Breast cancer
Conditions
Interventions
Endocrine therapy +Zishui Qinggan Decoction simulator:1.Endocrine Therapy:Tamoxifen 10mg twice a day
Or letrozole 2.5mg once a day
Or exemestane 25mg once/day
Or anastrozole 1mg once a day
Or 500mg intramuscular injection of fluvisetron once a month
The above can be combined with CDK4/6 inhibitors
2.Zishui Qinggan Granule simulator: The simulator takes 5% of the therapeutic dose of each crude drug, and adds bitters, food coloring and lake.The app
Endocrine therapy + Zishui Qinggan Decoction:1. Endocrine therapy: same as control group
2. Zishui Qinggan Decoction:once 1 bag, 2 times /Day, morning and night, for three months.
Sponsors
Jiangsu Province Hospital of Integrated Chinese and Western Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1) Patients with primary breast cancer confirmed by pathological or cytological diagnosis; all selected cases meet the diagnostic criteria for breast cancer in the "Diagnosis and Treatment Standards for Common Malignant Tumors in China" issued by the Ministry of Health; 2) Patients with hormone-dependent breast cancer; 3) Patients without contraindications to endocrine therapy and who are using endocrine therapy for the first time (endocrine therapy regimens include tamoxifen 10mg twice a day, letrozole 2.5mg once a day, exemestane 25mg once a day, anastrozole 1mg once a day, or goserelin 500mg intramuscular injection once a month, which can be combined with CDK4/6 inhibitors); 4) Patients with a Karnofsky Performance Status (KPS) score of 60 or above; 5) Patients with an expected survival period of more than 3 months; 6) Patients aged 18 to 75 years old; 7) Patients without severe heart, brain, liver, or kidney function disorders; 8) Patients who voluntarily participate in the clinical study and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1) Non-primary breast cancer; 2) Non-hormone-dependent breast cancer; 3) Patients who have previously received endocrine therapy; 4) Patients with contraindications to endocrine therapy and unwilling to receive it; 5) Patients with a Karnofsky Performance Scale (KPS) score of less than 60; 6) Patients with an expected survival period of less than 3 months; 7) Patients currently participating in interventional clinical studies or who have received other investigational drugs or used investigational devices within 4 weeks prior to the first dose; 8) Patients with any severe or uncontrolled systemic diseases; 9) Patients with underlying hyperlipidemia; 10) Pregnant or lactating women; 11) Patients with mental disorders who cannot cooperate; 12) Patients with a history, evidence of disease, or treatment that may interfere with the trial results or prevent full participation in the study, or abnormal laboratory test values, or other conditions deemed unsuitable for inclusion by the investigator, or patients with other potential risks deemed unsuitable for participation in this study by the investigator; 13) Patients allergic to the ingredients of Zishui Qinggan Granules.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of vasomotor symptoms;Incidence of psychological disorders; | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of menopausal genitourinary syndrom;Incidence of musculoskeletal symptoms;Lipid metabolism;Incidence of thromboembolic events;Quality of life;Clinical effect of endocrine therapy; | — |
Countries
China
Contacts
Public ContactHu CanHong
Jiangsu Province Hospital of Integrated Chinese and Western Medicine
Outcome results
None listed