breast cancer
Conditions
Interventions
Experimental group:Xiaopi granule
Control group:Xiaopi granule placebo
Sponsors
Guangdong Hospital of Traditional Chinese Medicine
Eligibility
Sex/Gender
Female
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18-60 years; 2. Pathological diagnosis of breast malignant tumor; 3. Immunohistochemistry indicated triple-negative breast malignancy, namely ER (-), PR (-), Her-2 (-); 4. Enter the follow-up period within 5 years after the initial treatment (including surgery and/or chemotherapy); 5. Patients without recurrence and metastasis.
Exclusion criteria
Exclusion criteria: 1. Family history of endometrial or ovarian cancer diagnosed before enrollment; 2. Patients during pregnancy, lactation or menopause, who have pregnancy plan; 3. Patients who took estrogen replacement therapy in the first 3 months of enrollment; 4. Patients who took birth control pills 3 months before enrollment; 5. Patients taking androgen drugs; 6. Patients who take other traditional Chinese medicine and botanical preparations (including TCM decoction pieces and proprietary Chinese medicine) with therapeutic effects such as soothing liver and tonifying kidney, promoting blood circulation and removing blood stasis, dispersing and relieving pain, etc.; 7. Allergic to the drug and the control drug; 8. Patients with serious primary heart, liver, kidney, lung, blood or serious diseases affecting their survival; 9. Patients with a history of deep vein thrombosis or pulmonary embolism; 10. Patients with mental and behavioral disorders who are not fully informed; 11. Suspected or confirmed history of alcohol or drug abuse, unable to cooperate with treatment; 12. Those with cognitive impairment or low educational level who cannot understand and fill in various scales correctly; 13. Patients with inability to swallow the drug and the control drug, chronic diarrhea and intestinal obstruction, and multiple factors affecting drug administration and absorption; 14. Patients enrolled in other clinical trials.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| CXCL-1 cytokine secreted by tumor macrophages (TAMs) in blood;Quality of life; | — |
Secondary
| Measure | Time frame |
|---|---|
| Immune index; | — |
Countries
China
Contacts
Public ContactGuo Li
Guangdong Hospital of Traditional Chinese Medicine
Outcome results
None listed