Breast Cancer
Conditions
Interventions
Observation group:NONE
Sponsors
First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
Eligibility
Sex/Gender
Female
Age
18 Years to 70 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 treated with Abemaciclib combined with endocrine therapy (the endocrine therapy was AI or AI+OFS or OFS+TAM);
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; (4) The time of receiving Abeceline combined with endocrine therapy is less than 4 weeks.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of diarrhea; | — |
Secondary
| Measure | Time frame |
|---|---|
| Medication status of Abemaciclib;Drug status of loperamide;Other gastrointestinal adverse reactions (nausea and vomiting);Incidence of hematological adverse reactions (neutropenia, anemia, thrombocytopenia);Incidence of liver toxic adverse reactions (increased bilirubin, AST transaminase and ALT transaminase);Venous thrombosis;Incidence of interstitial lung diseases;Incidence of pulmonary embolism;Incidence of serum creatinine elevation;Occurrence of infection;Fatigue occurrence;Headache occurrence;Incidence of stomatitis;Incidence of anorexia;Incidence of alopecia;Rash occurrence;Incidence of pneumonia; | — |
Countries
China
Contacts
Public ContactSun Binxu
First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
Outcome results
None listed