A global study to compare the effects of Fulvestrant and arimidex in a subset of patients with breast cancer. - FALCON

Study identifier:D699BC00001

ClinicalTrials.gov identifier:NCT01602380

EudraCT identifier:2011-006326-24

CTIS identifier:N/A

Recruitment Complete

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.

Medical condition

hormone receptor positive breast cancer

Phase

Phase 3

Healthy volunteers

Study drug

faslodex 500mg, arimidex 1mg, faslodex dummy, arimidex dummy

Sex

Female

Actual Enrollment

462

Study type

Interventional

Age

18 Years - 130 Years

Date

Study Start Date: 17 Oct 2012

Primary Completion Date: 11 Apr 2016

Estimated Study Completion Date: 06 Aug 2027

Study design

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment

Verification:

Verified 01 Jun 2025 by AstraZeneca

Collaborators

Inclusion and exclusion 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).

Location

Research Site

Rosario, Argentina, S2000KZE

Location

Research Site

Pergamino, Argentina, B2700CPM

Location

Research Site

Mar del Plata, Argentina, B7600CTO

Location

Research Site

La Rioja, Argentina, 5300

Location

Research Site

Porto Alegre, Brazil, 91350-200

Location

Research Site

Santo Andre, Brazil, 09060-870

Location

Research Site

Montreal, Quebec, Canada, H4A 3J1

Location

Research Site

Kitchener, ON, Canada, N2G 1G3

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

Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
First patient enrolled: 17 October 2012.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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.

Reporting Groups

	Description
Fulvestrant 500 mg	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).
Anastrozole 1 mg	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).

Description

Fulvestrant 500 mg

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).

Anastrozole 1 mg

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).

Participant Flow: Overall Study

	Fulvestrant 500 mg	Anastrozole 1 mg
STARTED	230	232
COMPLETED	25	31
NOT COMPLETED	205	201
Death	147	145
Withdrawal by Subject	39	41
Lost to Follow-up	15	12
Eligibility criteria not fulfilled	2	3
Unspecified	2	0

Baseline Characteristics

Analysis Population Description -- Explanation of how the number of participants for analysis was determined.

The intention to treat (ITT) analysis set included all randomised patients.

Reporting Groups

	Description
Fulvestrant 500 mg	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).
Anastrozole 1 mg	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).

Description

Fulvestrant 500 mg

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).

Anastrozole 1 mg

Baseline Measures

	Fulvestrant 500 mg	Anastrozole 1 mg	Total
Number of Participants [units: Participants]	230	232	462
Age Continuous [units: years] Mean ± Standard Deviation	63.8 ± 9.86	63.3 ± 10.38	63.5 ± 10.12
Sex: Female, Male [units: ]
Female	230	232	462
Male	0	0	0
Race/Ethnicity, Customized [units: ]
American Indian or Alaska Native	1	5	6
Asian	36	34	70
Black or African American	4	4	8
White	175	174	349
Other	14	15	29

Outcome Measures

1. Primary Outcome Measure: Comparison of Progression-Free Survival (PFS) in Patients Treated With Fulvestrant With Those Treated With Anastrozole [ 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) ]

Measure Type	Primary
Measure Name	Comparison of Progression-Free Survival (PFS) in Patients Treated With Fulvestrant With Those Treated With Anastrozole
Measure 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)
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The ITT analysis set included all randomised patients.

Reporting Groups

	Description
Fulvestrant 500 mg	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).
Anastrozole 1 mg	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).

Description

Fulvestrant 500 mg

Anastrozole 1 mg

Measured Values

	Fulvestrant 500 mg	Anastrozole 1 mg
Number of Participants Analyzed [units:participants]	230	232
Comparison of Progression-Free Survival (PFS) in Patients Treated With Fulvestrant With Those Treated With Anastrozole [units: Months] Median (95% Confidence Interval)	16.6 (13.83 to 20.99)	13.8 (11.99 to 16.59)

Statistical Analysis 1 for Comparison of Progression-Free Survival (PFS) in Patients Treated With Fulvestrant With Those Treated With Anastrozole

Groups^[1]	All groups
Method^[3]	Log Rank
P-Value^[4]	0.0486
Hazard Ratio (HR)^[5]	0.797
95% Confidence Interval	( 0.637 to 0.999 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	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%).
[3]	Other relevant information, such as adjustments or degrees of freedom:
	Stratified log-rank test with factors for prior chemotherapy for locally advanced or metastatic disease and measurable disease at baseline.
[4]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	2-sided p-value
[5]	Other relevant estimation information:
	A hazard ratio < 1 favours fulvestrant.

