breast precancerous lesions
Conditions
Interventions
Xiaopi Granule Group:receive Xiaopi Granule 8.5 g three times a day and placebo tablet of Tamoxifen 10 mg twice a day for 5 years.
Tamoxifen group:receive Tamoxifen 10 mg twice a day and placebo Granule 8.5 g three times a day for 5 years.
Sponsors
Guangdong Provincial Hospital of Chinese Medicine
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: (1) Women aged between 18-60 years; (2) subjects with high risk of breast cancer, or atypical hyperplasia of breast, or intraductal papilloma, or LCIS; (3) received chest radiotherapy before 30 years old; (4) subjects = 35 years old have no signs of breast cancer diagnosed by color ultrasound; and (5) subjects > 35 years old have no signs of breast cancer diagnosed by both color ultrasound and mammography.
Exclusion criteria
Exclusion criteria: (1) Patients with breast cancer; (2) endometrial cancer or ovarian cancer, or have a family history of endometrial cancer or ovarian cancer; (3) pregnancy or potential pregnancy, lactation and menopause; (4) received estrogen or progesterone replacement therapy, or oral contraceptives within 3 months; (5) receiving androgen drugs; (6) receiving Chinese medicine or botanical drugs with function of soothing liver and smoothing qi, promoting blood circulation and removing blood stasis, and softening hardness to dissipate stagnation; (7) serious primary heart, liver, kidney, lung, blood diseases or other diseases which can affect the survival; (8) a history of deep vein thrombosis or pulmonary embolism; (9) any severe mental disorders or history of psychiatric illness or taking psychotropic drugs; (10) a history of alcohol or drug abuse; (11) pregnancy or potential pregnancy; (12) cognitive impairment or low level of education so that can not understand and correctly fill in questionnaires; (13) unable to swallow, chronic diarrhea and intestinal obstruction, and many other factors affecting drug use and absorption; and (14) subjects who are allergic to Xiaopi Granule or Tamoxifen.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| the incidence of breast cancer (including invasive and noninvasive carcinoma); | — |
Secondary
| Measure | Time frame |
|---|---|
| the evaluation of breast pain, sleep quality, depression and anxiety, and some other detection of cytokines and hormones, and analysis of tumor characteristics.; | — |
Countries
China
Contacts
Public ContactGuo Li
Guangdong Provincial Hospital of Chinese Medicine
Outcome results
None listed