breast cancer
Conditions
Interventions
toromiphene:Toremifene, once daily, 30mg, oral
Control group:Placebo
Sponsors
Huashan Hospital, Fudan University
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: Women aged 35-70 years with a life expectancy of more than 10 years, not pregnant or lactating and meet one of the following conditions: 1. The first-degree family history of breast cancer, and developed at <=50 years of age; 2. The first-degree family history of breast cancer was bilateral breast cancer; 3. More than two patients with first or second-degree breast cancer family history; 4. The first-degree family history of breast cancer and nulliparous(or first birth at =30 years of age); 5. The patients had a family history of breast cancer and had a history of breast hyperplasia; 6. The age of menopause was 55 years old or above; 7. BRCA1 / 2 gene mutation; 8. ER positive ductal carcinoma in situ and treated by mastectomy; 9. Lobular carcinoma in situ; 10. Atypical hyperplasia of breast.
Exclusion criteria
Exclusion criteria: 1. Have used selective hormone receptor modulators (tamoxifen, toremifene, raloxifene, etc.) or aromatase inhibitors (letrozole, anastrozole, exemestane, etc.); 2. Previous history of malignant tumor (except ductal carcinoma in situ and lobular carcinoma in situ); 3. History of thrombotic diseases; 4. The endometrial thickness of premenopausal women was more than 8 mm; 5. Liver function and renal function were abnormal; 6. Abnormal cardiac function; 7. Participated in clinical trials of other drugs within 6 months; 8. Had received hormone replacement therapy within 6 months before the test; 9. Dyslipidemia.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence rate of breast cancer and precancerous lesions; | — |
Secondary
| Measure | Time frame |
|---|---|
| incidence rate of estrogen receptor-positive breast cancer; | — |
Countries
China
Contacts
Public ContactWei Zhang
Huashan Hospital, Fudan University
Outcome results
None listed