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

Phase 2

Terminated

• Conditions: Neoplasms; Breast Neoplasms; Breast Cancer
• Interventions: Drug: AZD8931; Drug: anastrozole; Drug: Placebo

• Registration Number: NCT01151215
• Lead Sponsor: AstraZeneca

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-06
• Study First Submitted: 2010-06-15
• Study First Submitted QC: 2010-06-24
• Study First Posted: 2010-06-28
• Primary Completion: 2013-01
• Study Completion: 2013-01
• Results First Submitted: 2014-01-29
• Results First Submitted QC: 2014-04-07
• Results First Posted: 2014-05-08
• Status Verified: 2014-07
• Last Update Submitted: 2014-07-15
• Last Update Posted: 2014-07-25

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 482

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	anastrozole	AZD8931 40mg (bd) plus anastrozole 1mg (od)
2	anastrozole	AZD8931 20mg (bd) plus anastrozole 1mg (od)
1	AZD8931	AZD8931 40mg (bd) plus anastrozole 1mg (od)
3	Placebo	Placebo (bd) plus anastrozole 1mg (od)
2	AZD8931	AZD8931 20mg (bd) plus anastrozole 1mg (od)
3	anastrozole	Placebo (bd) plus anastrozole 1mg (od)

Primary Outcome Measures

Name	Time	Method
Progression Free Survival as Evaluated by Response Evaluation Criteria In Solid Tumors (RECIST) 1.1	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.

Secondary Outcome Measures

Name	Time	Method
Compare the Overall Survival in Patients Treated With AZD8931 in Combination With Anastrozole Versus Anastrozole Alone	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)

Trial Locations

Locations (1)

Research Site; 🇬🇧 Wythenshawe, Manchester, United Kingdom