Study of Anastrozole +/- AZD8931 in Postmenopausal Women With Endocrine Therapy Naive Breast Cancer (MINT)

July 15, 2014 updated by: AstraZeneca

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).

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

482

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • Belo Horizonte, Brazil
        • Research Site
      • Goiânia, Brazil
        • Research Site
      • Ijuí, Brazil
        • Research Site
      • Porto Alegre, Brazil
        • Research Site
      • Rio de Janeiro, Brazil
        • Research Site
      • Sao Paulo, Brazil
        • Research Site
      • São Paulo, Brazil
        • Research Site
  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada
        • Research Site
    • Ontario
      • Ottawa, Ontario, Canada
        • Research Site
    • Quebec
      • Montreal, Quebec, Canada
        • Research Site
  • Czech Republic
      • Brno, Czech Republic
        • Research Site
      • Olomouc, Czech Republic
        • Research Site
      • Praha 2, Czech Republic
        • Research Site
      • Praha 4, Czech Republic
        • Research Site
  • Finland
      • Helsinki, Finland
        • Research Site
      • Tampere, Finland
        • Research Site
      • Turku, Finland
        • Research Site
  • India
      • Bangalore, India
        • Research Site
      • Hyderabad, India
        • Research Site
      • Mumbai, India
        • Research Site
      • Pune, India
        • Research Site
      • Trivandrum, India
        • Research Site
      • Vellore, India
        • Research Site
  • Japan
      • Niigata-shi, Japan
        • Research Site
      • Osaka-shi, Japan
        • Research Site
      • Ota-shi, Japan
        • Research Site
      • Sapporo-shi, Japan
        • Research Site
  • Korea, Republic of
      • Seoul, Korea, Republic of
        • Research Site
  • Mexico
      • Durango, Mexico
        • Research Site
      • Juchitan, Mexico
        • Research Site
      • Merida, Mexico
        • Research Site
      • Monterrey, Mexico
        • Research Site
  • Peru
      • Callao, Peru
        • Research Site
      • Lima, Peru
        • Research Site
      • Piura, Peru
        • Research Site
  • Philippines
      • Iloilo City, Philippines
        • Research Site
      • Lipa City, Philippines
        • Research Site
      • Pasay City, Philippines
        • Research Site
      • Quezon City, Philippines
        • Research Site
  • Poland
      • Białystok, Poland
        • Research Site
      • Elbląg, Poland
        • Research Site
      • Kraków, Poland
        • Research Site
      • Warszawa, Poland
        • Research Site
  • Russian Federation
      • Kuzmolovsky, Russian Federation
        • Research Site
      • Moscow, Russian Federation
        • Research Site
      • Saint Petersburg, Russian Federation
        • Research Site
  • South Africa
      • Durban, South Africa
        • Research Site
      • Pretoria, South Africa
        • Research Site
  • Taiwan
      • Taipei, Taiwan
        • Research Site
  • Thailand
      • Bangkok, Thailand
        • Research Site
      • Songkla, Thailand
        • Research Site
  • Ukraine
      • Dnipropetrovsk, Ukraine
        • Research Site
      • Lviv, Ukraine
        • Research Site
  • United Kingdom
      • 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
        • Research Site
  • United States
    • New York
      • Lake Success, New York, United States
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
AZD8931 40mg (bd) plus anastrozole 1mg (od)
Drug: AZD8931
Tablet, oral, bd
Drug: anastrozole
Tablet, oral, od
Other Names:
  • Arimidex
Experimental: 2
AZD8931 20mg (bd) plus anastrozole 1mg (od)
Drug: AZD8931
Tablet, oral, bd
Drug: anastrozole
Tablet, oral, od
Other Names:
  • Arimidex
Placebo Comparator: 3
Placebo (bd) plus anastrozole 1mg (od)
Drug: anastrozole
Tablet, oral, od
Other Names:
  • Arimidex
Drug: Placebo
Tablet, oral

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression Free Survival as Evaluated by Response Evaluation Criteria In Solid Tumors (RECIST) 1.1
Time Frame: Tumour assessment by RECIST 1.1 every 12 weeks until data cut-off at 31 August 2012
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Compare the Overall Survival in Patients Treated With AZD8931 in Combination With Anastrozole Versus Anastrozole Alone
Time Frame: Following progression, patients were contacted at 12 weekly intervals until data cut-off at 31 August 2012 to determine survival status
Time from the date of randomization to the date of death (by any cause)
Following progression, patients were contacted at 12 weekly intervals until data cut-off at 31 August 2012 to determine survival status

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Investigators

  • Study Director: Dr Serban Ghiorghiu, MD, AstraZeneca
  • Principal Investigator: Stephen Johnston, MA, PhD, FRCP, The Royal Marsden Hospital, London

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2010

Primary Completion (Actual)

January 1, 2013

Study Completion (Actual)

January 1, 2013

Study Registration Dates

First Submitted

June 15, 2010

First Submitted That Met QC Criteria

June 24, 2010

First Posted (Estimate)

June 28, 2010

Study Record Updates

Last Update Posted (Estimate)

July 25, 2014

Last Update Submitted That Met QC Criteria

July 15, 2014

Last Verified

July 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D0102C00004

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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