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

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ClinicalTrials.gov Identifier: NCT01602380
Recruitment Status : Active, not recruiting
First Posted : May 21, 2012
Results First Posted : May 17, 2017
Last Update Posted : February 9, 2024
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Hormone Receptor Positive Breast Cancer
Interventions Drug: faslodex 500mg
Drug: arimidex 1mg
Drug: faslodex dummy
Drug: arimidex dummy
Enrollment 462
Recruitment Details First patient enrolled: 17 October 2012.
Pre-assignment Details 524 patients were enrolled (signed informed consent). Patients were assigned to treatment if they met all inclusion and none of the exclusion criteria. 62 patients were not randomised, mainly due to eligibility criteria not being fulfilled (44/62 patients) or patient decision (13/62 patients). 462 patients were randomised to receive treatment.
Arm/Group Title Fulvestrant 500 mg Anastrozole 1 mg
Hide Arm/Group Description Patients received fulvestrant (Faslodex™) 500 milligrams (mg), administered as two 5 milliliters (mL) intramuscular injections, 1 in each buttock, at each visit on Days 0, 14 (±3), 28 (±3) and every 28 (±3) days thereafter. In order to support the double-blind, double-dummy design of the trial, each patient randomised to receive fulvestrant, also received placebo to match the anastrozole schedule (tablets, once daily). Patients received anastrozole (Arimidex™), administered orally as a single tablet at a dose of 1 mg/day from randomisation on Day 0 and once daily thereafter. In order to support the double-blind, double-dummy design of the trial, each patient randomised to receive anastrozole also received placebo to match the fulvestrant schedule (injections on Days 0, 14 [±3], 28 [±3] and every 28 [±3] days thereafter).
Period Title: Overall Study
Started 230 232
Completed 25 31
Not Completed 205 201
Reason Not Completed
Death             147             145
Withdrawal by Subject             39             41
Lost to Follow-up             15             12
Eligibility criteria not fulfilled             2             3
Other             2             0
Arm/Group Title Fulvestrant 500 mg Anastrozole 1 mg Total
Hide Arm/Group Description Patients received fulvestrant (Faslodex™) 500 mg, administered as two 5 mL intramuscular injections, 1 in each buttock, at each visit on Days 0, 14 (±3), 28 (±3) and every 28 (±3) days thereafter. In order to support the double-blind, double-dummy design of the trial, each patient randomised to receive fulvestrant, also received placebo to match the anastrozole schedule (tablets, once daily). Patients received anastrozole (Arimidex™), administered orally as a single tablet at a dose of 1 mg/day from randomisation on Day 0 and once daily thereafter. In order to support the double-blind, double-dummy design of the trial, each patient randomised to receive anastrozole also received placebo to match the fulvestrant schedule (injections on Days 0, 14 [±3], 28 [±3] and every 28 [±3] days thereafter). Total of all reporting groups
Overall Number of Baseline Participants 230 232 462
Hide Baseline Analysis Population Description
The intention to treat (ITT) analysis set included all randomised patients.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 230 participants 232 participants 462 participants
63.8  (9.86) 63.3  (10.38) 63.5  (10.12)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 230 participants 232 participants 462 participants
Female
230
 100.0%
232
 100.0%
462
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 230 participants 232 participants 462 participants
American Indian or Alaska Native
1
   0.4%
5
   2.2%
6
   1.3%
Asian
36
  15.7%
34
  14.7%
70
  15.2%
Black or African American
4
   1.7%
4
   1.7%
8
   1.7%
White
175
  76.1%
174
  75.0%
349
  75.5%
Other
14
   6.1%
15
   6.5%
29
   6.3%
1.Primary Outcome
Title Comparison of Progression-Free Survival (PFS) in Patients Treated With Fulvestrant With Those Treated With Anastrozole
Hide 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 (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)
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT analysis set included all randomised patients.
