A Global Study to Compare the Effects of Fulvestrant and Arimidex in a Subset of Patients With Breast Cancer.
FALCON
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.
2 other identifiers
interventional
462
20 countries
118
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Oct 2012
Longer than P75 for phase_3
118 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 11, 2012
CompletedFirst Posted
Study publicly available on registry
May 21, 2012
CompletedStudy Start
First participant enrolled
October 17, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 11, 2016
CompletedResults Posted
Study results publicly available
May 17, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
January 16, 2026
CompletedFebruary 27, 2026
February 1, 2026
3.5 years
May 11, 2012
March 23, 2017
February 6, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Comparison of Progression-Free Survival (PFS) in Patients Treated With Fulvestrant With Those Treated With Anastrozole
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 Outcomes (8)
Comparison of Overall Survival (OS) in Patients Treated With Fulvestrant With Those Treated With Anastrozole; 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
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
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
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
Baseline RECIST 1.1 assessments (Day 0) and then every 12 weeks until disease progression or treatment discontinuation (up to approximately 38 months)
- +3 more secondary outcomes
Study Arms (2)
faslodex+placebo
EXPERIMENTALBlinded: Fulvestrant 500mg intramuscular injection (2x250mg) plus dummy Anastrozole tablets
arimidex +placebo
ACTIVE COMPARATORBlinded: Anastrozole 1mg tablets plus dummy Fulvestrant intramuscular injection (2x0mg)
Interventions
2 x intramuscular injections at day 1, 14, 28 and every 28 days thereafter
2 x intramuscular injections at day 1, 14, 28 and every 28 days thereafter
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (118)
Research Site
Modesto, California, 95355, United States
Research Site
Savannah, Georgia, 31405, United States
Research Site
Auburn, Maine, 04212, United States
Research Site
Worcester, Massachusetts, 01608, United States
Research Site
Detroit, Michigan, 48202, United States
Research Site
St Louis, Missouri, 63110, United States
Research Site
Lincoln, Nebraska, 68506, United States
Research Site
Somerset, New Jersey, 08873, United States
Research Site
Columbus, Ohio, 43202, United States
Research Site
Montgomery, Ohio, 45242, United States
Research Site
Memphis, Tennessee, 38120, United States
Research Site
Salt Lake City, Utah, 84107, United States
Research Site
La Rioja, 5300, Argentina
Research Site
Mar del Plata, B7600CTO, Argentina
Research Site
Pergamino, B2700CPM, Argentina
Research Site
Rosario, S2000KZE, Argentina
Research Site
Porto Alegre, 91350-200, Brazil
Research Site
Santo André, 09060-870, Brazil
Research Site
Abbotsford British Columbia, British Columbia, V2S0C2, Canada
Research Site
Vancouver, British Columbia, V5Z 4E6, Canada
Research Site
Kitchener, Ontario, N2G 1G3, Canada
Research Site
Thunder Bay, Ontario, P7B 6V4, Canada
Research Site
Montreal, Quebec, H3T 1E2, Canada
Research Site
Montreal, Quebec, H4A 3J1, Canada
Research Site
Chengdu, 610041, China
Research Site
Dalian, 116011, China
Research Site
Fuzhou, 350025, China
Research Site
Guangzhou, 510060, China
Research Site
Shanghai, 200032, China
Research Site
Shenyang, 110001, China
Research Site
Suzhou, 215004, China
Research Site
Tianjin, 300060, China
Research Site
Prague, 150 06, Czechia
Research Site
Příbram, 261 01, Czechia
Research Site
Avellino, 83100, Italy
Research Site
Bari, 70124, Italy
Research Site
Benevento, 82100, Italy
Research Site
Catania, 95126, Italy
Research Site
Genova, 16128, Italy
Research Site
Pisa, 56100, Italy
Research Site
Roma, 00100, Italy
Research Site
Roma, 00144, Italy
Research Site
Roma, 00161, Italy
Research Site
Treviglio, 24047, Italy
Research Site
Fukuoka, 811-1395, Japan
Research Site
Hamamatsu, 430-0906, Japan
Research Site
Kagoshima, 892-0833, Japan
Research Site
Kumamoto, 860-8556, Japan
Research Site
Matsuyama, 791-0280, Japan
Research Site
Mitaka-shi, 181-8611, Japan
Research Site
Nishinomiya-shi, 663-8501, Japan
Research Site
Osaka, 540-0006, Japan
Research Site
Sakaishi, 590-0064, Japan
Research Site
Suita-shi, 565-0871, Japan
Research Site
Mexico City, 6760, Mexico
Research Site
Mérida, 97000, Mexico
Research Site
Monterrey, 64000, Mexico
Research Site
Monterrey, 64060, Mexico
Research Site
Monterrey, 64710, Mexico
Research Site
