A Global Study to Compare the Effects of Fulvestrant and Arimidex in a Subset of Patients With Breast Cancer. (FALCON)

February 6, 2026 updated by: AstraZeneca

A Randomised, Double-blind, Parallel-group, Multicentre, Phase III Study to Compare the Efficacy and Tolerability of Fulvestrant (FASLODEX) 500 mg With Anastrozole (ARIMIDEX) 1 mg as Hormonal Treatment for Postmenopausal Women With Hormone Receptor-Positive Locally Advanced or Metastatic Breast Cancer Who Have Not Previously Been Treated With Any Hormonal Therapy.

The purpose of the study is to compare how treatment with Fulvestrant (FASLODEX) or Anastrozole (ARIMIDEX) effects disease progression for women with locally advanced or metastatic breast cancer who have not had prior hormonal treatment.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

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.

Detailed Description

A Randomised, Double-blind, Parallel-group, Multicentre, Phase III Study to Compare the Efficacy and Tolerability of Fulvestrant (FASLODEX) 500 mg with Anastrozole (ARIMIDEX) 1 mg as Hormonal Treatment for Postmenopausal Women with Hormone Receptor-Positive Locally Advanced or Metastatic Breast Cancer Who Have Not Previously Been Treated With Any Hormonal Therapy.