2. Secondary Outcome Measure: Comparison of Overall Survival (OS) in Patients Treated With Fulvestrant With Those Treated With Anastrozole; 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 ]

Measure Type	Secondary
Measure Name	Comparison of Overall Survival (OS) in Patients Treated With Fulvestrant With Those Treated With Anastrozole; Percentage of Patients With Events
Measure 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
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Reporting Groups

	Description
Fulvestrant 500 mg	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).
Anastrozole 1 mg	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).

Description

Fulvestrant 500 mg

Anastrozole 1 mg

Measured Values

	Fulvestrant 500 mg	Anastrozole 1 mg
Number of Participants Analyzed [units:participants]	230	232
Comparison of Overall Survival (OS) in Patients Treated With Fulvestrant With Those Treated With Anastrozole; Percentage of Patients With Events [units: Percentage of patients]	68.3	67.7

Statistical Analysis 1 for Comparison of Overall Survival (OS) in Patients Treated With Fulvestrant With Those Treated With Anastrozole; Percentage of Patients With Events

Groups^[1]	All groups
Method^[3]	Log Rank
P-Value^[4]	0.7579
Hazard Ratio (HR)^[5]	0.966
95% Confidence Interval	( 0.773 to 1.206 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	65% OS maturity
[3]	Other relevant information, such as adjustments or degrees of freedom:
	Stratified log-rank test with factors for prior chemotherapy for locally advanced or metastatic disease and measurable disease at baseline.
[4]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	2-sided p-value
[5]	Other relevant estimation information:
	A HR of <1 favours fulvestrant.

3. Secondary Outcome Measure: Objective Response Rate (ORR) for Fulvestrant Treatment Versus Anastrozole Treatment [ 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) ]

Measure Type	Secondary
Measure Name	Objective Response Rate (ORR) for Fulvestrant Treatment Versus Anastrozole Treatment
Measure 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)
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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).

Reporting Groups

	Description
Fulvestrant 500 mg	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).
Anastrozole 1 mg	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).

Description

Fulvestrant 500 mg

Anastrozole 1 mg

Measured Values

	Fulvestrant 500 mg	Anastrozole 1 mg
Number of Participants Analyzed [units:participants]	193	196
Objective Response Rate (ORR) for Fulvestrant Treatment Versus Anastrozole Treatment [units: Percentage of participants]	46.1	44.9

Statistical Analysis 1 for Objective Response Rate (ORR) for Fulvestrant Treatment Versus Anastrozole Treatment

Groups^[1]	All groups
Method^[3]	Regression, Logistic
P-Value^[4]	0.7290
Odds Ratio (OR)^[5]	1.074
95% Confidence Interval	( 0.716 to 1.614 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[3]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[4]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	2-sided p-value
[5]	Other relevant estimation information:
	No text entered.

4. Secondary Outcome Measure: Duration of Response (DoR) for Fulvestrant Treatment Versus Anastrozole Treatment [ 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) ]

Measure Type	Secondary
Measure Name	Duration of Response (DoR) for Fulvestrant Treatment Versus Anastrozole Treatment
Measure 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)
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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).

Reporting Groups

	Description
Fulvestrant 500 mg	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).
Anastrozole 1 mg	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).

Description

Fulvestrant 500 mg

Anastrozole 1 mg

Measured Values

	Fulvestrant 500 mg	Anastrozole 1 mg
Number of Participants Analyzed [units:participants]	89	88
Duration of Response (DoR) for Fulvestrant Treatment Versus Anastrozole Treatment [units: Months] Median (Inter-Quartile Range)	20.0 (10.6 to NA) ^[1]	13.2 (8.3 to 24.7)

No statistical analysis provided for Duration of Response (DoR) for Fulvestrant Treatment Versus Anastrozole Treatment

5. Secondary Outcome Measure: 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) ]

Measure Type	Secondary
Measure Name	Expected Duration of Response (EDoR) for Fulvestrant Treatment Versus Anastrozole Treatment
Measure 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)
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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).

