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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01602380
First Posted: May 21, 2012
Last Update Posted: July 31, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
AstraZeneca
  Purpose
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.

Condition Intervention Phase
Hormone Receptor Positive Breast Cancer Drug: faslodex 500mg Drug: arimidex 1mg Drug: faslodex dummy Drug: arimidex dummy Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Comparison of Progression Free Survival (PFS) in Patients Treated With Fulvestrant With Those Treated With Anastrozole [ Time Frame: Baseline RECIST 1.1 assessments 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 for the primary analysis data cut-off). ]
    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.


Secondary Outcome Measures:
  • Comparison of Overall Survival (OS) in Patients Treated With Fulvestrant With Those Treated With Anastrozole; Percentage of Patients With Events [ Time Frame: Baseline up to data cut-off for PFS analysis (up to approximately 38 months). Following disease progression, patients were to be contacted at 12 weekly intervals to to determine survival status. ]
    OS was defined as the time from randomisation until death by any cause. Two timepoints were planned for OS analysis: an interim OS analysis at the time of the data cut-off for PFS analysis and a final OS analysis when 50% of the deaths have occurred. The current OS data correspond to that of the interim analysis only and the outcome measure is reported as percentage of patients with events.

  • Objective Response Rate (ORR) 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 for the primary analysis data cut-off). ]
    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.

  • Duration of Response (DoR) 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 for the primary analysis data cut-off).. ]
    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.

  • 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 for the primary analysis data cut-off). ]
    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).

  • Clinical Benefit Rate (CBR) 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 for the primary analysis data cut-off). ]
    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.

  • Duration of Clinical Benefit (DoCB) 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 for the primary analysis data cut-off). ]
    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.

  • Expected Duration of Clinical Benefit (EDoCB) 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 for the primary analysis data cut-off). ]
    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).

  • 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 completed at baseline and then every 12 weeks until disease progression or treatment discontinuation (up to approximately 38 months for the primary analysis data cut-off). ]
    The Functional Assessment of Cancer Therapy - Breast (FACT-B) questionnaire was the instrument selected to assess HRQoL and comprises the 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 randomisation 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.


Enrollment: 462
Actual Study Start Date: October 17, 2012
Estimated Study Completion Date: February 12, 2018
Primary Completion Date: April 11, 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 130 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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).
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01602380


