An Open-label, Randomized, Parallel Group, Multicentre Study to Compare Oestradiol Suppression Between ZOLADEX 10.8 mg Depot Given 3 Monthly and ZOLADEX 3.6 mg Depot Given Monthly in Pre-menopausal Patients With ER Positive Early Breast Cancer
20 Years
N/A
Female
Breast Cancer
Trial Information
An Open-label, Randomized, Parallel Group, Multicentre Study to Compare Oestradiol Suppression Between ZOLADEX 10.8 mg Depot Given 3 Monthly and ZOLADEX 3.6 mg Depot Given Monthly in Pre-menopausal Patients With ER Positive Early Breast Cancer
Inclusion Criteria:
- Pre-menopausal women aged 20 years or over with histological/cytologically-confirmed
ER +ve breast cancer who have undergone radical surgery and WHO performance status
0,1 or 2.
Exclusion Criteria:
- Evidence of metastatic disease, previous bilateral oophorectomy or radiotherapy to
the ovaries, previous chemotherapy, breast surgery completed over 12 weeks before
starting trial treatment, previous neo-adjuvant/adjuvant hormonal breast cancer
therapy
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Zoladex 10.8mg depot (every 12 weeks) is non-inferior to Zoladex 3.6mg depot (every 4 weeks) in terms of oestradiol (E2) suppression in patient population by assessment of area under the curve of E2 concentration during the first 24 weeks of treatment.
Outcome Time Frame:
every 12 weeks
Safety Issue:
No
Principal Investigator
AstraZeneca Japan Medical Director, MD
Investigator Role:
Study Director
Investigator Affiliation:
AstraZeneca
Authority:
Japan: Ministry of Health, Labor and Welfare
Study ID:
D8664C00004
NCT ID:
NCT00303524
Start Date:
February 2006
Completion Date:
February 2009
Related Keywords:
- Breast Cancer
- Breast Neoplasms
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