Breast Cancer
Conditions
Interventions
therapy group:Traditional Chinese Medicine Granules(Supplementing qi, activating blood and detoxifying method) combined with capecitabine metronomic chemotherapy
control group:Traditional Chinese medicine granule placebo combined with capecitabine metronomic chemotherapy
Sponsors
Beijing Hospital of Traditional Chinese Medicine Affiliated to Capital Medical University
Eligibility
Sex/Gender
All
Age
65 Years to 100 Years
Inclusion criteria
Inclusion criteria: ?Age = 65 years old;? Clear pathological and molecular classification of breast cancer; ? Locally advanced unresectable or stage IV breast cancer with measurable lesions;?Hormone receptor-positive breast cancer or triple-negative breast cancer that failed CDK4/6 inhibitor therapy; ?KPS score = 60 points;?Bone marrow function and liver and kidney function up to standard (hemoglobin HB=90g/L, neutrophil count NC=1.5×109/L, platelet count PLT=90×109/L. Liver function is basically normal: ALT=2.5×ULN,AST=2.5×ULN, TBIL =1.5×ULN (ALT=5×ULN, AST=5×ULN, TBIL=3×ULN in patients with liver metastases);?Conform to clinical syndrome differentiation of Qi deficiency and blood stasis syndrome; ?Volunteer to participate in this study and sign the informed consent.
Exclusion criteria
Exclusion criteria: ? HER2-positive breast cancer, ? patients with heavy tumor burden and rapid tumor progression determined by clinicians to be combined with chemotherapy for rapid relief of symptoms; ? patients with visceral crisis; ? patients who refused to take oral chemotherapy drugs;? Those who cannot cooperate with the evaluation and inspection of the test specifications; ? Those who cannot cooperate with the scale and symptoms for evaluation; ?Those who are allergic to the study drug.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| clinical benefit rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression Free Survival Time;Quality of Life; | — |
Countries
China
Contacts
Public ContactXue Na
Beijing Hospital of Traditional Chinese Medicine Affiliated to Capital Medical University, Dongcheng District, Beijing
Outcome results
None listed