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Sponsored by: |
AstraZeneca |
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Information provided by: | AstraZeneca |
ClinicalTrials.gov Identifier: | NCT00303524 |
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 with oestrogen receptor positive early breast cancer.
Condition | Intervention | Phase |
---|---|---|
Breast Cancer |
Drug: Goserelin acetate |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety/Efficacy Study |
Official Title: | 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 |
Enrollment: | 170 |
Study Start Date: | February 2006 |
Estimated Study Completion Date: | February 2009 |
Primary Completion Date: | August 2007 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Zoladex 3-month depot
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Drug: Goserelin acetate
injection 10.8 mg every 3 months
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2: Experimental
Zoladex 1-month depot
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Drug: Goserelin acetate
Injection 3.6 mg monthly
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Ages Eligible for Study: | 20 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Japan | |
Research Site | |
Fukushima, Japan | |
Research Site | |
Shimotsuke, Japan | |
Research Site | |
Utsunomiya, Japan | |
Research Site | |
Saitama, Japan | |
Research Site | |
Tokyo, Japan | |
Research Site | |
Chiba, Japan | |
Research Site | |
Ota, Japan | |
Research Site | |
Niigata, Japan | |
Research Site | |
Tokorozawa, Japan | |
Research Site | |
Kashiwa, Japan | |
Research Site | |
Fukuoka, Japan | |
Research Site | |
Kitakyushu, Japan | |
Research Site | |
Miyazaki, Japan | |
Research Site | |
Kagoshima, Japan | |
Research Site | |
Isehara, Japan | |
Research Site | |
Kawasaki, Japan | |
Research Site | |
Nagoya, Japan | |
Research Site | |
Suita, Japan | |
Research Site | |
Osaka, Japan | |
Research Site | |
Osakasayama, Japan | |
Research Site | |
Matsuyama, Japan | |
Research Site | |
Kumamoto, Japan |
Study Director: | AstraZeneca Japan Medical Director, MD | AstraZeneca |
Study ID Numbers: | D8664C00004, Zoladex EBC Study |
Study First Received: | March 16, 2006 |
Last Updated: | April 8, 2009 |
ClinicalTrials.gov Identifier: | NCT00303524 History of Changes |
Health Authority: | Japan: Ministry of Health, Labor and Welfare |
Antineoplastic Agents, Hormonal Skin Diseases Estradiol 3-benzoate Estradiol valerate Goserelin Breast Neoplasms |
Estradiol 17 beta-cypionate Polyestradiol phosphate Estradiol Menopause Breast Diseases |
Neoplasms Neoplasms by Site Antineoplastic Agents, Hormonal Skin Diseases Antineoplastic Agents |
Therapeutic Uses Goserelin Breast Neoplasms Pharmacologic Actions Breast Diseases |