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
- Conditions
- Breast Cancer
- Registration Number
- JPRN-jRCT2080221070
- Lead Sponsor
- AstraZeneca
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- Female
- Target Recruitment
- Not specified
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method