Randomized double blind clinical study of Shugan Yishen in prevention and treatment of osteoporosis in postmenopausal patients with estrogen receptor positive breast cancer
- Conditions
- Estrogen receptor-positive breast cancer
Recruitment & Eligibility
- Status
- Pending
- Sex
- Female
- Target Recruitment
- Not specified
1. Breast cancer patients with previous postoperative histopathological diagnosis and tumor staging between Stage I and III, but not stage IV;
2. The patient is already in the postmenopausal state;
3. Postoperatively,
4. Immunohistochemical patients were ER positive or PR positive and HER2 negative.
5. Patients aged between 45 and 80 years;
6. Physical condition score KPS >= 80, and the expected survival time is more than 1 year.
7. No obvious dysfunction of important organs such as heart, lung, liver and kidney. White blood cells >= 4.0 x 10^9/L; For granulogram count >= 2.0 x 10^9/L, hemoglobin >= 10g/L, total bilirubin <= 30 mol/L, alanine aminotransferase <= 40 u /L, alanine aminotransferase <= 40U/L, creatinine <= 130 mg/dl, urea nitrogen <= 7.14mmol/L;
8. Meet the diagnostic criteria of osteopenia and osteoporosis;
9. Is taking letrozole, anastrozole and exemestane, one of the endocrine drugs;
10. Syndrome differentiation of TCM belongs to liver depression and spleen deficiency syndrome.
1. Allergic to letrozole, anastrozole and exemestane;
2. The patient has uncontrolled infection or severe medical disease;
3. Those with tumor invasion of the brain and not effectively controlled;
4. Those who fail to use the medicine according to the regulations and the incomplete data affect the judgment of curative effect.
Study & Design
- Study Type
- Interventional study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Bone density;progression-free survival;
- Secondary Outcome Measures
Name Time Method traditional Chinese medicine symptom;tumor marker;Immunity;