Clinical trial NCT01151215: Study of Anastrozole +/- AZD8931 in Postmenopausal Women With Endocrine Therapy Naive Breast Cancer
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
Overall status: TERMINATED
Phase: PHASE2
Conditions: Neoplasms
Breast Neoplasms
Breast Cancer
Keywords: Cancer
tumour
breast cancer
metastatic
secondary
locally advanced
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2010-06-28
Enrollment: 482
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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)

Primary outcomes:
measure: Progression Free Survival as Evaluated by Response Evaluation Criteria In Solid Tumors (RECIST) 1.1
timeFrame: Tumour assessment by RECIST 1.1 every 12 weeks until data cut-off at 31 August 2012
Secondary outcomes:
measure: Compare the Overall Survival in Patients Treated With AZD8931 in Combination With Anastrozole Versus Anastrozole Alone
timeFrame: Following progression, patients were contacted at 12 weekly intervals until data cut-off at 31 August 2012 to determine survival status
Other outcomes:
Locations:
city: Lake Success
country: United States
facility: Research Site
state: New York
city: Belo Horizonte
country: Brazil
facility: Research Site
city: Goiânia
country: Brazil
facility: Research Site
city: Ijuí
country: Brazil
facility: Research Site
city: Porto Alegre
country: Brazil
facility: Research Site
city: Rio de Janeiro
country: Brazil
facility: Research Site
city: Sao Paulo
country: Brazil
facility: Research Site
city: São Paulo
country: Brazil
facility: Research Site
city: Vancouver
country: Canada
facility: Research Site
state: British Columbia
city: Ottawa
country: Canada
facility: Research Site
state: Ontario
city: Montreal
country: Canada
facility: Research Site
state: Quebec
city: Brno
country: Czech Republic
facility: Research Site
city: Olomouc
country: Czech Republic
facility: Research Site
city: Praha 2
country: Czech Republic
facility: Research Site
city: Praha 4
country: Czech Republic
facility: Research Site
city: Helsinki
country: Finland
facility: Research Site
city: Tampere
country: Finland
facility: Research Site
city: Turku
country: Finland
facility: Research Site
city: Bangalore
country: India
facility: Research Site
city: Hyderabad
country: India
facility: Research Site
city: Mumbai
country: India
facility: Research Site
city: Pune
country: India
facility: Research Site
city: Trivandrum
country: India
facility: Research Site
city: Vellore
country: India
facility: Research Site
city: Niigata-shi
country: Japan
facility: Research Site
city: Osaka-shi
country: Japan
facility: Research Site
city: Ota-shi
country: Japan
facility: Research Site
city: Sapporo-shi
country: Japan
facility: Research Site
city: Seoul
country: Korea, Republic of
facility: Research Site
city: Durango
country: Mexico
facility: Research Site
city: Juchitan
country: Mexico
facility: Research Site
city: Merida
country: Mexico
facility: Research Site
city: Monterrey
country: Mexico
facility: Research Site
city: Callao
country: Peru
facility: Research Site
city: Lima
country: Peru
facility: Research Site
city: Piura
country: Peru
facility: Research Site
city: Iloilo City
country: Philippines
facility: Research Site
city: Lipa City
country: Philippines
facility: Research Site
city: Pasay City
country: Philippines
facility: Research Site
city: Quezon City
country: Philippines
facility: Research Site
city: Białystok
country: Poland
facility: Research Site
city: Elbląg
country: Poland
facility: Research Site
city: Kraków
country: Poland
facility: Research Site
city: Warszawa
country: Poland
facility: Research Site
city: Kuzmolovsky
country: Russian Federation
facility: Research Site
city: Moscow
country: Russian Federation
facility: Research Site
city: Saint Petersburg
country: Russian Federation
facility: Research Site
city: Durban
country: South Africa
facility: Research Site
city: Pretoria
country: South Africa
facility: Research Site
city: Taipei
country: Taiwan
facility: Research Site
city: Bangkok
country: Thailand
facility: Research Site
city: Songkla
country: Thailand
facility: Research Site
city: Dnipropetrovsk
country: Ukraine
facility: Research Site
city: Lviv
country: Ukraine
facility: Research Site
city: Birmingham
country: United Kingdom
facility: Research Site
city: Bournemouth
country: United Kingdom
facility: Research Site
city: Coventry
country: United Kingdom
facility: Research Site
city: Leicester
country: United Kingdom
facility: Research Site
city: London
country: United Kingdom
facility: Research Site
city: Nottingham
country: United Kingdom
facility: Research Site
city: Surrey
country: United Kingdom
facility: Research Site
city: Wythenshawe, Manchester
country: United Kingdom
facility: Research Site
Study officials:
affiliation: AstraZeneca
name: Dr Serban Ghiorghiu, MD
role: STUDY_DIRECTOR
affiliation: The Royal Marsden Hospital, London
name: Stephen Johnston, MA, PhD, FRCP
role: PRINCIPAL_INVESTIGATOR
References:
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.