Reporting Groups

	Description
Fulvestrant 500 mg	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).
Anastrozole 1 mg	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).

Description

Fulvestrant 500 mg

Anastrozole 1 mg

Measured Values

	Fulvestrant 500 mg	Anastrozole 1 mg
Number of Participants Analyzed [units:participants]	193	196
Expected Duration of Response (EDoR) for Fulvestrant Treatment Versus Anastrozole Treatment [units: Days]	346.84	227.58

Statistical Analysis 1 for Expected Duration of Response (EDoR) for Fulvestrant Treatment Versus Anastrozole Treatment

Groups^[1]	All groups
Method^[3]	Other [Method of Ellis et al]
P-Value^[4]	0.0367
Other^[5]	1.52
95% Confidence Interval	( 1.03 to 2.26 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[3]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[4]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	2-sided p-value
[5]	Other relevant estimation information:
	No text entered.

6. Secondary Outcome Measure: Clinical Benefit Rate (CBR) for Fulvestrant Treatment Versus Anastrozole Treatment [ 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) ]

Measure Type	Secondary
Measure Name	Clinical Benefit Rate (CBR) for Fulvestrant Treatment Versus Anastrozole Treatment
Measure 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)
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The ITT analysis set included all randomised patients.

Reporting Groups

	Description
Fulvestrant 500 mg	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).
Anastrozole 1 mg	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).

Description

Fulvestrant 500 mg

Anastrozole 1 mg

Measured Values

	Fulvestrant 500 mg	Anastrozole 1 mg
Number of Participants Analyzed [units:participants]	230	232
Clinical Benefit Rate (CBR) for Fulvestrant Treatment Versus Anastrozole Treatment [units: Percentage of participants]	78.3	74.1

Statistical Analysis 1 for Clinical Benefit Rate (CBR) for Fulvestrant Treatment Versus Anastrozole Treatment

Groups^[1]	All groups
Method^[3]	Regression, Logistic
P-Value^[4]	0.3045
Odds Ratio (OR)^[5]	1.253
95% Confidence Interval	( 0.815 to 1.932 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[3]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[4]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	2-sided p-value
[5]	Other relevant estimation information:
	No text entered.

7. Secondary Outcome Measure: Duration of Clinical Benefit (DoCB) for Fulvestrant Treatment Versus Anastrozole Treatment [ 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) ]

Measure Type	Secondary
Measure Name	Duration of Clinical Benefit (DoCB) for Fulvestrant Treatment Versus Anastrozole Treatment
Measure 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)
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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).

Reporting Groups

	Description
Fulvestrant 500 mg	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).
Anastrozole 1 mg	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).

Description

Fulvestrant 500 mg

Anastrozole 1 mg

Measured Values

	Fulvestrant 500 mg	Anastrozole 1 mg
Number of Participants Analyzed [units:participants]	180	172
Duration of Clinical Benefit (DoCB) for Fulvestrant Treatment Versus Anastrozole Treatment [units: Months] Median (Inter-Quartile Range)	22.1 (11.2 to NA) ^[1]	19.1 (11.3 to 30.4)

No statistical analysis provided for Duration of Clinical Benefit (DoCB) for Fulvestrant Treatment Versus Anastrozole Treatment

8. Secondary Outcome Measure: Expected Duration of Clinical Benefit (EDoCB) for Fulvestrant Treatment Versus Anastrozole Treatment [ 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) ]

Measure Type	Secondary
Measure Name	Expected Duration of Clinical Benefit (EDoCB) for Fulvestrant Treatment Versus Anastrozole Treatment
Measure 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)
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The ITT analysis set included all randomised patients.

Reporting Groups

	Description
Fulvestrant 500 mg	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).
Anastrozole 1 mg	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).

