Back to resultsComparison of Fulvestrant (FASLODEX™) 250 mg and 500 mg in Postmenopausal Women With Oestrogen Receptor Positive Advanced Breast Cancer Progressing or Relapsing After Previous Endocrine Therapy. (CONFIRM)
Primary Purpose
Breast Cancer
Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Fulvestrant
Sponsored by
About this trial
This is an interventional treatment trial for Breast Cancer focused on measuring Advanced Breast Cancer, Metastatic 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 Evidence of positive estrogen receptor hormone sensitivity Written informed consent to participate in the trial Exclusion Criteria: Treatment with an investigational or non-approved drug within one month An existing serious disease, illness, or condition that will prevent participation or compliance with study procedures A history of allergies to any active or inactive ingredients of Faslodex (i.e. castor oil) Treatment with more than one regimen of chemotherapy for advanced breast cancer Treatment with more than one regimen of hormonal treatment for advanced breast cancer
Sites / Locations
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Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
1
2
Arm Description
Fulvestrant 500 mg
Fulvestrant 250 mg
Outcomes
Primary Outcome Measures
Time to Progression (TTP)
Median time (in months) from randomisation until objective disease progression or death (in the absence of objective progression).
Secondary Outcome Measures
Objective Response Rate (ORR)
Using the RECIST scan data, an objective response (OR) is defined as a patient having a best overall response of either complete response (CR) or partial response (PR) which is subsequently confirmed as per RECIST. ORR is defined as the percentage of patients with OR.
Clinical Benefit Rate (CBR)
A Clinical Benefit (CB) responder is defined as a patient having a best overall response of CR, PR or SD (stable disease) >=24 weeks. The Clinical Benefit Rate is the percentage of patients with CB.
Duration of Response (DoR)
Time from randomisation until objective progression or death (in the absence of objective progression), measured only in those patients who achieve a confirmed complete response (CR) or confirmed partial response (PR)
Duration of Clinical Benefit (DoCB)
Time from randomisation until objective progression or death (in the absence of objective progression), measured only in those patients who achieve a confirmed complete response (CR), confirmed partial response (PR), or stable disease (SD) >=24 weeks
Overall Survival (OS)
Median time (in months) from randomisation until death (from any cause) (analysis at 50% deaths )
Change From Randomisation in Trial Outcome Index (TOI) Over the Course of the Study
Mean (and standard deviation) change from randomisation until treatment discontinuation in TOI (defined as the first visit response of 'worsened' which is a decrease in TOI from baseline of 5 points or more) using the Kaplan-Meier method. If a subject has not shown a reduction of 5 points or more at the time of analysis then the observation will be right censored using the last QOL assessment date. Trial Outcome Index (TOI) is derived from the FACT-B questionnaire (Cella et al, 1993) by adding together the scores from the following 3 subscales; Physical well-being (PWB), Functional well-being (FWB) and Breast cancer subscale (BCS). The TOI score range is 0-92 with the higher scores representing the more favourable outcomes. Data were collected from a subgroup of patients.
Overall Survival (OS) - Follow-up
Overall Survival is equivalent to time to death. For this endpoint, all deaths occurring during the study as a whole until the data cut-off for the survival extension (31st October 2011) are presented (analysis at 75% deaths)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00099437
Brief Title
Comparison of Fulvestrant (FASLODEX™) 250 mg and 500 mg in Postmenopausal Women With Oestrogen Receptor Positive Advanced Breast Cancer Progressing or Relapsing After Previous Endocrine Therapy.