Arm/Group Title Fulvestrant 500 mg Anastrozole 1 mg
Hide Arm/Group Description:
Patients received fulvestrant (Faslodex™) 500 mg, administered as two 5 mL intramuscular injections, 1 in each buttock, at each visit on Days 0, 14 (±3), 28 (±3) and every 28 (±3) days thereafter. In order to support the double-blind, double-dummy design of the trial, each patient randomised to receive fulvestrant, also received placebo to match the anastrozole schedule (tablets, once daily).
Patients received anastrozole (Arimidex™), administered orally as a single tablet at a dose of 1 mg/day from randomisation on Day 0 and once daily thereafter. In order to support the double-blind, double-dummy design of the trial, each patient randomised to receive anastrozole also received placebo to match the fulvestrant schedule (injections on Days 0, 14 [±3], 28 [±3] and every 28 [±3] days thereafter).
Overall Number of Participants Analyzed 230 232
Median (95% Confidence Interval)
Unit of Measure: Months
16.6
(13.83 to 20.99)
13.8
(11.99 to 16.59)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Fulvestrant 500 mg, Anastrozole 1 mg
Comments If the true PFS HR for comparison of fulvestrant vs. anastrozole was 0.69 (likely to correspond to a 45% prolongation of PFS) the study had 90% power to demonstrate a statistically significant difference for PFS with a one-sided type 1 error of 2.5% (two-sided 5%).
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0486
Comments 2-sided p-value
Method Log Rank
Comments Stratified log-rank test with factors for prior chemotherapy for locally advanced or metastatic disease and measurable disease at baseline.
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.797
Confidence Interval (2-Sided) 95%
0.637 to 0.999
Estimation Comments A hazard ratio < 1 favours fulvestrant.
2.Secondary Outcome
Title Comparison of Overall Survival (OS) in Patients Treated With Fulvestrant With Those Treated With Anastrozole; Percentage of Patients With Events
Hide Description OS was defined as the time from randomisation until death by any cause. The current OS data correspond to that of the final analysis and the outcome measure is reported as percentage of patients with events.
Time Frame 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
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT analysis set included all randomised patients. Date of death of 2 participants were unknown in the Anastrozole 1mg arm, hence they were censored for OS analysis.
Arm/Group Title Fulvestrant 500 mg Anastrozole 1 mg
Hide Arm/Group Description:
Patients received fulvestrant (Faslodex™) 500 mg, administered as two 5 mL intramuscular injections, 1 in each buttock, at each visit on Days 0, 14 (±3), 28 (±3) and every 28 (±3) days thereafter. In order to support the double-blind, double-dummy design of the trial, each patient randomised to receive fulvestrant, also received placebo to match the anastrozole schedule (tablets, once daily).
Patients received anastrozole (Arimidex™), administered orally as a single tablet at a dose of 1 mg/day from randomisation on Day 0 and once daily thereafter. In order to support the double-blind, double-dummy design of the trial, each patient randomised to receive anastrozole also received placebo to match the fulvestrant schedule (injections on Days 0, 14 [±3], 28 [±3] and every 28 [±3] days thereafter).
Overall Number of Participants Analyzed 230 232
Measure Type: Number
Unit of Measure: Percentage of patients
68.3 67.7
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Fulvestrant 500 mg, Anastrozole 1 mg
Comments 65% OS maturity
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7579
Comments 2-sided p-value
Method Log Rank
Comments Stratified log-rank test with factors for prior chemotherapy for locally advanced or metastatic disease and measurable disease at baseline.
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.966
Confidence Interval (2-Sided) 95%
0.773 to 1.206
Estimation Comments A HR of <1 favours fulvestrant.
3.Secondary Outcome
Title Objective Response Rate (ORR) for Fulvestrant Treatment Versus Anastrozole Treatment
Hide 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. CR was disappearance of all target lesions since baseline; was any pathological lymph nodes selected as target lesions (TL) to have a reduction in short axis to <10 millimeter. PR was at least a 30% decrease in the sum of the diameters of TL, taking as reference the baseline sum of diameters.
