Study Stopped
Futility
Study of Anastrozole +/- AZD8931 in Postmenopausal Women With Endocrine Therapy Naive Breast Cancer
MINT
A Phase II, Randomised, Double-blind, Placebo-controlled, Multi-centre Study to Assess the Efficacy and Safety of AZD8931 In Combination With Anastrozole, Compared to Anastrozole Alone, in Post Menopausal Women With Hormone Receptor Positive, Endocrine Therapy Naive, Locally Advanced or Metastatic Breast Cancer (MINT).
1 other identifier
interventional
482
18 countries
60
Brief Summary
The main purpose of this study is to compare progression free survival in patients treated with AZD8931 given in combination with anastrozole versus anastrozole alone. The secondary objective is to investigate the safety and tolerability of AZD8931 given in combination with anastrozole.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jun 2010
60 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2010
CompletedFirst Submitted
Initial submission to the registry
June 15, 2010
CompletedFirst Posted
Study publicly available on registry
June 28, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2013
CompletedResults Posted
Study results publicly available
May 8, 2014
CompletedJuly 25, 2014
July 1, 2014
2.6 years
June 15, 2010
January 29, 2014
July 15, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Progression Free Survival as Evaluated by Response Evaluation Criteria In Solid Tumors (RECIST) 1.1
Time from the date of randomization until the date of objective disease progression (as per RECIST 1.1) or the date of death (by any cause in the absence of progression). Disease progression is defined using RECIST 1.1 as \>=20% increase in the sum of longest diameters of target lesions and an absolute increase of \>=5mm, taking as reference the smallest sum of longest diameters of target lesions since study start, or unequivocal progression in non-target lesions, or appearance of any new lesions.
Tumour assessment by RECIST 1.1 every 12 weeks until data cut-off at 31 August 2012
Secondary Outcomes (1)
Compare the Overall Survival in Patients Treated With AZD8931 in Combination With Anastrozole Versus Anastrozole Alone
Following progression, patients were contacted at 12 weekly intervals until data cut-off at 31 August 2012 to determine survival status
Study Arms (3)
1
EXPERIMENTALAZD8931 40mg (bd) plus anastrozole 1mg (od)
2
EXPERIMENTALAZD8931 20mg (bd) plus anastrozole 1mg (od)
3
PLACEBO COMPARATORPlacebo (bd) plus anastrozole 1mg (od)
Interventions
Eligibility Criteria
You may qualify if:
- Patients that have locally advanced or metastatic breast cancer. Lesions should not be amenable to surgery or radiation of curative intent
- Hormone therapy-naive
- Estimated life expectancy of more than 12 weeks
You may not qualify if:
- Last dose of prior anti-cancer therapy received within 14 days (or longer if required)
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (60)
Research Site
Lake Success, New York, United States
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Belo Horizonte, Brazil
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Goiânia, Brazil
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Ijuí, Brazil
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Porto Alegre, Brazil
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Rio de Janeiro, Brazil
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São Paulo, Brazil
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Vancouver, British Columbia, Canada
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Ottawa, Ontario, Canada
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Montreal, Quebec, Canada
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Brno, Czechia
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Olomouc, Czechia
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Prague, Czechia
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Helsinki, Finland
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Tampere, Finland
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Turku, Finland
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Bangalore, India
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Hyderabad, India
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Mumbai, India
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Pune, India
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Trivandrum, India
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Vellore, India
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Niigata, Japan
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Osaka, Japan
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Ota-shi, Japan
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Sapporo, Japan
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Durango, Mexico
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Juchitán, Mexico
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Mérida, Mexico
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Monterrey, Mexico
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Callao, Peru
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Lima, Peru
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Piura, Peru
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Iloilo City, Philippines
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Lipa City, Philippines
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Pasay, Philippines
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Quezon City, Philippines
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Bialystok, Poland
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Elblag, Poland
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Krakow, Poland
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Warsaw, Poland
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Kuzmolovsky, Russia
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Moscow, Russia
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Saint Petersburg, Russia
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Durban, South Africa
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Pretoria, South Africa
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Seoul, South Korea
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Taipei, Taiwan
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Bangkok, Thailand
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Songkhla, Thailand
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Dnipropetrovsk, Ukraine
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Lviv, Ukraine
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Birmingham, United Kingdom
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Bournemouth, United Kingdom
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Coventry, United Kingdom
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Leicester, United Kingdom
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London, United Kingdom
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Nottingham, United Kingdom
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Surrey, United Kingdom
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Wythenshawe, Manchester, United Kingdom
Related Publications (1)
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.
PMID: 27654971DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
The final analysis for this study is the analysis that was sent to the study's IDMC, based on a data cut-off of 31 August 2012. At the data cut-off point the data was cleaned, but 9 adverse events were not coded. These events are not included here.
Results Point of Contact
- Title
- Dr Serban Ghiorghiu
- Organization
- Astrazeneca
Study Officials
- STUDY DIRECTOR
Dr Serban Ghiorghiu, MD
AstraZeneca
- PRINCIPAL INVESTIGATOR
Stephen Johnston, MA, PhD, FRCP
The Royal Marsden Hospital, London
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 15, 2010
First Posted
June 28, 2010
Study Start
June 1, 2010
Primary Completion
January 1, 2013
Study Completion
January 1, 2013
Last Updated
July 25, 2014
Results First Posted
May 8, 2014
Record last verified: 2014-07