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

Primary Purpose

Hormone Receptor Positive Breast Cancer

Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
faslodex 500mg
arimidex 1mg
faslodex dummy
arimidex dummy
Sponsored by
AstraZeneca
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hormone Receptor Positive Breast Cancer focused on measuring hormone receptor positive breast cancer, endocrine, no hormone therapy, hormone, breast, cancer, neoplasm, metastatic, tumour

Eligibility Criteria

18 Years - 130 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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).

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Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

faslodex+placebo

arimidex +placebo

Arm Description

Blinded: Fulvestrant 500mg intramuscular injection (2x250mg) plus dummy Anastrozole tablets

Blinded: Anastrozole 1mg tablets plus dummy Fulvestrant intramuscular injection (2x0mg)

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Comparison of Overall Survival (OS) in Patients Treated With Fulvestrant With Those Treated With Anastrozole; Percentage of Patients With Events
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 75% 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
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
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
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
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
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
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)
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.

Full Information

First Posted
May 11, 2012
Last Updated
January 31, 2023
Sponsor
AstraZeneca
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1. Study Identification

Unique Protocol Identification Number
NCT01602380
Brief Title
A Global Study to Compare the Effects of Fulvestrant and Arimidex in a Subset of Patients With Breast Cancer.
Acronym
FALCON
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

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 17, 2012 (Actual)
Primary Completion Date
April 11, 2016 (Actual)
Study Completion Date
December 29, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AstraZeneca

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hormone Receptor Positive Breast Cancer
Keywords
hormone receptor positive breast cancer, endocrine, no hormone therapy, hormone, breast, cancer, neoplasm, metastatic, tumour

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
462 (Actual)

8. Arms, Groups, and Interventions

Arm Title
faslodex+placebo
Arm Type
Experimental
Arm Description
Blinded: Fulvestrant 500mg intramuscular injection (2x250mg) plus dummy Anastrozole tablets
Arm Title
arimidex +placebo
Arm Type
Active Comparator
Arm Description
Blinded: Anastrozole 1mg tablets plus dummy Fulvestrant intramuscular injection (2x0mg)
Intervention Type
Drug
Intervention Name(s)
faslodex 500mg
Intervention Description
2 x intramuscular injections at day 1, 14, 28 and every 28 days thereafter
Intervention Type
Drug
Intervention Name(s)
arimidex 1mg
Intervention Description
oral tablet 1 daily
Intervention Type
Drug
Intervention Name(s)
faslodex dummy
Intervention Description
2 x intramuscular injections at day 1, 14, 28 and every 28 days thereafter
Intervention Type
Drug
Intervention Name(s)
arimidex dummy
Intervention Description
oral tablet 1 daily
Primary Outcome Measure Information:
Title
Comparison of Progression Free Survival (PFS) in Patients Treated With Fulvestrant With Those Treated With Anastrozole
Description
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.
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).
Secondary Outcome Measure Information:
Title
Comparison of Overall Survival (OS) in Patients Treated With Fulvestrant With Those Treated With Anastrozole; Percentage of Patients With Events
Description
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 75% 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.
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.
Title
Objective Response Rate (ORR) for Fulvestrant Treatment Versus Anastrozole Treatment
Description
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.
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).
Title
Duration of Response (DoR) for Fulvestrant Treatment Versus Anastrozole Treatment
Description
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.
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)..
Title
Expected Duration of Response (EDoR) for Fulvestrant Treatment Versus Anastrozole Treatment
Description
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).
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).
Title
Clinical Benefit Rate (CBR) for Fulvestrant Treatment Versus Anastrozole Treatment
Description
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.
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).
Title
Duration of Clinical Benefit (DoCB) for Fulvestrant Treatment Versus Anastrozole Treatment
Description
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.
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).
Title
Expected Duration of Clinical Benefit (EDoCB) for Fulvestrant Treatment Versus Anastrozole Treatment
Description
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).
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).
Title
Comparison of the Effect of Fulvestrant Treatment Versus Anastrozole Treatment on Time to Deterioration of Health Related Quality of Life (HRQoL)
Description
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.
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).