Time Frame Baseline RECIST 1.1 assessments (Day 0) and then every 12 weeks until disease progression or treatment discontinuation (up to approximately 38 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Percentages for ORR were calculated based on the number of patients in the ITT analysis set (which included all randomised patients) who had measurable disease at baseline (n=193 for Fulvestrant arm and n=196 for Anastrozole arm).
Arm/Group Title Fulvestrant 500 mg Anastrozole 1 mg
Hide Arm/Group Description:
Patients received fulvestrant (Faslodex™) 500 mg, administered as two 5 mL intramuscular injections, 1 in each buttock, at each visit on Days 0, 14 (±3), 28 (±3) and every 28 (±3) days thereafter. In order to support the double-blind, double-dummy design of the trial, each patient randomised to receive fulvestrant, also received placebo to match the anastrozole schedule (tablets, once daily).
Patients received anastrozole (Arimidex™), administered orally as a single tablet at a dose of 1 mg/day from randomisation on Day 0 and once daily thereafter. In order to support the double-blind, double-dummy design of the trial, each patient randomised to receive anastrozole also received placebo to match the fulvestrant schedule (injections on Days 0, 14 [±3], 28 [±3] and every 28 [±3] days thereafter).
Overall Number of Participants Analyzed 193 196
Measure Type: Number
Unit of Measure: Percentage of participants
46.1 44.9
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Fulvestrant 500 mg, Anastrozole 1 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7290
Comments 2-sided p-value
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.074
Confidence Interval (2-Sided) 95%
0.716 to 1.614
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Duration of Response (DoR) for Fulvestrant Treatment Versus Anastrozole Treatment
Hide 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. CR was disappearance of all target lesions since baseline; any pathological lymph nodes selected as TL to have a reduction in short axis to <10 mm. At least a 30% decrease in the sum of the diameters of TL, taking as reference the baseline sum of diameters.
Time Frame Baseline RECIST 1.1 assessments (Day 0) and then every 12 weeks until disease progression or treatment discontinuation (up to approximately 38 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Only patients in the ITT analysis set (which included all randomised patients), who also had an objective response and had measurable disease at baseline were included in the DoR analysis (n=89 for Fulvestrant arm and n=88 for Anastrozole arm).
Arm/Group Title Fulvestrant 500 mg Anastrozole 1 mg
Hide Arm/Group Description:
Patients received fulvestrant (Faslodex™) 500 mg, administered as two 5 mL intramuscular injections, 1 in each buttock, at each visit on Days 0, 14 (±3), 28 (±3) and every 28 (±3) days thereafter. In order to support the double-blind, double-dummy design of the trial, each patient randomised to receive fulvestrant, also received placebo to match the anastrozole schedule (tablets, once daily).
Patients received anastrozole (Arimidex™), administered orally as a single tablet at a dose of 1 mg/day from randomisation on Day 0 and once daily thereafter. In order to support the double-blind, double-dummy design of the trial, each patient randomised to receive anastrozole also received placebo to match the fulvestrant schedule (injections on Days 0, 14 [±3], 28 [±3] and every 28 [±3] days thereafter).
Overall Number of Participants Analyzed 89 88
Median (Inter-Quartile Range)
Unit of Measure: Months
20.0 [1] 
(10.6 to NA)
13.2
(8.3 to 24.7)
[1]
NA = Not Available. 75th percentile value not calculable due to insufficient data.
5.Secondary Outcome
Title Expected Duration of Response (EDoR) for Fulvestrant Treatment Versus Anastrozole Treatment
Hide 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)
Hide Outcome Measure Data
Hide Analysis Population Description
EDoR analysis was based on the number of patients in the ITT analysis set (which included all randomised patients) who had measurable disease at baseline (n=193 for Fulvestrant arm and n=196 for Anastrozole arm).
Arm/Group Title Fulvestrant 500 mg Anastrozole 1 mg
Hide Arm/Group Description:
Patients received fulvestrant (Faslodex™) 500 mg, administered as two 5 mL intramuscular injections, 1 in each buttock, at each visit on Days 0, 14 (±3), 28 (±3) and every 28 (±3) days thereafter. In order to support the double-blind, double-dummy design of the trial, each patient randomised to receive fulvestrant, also received placebo to match the anastrozole schedule (tablets, once daily).
