Status:
COMPLETED
Remifemin Preventing the Climacteric Symptoms in Breast Cancer
Lead Sponsor:
Zhejiang Cancer Hospital
Conditions:
Effect of Drugs
Safety Issues
Eligibility:
FEMALE
18-55 years
Phase:
PHASE2
Brief 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 climacter...
Detailed Description
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 h...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 4 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 30 2018
Estimated Enrollment :
85 Patients enrolled
Trial Details
Trial ID
NCT03339882
Start Date
January 4 2017
End Date
January 30 2018
Last Update
July 6 2018
Active Locations (1)
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1
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China, 310000