Clinical trial NCT00313170: A Clinical Trial to Compare Efficacy and Tolerability of Fulvestrant 250mg, 250mg Plus 250mg Loading Regimen and 500mg
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Advanced Breast Cancer
Metastatic Breast Cancer
Keywords: oncology
cancer
breast cancer
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2006-04-12
Enrollment: 144
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 130
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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.

Primary outcomes:
measure: Objective Response (ORR)
timeFrame: The planned data cut-off for this study was when all patients, except withdrawals, had been followed up for at least 24 weeks. Patients received treatment up to approximately 2 years.
Secondary outcomes:
measure: Time to Progression (TTP)
timeFrame: The planned data cut-off for this study was when all patients, except withdrawals, had been followed up for at least 24 weeks. Patients received treatment up to approximately 2 years.
measure: Duration of Response (DoR)
timeFrame: The planned data cut-off for this study was when all patients, except withdrawals, had been followed up for at least 24 weeks. Patients received treatment up to approximately 2 years.
measure: Clinical Benefit Rate (CBR)
timeFrame: The planned data cut-off for this study was when all patients, except withdrawals, had been followed up for at least 24 weeks. Patients received treatment up to approximately 2 years.
measure: Pharmacokinetic Parameter: Mean Population Clearance, a Measure of the Efficiency With Which Fulvestrant is Eliminated From the Body
timeFrame: Baseline to 12 weeks
measure: Pharmacokinetic Parameter: Mean Volume of Distribution at Steady State, a Measure of the Apparent Volume in the Body Into Which Fulvestrant Distributes
timeFrame: Baseline to 12 weeks
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Research Site
city: Leuven
country: Belgium
facility: Research Site
city: Roeselare
country: Belgium
facility: Research Site
city: Wilrijk
country: Belgium
facility: Research Site
city: Edmonton
country: Canada
facility: Research Site
state: Alberta
city: Vancouver
country: Canada
facility: Research Site
state: British Columbia
city: Cambridge
country: Canada
facility: Research Site
state: Ontario
city: London
country: Canada
facility: Research Site
state: Ontario
city: Oshawa
country: Canada
facility: Research Site
state: Ontario
city: Sault Ste. Marie
country: Canada
facility: Research Site
state: Ontario
city: Toronto
country: Canada
facility: Research Site
state: Ontario
city: Toronto
country: Canada
facility: Research Site
state: Ontario
city: Montreal
country: Canada
facility: Research Site
state: Quebec
city: Quebec
country: Canada
facility: Research Site
city: Cheb
country: Czechia
facility: Research Site
city: Jicin
country: Czechia
facility: Research Site
city: Praha 4
country: Czechia
facility: Research Site
city: Bordeaux
country: France
facility: Research Site
city: Brive
country: France
facility: Research Site
city: Clermont Ferrand cedex 01
country: France
facility: Research Site
city: Poitiers
country: France
facility: Research Site
city: Budapest
country: Hungary
facility: Research Site
city: Debrecen
country: Hungary
facility: Research Site
city: Györ
country: Hungary
facility: Research Site
city: Szeged
country: Hungary
facility: Research Site
city: Tatabánya
country: Hungary
facility: Research Site
city: Bydgoszcz
country: Poland
facility: Research Site
city: Gdańsk
country: Poland
facility: Research Site
city: Gdańsk
country: Poland
facility: Research Site
city: Kraków
country: Poland
facility: Research Site
city: Olsztyn
country: Poland
facility: Research Site
city: Bucharest
country: Romania
facility: Research Site
city: Bucuresti
country: Romania
facility: Research Site
city: Cluj Napoca
country: Romania
facility: Research Site
city: Istanbul
country: Turkey
facility: Research Site
Study officials:
affiliation: AstraZeneca
name: AstraZeneca Breast Cancer Established Brands Team Medical Science Director, MD
role: STUDY_DIRECTOR
References:
citation: Pritchard KI, Rolski J, Papai Z, Mauriac L, Cardoso F, Chang J, Panasci L, Ianuli C, Kahan Z, Fukase K, Lindemann JP, Macpherson MP, Neven P. Results of a phase II study comparing three dosing regimens of fulvestrant in postmenopausal women with advanced breast cancer (FINDER2). Breast Cancer Res Treat. 2010 Sep;123(2):453-61. doi: 10.1007/s10549-010-1022-9. Epub 2010 Jul 15.