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. (CONFIRM)

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Breast Cancer
• Intervention / Treatment: Drug: Fulvestrant

• Study Type: Interventional
• Enrollment (Actual): 736
• Phase: Phase 3

Contacts and Locations

Study Locations

• Belgium
  • Brasschaat, Belgium, 2930
    • Research Site
  • Brussels, Belgium, 1090
    • Research Site
  • Brussels, Belgium, 1070
    • Research Site
  • Edegem, Belgium, 2650
    • Research Site
  • Ghent, Belgium, 9000
    • Research Site
  • Hasselt, Belgium, 3500
    • Research Site
  • Liège, Belgium, 4000
    • Research Site
  • Turnhout, Belgium, 2300
    • Research Site
• Brazil
  • Barretos, Brazil, 14784-400
    • Research Site
  • Londrina, Brazil, 86010-640
    • Research Site
  • Porto Alegre, Brazil, 91350-200
    • Research Site
  • Recife, Brazil, 50670-420
    • Research Site
  • Salvador, Brazil, 40170-070
    • Research Site
  • São Paulo, Brazil, 04039-001
    • Research Site
• Chile
  • Antofagasta, Chile, 1240000
    • Research Site
  • Santiago, Chile
    • Research Site
  • Santiago, Chile, 8380455
    • Research Site
• Colombia
  • Bogotá, Colombia
    • Research Site
  • Cali, Colombia
    • Research Site
• Czechia
  • Brno, Czechia, 656 53
    • Research Site
  • Pardubice, Czechia, 520 03
    • Research Site
  • Prague, Czechia, 100 34
    • Research Site
  • Prague, Czechia, 128 08
    • Research Site
  • Prague, Czechia, 180 00
    • Research Site
  • Tábor, Czechia, 390 03
    • Research Site
  • V Uvalu 84, Czechia, 150 06
    • Research Site
  • České Budějovice, Czechia, 370 87
    • Research Site
• Hungary
  • Nyíregyháza, Hungary, 4400
    • Research Site
  • Szombathely, Hungary, 9700
    • Research Site
  • Székesfehérvár, Hungary, 8000
    • Research Site
• India
  • Ansārinagar, India, 110 029
    • Research Site
  • Bhopal, India, 462001
    • Research Site
  • Hyderabad, India, 500082
    • Research Site
  • Jaipur, India, 302013
    • Research Site
  • Kolkata, India, 700054
    • Research Site
  • Manipal, India, 576 104
    • Research Site
  • Marg Jaipur, India, 302004
    • Research Site
  • Mumbai, India, 400012
    • Research Site
  • Pune, India, 411001
    • Research Site
  • Trivandrum, India, 2417
    • Research Site
  • Vellore, India, 632004
    • Research Site
• Italy
  • Aviano, Italy, 33081
    • Research Site
  • Bergamo, Italy, 24128
    • Research Site
  • Carpi, Italy, 41012
    • Research Site
  • Genova, Italy, 16132
    • Research Site
  • Prato, Italy, 59100
    • Research Site
  • Reggio Emilia, Italy, 42100
    • Research Site
  • Varese, Italy, 21100
    • Research Site
• Malta
  • Floriana, Malta, VLT 14
    • Research Site
• Mexico
  • Mexico City, Mexico, 06720
    • Research Site
  • México, Mexico, 01090
    • Research Site
  • México, Mexico, 14140
    • Research Site
• Poland
  • Bialystok, Poland, 15-027
    • Research Site
  • Lodz, Poland, 90-553
    • Research Site
  • Poznan, Poland, 61-878
    • Research Site
• Russia
  • Ivanovo, Russia, 153040
    • Research Site
  • Kazan, Tatarstan, Russia, 420029
    • Research Site
  • Kazan, Tatarstan, Russia, 420111
    • Research Site
  • Krasnodar, Russia, 350040
    • Research Site
  • Lipetsk, Russia, 398005
    • Research Site
  • Moscow, Russia, 115478
    • Research Site
  • Moscow, Russia, 107005
    • Research Site
  • Moscow, Russia, 121356
    • Research Site
  • Moscow, Russia, 59401
    • Research Site
  • Nizhny Novgorod, Russia, 603081
    • Research Site
  • Obninsk, Russia, 249020
    • Research Site
  • Ryazan, Russia, 390046
    • Research Site
  • Saint Petersburg, Russia, 197758
    • Research Site
  • Saint Petersburg, Russia, 191014
    • Research Site
  • Saint Petersburg, Russia, 197089
    • Research Site
  • Yaroslavl, Russia, 150054
    • Research Site
• Slovakia
  • Bardejov, Slovakia, 08501
    • Research Site
  • Bratislava, Slovakia, 812 50
    • Research Site
  • Nitra, Slovakia, 949 01
    • Research Site
  • Trnava, Slovakia, 917 75
