A Clinical Trial to Compare Efficacy and Tolerability of Fulvestrant 250mg, 250mg Plus 250mg Loading Regimen and 500mg
FINDER II
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
2 other identifiers
interventional
144
8 countries
34
Brief Summary
This study will assess the relationship between fulvestrant dose and efficacy in postmenopausal women with oestrogen receptor positive advanced breast cancer.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started May 2006
Longer than P75 for phase_2
34 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 10, 2006
CompletedFirst Posted
Study publicly available on registry
April 12, 2006
CompletedStudy Start
First participant enrolled
May 30, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 13, 2008
CompletedResults Posted
Study results publicly available
August 29, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
March 13, 2019
CompletedJanuary 6, 2020
December 1, 2019
2 years
April 10, 2006
June 10, 2009
December 17, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (5)
Time to Progression (TTP)
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.
Duration of Response (DoR)
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.
Clinical Benefit Rate (CBR)
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.
Pharmacokinetic Parameter: Mean Population Clearance, a Measure of the Efficiency With Which Fulvestrant is Eliminated From the Body
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
Baseline to 12 weeks
Study Arms (3)
1
EXPERIMENTALFulvestrant 250 mg (intramuscular injection 250 mg)
2
EXPERIMENTALFulvestrant 250 mg (+ 250 mg loading regimen)
3
EXPERIMENTALFulvestrant 500 mg (intramuscular injection 500 mg)
Interventions
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (34)
Research Site
Brussels, 1000, Belgium
Research Site
Leuven, 3000, Belgium
Research Site
Roeselare, 8800, Belgium
Research Site
Wilrijk, 2610, Belgium
Research Site
Edmonton, Alberta, T6G 1Z2, Canada
Research Site
Vancouver, British Columbia, V5Z 4E6, Canada
Research Site
Cambridge, Ontario, N1R 3G2, Canada
Research Site
London, Ontario, N6A 4L6, Canada
Research Site
Oshawa, Ontario, L1G 2B9, Canada
Research Site
Sault Ste. Marie, Ontario, P6A 2C4, Canada
Research Site
Toronto, Ontario, M4C 3E7, Canada
Research Site
Toronto, Ontario, M4N 3M5, Canada
Research Site
Montreal, Quebec, H3T 1E2, Canada
Research Site
Québec, Quebec, G1S 4L8, Canada
Research Site
Cheb, 350 02, Czechia
Research Site
Jičín, 506 43, Czechia
Research Site
Prague, 140 00, Czechia
Research Site
Bordeaux, 33000, France
Research Site
Brivé, 19312, France
Research Site
Clermont-Ferrand, 63011, France
Research Site
Poitiers, 86000, France
Research Site
Budapest, 1062, Hungary
Research Site
Debrecen, 4032, Hungary
Research Site
Győr, 9024, Hungary
Research Site
Szeged, 6720, Hungary
Research Site
Tatabánya, 2800, Hungary
Research Site
Bydgoszcz, 85-796, Poland
Research Site
Gdansk, 80-214, Poland
Research Site
Gdansk, 80-462, Poland
Research Site
Krakow, 31-115, Poland
Research Site
Olsztyn, 10-228, Poland
Research Site
Bucharest, Romania
Research Site
Cluj-Napoca, 40015, Romania
Research Site
Istanbul, Turkey (Türkiye)
Related Publications (1)
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.
PMID: 20632084DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Gerard Lynch
- Organization
- AstraZeneca
Study Officials
- STUDY DIRECTOR
AstraZeneca Breast Cancer Established Brands Team Medical Science Director, MD
AstraZeneca
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 10, 2006
First Posted
April 12, 2006
Study Start
May 30, 2006
Primary Completion
June 13, 2008
Study Completion
March 13, 2019
Last Updated
January 6, 2020
Results First Posted
August 29, 2011
Record last verified: 2019-12