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
130 Years
Accepts Healthy Volunteers
No
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shankar S, MD
Organizational Affiliation
AstraZeneca
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
John Robertson, MD
Organizational Affiliation
Graduate Medicine and Health School, University of Nottingham, UK
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Matthew Ellis, DM
Organizational Affiliation
Washington University School of Medicine, USA
Official's Role
Principal Investigator
Facility Information:
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Research Site
City
Modesto
State/Province
California
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95355
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United States
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Research Site
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Savannah
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Georgia
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31405
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United States
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Auburn
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Maine
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04212
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United States
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Worcester
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Massachusetts
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01608
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United States
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Detroit
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Michigan
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48202
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United States
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Saint Louis
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Missouri
ZIP/Postal Code
63110
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United States
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Lincoln
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Nebraska
ZIP/Postal Code
68506
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United States
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Somerset
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New Jersey
ZIP/Postal Code
08873
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United States
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Columbus
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Ohio
ZIP/Postal Code
43202
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United States
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City
Montgomery
State/Province
Ohio
ZIP/Postal Code
45242
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United States
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City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38120
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United States
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City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84107
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United States
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City
La Rioja
ZIP/Postal Code
5300
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Argentina
Facility Name
Research Site
City
Mar del Plata
ZIP/Postal Code
B7600CTO
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Argentina
Facility Name
Research Site
City
Pergamino
ZIP/Postal Code
B2700CPM
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Argentina
Facility Name
Research Site
City
Rosario
ZIP/Postal Code
S2000KZE
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Argentina
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City
Porto Alegre
ZIP/Postal Code
91350-200
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Brazil
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Research Site
City
Santo Andre
ZIP/Postal Code
09060-870
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Brazil
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Research Site
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Abbotsford
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British Columbia
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V2S0C2
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Canada
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Research Site
City
Vancouver
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British Columbia
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V5Z 4E6
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Canada
Facility Name
Research Site
City
Kitchener
State/Province
Ontario
ZIP/Postal Code
N2G 1G3
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Canada
Facility Name
Research Site
City
Thunder Bay
State/Province
Ontario
ZIP/Postal Code
P7B 6V4
Country
Canada
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Research Site
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3T 1E2
Country
Canada
Facility Name
Research Site
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H4A 3J1
Country
Canada
Facility Name
Research Site
City
Chengdu
ZIP/Postal Code