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.
462

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

  • Argentina
      • La Rioja, Argentina, 5300
        • Research Site
      • Mar del Plata, Argentina, B7600CTO
        • Research Site
      • Pergamino, Argentina, B2700CPM
        • Research Site
      • Rosario, Argentina, S2000KZE
        • Research Site
  • Brazil
      • Porto Alegre, Brazil, 91350-200
        • Research Site
      • Santo André, Brazil, 09060-870
        • Research Site
  • Canada
    • British Columbia
      • Abbotsford, British Columbia, Canada, V2S0C2
        • Research Site
      • Vancouver, British Columbia, Canada, V5Z 4E6
        • Research Site
    • Ontario
      • Kitchener, Ontario, Canada, N2G 1G3
        • Research Site
      • Thunder Bay, Ontario, Canada, P7B 6V4
        • Research Site
    • Quebec
      • Montreal, Quebec, Canada, H4A 3J1
        • Research Site
      • Montreal, Quebec, Canada, H3T 1E2
        • Research Site
  • China
      • Chengdu, China, 610041
        • Research Site
      • Dalian, China, 116011
        • Research Site
      • Fuzhou, China, 350025
        • Research Site
      • Guangzhou, China, 510060
        • Research Site
      • Shanghai, China, 200032
        • Research Site
      • Shenyang, China, 110001
        • Research Site
      • Suzhou, China, 215004
        • Research Site
      • Tianjin, China, 300060
        • Research Site
  • Czechia
      • Prague, Czechia, 150 06
        • Research Site
      • Příbram, Czechia, 261 01
        • Research Site
  • Italy
      • Avellino, Italy, 83100
        • Research Site
      • Bari, Italy, 70124
        • Research Site
      • Benevento, Italy, 82100
        • Research Site
      • Catania, Italy, 95126
        • Research Site
      • Genova, Italy, 16128
        • Research Site
      • Pisa, Italy, 56100
        • Research Site
      • Roma, Italy, 00144
        • Research Site
      • Roma, Italy, 00161
        • Research Site
      • Roma, Italy, 00100
        • Research Site
      • Treviglio, Italy, 24047
        • Research Site
  • Japan
      • Fukuoka, Japan, 811-1395
        • Research Site
      • Hamamatsu, Japan, 430-0906
        • Research Site
      • Kagoshima, Japan, 892-0833
        • Research Site
      • Kumamoto, Japan, 860-8556
        • Research Site
      • Matsuyama, Japan, 791-0280
        • Research Site
      • Mitaka-shi, Japan, 181-8611
        • Research Site
      • Nishinomiya-shi, Japan, 663-8501
        • Research Site
      • Osaka, Japan, 540-0006
        • Research Site
      • Sakaishi, Japan, 590-0064
        • Research Site
      • Suita-shi, Japan, 565-0871
        • Research Site
  • Mexico
      • Mexico City, Mexico, 6760
        • Research Site
      • Monterrey, Mexico, 64710
        • Research Site
      • Monterrey, Mexico, 64000
        • Research Site
      • Monterrey, Mexico, 64060
        • Research Site
      • Mérida, Mexico, 97000
        • Research Site
  • Peru
      • Lima, Peru, LIMA 27
        • Research Site
      • Lima, Peru, LIMA 41
        • Research Site
      • Lima, Peru, Lima 18
        • Research Site
      • Lima, Peru, LIMA 33
        • Research Site
  • Poland
      • Katowice, Poland, 40-635
        • Research Site
      • Lodz, Poland, 90-242
        • Research Site
      • Lublin, Poland, 20-718
        • Research Site
  • Romania
      • Brăila, Romania, 810325
        • Research Site
      • Craiova, Romania, 200347
        • Research Site
      • Onești, Romania, 601048
        • Research Site
      • Timișoara, Romania, 300239
        • Research Site
  • Russia
      • Barnaul, Russia, 656052
        • Research Site
      • Moscow, Russia, 115478
        • Research Site
      • Omsk, Russia, 644013
        • Research Site
      • Ryazan, Russia, 390046
        • Research Site
      • Saint Petersburg, Russia, 197758
        • Research Site
      • Saint Petersburg, Russia, 191014
        • Research Site
      • Saint Petersburg, Russia, 197022
        • Research Site
      • Saint Petersburg, Russia, 195271
        • Research Site
      • Tomsk, Russia, 634028
        • Research Site
  • Slovakia
      • Bardejov, Slovakia, 085 01
        • Research Site
      • Bratislava, Slovakia, 833 10
        • Research Site
      • Bratislava, Slovakia, 814 65
        • Research Site
      • Trenčín, Slovakia, 91171
        • Research Site
  • South Africa
      • Cape Town, South Africa, 7700
        • Research Site
      • Cape Town, South Africa, 7570
        • Research Site
      • Cape Town, South Africa, 7925
        • Research Site
      • Pietermaritzburg, South Africa, 3201
        • Research Site
      • Pretoria, South Africa, 0081
        • Research Site
      • Pretoria, South Africa, 0001
        • Research Site
  • Spain
      • Madrid, Spain, 28034
        • Research Site
      • Madrid, Spain, 28050
        • Research Site
      • Pamplona, Spain, 31008
        • Research Site
      • Pozuelo de Alarcón, Spain, 28223
        • Research Site
      • Sabadell, Spain, 8208
        • Research Site
      • Seville, Spain, 41009
        • Research Site
      • Seville, Spain, 41013
        • Research Site
      • Seville, Spain, 41014
        • Research Site
      • Valencia, Spain, 46026
        • Research Site
      • Valencia, Spain, 46014
        • Research Site
  • Taiwan
      • Taichung, Taiwan, 40447
        • Research Site
      • Taipei, Taiwan, 235
        • Research Site
      • Taipei, Taiwan, 10449
        • Research Site
      • Taipei, Taiwan, 112
        • Research Site
  • Turkey (Türkiye)
      • Ankara, Turkey (Türkiye), 06100
        • Research Site
      • Gaziantep, Turkey (Türkiye), 27310
        • Research Site
  • Ukraine
      • Cherkasy, Ukraine, 18009
        • Research Site
      • Dnipro, Ukraine, 49102
        • Research Site
      • Donetsk, Ukraine, 83092
        • Research Site
      • Ivano-Frankivsk, Ukraine, 76014
        • Research Site
      • Kharkiv Region, Ukraine, 61070
        • Research Site
      • Kyiv, Ukraine, 3115
        • Research Site
      • Lviv, Ukraine, 79031
        • Research Site
      • Mariupol, Ukraine, 87500
        • Research Site
      • Uzhhorod, Ukraine, 88000
        • Research Site
      • Vinnytsia, Ukraine, 21029
        • Research Site
  • United Kingdom
      • Airdrie, United Kingdom, ML6 0JS
        • Research Site
      • Derby, United Kingdom, DE22 3NE
        • Research Site
      • Stoke-on-Trent, United Kingdom, ST4 6QG
        • Research Site
  • United States
    • California
      • Modesto, California, United States, 95355
        • Research Site
    • Georgia
      • Savannah, Georgia, United States, 31405
        • Research Site
    • Maine
      • Auburn, Maine, United States, 04212
        • Research Site
    • Massachusetts
      • Worcester, Massachusetts, United States, 01608
        • Research Site
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Research Site
    • Missouri
      • St Louis, Missouri, United States, 63110
        • Research Site
    • Nebraska
      • Lincoln, Nebraska, United States, 68506
        • Research Site
    • New Jersey
      • Somerset, New Jersey, United States, 08873
        • Research Site
    • Ohio
      • Columbus, Ohio, United States, 43202
        • Research Site
      • Montgomery, Ohio, United States, 45242
        • Research Site
    • Tennessee
      • Memphis, Tennessee, United States, 38120
        • Research Site
    • Utah
      • Salt Lake City, Utah, United States, 84107
        • 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

14 years to 126 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Histological confirmation of breast cancer in post menopausal women (age >=60). Positive hormone receptor status (ER +ve and/or PgR +ve) of primary or metastatic tumour tissue based on local laboratory assessment.
  • EITHER locally advanced disease (1 line of chemotherapy allowed only if remain unsuitable for therapy of curative intent) OR Metastatic disease. (1 line of chemotherapy for breast cancer allowed only if subsequent evidence of further progressive disease)
  • At least 1 lesion (measurable and/or non-measurable) that can be accurately assessed at baseline and is suitable for repeated assessment.