    • Research Site
• Spain
  • A Coruña, Spain, 15006
    • Research Site
  • Madrid, Spain, 28040
    • Research Site
  • Málaga, Spain, 29010
    • Research Site
  • Oviedo, Spain, 33011
    • Research Site
  • Salamanca, Spain, 37007
    • Research Site
  • Seville, Spain, 41013
    • Research Site
• Ukraine
  • Cherkasy, Ukraine, 18009
    • Research Site
  • Dnipro, Ukraine, 49102
    • Research Site
  • Donetsk, Ukraine, 83092
    • Research Site
  • Kyiv, Ukraine, 03022
    • Research Site
  • Lviv, Ukraine, 79031
    • Research Site
  • Sumy, Ukraine, 40022
    • Research Site
  • Ternopil, Ukraine, 46023
    • Research Site
  • Uzhhorod, Ukraine, 88000
    • Research Site
• United States
  • Arizona
    • Casa Grande, Arizona, United States, 85122
      • Research Site
  • California
    • Fountain Valley, California, United States, 92708
      • Research Site
  • Connecticut
    • New Britain, Connecticut, United States, 06052
      • Research Site
  • Florida
    • Crystal River, Florida, United States, 34429
      • Research Site
    • Fort Lauderdale, Florida, United States, 33308
      • Research Site
  • Illinois
    • Urbana, Illinois, United States, 61801
      • Research Site
  • Maryland
    • Rosedale, Maryland, United States, 21237
      • Research Site
  • Michigan
    • Detroit, Michigan, United States, 48202
      • Research Site
  • Missouri
    • Kansas City, Missouri, United States, 64131
      • Research Site
    • St Louis, Missouri, United States, 63141
      • Research Site
  • New Jersey
    • Voorhees Township, New Jersey, United States, 08043
      • Research Site
  • North Carolina
    • Greenville, North Carolina, United States, 27858
      • Research Site
  • Texas
    • Pasadena, Texas, United States, 77504
      • Research Site
  • Wisconsin
    • West Bend, Wisconsin, United States, 53095
      • Research Site
• Venezuela
  • Caracas, Venezuela, 1010
    • Research Site
  • Caracas, Venezuela, 1053
    • Research Site
  • Caracas, Venezuela, 1060
    • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 130 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1; Fulvestrant 500 mg	Drug: Fulvestrant; intramuscular injection; Other Names: Faslodex; ZD9238
Experimental: 2; Fulvestrant 250 mg	Drug: Fulvestrant; intramuscular injection; Other Names: Faslodex; ZD9238

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)
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)
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)
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)
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)
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

Collaborators and Investigators

• Sponsor: AstraZeneca
• Investigators: Study Director: Faslodex Medical Science Director, MD, AstraZeneca

Publications and helpful links

General Publications

• 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.

Helpful Links

• CSP-D6997C00002.PDF
• D6997C00002 Study Report Synopsis

Study record dates

Study Major Dates

• Study Start (Actual): February 13, 2005
• Primary Completion (Actual): February 27, 2009
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: December 13, 2004
• First Submitted That Met QC Criteria: December 13, 2004
• First Posted (Estimated): December 14, 2004

Study Record Updates

• Last Update Posted (Actual): March 18, 2026
• Last Update Submitted That Met QC Criteria: February 26, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Advanced Breast Cancer; Metastatic Breast Cancer
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Skin and Connective Tissue Diseases; Breast Neoplasms; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Polycyclic Compounds; Steroids; Fused-Ring Compounds; Estradiol; Estrenes; Estranes; Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Fulvestrant
• Other Study ID Numbers: D6997C00002; 2004-002371-16 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD 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 Supporting Information Type: STUDY_PROTOCOL; SAP