Acronym
CONFIRM
Official Title
A Randomised, Double-Blind, Parallel-group, Multicentre, Phase III Study Comparing the Efficacy and Tolerability of Fulvestrant (FASLODEX™) 500 mg With Fulvestrant (FASLODEX™) 250 mg in Postmenopausal Women With Oestrogen Receptor Positive Advanced Breast Cancer Progressing or Relapsing After Previous Endocrine Therapy
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
February 13, 2005 (Actual)
Primary Completion Date
February 27, 2009 (Actual)
Study Completion Date
December 29, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AstraZeneca
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to evaluate the efficacy of a new dose of 500 mg Fulvestrant with the standard dose of 250 mg in postmenopausal women with oestrogen receptor positive advanced breast cancer who have failed on a previous endocrine treatment.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
Advanced Breast Cancer, Metastatic Breast Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
736 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Fulvestrant 500 mg
Arm Title
2
Arm Type
Experimental
Arm Description
Fulvestrant 250 mg
Intervention Type
Drug
Intervention Name(s)
Fulvestrant
Other Intervention Name(s)
Faslodex, ZD9238
Intervention Description
intramuscular injection
Primary Outcome Measure Information:
Title
Time to Progression (TTP)
Description
Median time (in months) from randomisation until objective disease progression or death (in the absence of objective progression).
Time Frame
RECIST(Response Evaluation Criteria in Solid Tumors ) tumour assessments carried out every 12 weeks (+/- 2 weeks) from randomisation for study duration (48 months)
Secondary Outcome Measure Information:
Title
Objective Response Rate (ORR)
Description
Using the RECIST scan data, an objective response (OR) is defined as a patient having a best overall response of either complete response (CR) or partial response (PR) which is subsequently confirmed as per RECIST. ORR is defined as the percentage of patients with OR.
Time Frame
RECIST tumour assessments carried out every 12 weeks (+/- 2 weeks) from randomisation for study duration (48 months)
Title
Clinical Benefit Rate (CBR)
Description
A Clinical Benefit (CB) responder is defined as a patient having a best overall response of CR, PR or SD (stable disease) >=24 weeks. The Clinical Benefit Rate is the percentage of patients with CB.
Time Frame
Clinical Benefit from the sequence of RECIST scan data for study duration (48 months) . RECIST (Response Evaluation Criteria in Solid Tumours) scans were performed every 12 weeks (+/- 2 weeks) from randomisation for study duration (48 months)
Title
Duration of Response (DoR)
Description
Time from randomisation until objective progression or death (in the absence of objective progression), measured only in those patients who achieve a confirmed complete response (CR) or confirmed partial response (PR)
Time Frame
RECIST tumour assessments carried out every 12 weeks (+/- 2 weeks) from randomisation for study duration (48 months)
Title
Duration of Clinical Benefit (DoCB)
Description
Time from randomisation until objective progression or death (in the absence of objective progression), measured only in those patients who achieve a confirmed complete response (CR), confirmed partial response (PR), or stable disease (SD) >=24 weeks
Time Frame
RECIST tumour assessments carried out every 12 weeks (+/- 2 weeks) from randomisation for study duration (48 months)
Title
Overall Survival (OS)
Description
Median time (in months) from randomisation until death (from any cause) (analysis at 50% deaths )
Time Frame
Overall Survival is equivalent to time to death. For this endpoint, all deaths occurring for study duration (48 months)
Title
Change From Randomisation in Trial Outcome Index (TOI) Over the Course of the Study
Description
Mean (and standard deviation) change from randomisation until treatment discontinuation in TOI (defined as the first visit response of 'worsened' which is a decrease in TOI from baseline of 5 points or more) using the Kaplan-Meier method. If a subject has not shown a reduction of 5 points or more at the time of analysis then the observation will be right censored using the last QOL assessment date. Trial Outcome Index (TOI) is derived from the FACT-B questionnaire (Cella et al, 1993) by adding together the scores from the following 3 subscales; Physical well-being (PWB), Functional well-being (FWB) and Breast cancer subscale (BCS). The TOI score range is 0-92 with the higher scores representing the more favourable outcomes. Data were collected from a subgroup of patients.