Lima, Lima 18, Peru
Research Site
Lima, LIMA 27, Peru
Research Site
Lima, LIMA 33, Peru
Research Site
Lima, LIMA 41, Peru
Research Site
Katowice, 40-635, Poland
Research Site
Lodz, 90-242, Poland
Research Site
Lublin, 20-718, Poland
Research Site
Brăila, 810325, Romania
Research Site
Craiova, 200347, Romania
Research Site
Onești, 601048, Romania
Research Site
Timișoara, 300239, Romania
Research Site
Barnaul, 656052, Russia
Research Site
Moscow, 115478, Russia
Research Site
Omsk, 644013, Russia
Research Site
Ryazan, 390046, Russia
Research Site
Saint Petersburg, 191014, Russia
Research Site
Saint Petersburg, 195271, Russia
Research Site
Saint Petersburg, 197022, Russia
Research Site
Saint Petersburg, 197758, Russia
Research Site
Tomsk, 634028, Russia
Research Site
Bardejov, 085 01, Slovakia
Research Site
Bratislava, 814 65, Slovakia
Research Site
Bratislava, 833 10, Slovakia
Research Site
Trenčín, 91171, Slovakia
Research Site
Cape Town, 7570, South Africa
Research Site
Cape Town, 7700, South Africa
Research Site
Cape Town, 7925, South Africa
Research Site
Pietermaritzburg, 3201, South Africa
Research Site
Pretoria, 0001, South Africa
Research Site
Pretoria, 0081, South Africa
Research Site
Madrid, 28034, Spain
Research Site
Madrid, 28050, Spain
Research Site
Pamplona, 31008, Spain
Research Site
Pozuelo de Alarcón, 28223, Spain
Research Site
Sabadell, 8208, Spain
Research Site
Seville, 41009, Spain
Research Site
Seville, 41013, Spain
Research Site
Seville, 41014, Spain
Research Site
Valencia, 46014, Spain
Research Site
Valencia, 46026, Spain
Research Site
Taichung, 40447, Taiwan
Research Site
Taipei, 10449, Taiwan
Research Site
Taipei, 112, Taiwan
Research Site
Taipei, 235, Taiwan
Research Site
Ankara, 06100, Turkey (Türkiye)
Research Site
Gaziantep, 27310, Turkey (Türkiye)
Research Site
Cherkasy, 18009, Ukraine
Research Site
Dnipro, 49102, Ukraine
Research Site
Donetsk, 83092, Ukraine
Research Site
Ivano-Frankivsk, 76014, Ukraine
Research Site
Kharkiv Region, 61070, Ukraine
Research Site
Kyiv, 3115, Ukraine
Research Site
Lviv, 79031, Ukraine
Research Site
Mariupol, 87500, Ukraine
Research Site
Uzhhorod, 88000, Ukraine
Research Site
Vinnytsia, 21029, Ukraine
Research Site
Airdrie, ML6 0JS, United Kingdom
Research Site
Derby, DE22 3NE, United Kingdom
Research Site
Stoke-on-Trent, ST4 6QG, United Kingdom
Related Publications (4)
Robertson JFR, Shao Z, Noguchi S, Bondarenko I, Panasci L, Singh S, Subramaniam S, Ellis MJ. Fulvestrant Versus Anastrozole in Endocrine Therapy-Naive Women With Hormone Receptor-Positive Advanced Breast Cancer: Final Overall Survival in the Phase III FALCON Trial. J Clin Oncol. 2025 May;43(13):1539-1545. doi: 10.1200/JCO.24.00994. Epub 2025 Jan 7.
PMID: 39772884DERIVEDRobertson JFR, Cheung KL, Noguchi S, Shao Z, Degboe A, Lichfield J, Thirlwell J, Fazal M, Ellis MJ. Health-related quality of life from the FALCON phase III randomised trial of fulvestrant 500 mg versus anastrozole for hormone receptor-positive advanced breast cancer. Eur J Cancer. 2018 May;94:206-215. doi: 10.1016/j.ejca.2018.02.026. Epub 2018 Mar 22.
PMID: 29574365DERIVEDRobertson JFR, Bondarenko IM, Trishkina E, Dvorkin M, Panasci L, Manikhas A, Shparyk Y, Cardona-Huerta S, Cheung KL, Philco-Salas MJ, Ruiz-Borrego M, Shao Z, Noguchi S, Rowbottom J, Stuart M, Grinsted LM, Fazal M, Ellis MJ. Fulvestrant 500 mg versus anastrozole 1 mg for hormone receptor-positive advanced breast cancer (FALCON): an international, randomised, double-blind, phase 3 trial. Lancet. 2016 Dec 17;388(10063):2997-3005. doi: 10.1016/S0140-6736(16)32389-3. Epub 2016 Nov 29.
PMID: 27908454DERIVEDEllis MJ, Llombart-Cussac A, Feltl D, Dewar JA, Jasiowka M, Hewson N, Rukazenkov Y, Robertson JF. Fulvestrant 500 mg Versus Anastrozole 1 mg for the First-Line Treatment of Advanced Breast Cancer: Overall Survival Analysis From the Phase II FIRST Study. J Clin Oncol. 2015 Nov 10;33(32):3781-7. doi: 10.1200/JCO.2015.61.5831. Epub 2015 Sep 14.
PMID: 26371134DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Global Clinical Lead
- Organization
- AstraZeneca
Study Officials
- 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
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 11, 2012
First Posted
May 21, 2012
Study Start
October 17, 2012
Primary Completion
April 11, 2016
Study Completion
January 16, 2026
Last Updated
February 27, 2026
Results First Posted
May 17, 2017
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- 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.
- 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.
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.