Patients received anastrozole (Arimidex™), administered orally as a single tablet at a dose of 1 mg/day from randomisation on Day 0 and once daily thereafter. In order to support the double-blind, double-dummy design of the trial, each patient randomised to receive anastrozole also received placebo to match the fulvestrant schedule (injections on Days 0, 14 [±3], 28 [±3] and every 28 [±3] days thereafter).
Overall Number of Participants Analyzed 193 196
Measure Type: Number
Unit of Measure: Days
346.84 227.58
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Fulvestrant 500 mg, Anastrozole 1 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0367
Comments 2-sided p-value
Method Method of Ellis et al
Comments [Not Specified]
Method of Estimation Estimation Parameter Rato of EDoR
Estimated Value 1.52
Confidence Interval (2-Sided) 95%
1.03 to 2.26
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Clinical Benefit Rate (CBR) for Fulvestrant Treatment Versus Anastrozole Treatment
Hide 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 (Day 0) and then every 12 weeks until disease progression or treatment discontinuation (up to approximately 38 months)
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT analysis set included all randomised patients.
Arm/Group Title Fulvestrant 500 mg Anastrozole 1 mg
Hide Arm/Group Description:
Patients received fulvestrant (Faslodex™) 500 mg, administered as two 5 mL intramuscular injections, 1 in each buttock, at each visit on Days 0, 14 (±3), 28 (±3) and every 28 (±3) days thereafter. In order to support the double-blind, double-dummy design of the trial, each patient randomised to receive fulvestrant, also received placebo to match the anastrozole schedule (tablets, once daily).
Patients received anastrozole (Arimidex™), administered orally as a single tablet at a dose of 1 mg/day from randomisation on Day 0 and once daily thereafter. In order to support the double-blind, double-dummy design of the trial, each patient randomised to receive anastrozole also received placebo to match the fulvestrant schedule (injections on Days 0, 14 [±3], 28 [±3] and every 28 [±3] days thereafter).
Overall Number of Participants Analyzed 230 232
Measure Type: Number
Unit of Measure: Percentage of participants
78.3 74.1
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Fulvestrant 500 mg, Anastrozole 1 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3045
Comments 2-sided p-value
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.253
Confidence Interval (2-Sided) 95%
0.815 to 1.932
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Duration of Clinical Benefit (DoCB) for Fulvestrant Treatment Versus Anastrozole Treatment
Hide 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 (Day 0) and then every 12 weeks until disease progression or treatment discontinuation (up to approximately 38 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Only patients in the ITT analysis set (which included all randomised patients) who also had a clinical benefit were included in the DoCB analysis (n=180 for Fulvestrant arm and n=172 for Anastrozole arm).
Arm/Group Title Fulvestrant 500 mg Anastrozole 1 mg
Hide Arm/Group Description:
Patients received fulvestrant (Faslodex™) 500 mg, administered as two 5 mL intramuscular injections, 1 in each buttock, at each visit on Days 0, 14 (±3), 28 (±3) and every 28 (±3) days thereafter. In order to support the double-blind, double-dummy design of the trial, each patient randomised to receive fulvestrant, also received placebo to match the anastrozole schedule (tablets, once daily).
Patients received anastrozole (Arimidex™), administered orally as a single tablet at a dose of 1 mg/day from randomisation on Day 0 and once daily thereafter. In order to support the double-blind, double-dummy design of the trial, each patient randomised to receive anastrozole also received placebo to match the fulvestrant schedule (injections on Days 0, 14 [±3], 28 [±3] and every 28 [±3] days thereafter).
Overall Number of Participants Analyzed 180 172
Median (Inter-Quartile Range)
Unit of Measure: Months
22.1 [1] 
(11.2 to NA)
19.1
(11.3 to 30.4)
[1]
75th percentile value not calculable due to insufficient data.
