Clinical trial NCT00305448: 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: 2006-03-22
Enrollment: 143
Sex: FEMALE
Standard ages: CHILD
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, and determine the dosing regimen as a second line therapy for Japanese 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 defined as a 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 breast cancer
* Treatment with more than one previous regimen of endocrine therapy for advanced breast cancer
* An existing serious disease, illness, or condition that will prevent participation or compliance with study procedures

Primary outcomes:
measure: Objective Response Rate (ORR)
timeFrame: baseline and every 12 weeks (+/- 2weeks) from randomization data up to data cut-off (19th march 2008)
Secondary outcomes:
measure: Time to Progression (TTP)
timeFrame: every 12 weeks from randomization (+/- 2 weeks) until data cut-off (19th march 2008)
measure: Duration of Response (DoR)
timeFrame: RECIST tumour assessments carried out every 12 weeks from randomisation (+/- 2 weeks) until data cut-off on19th March 2008.
measure: Clinical Benefit Rate (CBR)
timeFrame: every 12 weeks(+/- 2 weeks) from randomization to data up to data cut-off, 19th March 2008.
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: Nagoya
country: Japan
facility: Research Site
state: Aichi
city: Asahi
country: Japan
facility: Research Site
state: Chiba
city: Matsuyama
country: Japan
facility: Research Site
state: Ehime
city: Kitakyushu
country: Japan
facility: Research Site
state: Fukuoka
city: Kurume
country: Japan
facility: Research Site
state: Fukuoka
city: Daito
country: Japan
facility: Research Site
state: Fukushima
city: Koriyama
country: Japan
facility: Research Site
state: Fukushima
city: Ota
country: Japan
facility: Research Site
state: Gunma
city: Fukuyama
country: Japan
facility: Research Site
state: Hiroshima
city: Kure
country: Japan
facility: Research Site
state: Hiroshima
city: Sapporo
country: Japan
facility: Research Site
state: Hokkaido
city: Amagasaki
country: Japan
facility: Research Site
state: Hyogo
city: Matsubaracho
country: Japan
facility: Research Site
state: Kagoshima
city: Isehara
country: Japan
facility: Research Site
state: Kanagawa
city: Sagamihara
country: Japan
facility: Research Site
state: Kanagawa
city: Yokohama
country: Japan
facility: Research Site
state: Kanagawa
city: Sendai
country: Japan
facility: Research Site
state: Miyagi
city: Kurashiki
country: Japan
facility: Research Site
state: Okayama
city: Izumisano
country: Japan
facility: Research Site
state: Osaka
city: Sakai
country: Japan
facility: Research Site
state: Osaka
city: Suita
country: Japan
facility: Research Site
state: Osaka
city: Ina
country: Japan
facility: Research Site
state: Saitama
city: Moroyama
country: Japan
facility: Research Site
state: Saitama
city: Shimotsuke
country: Japan
facility: Research Site
state: Tochigi
city: Chuo
country: Japan
facility: Research Site
state: Tokyo
city: Koto-ku
country: Japan
facility: Research Site
state: Tokyo
city: Chiba
country: Japan
facility: Research Site
city: Fukuoka
country: Japan
facility: Research Site
city: Hiroshima
country: Japan
facility: Research Site
city: Kawasaki
country: Japan
facility: Research Site
city: Kumamoto
country: Japan
facility: Research Site
city: Niigata
country: Japan
facility: Research Site
city: Oita
country: Japan
facility: Research Site
city: Osaka
country: Japan
facility: Research Site
city: Shizuoka
country: Japan
facility: Research Site
Study officials:
affiliation: AstraZeneca
name: AstraZeneca Japan Medical Director, MD
role: STUDY_DIRECTOR
References: