Clinical trial NCT01602380: A Global Study to Compare the Effects of Fulvestrant and Arimidex in a Subset of Patients With Breast Cancer.
Official title: 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: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Hormone Receptor Positive Breast Cancer
Keywords: hormone receptor positive breast cancer
endocrine
no hormone therapy
hormone
breast
cancer
neoplasm
metastatic
tumour
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2012-05-21
Enrollment: 462
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 130
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Comparison of Progression-Free Survival (PFS) in Patients Treated With Fulvestrant With Those Treated With Anastrozole
timeFrame: 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:
measure: Comparison of Overall Survival (OS) in Patients Treated With Fulvestrant With Those Treated With Anastrozole; Percentage of Patients With Events
timeFrame: 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
measure: Objective Response Rate (ORR) for Fulvestrant Treatment Versus Anastrozole Treatment
timeFrame: Baseline RECIST 1.1 assessments (Day 0) and then every 12 weeks until disease progression or treatment discontinuation (up to approximately 38 months)
measure: Duration of Response (DoR) for Fulvestrant Treatment Versus Anastrozole Treatment
timeFrame: Baseline RECIST 1.1 assessments (Day 0) and then every 12 weeks until disease progression or treatment discontinuation (up to approximately 38 months)
measure: Expected Duration of Response (EDoR) for Fulvestrant Treatment Versus Anastrozole Treatment
timeFrame: Baseline RECIST 1.1 assessments and then every 12 weeks until disease progression or treatment discontinuation (up to approximately 38 months)
measure: Clinical Benefit Rate (CBR) for Fulvestrant Treatment Versus Anastrozole Treatment
timeFrame: Baseline RECIST 1.1 assessments (Day 0) and then every 12 weeks until disease progression or treatment discontinuation (up to approximately 38 months)
measure: Duration of Clinical Benefit (DoCB) for Fulvestrant Treatment Versus Anastrozole Treatment
timeFrame: Baseline RECIST 1.1 assessments (Day 0) and then every 12 weeks until disease progression or treatment discontinuation (up to approximately 38 months)
measure: Expected Duration of Clinical Benefit (EDoCB) for Fulvestrant Treatment Versus Anastrozole Treatment
timeFrame: Baseline RECIST 1.1 assessments (Day 0) and then every 12 weeks until disease progression or treatment discontinuation (up to approximately 38 months)
measure: Comparison of the Effect of Fulvestrant Treatment Versus Anastrozole Treatment on Time to Deterioration of Health-Related Quality of Life (HRQoL)
timeFrame: Quality of life questionnaires administered at 3 months post objective disease progression, then at 6-monthly intervals (approximately 75 months)
Other outcomes:
Locations:
city: Modesto
country: United States
facility: Research Site
state: California
city: Savannah
country: United States
facility: Research Site
state: Georgia
city: Auburn
country: United States
facility: Research Site
state: Maine
city: Worcester
country: United States
facility: Research Site
state: Massachusetts
city: Detroit
country: United States
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state: Michigan
city: Saint Louis
country: United States
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state: Missouri
city: Lincoln
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state: Nebraska
city: Somerset
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state: New Jersey
city: Columbus
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state: Ohio
city: Montgomery
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state: Ohio
city: Memphis
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state: Tennessee
city: Salt Lake City
country: United States
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state: Utah
city: La Rioja
country: Argentina
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city: Mar del Plata
country: Argentina
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city: Pergamino
country: Argentina
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city: Rosario
country: Argentina
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city: Porto Alegre
country: Brazil
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city: Santo Andre
country: Brazil
facility: Research Site
city: Abbotsford
country: Canada
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state: British Columbia
city: Vancouver
country: Canada
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state: British Columbia
city: Kitchener
country: Canada
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state: Ontario
city: Thunder Bay
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state: Ontario
city: Montreal
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state: Quebec
city: Montreal
country: Canada
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state: Quebec
city: Chengdu
country: China
facility: Research Site
city: Dalian
country: China
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city: Fuzhou
country: China
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city: Guangzhou
country: China
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city: Shanghai
country: China
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city: Shenyang
country: China
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city: Suzhou
country: China
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city: Tianjin
country: China
facility: Research Site
city: Praha 5
country: Czechia
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city: Pribram
country: Czechia
facility: Research Site
city: Avellino
country: Italy
facility: Research Site
city: Bari
country: Italy
facility: Research Site
city: Benevento
country: Italy
facility: Research Site
city: Catania
country: Italy
facility: Research Site
city: Genova
country: Italy
facility: Research Site
city: Pisa
country: Italy
facility: Research Site
city: Roma
country: Italy
facility: Research Site
city: Roma
country: Italy
facility: Research Site
city: Roma
country: Italy
facility: Research Site
city: Treviglio
country: Italy
facility: Research Site
city: Fukuoka-shi
country: Japan
facility: Research Site
city: Hamamatsu-shi
country: Japan
facility: Research Site
city: Kagoshima-shi
country: Japan
facility: Research Site
city: Kumamoto-shi
country: Japan
facility: Research Site
city: Matsuyama-shi
country: Japan
facility: Research Site
city: Mitaka-shi
country: Japan
facility: Research Site
city: Nishinomiya-shi
country: Japan
facility: Research Site
city: Osaka-city
country: Japan
facility: Research Site
city: Sakai-shi
country: Japan
facility: Research Site
city: Suita-shi
country: Japan
facility: Research Site
city: Merida
country: Mexico
facility: Research Site
city: Mexico, D.F.
