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

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
482

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
AstraZeneca

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2010

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2013

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2013

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 15, 2010

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 24, 2010

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 28, 2010

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 25, 2014

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 15, 2014

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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