8.Secondary Outcome
Title Expected Duration of Clinical Benefit (EDoCB) for Fulvestrant Treatment Versus Anastrozole Treatment
Hide 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 (Day 0) and then every 12 weeks until disease progression or treatment discontinuation (up to approximately 38 months)
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT analysis set included all randomised patients.
Arm/Group Title Fulvestrant 500 mg Anastrozole 1 mg
Hide Arm/Group Description:
Patients received fulvestrant (Faslodex™) 500 mg, administered as two 5 mL intramuscular injections, 1 in each buttock, at each visit on Days 0, 14 (±3), 28 (±3) and every 28 (±3) days thereafter. In order to support the double-blind, double-dummy design of the trial, each patient randomised to receive fulvestrant, also received placebo to match the anastrozole schedule (tablets, once daily).
Patients received anastrozole (Arimidex™), administered orally as a single tablet at a dose of 1 mg/day from randomisation on Day 0 and once daily thereafter. In order to support the double-blind, double-dummy design of the trial, each patient randomised to receive anastrozole also received placebo to match the fulvestrant schedule (injections on Days 0, 14 [±3], 28 [±3] and every 28 [±3] days thereafter).
Overall Number of Participants Analyzed 230 232
Measure Type: Number
Unit of Measure: Days
667.94 532.04
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Fulvestrant 500 mg, Anastrozole 1 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0561
Comments 2-sided p-value
Method Method of Ellis et al
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio of EDoCB
Estimated Value 1.26
Confidence Interval 95%
0.99 to 1.59
Estimation Comments [Not Specified]
9.Secondary Outcome
Title Comparison of the Effect of Fulvestrant Treatment Versus Anastrozole Treatment on Time to Deterioration of Health-Related Quality of Life (HRQoL)
Hide Description The Functional Assessment of Cancer Therapy - Breast (FACT-B) questionnaire was the instrument selected to assess HRQoL and comprised of 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 baseline of final analysis 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 administered at 3 months post objective disease progression, then at 6-monthly intervals (approximately 75 months)
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT analysis set included all randomised patients.
Arm/Group Title Fulvestrant 500 mg Anastrozole 1 mg
Hide Arm/Group Description:
Patients received fulvestrant (Faslodex™) 500 mg, administered as two 5 mL intramuscular injections, 1 in each buttock, at each visit on Days 0, 14 (±3), 28 (±3) and every 28 (±3) days thereafter. In order to support the double-blind, double-dummy design of the trial, each patient randomised to receive fulvestrant, also received placebo to match the anastrozole schedule (tablets, once daily).
Patients received anastrozole (Arimidex™), administered orally as a single tablet at a dose of 1 mg/day from randomisation on Day 0 and once daily thereafter. In order to support the double-blind, double-dummy design of the trial, each patient randomised to receive anastrozole also received placebo to match the fulvestrant schedule (injections on Days 0, 14 [±3], 28 [±3] and every 28 [±3] days thereafter).
Overall Number of Participants Analyzed 230 232
Median (Inter-Quartile Range)
Unit of Measure: months
Time to TOI deterioration
14.1
(5.5 to 44.1)
11.1
(5.5 to 38.3)
Time to FACT-B total score deterioration
13.8
(5.5 to 38.7)
11.1
(4.8 to 33.6)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Fulvestrant 500 mg, Anastrozole 1 mg
Comments Comparative statistical analysis for time to deterioration of TOI score is presented (fulvestrant versus anastrozole).
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2846
Comments 2-sided p-value
Method Log Rank
Comments Stratified log-rank test with factors for prior chemotherapy for locally advanced/metastatic disease and measurable/non-measurable disease at baseline
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.88
Confidence Interval (2-Sided) 95%
0.70 to 1.11
Estimation Comments A hazard ratio < 1 favours fulvestrant.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Fulvestrant 500 mg, Anastrozole 1 mg
Comments Comparative statistical analysis for time to deterioration of FACT-B total score is presented (fulvestrant versus anastrozole).