Description

Fulvestrant 500 mg

Anastrozole 1 mg

Measured Values

	Fulvestrant 500 mg	Anastrozole 1 mg
Number of Participants Analyzed [units:participants]	230	232
Expected Duration of Clinical Benefit (EDoCB) for Fulvestrant Treatment Versus Anastrozole Treatment [units: Days]	667.94	532.04

Statistical Analysis 1 for Expected Duration of Clinical Benefit (EDoCB) for Fulvestrant Treatment Versus Anastrozole Treatment

Groups^[1]	All groups
Method^[3]	Other [Method of Ellis et al]
P-Value^[4]	0.0561
Other^[5]	1.26
95% Confidence Interval	( 0.99 to 1.59 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[3]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[4]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	2-sided p-value
[5]	Other relevant estimation information:
	No text entered.

9. Secondary Outcome Measure: 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 administered at 3 months post objective disease progression, then at 6-monthly intervals (approximately 75 months) ]

Measure Type	Secondary
Measure Name	Comparison of the Effect of Fulvestrant Treatment Versus Anastrozole Treatment on Time to Deterioration of Health-Related Quality of Life (HRQoL)
Measure 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)
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The ITT analysis set included all randomised patients.

Reporting Groups

Description

Fulvestrant 500 mg

Anastrozole 1 mg

Measured Values

	Fulvestrant 500 mg	Anastrozole 1 mg
Number of Participants Analyzed [units:participants]	230	232
Comparison of the Effect of Fulvestrant Treatment Versus Anastrozole Treatment on Time to Deterioration of Health-Related Quality of Life (HRQoL) [units: months] Median (Inter-Quartile Range)
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)

Statistical Analysis 1 for Comparison of the Effect of Fulvestrant Treatment Versus Anastrozole Treatment on Time to Deterioration of Health-Related Quality of Life (HRQoL)

Groups^[1]	All groups
Method^[3]	Log Rank
P-Value^[4]	0.2846
Hazard Ratio (HR)^[5]	0.88
95% Confidence Interval	( 0.70 to 1.11 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Comparative statistical analysis for time to deterioration of TOI score is presented (fulvestrant versus anastrozole).
[3]	Other relevant information, such as adjustments or degrees of freedom:
	Stratified log-rank test with factors for prior chemotherapy for locally advanced/metastatic disease and measurable/non-measurable disease at baseline
[4]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	2-sided p-value
[5]	Other relevant estimation information:
	A hazard ratio < 1 favours fulvestrant.

Statistical Analysis 2 for Comparison of the Effect of Fulvestrant Treatment Versus Anastrozole Treatment on Time to Deterioration of Health-Related Quality of Life (HRQoL)

Groups^[1]	All groups
Method^[3]	Log Rank
P-Value^[4]	0.0844
Hazard Ratio (HR)^[5]	0.82
95% Confidence Interval	( 0.66 to 1.03 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Comparative statistical analysis for time to deterioration of FACT-B total score is presented (fulvestrant versus anastrozole).
[3]	Other relevant information, such as adjustments or degrees of freedom:
	Stratified log-rank test with factors for prior chemotherapy for locally advanced/metastatic disease and measurable/non-measurable disease at baseline
[4]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	2-sided p-value
[5]	Other relevant estimation information:
	A hazard ratio < 1 favours fulvestrant.

Serious Adverse Events

Time Frame	116 months (duration from first patient enrolled to data cut-off for the final analysis)
Additional 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.

Reporting Groups

Description

Fulvestrant 500 mg

Anastrozole 1 mg

Serious Adverse Events

Fulvestrant 500 mg

Anastrozole 1 mg

Total, serious adverse events

# participants affected / at risk

39/228 (17.11%)

36/232 (15.52%)

Blood and lymphatic system disorders

Anaemia¹,^†

# participants affected / at risk

1/228 (0.44%)

2/232 (0.86%)

# events

Blood and lymphatic system disorders

Anaemia macrocytic¹,^†

# participants affected / at risk

1/228 (0.44%)

0/232 (0.00%)

# events

Blood and lymphatic system disorders

Thrombocytopenia¹,^†

# participants affected / at risk

0/228 (0.00%)

1/232 (0.43%)

# events

Cardiac disorders

Atrial flutter¹,^†

# participants affected / at risk

0/228 (0.00%)

1/232 (0.43%)

# events

Cardiac disorders

Cardiac failure acute¹,^†

# participants affected / at risk

0/228 (0.00%)