country: Mexico
facility: Research Site
city: Monterrey
country: Mexico
facility: Research Site
city: Monterrey
country: Mexico
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city: Monterrey
country: Mexico
facility: Research Site
city: Lima
country: Peru
facility: Research Site
city: Lima
country: Peru
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city: Lima
country: Peru
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city: Lima
country: Peru
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city: Katowice
country: Poland
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city: Lublin
country: Poland
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city: Łódź
country: Poland
facility: Research Site
city: Braila
country: Romania
facility: Research Site
city: Craiova
country: Romania
facility: Research Site
city: Onesti
country: Romania
facility: Research Site
city: Timisoara
country: Romania
facility: Research Site
city: Barnaul
country: Russian Federation
facility: Research Site
city: Moscow
country: Russian Federation
facility: Research Site
city: Omsk
country: Russian Federation
facility: Research Site
city: Ryazan
country: Russian Federation
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city: Saint Petersburg
country: Russian Federation
facility: Research Site
city: Saint Petersburg
country: Russian Federation
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city: St-Petersburg
country: Russian Federation
facility: Research Site
city: St. Petersburg
country: Russian Federation
facility: Research Site
city: St.Petersburg
country: Russian Federation
facility: Research Site
city: Tomsk
country: Russian Federation
facility: Research Site
city: Bardejov
country: Slovakia
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city: Bratislava
country: Slovakia
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city: Bratislava
country: Slovakia
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city: Trencin
country: Slovakia
facility: Research Site
city: Cape Town
country: South Africa
facility: Research Site
city: Cape town
country: South Africa
facility: Research Site
city: Cape Town
country: South Africa
facility: Research Site
city: Pietermaritzburg
country: South Africa
facility: Research Site
city: Pretoria
country: South Africa
facility: Research Site
city: Pretoria
country: South Africa
facility: Research Site
city: Madrid
country: Spain
facility: Research Site
city: Madrid
country: Spain
facility: Research Site
city: Pamplona
country: Spain
facility: Research Site
city: Pozuelo de Alarcon
country: Spain
facility: Research Site
city: Sabadell
country: Spain
facility: Research Site
city: Sevilla
country: Spain
facility: Research Site
city: Sevilla
country: Spain
facility: Research Site
city: Sevilla
country: Spain
facility: Research Site
city: Valencia
country: Spain
facility: Research Site
city: Valencia
country: Spain
facility: Research Site
city: Taichung
country: Taiwan
facility: Research Site
city: Taipei
country: Taiwan
facility: Research Site
city: Taipei
country: Taiwan
facility: Research Site
city: Taipei
country: Taiwan
facility: Research Site
city: Ankara
country: Turkey
facility: Research Site
city: Gaziantep
country: Turkey
facility: Research Site
city: Cherkasy
country: Ukraine
facility: Research Site
city: Dnipro
country: Ukraine
facility: Research Site
city: Donetsk
country: Ukraine
facility: Research Site
city: Ivano-Frankivsk
country: Ukraine
facility: Research Site
city: Kharkiv Region
country: Ukraine
facility: Research Site
city: Kyiv
country: Ukraine
facility: Research Site
city: Lviv
country: Ukraine
facility: Research Site
city: Mariupol
country: Ukraine
facility: Research Site
city: Uzhhorod
country: Ukraine
facility: Research Site
city: Vinnytsia
country: Ukraine
facility: Research Site
city: Airdrie
country: United Kingdom
facility: Research Site
city: Derby
country: United Kingdom
facility: Research Site
city: Stoke-on-Trent
country: United Kingdom
facility: Research Site
Study officials:
affiliation: AstraZeneca
name: Shankar S, MD
role: STUDY_DIRECTOR
affiliation: Graduate Medicine and Health School, University of Nottingham, UK
name: John Robertson, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Washington University School of Medicine, USA
name: Matthew Ellis, DM
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.