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0844
Comments 2-sided p-value
Method Log Rank
Comments Stratified log-rank test with factors for prior chemotherapy for locally advanced/metastatic disease and measurable/non-measurable disease at baseline
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.82
Confidence Interval (2-Sided) 95%
0.66 to 1.03
Estimation Comments A hazard ratio < 1 favours fulvestrant.
Time Frame 116 months (duration from first patient enrolled to data cut-off for the final analysis)
Adverse Event Reporting Description All-Cause Mortality: The ITT analysis set included all randomised patients. For serious adverse events and other (non-serious) adverse events: Safety population was defined as all patients who received at least 1 dose of randomised study medication. 2 patients in the Fulvestrant 500 mg arm did not receive treatment and were not included in the safety population.
 
Arm/Group Title Fulvestrant 500 mg Anastrozole 1 mg
Hide Arm/Group Description Patients received fulvestrant (Faslodex™) 500 mg, administered as two 5 mL intramuscular injections, 1 in each buttock, at each visit on Days 0, 14 (±3), 28 (±3) and every 28 (±3) days thereafter. In order to support the double-blind, double-dummy design of the trial, each patient randomised to receive fulvestrant, also received placebo to match the anastrozole schedule (tablets, once daily). Patients received anastrozole (Arimidex™), administered orally as a single tablet at a dose of 1 mg/day from randomisation on Day 0 and once daily thereafter. In order to support the double-blind, double-dummy design of the trial, each patient randomised to receive anastrozole also received placebo to match the fulvestrant schedule (injections on Days 0, 14 [±3], 28 [±3] and every 28 [±3] days thereafter).
All-Cause Mortality
Fulvestrant 500 mg Anastrozole 1 mg
Affected / at Risk (%) Affected / at Risk (%)
Total   157/230 (68.26%)      159/232 (68.53%)    
Hide Serious Adverse Events
Fulvestrant 500 mg Anastrozole 1 mg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   39/228 (17.11%)      36/232 (15.52%)    
Blood and lymphatic system disorders     
Anaemia † 1  1/228 (0.44%)  1 2/232 (0.86%)  6
Anaemia macrocytic † 1  1/228 (0.44%)  1 0/232 (0.00%)  0
Thrombocytopenia † 1  0/228 (0.00%)  0 1/232 (0.43%)  1
Cardiac disorders     
Atrial flutter † 1  0/228 (0.00%)  0 1/232 (0.43%)  1
Cardiac failure acute † 1  0/228 (0.00%)  0 1/232 (0.43%)  1
Acute coronary syndrome † 1  0/228 (0.00%)  0 1/232 (0.43%)  1
Acute myocardial infarction † 1  0/228 (0.00%)  0 1/232 (0.43%)  1
Angina pectoris † 1  1/228 (0.44%)  1 0/232 (0.00%)  0
Atrial fibrillation † 1  1/228 (0.44%)  1 2/232 (0.86%)  2
Cardiac arrest † 1  0/228 (0.00%)  0 1/232 (0.43%)  1
Cardiac failure † 1  0/228 (0.00%)  0 3/232 (1.29%)  3
Cardio-respiratory arrest † 1  0/228 (0.00%)  0 1/232 (0.43%)  1
Palpitations † 1  1/228 (0.44%)  1 0/232 (0.00%)  0
Gastrointestinal disorders     
Dysphagia † 1  1/228 (0.44%)  1 0/232 (0.00%)  0
