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)

September 10, 2026 updated by: AstraZeneca

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

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
736

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Time to Progression (TTP)
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)
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Objective Response Rate (ORR)
Time Frame: RECIST tumour assessments carried out every 12 weeks (+/- 2 weeks) from randomisation for study duration (48 months)
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)
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)
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 Frame: RECIST tumour assessments carried out every 12 weeks (+/- 2 weeks) from randomisation for study duration (48 months)
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 Frame: RECIST tumour assessments carried out every 12 weeks (+/- 2 weeks) from randomisation for study duration (48 months)
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)
Time Frame: Overall Survival is equivalent to time to death. For this endpoint, all deaths occurring for study duration (48 months)
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
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)
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
Time Frame: Median time (in months) from randomisation until death (from any cause),up to 80 months
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
AstraZeneca

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Faslodex Medical Science Director, MD, AstraZeneca

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 13, 2005

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 27, 2009

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 13, 2004

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 13, 2004

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 14, 2004

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 14, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 10, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • D6997C00002
  • 2004 (U.S. NIH Grant/Contract)
  • 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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