610041
Country
China
Facility Name
Research Site
City
Dalian
ZIP/Postal Code
116011
Country
China
Facility Name
Research Site
City
Fuzhou
ZIP/Postal Code
350025
Country
China
Facility Name
Research Site
City
Guangzhou
ZIP/Postal Code
510060
Country
China
Facility Name
Research Site
City
Shanghai
ZIP/Postal Code
200032
Country
China
Facility Name
Research Site
City
Shenyang
ZIP/Postal Code
110001
Country
China
Facility Name
Research Site
City
Suzhou
ZIP/Postal Code
215004
Country
China
Facility Name
Research Site
City
Tianjin
ZIP/Postal Code
300060
Country
China
Facility Name
Research Site
City
Praha 5
ZIP/Postal Code
150 06
Country
Czechia
Facility Name
Research Site
City
Pribram
ZIP/Postal Code
261 01
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Czechia
Facility Name
Research Site
City
Avellino
ZIP/Postal Code
83100
Country
Italy
Facility Name
Research Site
City
Bari
ZIP/Postal Code
70124
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Italy
Facility Name
Research Site
City
Benevento
ZIP/Postal Code
82100
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Italy
Facility Name
Research Site
City
Catania
ZIP/Postal Code
95126
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Italy
Facility Name
Research Site
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Genova
ZIP/Postal Code
16128
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Italy
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Research Site
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Pisa
ZIP/Postal Code
56100
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Italy
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Research Site
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Roma
ZIP/Postal Code
00100
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Italy
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Roma
ZIP/Postal Code
00144
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Italy
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Roma
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00161
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Italy
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Treviglio
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24047
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Italy
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Fukuoka-shi
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811-1395
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Japan
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Hamamatsu-shi
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430-0906
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Japan
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Kagoshima-shi
ZIP/Postal Code
892-0833
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Japan
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Research Site
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Kumamoto-shi
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860-8556
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Japan
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Research Site
City
Matsuyama-shi
ZIP/Postal Code
791-0280
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Japan
Facility Name
Research Site
City
Mitaka-shi
ZIP/Postal Code
181-8611
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Japan
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Research Site
City
Nishinomiya-shi
ZIP/Postal Code
663-8501
Country
Japan
Facility Name
Research Site
City
Osaka-city
ZIP/Postal Code
540-0006
Country
Japan
Facility Name
Research Site
City
Sakai-shi
ZIP/Postal Code
590-0064
Country
Japan
Facility Name
Research Site
City
Suita-shi
ZIP/Postal Code
565-0871
Country
Japan
Facility Name
Research Site
City
Merida
ZIP/Postal Code
97000
Country
Mexico
Facility Name
Research Site
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Mexico, D.F.
ZIP/Postal Code
6760
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Mexico
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Research Site
City
Monterrey
ZIP/Postal Code
64000
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Mexico
Facility Name
Research Site
City
Monterrey
ZIP/Postal Code
64060
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Mexico
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Research Site
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Monterrey
ZIP/Postal Code
64710
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Mexico
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Research Site
City
Lima
ZIP/Postal Code
Lima 18
Country
Peru
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Research Site
City
Lima
ZIP/Postal Code
LIMA 27
Country
Peru
Facility Name
Research Site
City
Lima
ZIP/Postal Code
LIMA 33
Country
Peru
Facility Name
Research Site
City
Lima
ZIP/Postal Code
LIMA 41
Country
Peru
Facility Name
Research Site
City
Katowice
ZIP/Postal Code
40-635
Country
Poland
Facility Name
Research Site
City
Lublin
ZIP/Postal Code
20-718
Country
Poland
Facility Name
Research Site
City
Łódź
ZIP/Postal Code
90-242
Country
Poland
Facility Name
Research Site
City
Braila
ZIP/Postal Code
810325
Country
Romania
Facility Name
Research Site
City
Craiova
ZIP/Postal Code
200347
Country
Romania