Duodenal stenosis † 1  1/228 (0.44%)  1 0/232 (0.00%)  0
Gastric ulcer haemorrhage † 1  0/228 (0.00%)  0 1/232 (0.43%)  1
Large intestine perforation † 1  1/228 (0.44%)  1 0/232 (0.00%)  0
Oesophageal dilatation † 1  0/228 (0.00%)  0 1/232 (0.43%)  1
Small intestinal obstruction † 1  1/228 (0.44%)  2 0/232 (0.00%)  0
Hepatobiliary disorders     
Bile duct stone † 1  0/228 (0.00%)  0 1/232 (0.43%)  1
Cholecystitis † 1  1/228 (0.44%)  1 0/232 (0.00%)  0
Jaundice cholestatic † 1  0/228 (0.00%)  0 1/232 (0.43%)  1
Immune system disorders     
Drug hypersensitivity † 1  1/228 (0.44%)  1 0/232 (0.00%)  0
Infections and infestations     
Appendicitis † 1  1/228 (0.44%)  1 0/232 (0.00%)  0
Bronchitis † 1  0/228 (0.00%)  0 1/232 (0.43%)  1
COVID-19 † 1  0/228 (0.00%)  0 2/232 (0.86%)  2
Device related sepsis † 1  1/228 (0.44%)  1 0/232 (0.00%)  0
Gastroenteritis † 1  1/228 (0.44%)  1 0/232 (0.00%)  0
Infection † 1  0/228 (0.00%)  0 1/232 (0.43%)  1
Lower respiratory tract infection † 1  1/228 (0.44%)  1 1/232 (0.43%)  1
Peritonitis † 1  2/228 (0.88%)  2 0/232 (0.00%)  0
Pneumonia † 1  3/228 (1.32%)  3 4/232 (1.72%)  7
Pyelonephritis † 1  0/228 (0.00%)  0 1/232 (0.43%)  1
Septic shock † 1  1/228 (0.44%)  1 0/232 (0.00%)  0
Urinary tract infection † 1  2/228 (0.88%)  2 0/232 (0.00%)  0
Injury, poisoning and procedural complications     
Skin abrasion † 1  1/228 (0.44%)  1 0/232 (0.00%)  0
Ankle fracture † 1  0/228 (0.00%)  0 1/232 (0.43%)  1
Fall † 1  0/228 (0.00%)  0 1/232 (0.43%)  1
Humerus fracture † 1  1/228 (0.44%)  1 0/232 (0.00%)  0
Radius fracture † 1  2/228 (0.88%)  2 0/232 (0.00%)  0
Subdural haematoma † 1  1/228 (0.44%)  1 0/232 (0.00%)  0
Traumatic spinal cord compression † 1  1/228 (0.44%)  1 0/232 (0.00%)  0
Investigations     
Aspartate aminotransferase increased † 1  0/228 (0.00%)  0 1/232 (0.43%)  1
Alanine aminotransferase increased † 1  0/228 (0.00%)  0 1/232 (0.43%)  1
Hepatic enzyme increased † 1  0/228 (0.00%)  0 1/232 (0.43%)  2
Metabolism and nutrition disorders     
Dehydration † 1  0/228 (0.00%)  0 2/232 (0.86%)  2
Musculoskeletal and connective tissue disorders     
Neck pain † 1  0/228 (0.00%)  0 1/232 (0.43%)  1
Osteoarthritis † 1  0/228 (0.00%)  0 1/232 (0.43%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Colorectal cancer † 1  1/228 (0.44%)  1 0/232 (0.00%)  0
Acoustic neuroma † 1  0/228 (0.00%)  0 1/232 (0.43%)  1
Adenocarcinoma of colon † 1  1/228 (0.44%)  1 1/232 (0.43%)  1
Basal cell carcinoma † 1  0/228 (0.00%)  0 1/232 (0.43%)  1
Colon cancer † 1  1/228 (0.44%)  1 3/232 (1.29%)  3
Lymphoma † 1  1/228 (0.44%)  1 0/232 (0.00%)  0
Squamous cell carcinoma of the oral cavity † 1  1/228 (0.44%)  1 0/232 (0.00%)  0
Nervous system disorders     
Brain oedema † 1  1/228 (0.44%)  1 0/232 (0.00%)  0
Cerebral haemorrhage † 1  0/228 (0.00%)  0 1/232 (0.43%)  1
Cerebral infarction † 1  0/228 (0.00%)  0 1/232 (0.43%)  1
Cerebrovascular accident † 1  2/228 (0.88%)  2 0/232 (0.00%)  0
Haemorrhagic stroke † 1  1/228 (0.44%)  1 0/232 (0.00%)  0
