Remifemin Preventing the Climacteric Symptoms in Breast Cancer

• Status: Completed
• Trial end date: 2018-01-30
• Target enrollment: 0
• Participant gender: Female

Summary

LHRH-a is an important hormone treatment 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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Zhejiang Cancer Hospital

Criteria

Inclusion Criteria:

1. provision of informed consent

2. clinical stage I~IIIC

3. histologically proven invasive breast cancer

4. women defined as premenopausal according to NCCN guideline

5. plan to accept the LHRH-a as endocrine treatment or ovarian function protection

Exclusion Criteria:

1. clinical evidence of metastatic disease

2. bilateral oophorectomy

3. patients who, for whatever reason (e.g., confusion, infirmity, alcoholism), are unlikely to comply with trial requirements

4. patients who accepted anti-cancer treatment before

5. previous hormonal therapy as adjuvant treatment for non-cancer disease

6. 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

7. treatment with a non-approved or experimental drug during 1 month before entry into the study

8. 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)

9. leukopenia and/or thrombocytopenia

10. history of ocular fundus diseases

11. history of thromboembolic diseases

12. history of osteoporotic fractures