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

Overview

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.

Full Title of Study: “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

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: January 2013

Interventions

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

Arms, Groups and Cohorts

  • Experimental: 1
    • AZD8931 40mg (bd) plus anastrozole 1mg (od)
  • Experimental: 2
    • AZD8931 20mg (bd) plus anastrozole 1mg (od)
  • Placebo Comparator: 3
    • Placebo (bd) plus anastrozole 1mg (od)

Clinical Trial Outcome Measures

Primary Measures

  • 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.

Secondary Measures

  • 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)

Participating in This Clinical Trial

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)

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • AstraZeneca
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Dr Serban Ghiorghiu, MD, Study Director, AstraZeneca
    • Stephen Johnston, MA, PhD, FRCP, Principal Investigator, The Royal Marsden Hospital, London

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