A Global Study to Compare the Effects of Fulvestrant and Arimidex in a Subset of Patients With Breast Cancer.
NCT ID: NCT01602380
Last Updated: 2026-01-12
Study Results
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View full resultsBasic Information
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ACTIVE_NOT_RECRUITING
PHASE3
462 participants
INTERVENTIONAL
2012-10-17
2027-08-06
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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faslodex+placebo
Blinded: Fulvestrant 500mg intramuscular injection (2x250mg) plus dummy Anastrozole tablets
faslodex 500mg
2 x intramuscular injections at day 1, 14, 28 and every 28 days thereafter
arimidex dummy
oral tablet 1 daily
arimidex +placebo
Blinded: Anastrozole 1mg tablets plus dummy Fulvestrant intramuscular injection (2x0mg)
arimidex 1mg
oral tablet 1 daily
faslodex dummy
2 x intramuscular injections at day 1, 14, 28 and every 28 days thereafter
Interventions
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faslodex 500mg
2 x intramuscular injections at day 1, 14, 28 and every 28 days thereafter
arimidex 1mg
oral tablet 1 daily
faslodex dummy
2 x intramuscular injections at day 1, 14, 28 and every 28 days thereafter
arimidex dummy
oral tablet 1 daily
Eligibility Criteria
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Inclusion Criteria
* 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
* 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).
18 Years
130 Years
FEMALE
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Principal Investigators
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Shankar S, MD
Role: STUDY_DIRECTOR
AstraZeneca
John Robertson, MD
Role: PRINCIPAL_INVESTIGATOR
Graduate Medicine and Health School, University of Nottingham, UK
Matthew Ellis, DM
Role: PRINCIPAL_INVESTIGATOR
Washington University School of Medicine, USA
Locations
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Research Site
Modesto, California, United States
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Savannah, Georgia, United States
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Auburn, Maine, United States
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Worcester, Massachusetts, United States
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Detroit, Michigan, United States
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St Louis, Missouri, United States
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Lincoln, Nebraska, United States
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Somerset, New Jersey, United States
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Columbus, Ohio, United States
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Montgomery, Ohio, United States
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Memphis, Tennessee, United States
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Salt Lake City, Utah, United States
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La Rioja, , Argentina
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Mar del Plata, , Argentina
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Pergamino, , Argentina
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Rosario, , Argentina
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Porto Alegre, , Brazil
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Santo André, , Brazil
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Abbotsford, British Columbia, Canada
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Vancouver, British Columbia, Canada
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Kitchener, Ontario, Canada
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Thunder Bay, Ontario, Canada
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Montreal, Quebec, Canada
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Montreal, Quebec, Canada
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Chengdu, , China
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Dalian, , China
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Fuzhou, , China
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Guangzhou, , China
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Shanghai, , China
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Shenyang, , China
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Suzhou, , China
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Tianjin, , China
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Prague, , Czechia
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Příbram, , Czechia
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Avellino, , Italy
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Bari, , Italy
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Benevento, , Italy
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Catania, , Italy
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Genova, , Italy
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Pisa, , Italy
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Roma, , Italy
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Roma, , Italy
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Roma, , Italy
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Treviglio, , Italy
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Fukuoka, , Japan
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Hamamatsu, , Japan
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Kagoshima, , Japan
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Kumamoto, , Japan
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Matsuyama, , Japan
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Mitaka-shi, , Japan
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Nishinomiya-shi, , Japan
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Osaka, , Japan
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Sakaishi, , Japan
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Suita-shi, , Japan
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Mexico City, , Mexico
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Mérida, , Mexico
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Monterrey, , Mexico
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Monterrey, , Mexico
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Monterrey, , Mexico
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Lima, , Peru
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Lima, , Peru
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Lima, , Peru
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Lima, , Peru
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Katowice, , Poland
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Lodz, , Poland
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Lublin, , Poland
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Brăila, , Romania
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Craiova, , Romania
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Onești, , Romania
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Timișoara, , Romania
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Barnaul, , Russia
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Moscow, , Russia
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Omsk, , Russia
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Ryazan, , Russia
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Saint Petersburg, , Russia
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Saint Petersburg, , Russia
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Saint Petersburg, , Russia
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Saint Petersburg, , Russia
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Tomsk, , Russia
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Bardejov, , Slovakia
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Bratislava, , Slovakia
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Bratislava, , Slovakia
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Trenčín, , Slovakia
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Cape Town, , South Africa
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Cape Town, , South Africa
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Cape Town, , South Africa
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Pietermaritzburg, , South Africa
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Pretoria, , South Africa
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Pretoria, , South Africa
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Madrid, , Spain
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Madrid, , Spain
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Pamplona, , Spain
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Pozuelo de Alarcón, , Spain
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Sabadell, , Spain
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Seville, , Spain
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Seville, , Spain
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Seville, , Spain
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Valencia, , Spain
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Valencia, , Spain
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Taichung, , Taiwan
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Taipei, , Taiwan
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Taipei, , Taiwan
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Taipei, , Taiwan
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Ankara, , Turkey (Türkiye)
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Gaziantep, , Turkey (Türkiye)
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Cherkasy, , Ukraine
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Dnipro, , Ukraine
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Donetsk, , Ukraine
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Ivano-Frankivsk, , Ukraine
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Kharkiv Region, , Ukraine
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Kyiv, , Ukraine
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Lviv, , Ukraine
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Mariupol, , Ukraine
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Uzhhorod, , Ukraine
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Vinnytsia, , Ukraine
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Airdrie, , United Kingdom
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Derby, , United Kingdom
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Stoke-on-Trent, , United Kingdom
Countries
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References
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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.
Robertson 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.
Robertson 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.
Ellis 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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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Other Identifiers
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2011-006326-24
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
D699BC00001
Identifier Type: -
Identifier Source: org_study_id
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