  • Postmenopausal women, fulfilling 1 of:

    • Prior bilateral oophorectomy
    • Age >60 years
    • Age < 60 years and amenorrheic for 12+months in the absence of chemotherapy, tamoxifen, toremifene, or ovarian suppression and FSH and oestradiol in the postmenopausal range

Exclusion Criteria:

  • Presence of life-threatening metastatic disease

  • Any of:

    • Extensive hepatic involvement
    • involving brain or meninges
    • symptomatic pulmonary lymph spread
  • Discrete lung metastases are acceptable if respiratory function is not significantly compromised
  • Prior systemic therapy for breast cancer other than one line of cytotoxic chemotherapy (the last dose of chemotherapy must have been received more than 28 days prior to randomisation)
  • Radiation therapy if not completed within 28 days prior to randomisation (with the exception of radiotherapy given for control of bone pain, started prior to randomisation). Prior hormonal treatment for breast cancer.
  • Current or prior malignancy within previous 3 years (other than breast cancer or adequately treated basal cell or squamous cell carcinoma of the skin or in situ carcinoma of the cervix).

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: faslodex+placebo
Blinded: Fulvestrant 500mg intramuscular injection (2x250mg) plus dummy Anastrozole tablets
Drug: faslodex 500mg
2 x intramuscular injections at day 1, 14, 28 and every 28 days thereafter
Drug: arimidex dummy
oral tablet 1 daily
Active Comparator: arimidex +placebo
Blinded: Anastrozole 1mg tablets plus dummy Fulvestrant intramuscular injection (2x0mg)
Drug: arimidex 1mg
oral tablet 1 daily
Drug: faslodex dummy
2 x intramuscular injections at day 1, 14, 28 and every 28 days thereafter

