Study to Compare Zoladex™ 10.8 mg With Zoladex 3.6 mg in Pre-menopausal Women With Breast Cancer
NCT ID: NCT01073865
Last Updated: 2018-12-12
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
222 participants
INTERVENTIONAL
2010-02-26
2017-11-20
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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1
Zoladex 10.8 mg (goserelin acetate) will be injected once every 12 weeks (± 7 days).
One oral tamoxifen 20 mg tablet also will be taken daily
ZD9393 (Zoladex) 10.8 mg
10.8 mg (goserelin acetate): one subcutaneous depot injection once every 12 weeks (± 7 days).
2
Zoladex 3.6 mg (goserelin acetate) will be injected once every 4 weeks (± 7 days). One oral tamoxifen 20 mg tablet will also be taken daily.
ZD9393 (Zoladex) 3.6 mg
3.6 mg (goserelin acetate): one subcutaneous depot injection once every 4 weeks (± 7 days).
Interventions
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ZD9393 (Zoladex) 10.8 mg
10.8 mg (goserelin acetate): one subcutaneous depot injection once every 12 weeks (± 7 days).
ZD9393 (Zoladex) 3.6 mg
3.6 mg (goserelin acetate): one subcutaneous depot injection once every 4 weeks (± 7 days).
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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
20 Years
130 Years
FEMALE
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Principal Investigators
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Justin Lindemann, PO
Role: STUDY_DIRECTOR
AstraZeneca
Locations
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Research Site
Ahmedabad, , India
Research Site
Bangalore, , India
Research Site
Bangalore, , India
Research Site
Chennai, , India
Research Site
Hubli, , India
Research Site
Hyderabad, , India
Research Site
Jaipur, , India
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Mumbai, , India
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Nagpur, , India
Research Site
New Delhi, , India
Research Site
New Delhi, , India
Research Site
Pune, , India
Research Site
Pune, , India
Research Site
Pune, , India
Research Site
Thiruvananthapuram, , India
Research Site
Amagasaki-shi, , Japan
Research Site
Chiba, , Japan
Research Site
Chūōku, , Japan
Research Site
Fukuoka, , Japan
Research Site
Hamamatsu, , Japan
Research Site
Hiroshima, , Japan
Research Site
Kagoshima, , Japan
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Kamogawa-shi, , Japan
Research Site
Kitaadachi, , Japan
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Kumamoto, , Japan
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Kyoto, , Japan
Research Site
Mitaka-shi, , Japan
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Nagoya, , Japan
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Nagoya, , Japan
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Niigata, , Japan
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Osaka, , Japan
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Osaka, , Japan
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Sakaishi, , Japan
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Sapporo, , Japan
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Cebu City, , Philippines
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Iloilo City, , Philippines
Research Site
Lipa City, , Philippines
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Pasay, , Philippines
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Quezon City, , Philippines
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Quezon City, , Philippines
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Seoul, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
Research Site
Suwon, , South Korea
Research Site
Kaohsiung City, , Taiwan
Research Site
Taichung, , Taiwan
Research Site
Taichung, , Taiwan
Research Site
Taipei, , Taiwan
Research Site
Taipei, , Taiwan
Research Site
Bangkok, , Thailand
Research Site
Bangkok, , Thailand
Research Site
Bangkok, , Thailand
Research Site
Maharat Nakorn Ratchasima, , Thailand
Research Site
Songkhla, , Thailand
Research Site
Ubonratchathani, , Thailand
Countries
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Related Links
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D8666C00001ClinicalStudyProtocol\_personal\_info\_redacted\_12December.pdf
Other Identifiers
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D8666C00001
Identifier Type: -
Identifier Source: org_study_id