Status:
COMPLETED
Study of Zoladex Given Every 12 Weeks Versus Given Every Month in Advanced Breast Cancer (ABC) Pre-menopausal Women
Lead Sponsor:
AstraZeneca
Conditions:
Advanced Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief Summary
The primary objective is to evaluate whether Zoladex 10.8 mg (12-weekly) is non-inferior to Zoladex 3.6 mg (4-weekly) in pre-menopausal women with oestrogen receptor positive advanced breast cancer by...
Eligibility Criteria
Inclusion
- Pre-menopausal women aged 18 years or over with histologically/cytologically-confirmed oestrogen receptor positive (ER +ve) breast cancer
- World Health Organization (WHO) performance status of 0, 1, or 2
- Provided written informed consent
Exclusion
- Treatment with tamoxifen or other hormonal therapies as early breast cancer (EBC) adjuvant in the previous 24 weeks
- Received radiotherapy within the past 4 weeks
- History of systemic malignancy other than breast cancer within the previous 3 years
- Estimated survival less than 24 weeks
Key Trial Info
Start Date :
April 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2009
Estimated Enrollment :
98 Patients enrolled
Trial Details
Trial ID
NCT00322348
Start Date
April 1 2006
End Date
November 1 2009
Last Update
January 24 2011
Active Locations (14)
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1
Research Site
Prague, Czechia
2
Research Site
Arkhangelsk, Russia
3
Research Site
Belgorod, Russia
4
Research Site
Kaliningarad, Russia