Back to resultsStudy of Anastrozole +/- AZD8931 in Postmenopausal Women With Endocrine Therapy Naive Breast Cancer (MINT)
Primary Purpose
Neoplasms, Breast Neoplasms, Breast Cancer
Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
AZD8931
anastrozole
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Neoplasms focused on measuring Cancer, tumour, breast cancer, metastatic, secondary, locally advanced
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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)
Sites / Locations
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Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
1
2
3
Arm Description
AZD8931 40mg (bd) plus anastrozole 1mg (od)
AZD8931 20mg (bd) plus anastrozole 1mg (od)
Placebo (bd) plus anastrozole 1mg (od)
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Compare the Overall Survival in Patients Treated With AZD8931 in Combination With Anastrozole Versus Anastrozole Alone
Time from the date of randomization to the date of death (by any cause)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01151215
Brief Title
Study of Anastrozole +/- AZD8931 in Postmenopausal Women With Endocrine Therapy Naive Breast Cancer
Acronym
MINT
Official Title
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).
Study Type
Interventional
2. Study Status
Record Verification Date
July 2014
Overall Recruitment Status
Terminated
Why Stopped
Futility
Study Start Date
June 2010 (undefined)
Primary Completion Date
January 2013 (Actual)
Study Completion Date
January 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AstraZeneca
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neoplasms, Breast Neoplasms, Breast Cancer
Keywords
Cancer, tumour, breast cancer, metastatic, secondary, locally advanced
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
482 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
AZD8931 40mg (bd) plus anastrozole 1mg (od)
Arm Title
2
Arm Type
Experimental
Arm Description
AZD8931 20mg (bd) plus anastrozole 1mg (od)
Arm Title
3
Arm Type
Placebo Comparator
Arm Description
Placebo (bd) plus anastrozole 1mg (od)
Intervention Type
Drug
Intervention Name(s)
AZD8931
Intervention Description
Tablet, oral, bd
Intervention Type
Drug
Intervention Name(s)
anastrozole
Other Intervention Name(s)
Arimidex
Intervention Description
Tablet, oral, od
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Tablet, oral
Primary Outcome Measure Information:
Title
Progression Free Survival as Evaluated by Response Evaluation Criteria In Solid Tumors (RECIST) 1.1
Description
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.
Time Frame
Tumour assessment by RECIST 1.1 every 12 weeks until data cut-off at 31 August 2012
Secondary Outcome Measure Information:
Title
Compare the Overall Survival in Patients Treated With AZD8931 in Combination With Anastrozole Versus Anastrozole Alone
Description
Time from the date of randomization to the date of death (by any cause)
Time Frame
Following progression, patients were contacted at 12 weekly intervals until data cut-off at 31 August 2012 to determine survival status
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dr Serban Ghiorghiu, MD
Organizational Affiliation
AstraZeneca
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Stephen Johnston, MA, PhD, FRCP
Organizational Affiliation
The Royal Marsden Hospital, London
Official's Role
Principal Investigator
Facility Information:
Facility Name
Research Site
City
Lake Success
State/Province
New York
Country
United States
Facility Name
Research Site
City
Belo Horizonte
Country
Brazil
Facility Name
Research Site
City
Goiânia
Country
Brazil
Facility Name
Research Site
City
Ijuí
Country
Brazil
Facility Name
Research Site
City
Porto Alegre
Country
Brazil
Facility Name
Research Site
City
Rio de Janeiro
Country
Brazil
Facility Name
Research Site
City
Sao Paulo
Country
Brazil
Facility Name
Research Site
City
São Paulo
Country
Brazil
Facility Name
Research Site
City
Vancouver
State/Province
British Columbia
Country
Canada
Facility Name
Research Site
City
Ottawa
State/Province
Ontario
Country
Canada
Facility Name
Research Site
City
Montreal
State/Province
Quebec
Country
Canada
Facility Name
Research Site
City
Brno
Country
Czech Republic
Facility Name
Research Site
City
Olomouc
Country
Czech Republic
Facility Name
Research Site
City
Praha 2
Country
Czech Republic
Facility Name
Research Site
City
Praha 4
Country
Czech Republic
Facility Name
Research Site
City
Helsinki
Country
Finland
Facility Name
Research Site
City
Tampere
Country
Finland
Facility Name
Research Site
City
Turku
Country
Finland
Facility Name
Research Site
City
Bangalore
Country
India
Facility Name
Research Site
City
Hyderabad
Country
India
Facility Name
Research Site
City
Mumbai
Country
India
Facility Name
Research Site
City
Pune
Country
India
Facility Name
Research Site
City
Trivandrum
Country
India
Facility Name
Research Site
City
Vellore
Country
India
Facility Name
Research Site
City
Niigata-shi
Country
Japan
Facility Name
Research Site
City
Osaka-shi
Country
Japan
Facility Name
Research Site
City
Ota-shi
Country
Japan
Facility Name
Research Site
City
Sapporo-shi
Country
Japan
Facility Name
Research Site
City
Seoul
Country
Korea, Republic of
Facility Name
Research Site
City
Durango
Country
Mexico
Facility Name
Research Site
City
Juchitan
Country
Mexico
Facility Name
Research Site
City
Merida
Country
Mexico
Facility Name
Research Site
City
Monterrey
Country
Mexico
Facility Name
Research Site
City
Callao
Country
Peru
Facility Name
Research Site
City
Lima
Country
Peru
Facility Name
Research Site
City
Piura
Country
Peru
Facility Name
Research Site
City
Iloilo City
Country
Philippines
Facility Name
Research Site
City
Lipa City
Country
Philippines
Facility Name
Research Site
City
Pasay City
Country
Philippines
Facility Name
Research Site
City
Quezon City
Country
Philippines
Facility Name
Research Site
City
Białystok
Country
Poland
Facility Name
Research Site
City
Elbląg
Country
Poland
Facility Name
Research Site
City
Kraków
Country
Poland
Facility Name
Research Site
City
Warszawa
Country
Poland
Facility Name
Research Site
City
Kuzmolovsky
Country
Russian Federation
Facility Name
Research Site
City
Moscow
Country
Russian Federation
Facility Name
Research Site
City
Saint Petersburg
Country
Russian Federation
Facility Name
Research Site
City
Durban
Country
South Africa
Facility Name
Research Site
City
Pretoria
Country
South Africa
Facility Name
Research Site
City
Taipei
Country
Taiwan
Facility Name
Research Site
City
Bangkok
Country
Thailand
Facility Name
Research Site
City
Songkla
Country
Thailand
Facility Name
Research Site
City
Dnipropetrovsk
Country
Ukraine
Facility Name
Research Site
City
Lviv
Country
Ukraine
Facility Name
Research Site
City
Birmingham
Country
United Kingdom
Facility Name
Research Site
City
Bournemouth
Country
United Kingdom
Facility Name
Research Site
City
Coventry
Country
United Kingdom
Facility Name
Research Site
City
Leicester
Country
United Kingdom
Facility Name
Research Site
City
London
Country
United Kingdom
Facility Name
Research Site
City
Nottingham
Country
United Kingdom
Facility Name
Research Site
City
Surrey
Country
United Kingdom
Facility Name
Research Site
City
Wythenshawe, Manchester
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
27654971
Citation
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.
Results Reference
derived
Learn more about this trial
Study of Anastrozole +/- AZD8931 in Postmenopausal Women With Endocrine Therapy Naive Breast Cancer
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