Time Frame
TOI questionnaires were completed every 4 weeks from randomisation until week 24 and then again at treatment discontinuation, for study duration (48 months)
Title
Overall Survival (OS) - Follow-up
Description
Overall Survival is equivalent to time to death. For this endpoint, all deaths occurring during the study as a whole until the data cut-off for the survival extension (31st October 2011) are presented (analysis at 75% deaths)
Time Frame
Median time (in months) from randomisation until death (from any cause),up to 80 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
130 Years
Accepts Healthy Volunteers
No
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
Evidence of positive estrogen receptor hormone sensitivity
Written informed consent to participate in the trial
Exclusion Criteria:
Treatment with an investigational or non-approved drug within one month
An existing serious disease, illness, or condition that will prevent participation or compliance with study procedures
A history of allergies to any active or inactive ingredients of Faslodex (i.e. castor oil)
Treatment with more than one regimen of chemotherapy for advanced breast cancer
Treatment with more than one regimen of hormonal treatment for advanced breast cancer
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Faslodex Medical Science Director, MD
Organizational Affiliation
AstraZeneca
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
Casa Grande
State/Province
Arizona
ZIP/Postal Code
85122
Country
United States
Facility Name
Research Site
City
Fountain Valley
State/Province
California
ZIP/Postal Code
92708
Country
United States
Facility Name
Research Site
City
New Britain
State/Province
Connecticut
ZIP/Postal Code
06052
Country
United States
Facility Name
Research Site
City
Crystal River
State/Province
Florida
ZIP/Postal Code
34429
Country
United States
Facility Name
Research Site
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33308
Country
United States
Facility Name
Research Site
City
Urbana
State/Province
Illinois
ZIP/Postal Code
61801
Country
United States
Facility Name
Research Site
City
Rosedale
State/Province
Maryland
ZIP/Postal Code
21237
Country
United States
Facility Name
Research Site
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Research Site
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64131
Country
United States
Facility Name
Research Site
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
Research Site
City
Voorhees
State/Province
New Jersey
ZIP/Postal Code
08043
Country
United States
Facility Name
Research Site
City
Greenville
State/Province
North Carolina
ZIP/Postal Code
27858
Country
United States
Facility Name
Research Site
City
Pasadena
State/Province
Texas
ZIP/Postal Code
77504
Country
United States
Facility Name
Research Site
City
West Bend
State/Province
Wisconsin
ZIP/Postal Code
53095
Country
United States
Facility Name
Research Site
City
Brasschaat
ZIP/Postal Code
2930
Country
Belgium
Facility Name
Research Site
City
Brussels
ZIP/Postal Code
1070
Country
Belgium
Facility Name
Research Site
City
Brussels
ZIP/Postal Code
1090
Country
Belgium
Facility Name
Research Site
City
Edegem
ZIP/Postal Code
2650
Country
Belgium
Facility Name
Research Site
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
Research Site
City
Hasselt
ZIP/Postal Code
3500
Country
Belgium
Facility Name
Research Site
City
Liège
ZIP/Postal Code
4000
Country
Belgium
Facility Name
Research Site
City
Turnhout
ZIP/Postal Code
2300
Country
Belgium
Facility Name
Research Site
City
Barretos
ZIP/Postal Code
14784-400
Country
Brazil
Facility Name
Research Site
City
Londrina
ZIP/Postal Code
86010-640
Country
Brazil
Facility Name
Research Site
City
Porto Alegre
ZIP/Postal Code
91350-200
Country
Brazil
Facility Name
Research Site
