Overview

This trial is active, not recruiting.

Conditions advanced breast cancer, metastatic breast cancer
Treatment fulvestrant
Phase phase 2
Sponsor AstraZeneca
Start date May 2006
End date June 2008
Trial size 161 participants
Trial identifier NCT00313170, D6997C00006, FINDER II

Summary

This study will assess the relationship between fulvestrant dose and efficacy in postmenopausal women with oestrogen receptor positive advanced breast cancer.

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 250 mg
fulvestrant Faslodex
intramuscular injection 250 mg & 500 mg
(Experimental)
Fulvestrant 250 mg (+ 250 mg loading regimen)
fulvestrant Faslodex
intramuscular injection 250 mg & 500 mg
(Experimental)
Fulvestrant 500 mg
fulvestrant Faslodex
intramuscular injection 250 mg & 500 mg

Primary Outcomes

Measure
Objective Response (OR)
time frame: RECIST scans were performed every 12 weeks (+/- 2 weeks) from randomisation to until data cut off on 13th June 2008

Secondary Outcomes

Measure
Time to Progression (TTP)
time frame: RECIST tumour assessments carried out every 12 weeks (+/- 2 weeks) from randomisation until data cut off on 13th June 2008
Duration of Response (DoR)
time frame: RECIST tumour assessments were carried out every 12 weeks (+/- 2 weeks) from randomisation until data cut-off on 13th June 2008
Clinical Benefit Rate (CBR)
time frame: Each patient was assessed for Clinical Benefit from the sequence of RECIST (Response Evaluation Criteria in Solid Tumours) scan data up to the data cut-off, 13th June 2008. RECIST scans were performed every 12 weeks (+/- 2 weeks) from randomisation.
Pharmacokinetic Parameter: Mean Population Clearance, a Measure of the Efficiency With Which Fulvestrant is Eliminated From the Body
time frame: Baseline to 12 weeks
Pharmacokinetic Parameter: Mean Volume of Distribution at Steady State, a Measure of the Apparent Volume in the Body Into Which Fulvestrant Distributes
time frame: Baseline to 12 weeks

Eligibility Criteria

Female participants at least 45 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 (woman who has stopped having menstrual periods) Exclusion Criteria: - Treatment with more than one previous regimen of systemic anticancer therapy other than endocrine therapy for advanced BC. - Treatment with more than one previous regimen of endocrine therapy for advanced BC. - An existing condition that prevents compliance.

Additional Information

Official title Phase II Study to Evaluate the Efficacy and Tolerability of Fulvestrant 250mg, 250mg Plus 250mg Loading Regimen and 500mg in Postmenopausal Women With ER +ve Advanced Breast Cancer Progressing or Relapsing After Previous Endocrine Therapy
Trial information was received from ClinicalTrials.gov and was last updated in July 2015.
Information provided to ClinicalTrials.gov by AstraZeneca.