Status:
COMPLETED
Comparative Study of Oestradiol Suppression: Zoladex 10.8mg/3 Month vs. 3.6mg/Month in ER +ve EBC Pre-menopausal Patients
Lead Sponsor:
AstraZeneca
Conditions:
Breast Cancer
Eligibility:
FEMALE
20+ years
Phase:
PHASE2
Brief Summary
The primary purpose of this study is to establish if a 10.8 mg dose of ZOLADEX given 3 monthly is non-inferior to a 3.6 mg dose of ZOLADEX given monthly in terms of oestradiol suppression in patients ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2009
Estimated Enrollment :
170 Patients enrolled
Trial Details
Trial ID
NCT00303524
Start Date
February 1 2006
End Date
February 1 2009
Last Update
December 23 2009
Active Locations (22)
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1
Research Site
Chiba, Japan
2
Research Site
Fukuoka, Japan
3
Research Site
Fukushima, Japan
4
Research Site
Isehara, Japan