City
Recife
ZIP/Postal Code
50670-420
Country
Brazil
Facility Name
Research Site
City
Salvador
ZIP/Postal Code
40170-070
Country
Brazil
Facility Name
Research Site
City
Sao Paulo
ZIP/Postal Code
04039-001
Country
Brazil
Facility Name
Research Site
City
Antofagasta
Country
Chile
Facility Name
Research Site
City
Santiago
ZIP/Postal Code
8380455
Country
Chile
Facility Name
Research Site
City
Santiago
Country
Chile
Facility Name
Research Site
City
Bogota
Country
Colombia
Facility Name
Research Site
City
Cali
Country
Colombia
Facility Name
Research Site
City
Brno
ZIP/Postal Code
656 53
Country
Czechia
Facility Name
Research Site
City
Ceske Budejovice
ZIP/Postal Code
370 87
Country
Czechia
Facility Name
Research Site
City
Pardubice
ZIP/Postal Code
520 03
Country
Czechia
Facility Name
Research Site
City
Praha 10
ZIP/Postal Code
100 34
Country
Czechia
Facility Name
Research Site
City
Praha 2
ZIP/Postal Code
128 08
Country
Czechia
Facility Name
Research Site
City
Praha 8
ZIP/Postal Code
180 00
Country
Czechia
Facility Name
Research Site
City
Tabor
ZIP/Postal Code
390 03
Country
Czechia
Facility Name
Research Site
City
Nyíregyháza
ZIP/Postal Code
4400
Country
Hungary
Facility Name
Research Site
City
Szombathely
ZIP/Postal Code
9700
Country
Hungary
Facility Name
Research Site
City
Székesfehérvár
ZIP/Postal Code
8000
Country
Hungary
Facility Name
Research Site
City
Ansari Nagar
ZIP/Postal Code
110 029
Country
India
Facility Name
Research Site
City
Bhopal
ZIP/Postal Code
462001
Country
India
Facility Name
Research Site
City
Hyderabad
ZIP/Postal Code
500082
Country
India
Facility Name
Research Site
City
Jaipur
ZIP/Postal Code
302013
Country
India
Facility Name
Research Site
City
Kolkata
ZIP/Postal Code
700054
Country
India
Facility Name
Research Site
City
Manipal
ZIP/Postal Code
576 104
Country
India
Facility Name
Research Site
City
Marg Jaipur
ZIP/Postal Code
302004
Country
India
Facility Name
Research Site
City
Mumbai
ZIP/Postal Code
400012
Country
India
Facility Name
Research Site
City
Pune
ZIP/Postal Code
411001
Country
India
Facility Name
Research Site
City
Trivandrum
ZIP/Postal Code
2417
Country
India
Facility Name
Research Site
City
Vellore
ZIP/Postal Code
632004
Country
India
Facility Name
Research Site
City
Aviano
ZIP/Postal Code
33081
Country
Italy
Facility Name
Research Site
City
Bergamo
ZIP/Postal Code
24128
Country
Italy
Facility Name
Research Site
City
Carpi
ZIP/Postal Code
41012
Country
Italy
Facility Name
Research Site
City
Genova
ZIP/Postal Code
16132
Country
Italy
Facility Name
Research Site
City
Prato
ZIP/Postal Code
59100
Country
Italy
Facility Name
Research Site
City
Reggio Emilia
ZIP/Postal Code
42100
Country
Italy
Facility Name
Research Site
City
Varese
ZIP/Postal Code
21100
Country
Italy
Facility Name
Research Site
City
Floriana
ZIP/Postal Code
VLT 14
Country
Malta
Facility Name
Research Site
City
Mexico City
ZIP/Postal Code
06720
Country
Mexico
Facility Name
Research Site
City
Mexico
ZIP/Postal Code
01090
Country
Mexico
Facility Name
Research Site
City
Mexico
ZIP/Postal Code
14140
Country
Mexico
Facility Name
Research Site
City
Białystok
ZIP/Postal Code
15-027
Country
Poland
Facility Name
Research Site
City
Poznań
ZIP/Postal Code
61-878
Country
Poland
Facility Name
Research Site
City
Łódź
ZIP/Postal Code
90-553
Country
Poland
Facility Name
Research Site
City
Ivanovo
ZIP/Postal Code
153040
Country
Russian Federation
Facility Name
Research Site
City
Kazan, Tatarstan
ZIP/Postal Code
420029
Country
Russian Federation
Facility Name
Research Site
City
Kazan, Tatarstan
ZIP/Postal Code
420111
Country
Russian Federation
Facility Name
Research Site
City
Krasnodar
ZIP/Postal Code
350040
Country
Russian Federation
Facility Name
Research Site
City
Lipetsk
ZIP/Postal Code
398005
Country
Russian Federation
Facility Name
Research Site
