A randomized controlled study of Traditional Chinese Medicine Granules(Supplementing qi, activating blood and detoxifying method) combined with metronomic chemotherapy in the treatment of elderly patients with advanced breast cancer

Authors
Category Primary study
Registry of TrialsChinese Clinical Trial Register
Year 2023
INTERVENTION: 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 ; CONDITION: Breast Cancer PRIMARY OUTCOME: clinical benefit rate; SECONDARY OUTCOME: Progression Free Survival Time;Quality of Life; 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.
Epistemonikos ID: 00d2405aab014d6b017ad8e32421940a5b820505
First added on: Feb 20, 2024