A Randomised Phase III Study for Evaluating the Role of the Addition of Ovarian Function Suppression to Tamoxifen in Young Women With Hormone-Sensitive Breast Cancer Who Remain in Premenopause or Regain Menstruation After Chemotherapy
- To compare overall Survival(OS) between the patients added Goserelin(ZOLADEXTM) to
Tamoxifen and the patients treated with Tamoxifen alone in premenopausal status
- To compare 5-year disease free survival rate (DFS rate) between the patients who took
tamoxifen only in postmenopause and the patients added Goserelin(ZOLADEXTM) to
Tamoxifen for inducing ovarian function suppression in premenopause
- To determine the tolerability and safety of Tamoxifen with or without concomitant
Zoladex
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment
all cause recurrence
the first 5 years after surgery
Yes
Woo-Chul Noh, MD.PhD
Principal Investigator
Department of Surgery, Korea Cancer Center Hospital, 215-4 Gongneung-dong, Nowon-gu, Seoul, Korea
Korea: Food and Drug Administration
KBCSG005
NCT00912548
May 2009
December 2015
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