Study of Anastrozole +/- AZD8931 in Postmenopausal Women With Endocrine Therapy Naive Breast Cancer
NCT ID: NCT01151215
Last Updated: 2014-07-25
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
482 participants
INTERVENTIONAL
2010-06-30
2013-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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1
AZD8931 40mg (bd) plus anastrozole 1mg (od)
AZD8931
Tablet, oral, bd
anastrozole
Tablet, oral, od
2
AZD8931 20mg (bd) plus anastrozole 1mg (od)
AZD8931
Tablet, oral, bd
anastrozole
Tablet, oral, od
3
Placebo (bd) plus anastrozole 1mg (od)
anastrozole
Tablet, oral, od
Placebo
Tablet, oral
Interventions
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AZD8931
Tablet, oral, bd
anastrozole
Tablet, oral, od
Placebo
Tablet, oral
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Hormone therapy-naive
* Estimated life expectancy of more than 12 weeks
Exclusion Criteria
* Any eye injury or corneal surgery within 3 months prior to receiving first dose of study drug.
* Currently receiving (and unwilling to discontinue) oestrogen replacement therapy. (last dose \<7 days prior to randomisation)
18 Years
FEMALE
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Principal Investigators
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Dr Serban Ghiorghiu, MD
Role: STUDY_DIRECTOR
AstraZeneca
Stephen Johnston, MA, PhD, FRCP
Role: PRINCIPAL_INVESTIGATOR
The Royal Marsden Hospital, London
Locations
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Research Site
Lake Success, New York, United States
Research Site
Belo Horizonte, , Brazil
Research Site
Goiânia, , Brazil
Research Site
Ijuí, , Brazil
Research Site
Porto Alegre, , Brazil
Research Site
Rio de Janeiro, , Brazil
Research Site
São Paulo, , Brazil
Research Site
Vancouver, British Columbia, Canada
Research Site
Ottawa, Ontario, Canada
Research Site
Montreal, Quebec, Canada
Research Site
Brno, , Czechia
Research Site
Olomouc, , Czechia
Research Site
Prague, , Czechia
Research Site
Helsinki, , Finland
Research Site
Tampere, , Finland
Research Site
Turku, , Finland
Research Site
Bangalore, , India
Research Site
Hyderabad, , India
Research Site
Mumbai, , India
Research Site
Pune, , India
Research Site
Trivandrum, , India
Research Site
Vellore, , India
Research Site
Niigata, , Japan
Research Site
Osaka, , Japan
Research Site
Ota-shi, , Japan
Research Site
Sapporo, , Japan
Research Site
Durango, , Mexico
Research Site
Juchitán, , Mexico
Research Site
Mérida, , Mexico
Research Site
Monterrey, , Mexico
Research Site
Callao, , Peru
Research Site
Lima, , Peru
Research Site
Piura, , Peru
Research Site
Iloilo City, , Philippines
Research Site
Lipa City, , Philippines
Research Site
Pasay, , Philippines
Research Site
Quezon City, , Philippines
Research Site
Bialystok, , Poland
Research Site
Elblag, , Poland
Research Site
Krakow, , Poland
Research Site
Warsaw, , Poland
Research Site
Kuzmolovsky, , Russia
Research Site
Moscow, , Russia
Research Site
Saint Petersburg, , Russia
Research Site
Durban, , South Africa
Research Site
Pretoria, , South Africa
Research Site
Seoul, , South Korea
Research Site
Taipei, , Taiwan
Research Site
Bangkok, , Thailand
Research Site
Songkhla, , Thailand
Research Site
Dnipropetrovsk, , Ukraine
Research Site
Lviv, , Ukraine
Research Site
Birmingham, , United Kingdom
Research Site
Bournemouth, , United Kingdom
Research Site
Coventry, , United Kingdom
Research Site
Leicester, , United Kingdom
Research Site
London, , United Kingdom
Research Site
Nottingham, , United Kingdom
Research Site
Surrey, , United Kingdom
Research Site
Wythenshawe, Manchester, , United Kingdom
Countries
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References
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Johnston S, Basik M, Hegg R, Lausoontornsiri W, Grzeda L, Clemons M, Dreosti L, Mann H, Stuart M, Cristofanilli M. Inhibition of EGFR, HER2, and HER3 signaling with AZD8931 in combination with anastrozole as an anticancer approach: Phase II randomized study in women with endocrine-therapy-naive advanced breast cancer. Breast Cancer Res Treat. 2016 Nov;160(1):91-99. doi: 10.1007/s10549-016-3979-5. Epub 2016 Sep 21.
Other Identifiers
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D0102C00004
Identifier Type: -
Identifier Source: org_study_id
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