Breast Cancer
Conditions
Interventions
Observation group:On the basis of standard Abemaciclib combined with endocrine therapy, Yigong Powder decoction was used, which consisted of Radix Codonopsis 10g, Poria 10g, Radix Glycyrrhizae 10g, At
Control group:Only standard Abemaciclib combined with endocrine therapy was used.
Sponsors
First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
Eligibility
Sex/Gender
Female
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: ? Women (regardless of menopause), ? Age =18 years old ? It was diagnosed as HR+, HER2- and invasive breast cancer by pathology, and there was no evidence of distant metastasis. (According to the requirement of HR+ disease, the tumor must be ER or PR positive as determined by immunohistochemistry (IHC). ) ? Received definite surgery for primary breast tumor. ? Meet the diagnostic criteria of postoperative high-risk breast cancer. ? Patients were subsequently treated with Abemaciclib combined with endocrine therapy (the endocrine therapy was AI or AI+OFS); ? Patients have certain knowledge and understanding ability, can understand, and voluntarily participate in the experiment and sign the informed consent form.
Exclusion criteria
Exclusion criteria: ? Patients with gastrointestinal related diseases, or patients who are prone to diarrhea. ? Combined with other primary malignant tumors; ? Complicated with organic cardiovascular and cerebrovascular diseases, or serious diseases of respiratory system, digestive system, nervous system, urinary system, blood system and endocrine system, and severe mental illness;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Frequency and duration of diarrhea with grade =2; | — |
Secondary
| Measure | Time frame |
|---|---|
| Medication status of Abemaciclib;Medication status of Loperamide;FACIT-D(Version4);Frequency and duration of diarrhea at all levels;Frequency of vomiting;The frequency of nausea;Frequency of constipation;Traditional Chinese medicine symptom score;Functional Assessment of Cancer Therapy–Breast ( FACT-B);The Functional Assessment of Cancer Therapy–Endocrine Symptoms (FACT-ES);Functional Assessment of Chronic Illness Therapy–Fatigue Scale (FACIT-Fatigue);Adverse Events, AE; | — |
Countries
China
Contacts
Public ContactBinxu Sun
First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
Outcome results
None listed