Transient ischaemic attack † 1  1/228 (0.44%)  1 0/232 (0.00%)  0
Psychiatric disorders     
Anxiety † 1  0/228 (0.00%)  0 1/232 (0.43%)  1
Renal and urinary disorders     
Acute kidney injury † 1  0/228 (0.00%)  0 2/232 (0.86%)  2
Respiratory, thoracic and mediastinal disorders     
Bronchiectasis † 1  0/228 (0.00%)  0 1/232 (0.43%)  1
Acute respiratory failure † 1  0/228 (0.00%)  0 1/232 (0.43%)  1
Chronic obstructive pulmonary disease † 1  2/228 (0.88%)  2 0/232 (0.00%)  0
Dyspnoea † 1  0/228 (0.00%)  0 1/232 (0.43%)  1
Pleural effusion † 1  7/228 (3.07%)  10 2/232 (0.86%)  2
Pulmonary embolism † 1  3/228 (1.32%)  4 1/232 (0.43%)  1
Vascular disorders     
Circulatory collapse † 1  0/228 (0.00%)  0 1/232 (0.43%)  1
Deep vein thrombosis † 1  0/228 (0.00%)  0 2/232 (0.86%)  2
Hypertensive crisis † 1  2/228 (0.88%)  2 0/232 (0.00%)  0
1
Term from vocabulary, MedDRA 25.0
†
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Fulvestrant 500 mg Anastrozole 1 mg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   125/228 (54.82%)      127/232 (54.74%)    
Blood and lymphatic system disorders     
Anaemia † 1  9/228 (3.95%)  10 20/232 (8.62%)  21
Gastrointestinal disorders     
Constipation † 1  16/228 (7.02%)  16 11/232 (4.74%)  13
Diarrhoea † 1  15/228 (6.58%)  20 15/232 (6.47%)  17
Nausea † 1  25/228 (10.96%)  29 25/232 (10.78%)  27
General disorders     
Fatigue † 1  29/228 (12.72%)  35 18/232 (7.76%)  20
Injection site pain † 1  12/228 (5.26%)  15 10/232 (4.31%)  23
Oedema peripheral † 1  11/228 (4.82%)  11 14/232 (6.03%)  15
Investigations     
Alanine aminotransferase increased † 1  16/228 (7.02%)  18 8/232 (3.45%)  8
Aspartate aminotransferase increased † 1  12/228 (5.26%)  13 9/232 (3.88%)  9
Musculoskeletal and connective tissue disorders     
Arthralgia † 1  42/228 (18.42%)  65 31/232 (13.36%)  40
Back pain † 1  22/228 (9.65%)  25 18/232 (7.76%)  19
Myalgia † 1  16/228 (7.02%)  19 8/232 (3.45%)  11
Pain in extremity † 1  17/228 (7.46%)  22 11/232 (4.74%)  15
Nervous system disorders     
Headache † 1  12/228 (5.26%)  13 12/232 (5.17%)  12
Psychiatric disorders     
Anxiety † 1  12/228 (5.26%)  13 4/232 (1.72%)  4
Insomnia † 1  18/228 (7.89%)  19 15/232 (6.47%)  16
Respiratory, thoracic and mediastinal disorders     
Cough † 1  12/228 (5.26%)  15 9/232 (3.88%)  12
Dyspnoea † 1  10/228 (4.39%)  10 15/232 (6.47%)  17
Vascular disorders     
Hot flush † 1  26/228 (11.40%)  35 24/232 (10.34%)  32
Hypertension † 1  18/228 (7.89%)  19 22/232 (9.48%)  25
1
Term from vocabulary, MedDRA 25.0
†
Indicates events were collected by systematic assessment
[Not Specified]
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Global Clinical Lead
Organization: AstraZeneca
Phone: 1-877-240-9479
EMail: information.center@astrazeneca.com
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01602380    
Other Study ID Numbers: D699BC00001
2011-006326-24 ( EudraCT Number )
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: February 9, 2024