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A Randomized, Open-Label, Parallel-Group, Multicentre, Phase II Study to Compare the Efficacy and Tolerability of Fulvestrant (FASLODEX™) 500 mg With Anastrozole (ARIMIDEX™) 1 mg as First Line Hormonal Treatment for Postmenopausal Women With Hormone Receptor Positive Advanced Breast Cancer


Phase 2
N/A
N/A
Open (Enrolling)
Female
Metastatic Breast Cancer

Thank you

Trial Information

A Randomized, Open-Label, Parallel-Group, Multicentre, Phase II Study to Compare the Efficacy and Tolerability of Fulvestrant (FASLODEX™) 500 mg With Anastrozole (ARIMIDEX™) 1 mg as First Line Hormonal Treatment for Postmenopausal Women With Hormone Receptor Positive Advanced Breast Cancer


Inclusion Criteria:



- Confirmed hormone receptor positive advanced breast cancer, postmenopausal women

Exclusion Criteria:

- Previous treatment for advanced breast cancer (previous treatment for early breast
cancer is allowed).

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Clinical Benefit Rate

Outcome Description:

A Clinical Benefit (CB) responder is defined as a patient having a best overall response ofCR, PR or SD provided SD (or better) was present ≥ 154 days from randomization (ie SD ≥ 24weeks with the 2 week RECIST assessment time window allowed). The Clinical Benefit Rate is the percentage of patients with CB.

Outcome Time Frame:

Each patient was assessed for Clinical Benefit from the sequence of RECIST (Response Evaluation Criteria In Solid Tumours) scan data up to data cut-off, 10th Jan 2008. RECIST scans were performed every 12 weeks (+/- 2 weeks) from randomization.

Safety Issue:

No

Principal Investigator

AstraZeneca Faslodex Medical Science Director, MD

Investigator Role:

Study Director

Investigator Affiliation:

AstraZeneca

Authority:

United States: Food and Drug Administration

Study ID:

D6995C00006

NCT ID:

NCT00274469

Start Date:

February 2006

Completion Date:

January 2015

Related Keywords:

  • Metastatic Breast Cancer
  • oncology
  • cancer
  • breast cancer
  • Breast Neoplasms

Name

Location

Research SiteBaltimore, Maryland  
Research SiteBranson, Missouri  
Research SiteBelleville, New Jersey  
Research SiteAbilene, Texas