  Hide Study Locations
Locations
United States, California
Research Site
Modesto, California, United States, 95355
United States, Georgia
Research Site
Savannah, Georgia, United States
United States, Maine
Research Site
Auburn, Maine, United States, 04210
United States, Massachusetts
Research Site
Worcester, Massachusetts, United States, 01608
United States, Michigan
Research Site
Detroit, Michigan, United States, 48202
United States, Missouri
Research Site
Saint Louis, Missouri, United States, 63110
United States, Nebraska
Research Site
Lincoln, Nebraska, United States, 68506
United States, New Jersey
Research Site
Somerset, New Jersey, United States, 08873
United States, Ohio
Research Site
Cincinnati, Ohio, United States, 45247
Research Site
Columbus, Ohio, United States, 43202
United States, Tennessee
Research Site
Nashville, Tennessee, United States, 38120
United States, Utah
Research Site
Murray, Utah, United States, 84157
Argentina
Research Site
La Rioja, Argentina, F5300COE
Research Site
Mar del Plata, Argentina, B7600CTO
Research Site
Pergamino, Argentina, B2700CPM
Research Site
Rosario, Argentina, S2000KZE
Brazil
Research Site
Porto Alegre, Brazil, 91350-200
Research Site
Santo Andre, Brazil, 09060-650
Canada, British Columbia
Research Site
Abbotsford, British Columbia, Canada, V2S0C2
Research Site
Vancouver, British Columbia, Canada, V5Z 4E6
Canada, Ontario
Research Site
Kitchener, Ontario, Canada, N2G 1G3
Research Site
Thunder Bay, Ontario, Canada, P7B 6V4
Canada, Quebec
Research Site
Montreal, Quebec, Canada, H3G 1A4
Research Site
Montreal, Quebec, Canada, H3T 1E2
China
Research Site
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
Czechia
Research Site
Praha 5, Czechia, 150 06
Research Site
Pribram, Czechia, 261 95
Italy
Research Site
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, 00100
Research Site
Roma, Italy, 00144
Research Site
Roma, Italy, 00161
Research Site
Treviglio, Italy, 24047
Japan
Research Site
Fukuoka-shi, Japan, 811-1395
Research Site
Hamamatsu-shi, Japan, 430-0906
Research Site
Kagoshima-shi, Japan, 892-0833
Research Site
Kumamoto-shi, Japan, 860-8556
Research Site
Matsuyama-shi, Japan, 791-0280
Research Site
Mitaka-shi, Japan, 181-8611
Research Site
Nishinomiya-shi, Japan, 663-8501
Research Site
Osaka-shi, Japan, 540-0006
Research Site
Sakai-shi, Japan, 590-0064
Research Site
Suita-shi, Japan, 565-0871
Mexico
Research Site
Merida, Mexico, 97134
Research Site
Mexico, D.F., Mexico, 6760
Research Site
Monterrey, Mexico, 64000
Research Site
Monterrey, Mexico, 64060
Research Site
Monterrey, Mexico, 64710
Peru
Research Site
Lima, Peru, Lima 18
Research Site
Lima, Peru, LIMA 27
Research Site
Lima, Peru, LIMA 33
Research Site
Lima, Peru, LIMA 41
Poland
Research Site
Katowice, Poland, 40-635
Research Site
Lublin, Poland, 20-718
Research Site
Łódź, Poland, 90-242
Romania
Research Site
Braila, Romania, 810325
Research Site
Craiova, Romania, 200385
Research Site
Onesti, Romania, 601048
Research Site
Timisoara, Romania, 300239
Russian Federation
Research Site
Barnaul, Russian Federation, 656052
Research Site
Moscow, Russian Federation, 115478
Research Site
Omsk, Russian Federation, 644013
Research Site
Ryazan, Russian Federation, 390046
Research Site
Saint Petersburg, Russian Federation, 195271
Research Site
Saint Petersburg, Russian Federation, 197022
Research Site
St-Petersburg, Russian Federation, 197758
Research Site
St. Petersburg, Russian Federation, 197022
Research Site
St.Petersburg, Russian Federation, 191104
Research Site
Tomsk, Russian Federation, 634028
Slovakia
Research Site
Bardejov, Slovakia, 085 01
Research Site
Bratislava, Slovakia, 814 65
Research Site
Bratislava, Slovakia, 833 10
Research Site
Trencin, Slovakia, 91108
South Africa
Research Site
Cape Town, South Africa, 7570
Research Site
Cape town, South Africa, 7700
Research Site
Cape Town, South Africa, 7925
Research Site
Pietermaritzburg, South Africa, 3201
Research Site
Pretoria, South Africa, 0001
Research Site
Pretoria, South Africa, 0081
Spain
Research Site
Madrid, Spain, 28034
Research Site
Madrid, Spain, 28050
Research Site
Pamplona, Spain, 31008
Research Site
Pozuelo de Alarcon, Spain, 28223
Research Site
Sabadell, Spain, 8208
Research Site
Sevilla, Spain, 41013
Research Site
Sevilla, Spain, 41014
Research Site
Sevilla, Spain, 41071
Research Site
Valencia, Spain, 46014
Research Site
Valencia, Spain, 46026
Taiwan
Research Site
Taichung, Taiwan, 40447
Research Site
Taipei, Taiwan, 10449
Research Site
Taipei, Taiwan, 112
Research Site
Taipei, Taiwan, 235
Turkey
Research Site
Ankara, Turkey, 06100
Research Site
Gaziantep, Turkey, 27310
Ukraine
Research Site
Cherkassy, Ukraine, 18009
Research Site
Dnipropetrovsk, Ukraine, 49102
Research Site
Donetsk, Ukraine, 83092
Research Site
Ivano-Frankivsk, Ukraine, 76014
Research Site
Kharkiv, Ukraine, 61070
Research Site
Kiev, Ukraine, 3115
Research Site
Lviv, Ukraine, 79031
Research Site
Mariupol, Ukraine, 87500
Research Site
Uzhgorod, Ukraine, 88000
Research Site
Vinnytsia, Ukraine, 21029
United Kingdom
Research Site
Derby, United Kingdom, DE22 3NE
Research Site
Stoke-on-Trent, United Kingdom, ST4 6QG
Research Site
Wishaw, United Kingdom, ML2 0DP
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Mehdi Fazal, 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
  More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01602380     History of Changes
Other Study ID Numbers: D699BC00001
First Submitted: May 11, 2012
First Posted: May 21, 2012
Results First Submitted: March 23, 2017
Results First Posted: May 17, 2017
Last Update Posted: July 31, 2017
Last Verified: June 2017

Keywords provided by AstraZeneca:
hormone receptor positive breast cancer
endocrine
no hormone therapy
hormone
breast
cancer
neoplasm
metastatic
tumour

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Hormones
Estradiol
Fulvestrant
Anastrozole
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Estrogen Receptor Antagonists
Estrogen Antagonists
Hormone Antagonists
Estrogens
Aromatase Inhibitors
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action