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

Metastatic Breast Cancer Clinical Trial

— FINDER II  

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: NCT00313170
• Other study ID #: D6997C00006
• Secondary ID: FINDER II
• Status: Completed
• Phase: Phase 2
• Start date: May 30, 2006
• Est. completion date: March 13, 2019

Study information

• Verified date: December 2019
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 144
• Est. completion date: March 13, 2019
• Est. primary completion date: June 13, 2008
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 45 Years to 130 Years

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 (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.

Related Conditions & MeSH terms

• Advanced Breast Cancer
• Breast Neoplasms
• Metastatic Breast Cancer

Intervention

Drug:
• Fulvestrant
intramuscular injection 250 mg & 500 mg

Locations

Country	Name	City	State
Belgium	Research Site	Brussels
Belgium	Research Site	Leuven
Belgium	Research Site	Roeselare
Belgium	Research Site	Wilrijk
Canada	Research Site	Cambridge	Ontario
Canada	Research Site	Edmonton	Alberta
Canada	Research Site	London	Ontario
Canada	Research Site	Montreal	Quebec
Canada	Research Site	Oshawa	Ontario
Canada	Research Site	Quebec
Canada	Research Site	Sault Ste. Marie	Ontario
Canada	Research Site	Toronto	Ontario
Canada	Research Site	Toronto	Ontario
Canada	Research Site	Vancouver	British Columbia
Czechia	Research Site	Cheb
Czechia	Research Site	Jicin
Czechia	Research Site	Praha 4
France	Research Site	Bordeaux
France	Research Site	Brive
France	Research Site	Clermont Ferrand cedex 01
France	Research Site	Poitiers
Hungary	Research Site	Budapest
Hungary	Research Site	Debrecen
Hungary	Research Site	Györ
Hungary	Research Site	Szeged
Hungary	Research Site	Tatabánya
Poland	Research Site	Bydgoszcz
Poland	Research Site	Gdansk
Poland	Research Site	Gdansk
Poland	Research Site	Kraków
Poland	Research Site	Olsztyn
Romania	Research Site	Bucharest
Romania	Research Site	Bucuresti
Romania	Research Site	Cluj Napoca
Turkey	Research Site	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Countries where clinical trial is conducted

Belgium,  Canada,  Czechia,  France,  Hungary,  Poland,  Romania,  Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective Response (ORR)	Objective response rate was defined as percentage of patients with either complete response (CR - disappearance of all target lesions) or partial response (PR - at least 30% decrease in the sum of diameters of target lesions). All patients were to be followed up every 12 weeks for progression, defined by response evaluation criteria in solid tumors (RECIST v1.1).	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	Time to Progression (TTP)	Time from randomisation until objective disease progression or death (in the absence of objective progression) using the Kaplan-Meier method. RECIST tumor assessments were carried out every 12 weeks until progression.	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	Duration of Response (DoR)	DoR was defined as the time from date of first documentation of the response (CR or PR) until the date of disease progression or death from any cause.	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	Clinical Benefit Rate (CBR)	CBR was defined as the proportion of all randomised patients who had clinical benefit (response of CR, PR or SD>=24 weeks.	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	Pharmacokinetic Parameter: Mean Population Clearance, a Measure of the Efficiency With Which Fulvestrant is Eliminated From the Body	A 2-compartment model with a 1st order absorption and 1st order elimination process was fitted to the fulvestrant concentration-time data. Relative standard error is reported for the mean.	Baseline to 12 weeks
Secondary	Pharmacokinetic Parameter: Mean Volume of Distribution at Steady State, a Measure of the Apparent Volume in the Body Into Which Fulvestrant Distributes	A 2-compartment model with a 1st order absorption and 1st order elimination process was fitted to the fulvestrant concentration-time data. Relative standard error is reported for the mean. The mean estimate of volume of distribution at steady state was reported as the sum of V1/F and V2/F in the clinical study report.	Baseline to 12 weeks

External Links

•   AstraZeneca Clinical Trial Information - Outside US
•   CSR-D6997C00006.pdf
•   Related Info