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
Comparison of Progression-Free Survival (PFS) in Patients Treated With Fulvestrant With Those Treated With Anastrozole
Time Frame: Baseline RECIST 1.1 assessments (Day 0) and then every 12 weeks until the earliest of disease progression evident, patient dies or has surgery/radiotherapy for their disease (up to approximately 38 months)
PFS was defined as the time from randomisation until objective disease progression according to Response Evaluation Criteria in Solid Tumours version 1.1 (RECIST 1.1), surgery or radiotherapy to manage worsening of disease or death by any cause (in the absence of progression). Outcome measure is reported as median time from randomisation to PFS, calculated using the Kaplan-Meier technique.
Baseline RECIST 1.1 assessments (Day 0) and then every 12 weeks until the earliest of disease progression evident, patient dies or has surgery/radiotherapy for their disease (up to approximately 38 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
Comparison of Overall Survival (OS) in Patients Treated With Fulvestrant With Those Treated With Anastrozole; Percentage of Patients With Events
Time Frame: Baseline (Day 0) up to data cut-off for final analysis (up to approximately 116 months). Following disease progression, patients were to be contacted at 12 weekly intervals to determine survival status
OS was defined as the time from randomisation until death by any cause. The current OS data correspond to that of the final analysis and the outcome measure is reported as percentage of patients with events.
Baseline (Day 0) up to data cut-off for final analysis (up to approximately 116 months). Following disease progression, patients were to be contacted at 12 weekly intervals to determine survival status
Objective Response Rate (ORR) for Fulvestrant Treatment Versus Anastrozole Treatment
Time Frame: Baseline RECIST 1.1 assessments (Day 0) and then every 12 weeks until disease progression or treatment discontinuation (up to approximately 38 months)
ORR was defined as the percentage patients with an objective response (i.e. those recording a partial response [PR] or complete response [CR]) at some point during the study, prior to disease progression. ORR was assessed in patients with measurable disease at baseline only. The determination of measurable disease at baseline was done using baseline RECIST data. CR was disappearance of all target lesions since baseline; was any pathological lymph nodes selected as target lesions (TL) to have a reduction in short axis to <10 millimeter. PR was at least a 30% decrease in the sum of the diameters of TL, taking as reference the baseline sum of diameters.
Baseline RECIST 1.1 assessments (Day 0) and then every 12 weeks until disease progression or treatment discontinuation (up to approximately 38 months)
Duration of Response (DoR) for Fulvestrant Treatment Versus Anastrozole Treatment
Time Frame: Baseline RECIST 1.1 assessments (Day 0) and then every 12 weeks until disease progression or treatment discontinuation (up to approximately 38 months)
DoR was defined only for patients who had an objective response, as the time in days from date of first documentation of response (CR/PR) until date of disease progression. CR was disappearance of all target lesions since baseline; any pathological lymph nodes selected as TL to have a reduction in short axis to <10 mm. At least a 30% decrease in the sum of the diameters of TL, taking as reference the baseline sum of diameters.
Baseline RECIST 1.1 assessments (Day 0) and then every 12 weeks until disease progression or treatment discontinuation (up to approximately 38 months)
Expected Duration of Response (EDoR) for Fulvestrant Treatment Versus Anastrozole Treatment
Time Frame: Baseline RECIST 1.1 assessments and then every 12 weeks until disease progression or treatment discontinuation (up to approximately 38 months)
EDoR was estimated using the formula EDoR = p Efp(x), where x = DoR, p = proportion of responders, and Efp(x) = mean duration of response for responders. The estimation was completed by using the maximum likelihood estimates of p and Efp(x), as described by Ellis (Ellis S et al. Analysis of duration of response in oncology trials, Contemp Clin Trials 2008; 29:456-65).
Baseline RECIST 1.1 assessments and then every 12 weeks until disease progression or treatment discontinuation (up to approximately 38 months)
Clinical Benefit Rate (CBR) for Fulvestrant Treatment Versus Anastrozole Treatment
Time Frame: Baseline RECIST 1.1 assessments (Day 0) and then every 12 weeks until disease progression or treatment discontinuation (up to approximately 38 months)
CBR was defined as the percentage of patients who had a clinical benefit (i.e. best objective response of CR, PR or stable disease), that was maintained for at least 24 weeks, prior to any evidence of progression. Note that a minimum duration of 22 weeks for CBR was applicable in the analysis (rather than 24 weeks) to allow for the protocolled window of +/-2 weeks.
Baseline RECIST 1.1 assessments (Day 0) and then every 12 weeks until disease progression or treatment discontinuation (up to approximately 38 months)
Duration of Clinical Benefit (DoCB) for Fulvestrant Treatment Versus Anastrozole Treatment
Time Frame: Baseline RECIST 1.1 assessments (Day 0) and then every 12 weeks until disease progression or treatment discontinuation (up to approximately 38 months)
DoCB was defined only for patients who had clinical benefit, as the time in days from date of randomisation until the date of disease progression.
Baseline RECIST 1.1 assessments (Day 0) and then every 12 weeks until disease progression or treatment discontinuation (up to approximately 38 months)
Expected Duration of Clinical Benefit (EDoCB) for Fulvestrant Treatment Versus Anastrozole Treatment
Time Frame: Baseline RECIST 1.1 assessments (Day 0) and then every 12 weeks until disease progression or treatment discontinuation (up to approximately 38 months)
EDoCB was estimated using the formula EDoCB = p Efp(x), where x = EDoCB, p = proportion of responders, and Efp(x) = mean duration of response for responders. The estimation was completed by using the maximum likelihood estimates of p and Efp(x), as described by Ellis (Ellis S et al. Analysis of duration of response in oncology trials, Contemp Clin Trials 2008; 29:456-65).
Baseline RECIST 1.1 assessments (Day 0) and then every 12 weeks until disease progression or treatment discontinuation (up to approximately 38 months)
Comparison of the Effect of Fulvestrant Treatment Versus Anastrozole Treatment on Time to Deterioration of Health-Related Quality of Life (HRQoL)
Time Frame: Quality of life questionnaires administered at 3 months post objective disease progression, then at 6-monthly intervals (approximately 75 months)
The Functional Assessment of Cancer Therapy - Breast (FACT-B) questionnaire was the instrument selected to assess HRQoL and comprised of following subscales: physical well-being (PWB), functional well-being (FWB), social well-being, emotional well-being, and breast cancer subscale (BCS). The main outcome measure from the FACT-B questionnaire was the Trial Outcome Index (TOI), which was a summary of the following subscales: PWB, FWB, and BCS. Outcome measure is reported as median time to deterioration, defined as the interval from the date of baseline of final analysis to the first assessment of worsened without an improvement in the next 12 weeks in FACT-B TOI, or the date of death (by any cause in the absence of symptom deterioration). Time to deterioration as measured by FACT-B total score was derived similarly and is also reported.
Quality of life questionnaires administered at 3 months post objective disease progression, then at 6-monthly intervals (approximately 75 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: Shankar S, MD, AstraZeneca
  • Principal Investigator: John Robertson, MD, Graduate Medicine and Health School, University of Nottingham, UK
  • Principal Investigator: Matthew Ellis, DM, Washington University School of Medicine, USA

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.
October 17, 2012

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.
April 11, 2016

Study Completion (Actual)

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.
January 16, 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).
May 11, 2012

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.
May 17, 2012

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.
May 21, 2012

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.
February 27, 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.
February 6, 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.
February 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.
  • D699BC00001
  • 2011-006326-24 (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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