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

Breast Cancer Clinical Trial

— 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).

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01151215
• Other study ID #: D0102C00004
• Status: Terminated
• Phase: Phase 2
• First received: June 15, 2010
• Last updated: July 15, 2014
• Start date: June 2010
• Est. completion date: January 2013

Study information

• Verified date: July 2014
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationBrazil: National Health Surveillance AgencyFinland: Ethics CommitteeKorea: Food and Drug AdministrationMexico: Federal Commission for Protection Against Health RisksPeru: Ministry of HealthPhilippines: Bureau of Food and DrugsPhilippines: Department of HealthPoland: Ministry of HealthUnited Kingdom: Medicines and Healthcare Products Regulatory AgencyIndia: Drugs Controller General of IndiaSouth Africa: Medicines Control CouncilCanada: Health CanadaUkraine: State Pharmacological Center - Ministry of HealthRussia: Ministry of Health of the Russian FederationTaiwan: Department of HealthCzech Republic: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 482
• Est. completion date: January 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Neoplasms

Intervention

Drug:
• AZD8931
Tablet, oral, bd
• anastrozole
Tablet, oral, od
• Placebo
Tablet, oral

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Countries where clinical trial is conducted

United States,  Brazil,  Canada,  Czech Republic,  Finland,  India,  Japan,  Korea, Republic of,  Mexico,  Peru,  Philippines,  Poland,  Russian Federation,  South Africa,  Taiwan,  Thailand,  Ukraine,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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)	Following progression, patients were contacted at 12 weekly intervals until data cut-off at 31 August 2012 to determine survival status	No