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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).


Phase 2
18 Years
N/A
Not Enrolling
Female
Neoplasms, Breast Neoplasms, Breast Cancer

Thank you

Trial Information

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).


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)

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Progression free survival as evaluated by Response Evaluation Criteria In Solid Tumors (RECIST) 1.1

Outcome Time Frame:

Every 12 weeks

Safety Issue:

No

Principal Investigator

Dr Serban Ghiorghiu, MD

Investigator Role:

Study Director

Investigator Affiliation:

AstraZeneca

Authority:

United States: Food and Drug Administration

Study ID:

D0102C00004

NCT ID:

NCT01151215

Start Date:

June 2010

Completion Date:

March 2013

Related Keywords:

  • Neoplasms
  • Breast Neoplasms
  • Breast Cancer
  • Cancer
  • tumour
  • breast cancer
  • metastatic
  • secondary
  • locally advanced
  • Breast Neoplasms
  • Neoplasms

Name

Location

Research SiteAlbany, New York