Triple-Negative Breast Cancer
Conditions
Interventions
Dihydroartemisinin:Dihydroartemisinin 20 mg, orally three times daily for 5-7 days.
Sponsors
Sun Yat-sen University Cancer Center
Eligibility
Sex/Gender
Female
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Subjects participated voluntarily and signed an informed consent form; 2. Women aged 18-75 years old at the time of signing the informed consent; 3. patients with invasive triple-negative breast cancer diagnosed by histopathological examination: (1) HER-2 negative (according to 2018 CAP/ASCO HER-2 testing guidelines); (2) ER-negative and PR-negative (IHC showing =1% and =50% and no significant cardiac disease (= 1.5×10?/L; (2) Absolute white blood cell count (WBC) >= 3.0 × 10?/L; (3) Platelets >= 90 × 10?/L; (4) Haemoglobin >= 90 g/L; 8. Liver and renal function tests were essentially normal within 1 week before enrolment: (1) Total bilirubin (TBIL) = 60 ml/min; 9. meet the requirements of the Ethics Committee, with an informed consent form signed by the patient or his/her legal representative, or signed by the patient and his/her family; 10. have good compliance.
Exclusion criteria
Exclusion criteria: 1. Pregnant or breastfeeding women, and women of childbearing age with a baseline pregnancy test that is positive and who do not agree to practice effective contraception during the study period; 2. Individuals who have a severe allergic reaction to any component of the trial medication (NCI-CTCAE 5.0 grade greater than 3); 3. Patients with bilateral breast cancer or inflammatory breast cancer; 4. Patients with initially stage IV (metastatic) breast cancer that is inoperable or requires neoadjuvant treatment; 5. Individuals who have participated in any investigational drug treatment within four weeks before the start of treatment; 6. Individuals with a history of symptomatic cardiovascular, liver, respiratory, renal, or hematological endocrine system or psychiatric disorders; 7. Currently suffering from severe liver-related diseases, such as acute hepatitis, fulminant hepatitis, coagulopathy, etc.; those who test positive for HBV surface antigen or HBV core antibody must have a peripheral blood hepatitis B virus DNA titer test <1×103 IU/ml to be eligible; 8. Coexisting diseases or conditions that may interfere with study participation, or any serious medical conditions that may affect participant safety (e.g., active or uncontrolled infections, active liver or biliary diseases requiring antiviral treatment); 9. Other infiltrative tumors (including second primary breast cancer) that may affect the outcome assessment and protocol adherence; 10. Breast cancer patients who have previously undergone chemotherapy, radiotherapy, immunotherapy, or other related antitumor treatments (except for the diagnostic biopsy of primary breast cancer); 11. Individuals who have undergone major surgical procedures or are recovery from significant medical illnesses within four weeks prior to the trial; 12. Patients whose tumors are not measurable during treatment; 13. Any situation where the investigator believes the participant is not suitable for the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Tumor Neoantigen;Tumor Immune Microenvironment; | — |
Countries
China
Contacts
Public ContactJun Tang
Sun Yat-sen University Cancer Center
Outcome results
None listed