City
Moscow
ZIP/Postal Code
107005
Country
Russian Federation
Facility Name
Research Site
City
Moscow
ZIP/Postal Code
115478
Country
Russian Federation
Facility Name
Research Site
City
Moscow
ZIP/Postal Code
121356
Country
Russian Federation
Facility Name
Research Site
City
Moscow
ZIP/Postal Code
59401
Country
Russian Federation
Facility Name
Research Site
City
Nizhniy Novgorod
ZIP/Postal Code
603081
Country
Russian Federation
Facility Name
Research Site
City
Obninsk
ZIP/Postal Code
249020
Country
Russian Federation
Facility Name
Research Site
City
Ryazan
ZIP/Postal Code
390046
Country
Russian Federation
Facility Name
Research Site
City
St-Petersburg
ZIP/Postal Code
197758
Country
Russian Federation
Facility Name
Research Site
City
St.-Petersburg
ZIP/Postal Code
197089
Country
Russian Federation
Facility Name
Research Site
City
St.Petersburg
ZIP/Postal Code
191014
Country
Russian Federation
Facility Name
Research Site
City
Yaroslavl
ZIP/Postal Code
150054
Country
Russian Federation
Facility Name
Research Site
City
Bardejov
ZIP/Postal Code
08501
Country
Slovakia
Facility Name
Research Site
City
Bratislava
ZIP/Postal Code
812 50
Country
Slovakia
Facility Name
Research Site
City
Nitra
ZIP/Postal Code
949 01
Country
Slovakia
Facility Name
Research Site
City
Trnava
ZIP/Postal Code
917 75
Country
Slovakia
Facility Name
Research Site
City
A Coruña
ZIP/Postal Code
15006
Country
Spain
Facility Name
Research Site
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Research Site
City
Malaga
ZIP/Postal Code
29010
Country
Spain
Facility Name
Research Site
City
Oviedo
ZIP/Postal Code
33011
Country
Spain
Facility Name
Research Site
City
Salamanca
ZIP/Postal Code
37007
Country
Spain
Facility Name
Research Site
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Facility Name
Research Site
City
Cherkasy
ZIP/Postal Code
18009
Country
Ukraine
Facility Name
Research Site
City
Dnipro
ZIP/Postal Code
49102
Country
Ukraine
Facility Name
Research Site
City
Donetsk
ZIP/Postal Code
83092
Country
Ukraine
Facility Name
Research Site
City
Kyiv
ZIP/Postal Code
03022
Country
Ukraine
Facility Name
Research Site
City
Lviv
ZIP/Postal Code
79031
Country
Ukraine
Facility Name
Research Site
City
Sumy
ZIP/Postal Code
40022
Country
Ukraine
Facility Name
Research Site
City
Ternopil
ZIP/Postal Code
46023
Country
Ukraine
Facility Name
Research Site
City
Uzhhorod
ZIP/Postal Code
88000
Country
Ukraine
Facility Name
Research Site
City
Caracas
Country
Venezuela
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure
IPD Sharing Time Frame
AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure
IPD Sharing Access Criteria
When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure
IPD Sharing URL
https://astrazenecagroup-dt.pharmacm.com/DT/Home
Citations:
PubMed Identifier
29522361
Citation
Wedam SB, Beaver JA, Amiri-Kordestani L, Bloomquist E, Tang S, Goldberg KB, Sridhara R, Ibrahim A, Kim G, Kluetz P, McKee A, Pazdur R. US Food and Drug Administration Pooled Analysis to Assess the Impact of Bone-Only Metastatic Breast Cancer on Clinical Trial Outcomes and Radiographic Assessments. J Clin Oncol. 2018 Apr 20;36(12):1225-1231. doi: 10.1200/JCO.2017.74.6917. Epub 2018 Mar 9.
Results Reference
derived
Links:
URL
http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_6111&studyid=589&filename=CSP-D6997C00002.PDF
Description
CSP-D6997C00002.PDF
URL
http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_6111&studyid=589&filename=CSR-D6997C00002.pdf
Description
D6997C00002 Study Report Synopsis
Learn more about this trial
Comparison of Fulvestrant (FASLODEX™) 250 mg and 500 mg in Postmenopausal Women With Oestrogen Receptor Positive Advanced Breast Cancer Progressing or Relapsing After Previous Endocrine Therapy.
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