A Clinical Trial to Compare Efficacy and Tolerability of Fulvestrant 250mg, 250mg (Plus 250mg Loading Regimen) and 500mg

Metastatic Breast Cancer Clinical Trial

— FINDER I  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00305448
• Other study ID #: D6997C00004
• Secondary ID: FINDER I
• Status: Completed
• Phase: Phase 2
• First received: March 20, 2006
• Last updated: February 14, 2012
• Start date: March 2006
• Est. completion date: February 2012

Study information

• Verified date: February 2012
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Pharmaceuticals and Medical Devices Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 143
• Est. completion date: February 2012
• Est. primary completion date: March 2008
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Advanced Breast Cancer
• Breast Neoplasms
• Metastatic Breast Cancer

Intervention

Drug:
• Fulvestrant
250 intramuscular injection
• Fulvestrant
500 mg intramuscular injection

Locations

Country	Name	City	State
Japan	Research Site	Amagasaki	Hyogo
Japan	Research Site	Asahi	Chiba
Japan	Research Site	Chiba
Japan	Research Site	Chuo	Tokyo
Japan	Research Site	Daito	Fukushima
Japan	Research Site	Fukuoka
Japan	Research Site	Fukuyama	Hiroshima
Japan	Research Site	Hiroshima
Japan	Research Site	Ina	Saitama
Japan	Research Site	Isehara	Kanagawa
Japan	Research Site	Izumisano	Osaka
Japan	Research Site	Kawasaki
Japan	Research Site	Kitakyushu	Fukuoka
Japan	Research Site	Koriyama	Fukushima
Japan	Research Site	Koto-ku	Tokyo
Japan	Research Site	Kumamoto
Japan	Research Site	Kurashiki	Okayama
Japan	Research Site	Kure	Hiroshima
Japan	Research Site	Kurume	Fukuoka
Japan	Research Site	Matsubaracho	Kagoshima
Japan	Research Site	Matsuyama	Ehime
Japan	Research Site	Moroyama	Saitama
Japan	Research Site	Nagoya	Aichi
Japan	Research Site	Niigata
Japan	Research Site	Oita
Japan	Research Site	Osaka
Japan	Research Site	Ota	Gunma
Japan	Research Site	Sagamihara	Kanagawa
Japan	Research Site	Sakai	Osaka
Japan	Research Site	Sapporo	Hokkaido
Japan	Research Site	Sendai	Miyagi
Japan	Research Site	Shimotsuke	Tochigi
Japan	Research Site	Shizuoka
Japan	Research Site	Suita	Osaka
Japan	Research Site	Yokohama	Kanagawa

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective Response Rate (ORR)	An objective response (OR) is defined as a patient having a best overall response of either complete response (CR) or partial response (PR). A patient has best overall response of CR if she had overall response of CR or PR on one visit and met the confirmation criteria per RECIST. ORR is defined as percentage of patients with objective response.; Each patient with measurable disease at baseline was assessed for OR from the sequence of Response Evaluation Criteria in Solid Tumors (RECIST) scan data up to data cut-off. RECIST scans were performed every 12 weeks (+/- 2weeks) from randomization	baseline and every 12 weeks (+/- 2weeks) from randomization data up to data cut-off (19th march 2008)	No
Secondary	Time to Progression (TTP)	Time (in days) from randomization until objective disease progression or death (in the absence of objective progression). RECIST tumour assessments carried out every 12 weeks from randomization (+/- 2 weeks) until data cut-off on 19th March 2008.	every 12 weeks from randomization (+/- 2 weeks) until data cut-off (19th march 2008)	No
Secondary	Duration of Response (DoR)	Time from randomisation until objective progression or death (in the absence of objective progression), measured only in those patients who achieved a confirmed Complete Response or confirmed Partial Response.	RECIST tumour assessments carried out every 12 weeks from randomisation (+/- 2 weeks) until data cut-off on19th March 2008.	No
Secondary	Clinical Benefit Rate (CBR)	A Clinical Benefit (CB) responder is defined as a patient having a best overall response of Complete response (CR), Partial Response (PR) or Stable disease (SD) provided SD (or better) was present = 154 days from randomization (ie SD = 24 weeks with the 2 week RECIST assessment time window allowed). The Clinical Benefit Rate is the percentage of patients with CB.	every 12 weeks(+/- 2 weeks) from randomization to data up to data cut-off, 19th March 2008.	No
Secondary	Pharmacokinetic Parameter: Mean Population Clearance, a Measure of the Efficiency With Which Fulvestrant is Eliminated From the Body	The measure of dispersion for mean population clearance is based on the estimated inter-individual variance	Baseline to 12 weeks	No
Secondary	Pharmacokinetic Parameter: Mean Volume of Distribution at Steady State, a Measure of the Apparent Volume in the Body Into Which Fulvestrant Distributes	The measure of dispersion for volume of distribution is based on the inter-individual variance estimated for the apparent volume of plasma into which Fulvestrant distributes	Baseline to 12 weeks	No