An Open Label, Randomised, Parallel Group, Multicentre Study to Compare ZOLADEX 10.8 mg Given Every 12 Weeks With ZOLADEX 3.6 mg Given Every 4 Weeks in Pre-menopausal Women With Oestrogen Receptor Positive Advanced Breast Cancer

AstraZeneca0 个研究点开始时间: 2010年4月14日最近更新: 2023年10月17日

适应症

试验速览

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•Female 20 years or older and pre-menopausal.
•Pre-menopausal defined as
•1) last menses within 1 year of randomisation, and
•2) E2 10 pg/mL or more, and FSH 30 mIU/mL or less within 4 weeks of randomisation.
•For patients who have had a hysterectomy, it is acceptable to meet only 2)
•- Hormone sensitivity (ER positive) of primary or secondary tumour tissue.
•- Histological/cytological confirmation of breast cancer and are candidates to receive hormonal therapy as therapy for advanced breast cancer.

•- Patients who have received tamoxifen or other hormonal therapies as adjuvant therapy for breast cancer within 24 weeks before randomisation and/or who have received prior treatment with hormonal therapies for advanced breast cancer
•- Patients who have received LHRHa as adjuvant therapy for breast cancer within 48 weeks before randomisation
•- Patients who have relapsed during adjuvant hormonal therapy or within 48 weeks after completion of adjuvant hormonal therapy and/or patients who have relapsed during adjuvant chemotherapy or within 24 weeks after completion of adjuvant chemotherapy.

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