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.

Breast Cancer Clinical Trial

— 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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00099437
• Other study ID #: D6997C00002
• Secondary ID: 2004-002371-16
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: February 13, 2005
• Est. completion date: March 29, 2024

Study information

• Verified date: February 2024
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 736
• Est. completion date: March 29, 2024
• Est. primary completion date: February 27, 2009
• 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 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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• Fulvestrant
intramuscular injection

Locations

Country	Name	City	State
Belgium	Research Site	Brasschaat
Belgium	Research Site	Brussels
Belgium	Research Site	Brussels
Belgium	Research Site	Edegem
Belgium	Research Site	Gent
Belgium	Research Site	Hasselt
Belgium	Research Site	Liège
Belgium	Research Site	Turnhout
Brazil	Research Site	Barretos
Brazil	Research Site	Londrina
Brazil	Research Site	Porto Alegre
Brazil	Research Site	Recife
Brazil	Research Site	Salvador
Brazil	Research Site	Sao Paulo
Chile	Research Site	Antofagasta
Chile	Research Site	Santiago
Chile	Research Site	Santiago
Colombia	Research Site	Bogota
Colombia	Research Site	Cali
Czechia	Research Site	Brno
Czechia	Research Site	Ceske Budejovice
Czechia	Research Site	Pardubice
Czechia	Research Site	Praha 10
Czechia	Research Site	Praha 2
Czechia	Research Site	Praha 8
Czechia	Research Site	Tabor
Hungary	Research Site	Nyíregyháza
Hungary	Research Site	Székesfehérvár
Hungary	Research Site	Szombathely
India	Research Site	Ansari Nagar
India	Research Site	Bhopal
India	Research Site	Hyderabad
India	Research Site	Jaipur
India	Research Site	Kolkata
India	Research Site	Manipal
India	Research Site	Marg Jaipur
India	Research Site	Mumbai
India	Research Site	Pune
India	Research Site	Trivandrum
India	Research Site	Vellore
Italy	Research Site	Aviano
Italy	Research Site	Bergamo
Italy	Research Site	Carpi
Italy	Research Site	Genova
Italy	Research Site	Prato
Italy	Research Site	Reggio Emilia
Italy	Research Site	Varese
Malta	Research Site	Floriana
Mexico	Research Site	Mexico
Mexico	Research Site	Mexico
Mexico	Research Site	Mexico City
Poland	Research Site	Bialystok
Poland	Research Site	Lódz
Poland	Research Site	Poznan
Russian Federation	Research Site	Ivanovo
Russian Federation	Research Site	Kazan, Tatarstan
Russian Federation	Research Site	Kazan, Tatarstan
Russian Federation	Research Site	Krasnodar
Russian Federation	Research Site	Lipetsk
Russian Federation	Research Site	Moscow
Russian Federation	Research Site	Moscow
Russian Federation	Research Site	Moscow
Russian Federation	Research Site	Moscow
Russian Federation	Research Site	Nizhniy Novgorod
Russian Federation	Research Site	Obninsk
Russian Federation	Research Site	Ryazan
Russian Federation	Research Site	St-Petersburg
Russian Federation	Research Site	St.-Petersburg
Russian Federation	Research Site	St.Petersburg
Russian Federation	Research Site	Yaroslavl
Slovakia	Research Site	Bardejov
Slovakia	Research Site	Bratislava
Slovakia	Research Site	Nitra
Slovakia	Research Site	Trnava
Spain	Research Site	A Coruña
Spain	Research Site	Madrid
Spain	Research Site	Malaga
Spain	Research Site	Oviedo
Spain	Research Site	Salamanca
Spain	Research Site	Sevilla
Ukraine	Research Site	Cherkasy
Ukraine	Research Site	Dnipro
Ukraine	Research Site	Donetsk
Ukraine	Research Site	Kyiv
Ukraine	Research Site	Lviv
Ukraine	Research Site	Sumy
Ukraine	Research Site	Ternopil
Ukraine	Research Site	Uzhhorod
United States	Research Site	Casa Grande	Arizona
United States	Research Site	Crystal River	Florida
United States	Research Site	Detroit	Michigan
United States	Research Site	Fort Lauderdale	Florida
United States	Research Site	Fountain Valley	California
United States	Research Site	Greenville	North Carolina
United States	Research Site	Kansas City	Missouri
United States	Research Site	New Britain	Connecticut
United States	Research Site	Pasadena	Texas
United States	Research Site	Rosedale	Maryland
United States	Research Site	Saint Louis	Missouri
United States	Research Site	Urbana	Illinois
United States	Research Site	Voorhees	New Jersey
United States	Research Site	West Bend	Wisconsin
Venezuela	Research Site	Caracas

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Countries where clinical trial is conducted

United States,  Venezuela,  Belgium,  Brazil,  Chile,  Colombia,  Czechia,  Hungary,  India,  Italy,  Malta,  Mexico,  Poland,  Russian Federation,  Slovakia,  Spain,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to Progression (TTP)	Median time (in months) from randomisation until objective disease progression or death (in the absence of objective progression).	RECIST(Response Evaluation Criteria in Solid Tumors ) tumour assessments carried out every 12 weeks (+/- 2 weeks) from randomisation for study duration (48 months)
Secondary	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.	RECIST tumour assessments carried out every 12 weeks (+/- 2 weeks) from randomisation for study duration (48 months)
Secondary	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.	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)
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 achieve a confirmed complete response (CR) or confirmed partial response (PR)	RECIST tumour assessments carried out every 12 weeks (+/- 2 weeks) from randomisation for study duration (48 months)
Secondary	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	RECIST tumour assessments carried out every 12 weeks (+/- 2 weeks) from randomisation for study duration (48 months)
Secondary	Overall Survival (OS)	Median time (in months) from randomisation until death (from any cause) (analysis at 50% deaths )	Overall Survival is equivalent to time to death. For this endpoint, all deaths occurring for study duration (48 months)
Secondary	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.	TOI questionnaires were completed every 4 weeks from randomisation until week 24 and then again at treatment discontinuation, for study duration (48 months)
Secondary	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)	Median time (in months) from randomisation until death (from any cause),up to 80 months

External Links

•   CSP-D6997C00002.PDF
•   D6997C00002 Study Report Synopsis