Overview

This trial is active, not recruiting.

Condition breast cancer
Treatment fulvestrant
Phase phase 3
Sponsor AstraZeneca
Start date February 2005
End date February 2009
Trial size 834 participants
Trial identifier NCT00099437, D6997C00002

Summary

The purpose of this study is to evaluate the efficacy of a new dose of 500 mg Fulvestrant with the standard dose of 250 mg in postmenopausal women with oestrogen receptor positive advanced breast cancer who have failed on a previous endocrine treatment.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
Fulvestrant 500 mg
fulvestrant Faslodex
intramuscular injection
(Experimental)
Fulvestrant 250 mg
fulvestrant Faslodex
intramuscular injection

Primary Outcomes

Measure
Time to Progression (TTP)
time frame: RECIST(Response Evaluation Criteria in Solid Tumors ) tumour assessments carried out every 12 weeks (+/- 2 weeks) from randomisation for study duration (48 months)

Secondary Outcomes

Measure
Objective Response Rate (ORR)
time frame: RECIST tumour assessments carried out every 12 weeks (+/- 2 weeks) from randomisation for study duration (48 months)
Clinical Benefit Rate (CBR)
time frame: Clinical Benefit from the sequence of RECIST scan data for study duration (48 months) . RECIST (Response Evaluation Criteria in Solid Tumours) scans were performed every 12 weeks (+/- 2 weeks) from randomisation for study duration (48 months)
Duration of Response (DoR)
time frame: RECIST tumour assessments carried out every 12 weeks (+/- 2 weeks) from randomisation for study duration (48 months)
Duration of Clinical Benefit (DoCB)
time frame: RECIST tumour assessments carried out every 12 weeks (+/- 2 weeks) from randomisation for study duration (48 months)
Overall Survival (OS)
time frame: Overall Survival is equivalent to time to death. For this endpoint, all deaths occurring for study duration (48 months)
Change From Randomisation in Trial Outcome Index (TOI) Over the Course of the Study
time frame: TOI questionnaires were completed every 4 weeks from randomisation until week 24 and then again at treatment discontinuation, for study duration (48 months)
Overall Survival (OS) - Follow-up
time frame: Median time (in months) from randomisation until death (from any cause),up to 80 months

Eligibility Criteria

Female participants from 45 years up to 130 years old.

Inclusion Criteria: - Breast Cancer has continued to grow after having received treatment with an anti-estrogen hormonal treatment such as tamoxifen or an aromatase inhibitor - Requiring hormonal treatment - Postmenopausal women defined as a woman who has stopped having menstrual periods - Evidence of positive estrogen receptor hormone sensitivity - Written informed consent to participate in the trial Exclusion Criteria: - Treatment with an investigational or non-approved drug within one month - An existing serious disease, illness, or condition that will prevent participation or compliance with study procedures - A history of allergies to any active or inactive ingredients of Faslodex (i.e. castor oil) - Treatment with more than one regimen of chemotherapy for advanced breast cancer - Treatment with more than one regimen of hormonal treatment for advanced breast cancer

Additional Information

Official title A Randomised, Double-Blind, Parallel-group, Multicentre, Phase III Study Comparing the Efficacy and Tolerability of Fulvestrant (FASLODEX™) 500 mg With Fulvestrant (FASLODEX™) 250 mg in Postmenopausal Women With Oestrogen Receptor Positive Advanced Breast Cancer Progressing or Relapsing After Previous Endocrine Therapy
Trial information was received from ClinicalTrials.gov and was last updated in February 2016.
Information provided to ClinicalTrials.gov by AstraZeneca.