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

Study Overview
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Brief Summary
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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.

Official Title
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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).

Conditions
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Neoplasms, Breast Neoplasms, Breast Cancer

Intervention / Treatment
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* Drug: AZD8931
* Drug: anastrozole
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>AZD8931 40mg (bd) plus anastrozole 1mg (od) | Drug: AZD8931<br>* Tablet, oral, bd<br>Drug: anastrozole<br>* Tablet, oral, od<br>* Other names: Arimidex;|
| Experimental: 2<br>AZD8931 20mg (bd) plus anastrozole 1mg (od) | Drug: AZD8931<br>* Tablet, oral, bd<br>Drug: anastrozole<br>* Tablet, oral, od<br>* Other names: Arimidex;|
| Placebo Comparator: 3<br>Placebo (bd) plus anastrozole 1mg (od) | Drug: anastrozole<br>* Tablet, oral, od<br>* Other names: Arimidex;Drug: Placebo<br>* Tablet, oral<br>|

What is the study measuring?
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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 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 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cancer, tumour, breast cancer, metastatic, secondary, locally advanced