time frame |
|---|---|
| Cardiac markers (CK, CK-MB), ST2;Complete blood count, routine biochemistry (blood sugar, liver function, kidney function, electrolytes), blood lipid analysis;12-lead ECG, echocardiogram (LVEF, GLS, e/e'); | — |
Countries
China
Contacts
Public ContactFengqi Fang
The First Affiliated Hospital of Dalian Medical University
Outcome results
None listed