Overview

This trial is active, not recruiting.

Condition metastatic breast cancer
Treatments fulvestrant, anastrozole
Phase phase 2
Sponsor AstraZeneca
Start date February 2006
End date January 2008
Trial size 233 participants
Trial identifier NCT00274469, D6995C00006, FIRST

Summary

The purpose of this study is to compare the efficacy and tolerability of Faslodex (fulvestrant) with Arimidex (anastrozole) in postmenopausal women with hormone receptor positive advanced breast cancer.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Fulvestrant
fulvestrant Faslodex
500 mg intramuscular injection
(Active Comparator)
Anastrozole
anastrozole Arimidex
1 mg oral tablet

Primary Outcomes

Measure
Clinical Benefit Rate
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.

Secondary Outcomes

Measure
Objective Response Rate
time frame: Each patient with measurable disease at baseline was assessed for Objective Response from the sequence of RECIST scan data up to data cut-off, 10th Jan 2008. RECIST scans were performed every 12 weeks (+/- 2 weeks) from randomization.
Time to Progression
time frame: RECIST tumour assessments carried out every 12 weeks from randomization (+/- 2 weeks) until data cut-off on 10th January 2008.
Duration of Response
time frame: RECIST tumour assessments carried out every 12 weeks from randomization (+/- 2 weeks) until data cut-off on 10th January 2008.
Duration of Clinical Benefit
time frame: RECIST tumour assessments carried out every 12 weeks from randomization (+/- 2 weeks) until data cut-off on 10th January 2008.

Eligibility Criteria

Female participants at least 45 years old.

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).

Additional Information

Official title 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
Trial information was received from ClinicalTrials.gov and was last updated in July 2015.
Information provided to ClinicalTrials.gov by AstraZeneca.