A Phase III,Randomized,Open Label Study Comparing Simultaneous Versus Sequential Use of Adjuvant Chemotherapy and GnRHa up to 2-3 Years for ≤ 45 Year Old Pre-menopausal Hormone Receptor-positive Breast Cancer
Data showed that ovarian suppression therapy may protect the ovarian function in
premenopausal patients received chemotherapy for breast cancer. However this is still a
controversial issue. Sequential use of GnRHa (Zoladex) as ovarian suppression treatment
after chemotherapy has been established as an effective endocrine therapy for ER positive
premenopausal breast cancer. The present study is a randomized open-label phase III study
that aims to observe the efficacy and safety of the adjuvant chemotherapy with simultaneous
combination of Zoladex up to 2-3years and chemotherapy compared with the sequential schedule
in ≤ 45 year old premenopausal hormone receptor-positive breast cancer patients.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Resumption of menstruation
the Resumption that patients recover the natural menstrual or serum E2, FSH, LH return to the premenopausal range within 1 year after stopping Zoladex
1 year
No
Zhi-Min Shao, MD
Principal Investigator
Fudan University
China: Food and Drug Administration
CD trial
NCT01712893
June 2009
September 2018
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