The present study is a randomized open-label -phase III study that aims to compare the efficacy and safety of the adjuvant chemotherapy with simultaneous or sequential application of Zoladex up to 2-3 years for ≤ 45 year old premenopausal 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
216
Eligible patients were randomly divided into 2 groups, the intervention group should use Zoladex 3.6mg once a month up to 2-3 years combined with chemotherapy,and the control group should use chemotherapy alone followed by Zoladex
FUSCC
Shanghai, Shanghai Municipality, China
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
Time frame: 1 year
RFS
Relapse free survival (RFS): RFS related events ware defined as local-regional recurrence, distant metastasis or death, whichever occurred first.during follow up
Time frame: 5years
OS
Overall survival
Time frame: 5 years
Other adverse events
Other adverse events (Gynecological events, blood lipids, thrombosis, cardiovascular diseases, and etc.)
Time frame: 5years
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