Remifemin Preventing the Climacteric Symptoms in Breast Cancer

Ovarian function suppression (OFS) or protection has been studied widely in breast cancer. As an common drug in clinic, LHRH-a is an important method for OFS in breast cancer especially in high-risk hormone receptor-positive patients or hormone receptor-negative but needing ovarian function protecting. The climacteric symptoms caused by LHRH-a are often and prominent, which is a common clinical problem. Remifemin (cimicifuga racemosa / black cohosh) is effective in climacteric symptoms as a hormone replacement treatment, some research concluded that it is also safe in breast cancer patients who are postmenopausal or taking tamoxifen suffering from climacteric symptoms. While in China, more than 2/3 breast cancer patients are pre/peri-menopause, and some part of them should take OFS as an hormone treatment. OFS can cause sever climacteric symptoms in a short time. The investigators aim to estimate the effect and safety of Remifemin in climacteric symptoms caused by OFS in breast cancer.

Inclusion criteria

• provision of informed consent
• clinical stage I~IIIC
• histologically proven invasive breast cancer
• women defined as premenopausal according to NCCN guideline
• plan to accept the LHRH-a as endocrine treatment or ovarian function protection

Exclusion criteria

• clinical evidence of metastatic disease
• bilateral oophorectomy
• patients who, for whatever reason (e.g., confusion, infirmity, alcoholism), are unlikely to comply with trial requirements
• patients who accepted anti-cancer treatment before
• previous hormonal therapy as adjuvant treatment for non-cancer disease
• patients unwilling to stop taking any drug known to affect sex hormonal status, or in whom it would be inappropriate to stop previous history of invasive malignancy within the last 5 years, other than squamous or basal cell carcinoma of the skin or carcinoma in situ of the cervix, adequately cone biopsied
• treatment with a non-approved or experimental drug during 1 month before entry into the study
• history of bleeding diathesis (i.e., Disseminated intravascular coagulation, clotting factor deficiency), or long term anticoagulant therapy (other than antiplatelet therapy and low dose warfarin)
• leukopenia and/or thrombocytopenia
• history of ocular fundus diseases
• history of thromboembolic diseases
• history of osteoporotic fractures