Clinical Trial: Anastrozole and Fulvestrant Compared to Anastrozole as Adjuvant Treatment of Postmenopausal Patients With Breast Cancer

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Randomised Phase II Study Comparing Anastrozole and Fulvestrant to Anastrozole for Adjuvant Treatment of Postmenopausal Patients With Early Breast Cancer and Disseminated Tumour Cells in Bone Marrow

Brief Summary: Purpose is to compare the frequency of events (presence of Disseminated Tumour Cells, clinical recurrence and/or death) after 1 and 2 years of adjuvant treatment with anastrozole and fulvestrant or anastrozole alone in patients with early breast cancer.

Detailed Summary:
Sponsor: AstraZeneca

Current Primary Outcome: Patients Event-free at 12 Months (Where Event = Death (From Any Cause), Disseminated Tumour Cells (DTC) Positive at 12 Months or Clinical Disease Recurrence) [ Time Frame: 12 month period following randomisation ]

Number of patients event-free


Original Primary Outcome:

  • Frequency of events (Disseminated Tumour Cells present in bone marrow samples,
  • Clinical recurrence and/or death) after 12 months of randomised treatment.


Current Secondary Outcome:

Original Secondary Outcome:

  • Frequency of events (Disseminated Tumour Cells present in bone marrow samples,
  • Clinical recurrence and/or death) after 24 months of randomised treatment.
  • Frequency of adverse events after 12 and 24 months of randomised treatment.


Information By: AstraZeneca

Dates:
Date Received: July 20, 2006
Date Started: April 2006
Date Completion:
Last Updated: December 3, 2010
Last Verified: December 2010