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City
Onesti
ZIP/Postal Code
601048
Country
Romania
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Timisoara
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300239
Country
Romania
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Research Site
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Barnaul
ZIP/Postal Code
656052
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Russian Federation
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Research Site
City
Moscow
ZIP/Postal Code
115478
Country
Russian Federation
Facility Name
Research Site
City
Omsk
ZIP/Postal Code
644013
Country
Russian Federation
Facility Name
Research Site
City
Ryazan
ZIP/Postal Code
390046
Country
Russian Federation
Facility Name
Research Site
City
Saint Petersburg
ZIP/Postal Code
195271
Country
Russian Federation
Facility Name
Research Site
City
Saint Petersburg
ZIP/Postal Code
197022
Country
Russian Federation
Facility Name
Research Site
City
St-Petersburg
ZIP/Postal Code
197758
Country
Russian Federation
Facility Name
Research Site
City
St. Petersburg
ZIP/Postal Code
197022
Country
Russian Federation
Facility Name
Research Site
City
St.Petersburg
ZIP/Postal Code
191014
Country
Russian Federation
Facility Name
Research Site
City
Tomsk
ZIP/Postal Code
634028
Country
Russian Federation
Facility Name
Research Site
City
Bardejov
ZIP/Postal Code
085 01
Country
Slovakia
Facility Name
Research Site
City
Bratislava
ZIP/Postal Code
814 65
Country
Slovakia
Facility Name
Research Site
City
Bratislava
ZIP/Postal Code
833 10
Country
Slovakia
Facility Name
Research Site
City
Trencin
ZIP/Postal Code
91171
Country
Slovakia
Facility Name
Research Site
City
Cape Town
ZIP/Postal Code
7570
Country
South Africa
Facility Name
Research Site
City
Cape town
ZIP/Postal Code
7700
Country
South Africa
Facility Name
Research Site
City
Cape Town
ZIP/Postal Code
7925
Country
South Africa
Facility Name
Research Site
City
Pietermaritzburg
ZIP/Postal Code
3201
Country
South Africa
Facility Name
Research Site
City
Pretoria
ZIP/Postal Code
0001
Country
South Africa
Facility Name
Research Site
City
Pretoria
ZIP/Postal Code
0081
Country
South Africa
Facility Name
Research Site
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Facility Name
Research Site
City
Madrid
ZIP/Postal Code
28050
Country
Spain
Facility Name
Research Site
City
Pamplona
ZIP/Postal Code
31008
Country
Spain
Facility Name
Research Site
City
Pozuelo de Alarcon
ZIP/Postal Code
28223
Country
Spain
Facility Name
Research Site
City
Sabadell
ZIP/Postal Code
8208
Country
Spain
Facility Name
Research Site
City
Sevilla
ZIP/Postal Code
41009
Country
Spain
Facility Name
Research Site
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Facility Name
Research Site
City
Sevilla
ZIP/Postal Code
41014
Country
Spain
Facility Name
Research Site
City
Valencia
ZIP/Postal Code
46014
Country
Spain
Facility Name
Research Site
City
Valencia
ZIP/Postal Code
46026
Country
Spain
Facility Name
Research Site
City
Taichung
ZIP/Postal Code
40447
Country
Taiwan
Facility Name
Research Site
City
Taipei
ZIP/Postal Code
10449
Country
Taiwan
Facility Name
Research Site
City
Taipei
ZIP/Postal Code
112
Country
Taiwan
Facility Name
Research Site
City
Taipei
ZIP/Postal Code
235
Country
Taiwan
Facility Name
Research Site
City
Ankara
ZIP/Postal Code
06100
Country
Turkey
Facility Name
Research Site
City
Gaziantep
ZIP/Postal Code
27310
Country
Turkey
Facility Name
Research Site
City
Cherkasy
ZIP/Postal Code
18009
Country
Ukraine
Facility Name
Research Site
City
Dnipro
ZIP/Postal Code
49102
Country
Ukraine
Facility Name
Research Site
City
Donetsk
ZIP/Postal Code
83092
Country
Ukraine
Facility Name
Research Site
City
Ivano-Frankivsk
ZIP/Postal Code
76014
Country
Ukraine
Facility Name
Research Site
City
Kharkiv Region
ZIP/Postal Code
61070
Country
Ukraine
Facility Name
Research Site
City
Kyiv
ZIP/Postal Code
3115
Country
Ukraine
Facility Name
Research Site
City
Lviv
ZIP/Postal Code
79031
Country
Ukraine
Facility Name
Research Site
City
Mariupol
ZIP/Postal Code
87500
Country
Ukraine
Facility Name
Research Site
City
Uzhhorod
ZIP/Postal Code
88000
Country
Ukraine
Facility Name
Research Site
City
Vinnytsia
ZIP/Postal Code
21029
Country
Ukraine
Facility Name
Research Site
City
Airdrie
ZIP/Postal Code
ML6 0JS
Country
United Kingdom
Facility Name
Research Site
City
Derby
ZIP/Postal Code
DE22 3NE
Country
United Kingdom
Facility Name
Research Site
City
Stoke-on-Trent
ZIP/Postal Code
ST4 6QG
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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 URL
https://astrazenecagroup-dt.pharmacm.com/DT/Home
Citations:
PubMed Identifier
29574365
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.
Results Reference
derived
PubMed Identifier
27908454
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.
Results Reference
derived
PubMed Identifier
26371134
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.
Results Reference
derived
Links:
URL
http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=594&filename=D699BC00001_FALCON_Clinical_Study_Protocol_14_January_2013.pdf
Description
FALCON_Clinical_Study_Protocol

Learn more about this trial

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

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