1/232 (0.43%)

# events

Gastrointestinal disorders

Dysphagia¹,^†

# participants affected / at risk

1/228 (0.44%)

0/232 (0.00%)

# events

Infections and infestations

Appendicitis¹,^†

# participants affected / at risk

1/228 (0.44%)

0/232 (0.00%)

# events

Injury, poisoning and procedural complications

Skin abrasion¹,^†

# participants affected / at risk

1/228 (0.44%)

0/232 (0.00%)

# events

Investigations

Aspartate aminotransferase increased¹,^†

# participants affected / at risk

0/228 (0.00%)

1/232 (0.43%)

# events

Musculoskeletal and connective tissue disorders

Neck pain¹,^†

# participants affected / at risk

0/228 (0.00%)

1/232 (0.43%)

# events

Musculoskeletal and connective tissue disorders

Osteoarthritis¹,^†

# participants affected / at risk

0/228 (0.00%)

1/232 (0.43%)

# events

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Colorectal cancer¹,^†

# participants affected / at risk

1/228 (0.44%)

0/232 (0.00%)

# events

Respiratory, thoracic and mediastinal disorders

Bronchiectasis¹,^†

# participants affected / at risk

0/228 (0.00%)

1/232 (0.43%)

# events

Cardiac disorders

Acute coronary syndrome¹,^†

# participants affected / at risk

0/228 (0.00%)

1/232 (0.43%)

# events

Cardiac disorders

Acute myocardial infarction¹,^†

# participants affected / at risk

0/228 (0.00%)

1/232 (0.43%)

# events

Cardiac disorders

Angina pectoris¹,^†

# participants affected / at risk

1/228 (0.44%)

0/232 (0.00%)

# events

Hepatobiliary disorders

Bile duct stone¹,^†

# participants affected / at risk

0/228 (0.00%)

1/232 (0.43%)

# events

Hepatobiliary disorders

Cholecystitis¹,^†

# participants affected / at risk

1/228 (0.44%)

0/232 (0.00%)

# events

Hepatobiliary disorders

Jaundice cholestatic¹,^†

# participants affected / at risk

0/228 (0.00%)

1/232 (0.43%)

# events

Immune system disorders

Drug hypersensitivity¹,^†

# participants affected / at risk

1/228 (0.44%)

0/232 (0.00%)

# events

Infections and infestations

Bronchitis¹,^†

# participants affected / at risk

0/228 (0.00%)

1/232 (0.43%)

# events

Infections and infestations

COVID-19¹,^†

# participants affected / at risk

0/228 (0.00%)

2/232 (0.86%)

# events

Infections and infestations

Device related sepsis¹,^†

# participants affected / at risk

1/228 (0.44%)

0/232 (0.00%)

# events

Cardiac disorders

Atrial fibrillation¹,^†

# participants affected / at risk

1/228 (0.44%)

2/232 (0.86%)

# events

Infections and infestations

Gastroenteritis¹,^†

# participants affected / at risk

1/228 (0.44%)

0/232 (0.00%)

# events

Infections and infestations

Infection¹,^†

# participants affected / at risk

0/228 (0.00%)

1/232 (0.43%)

# events

Infections and infestations

Lower respiratory tract infection¹,^†

# participants affected / at risk

1/228 (0.44%)

1/232 (0.43%)

# events

Infections and infestations

Peritonitis¹,^†

# participants affected / at risk

2/228 (0.88%)

0/232 (0.00%)

# events

Infections and infestations

Pneumonia¹,^†

# participants affected / at risk

3/228 (1.32%)

4/232 (1.72%)

# events

Infections and infestations

Pyelonephritis¹,^†

# participants affected / at risk

0/228 (0.00%)

1/232 (0.43%)

# events

Infections and infestations

Septic shock¹,^†

# participants affected / at risk

1/228 (0.44%)

0/232 (0.00%)

# events

Infections and infestations

Urinary tract infection¹,^†

# participants affected / at risk

2/228 (0.88%)

0/232 (0.00%)

# events

Cardiac disorders

Cardiac arrest¹,^†

# participants affected / at risk

0/228 (0.00%)

1/232 (0.43%)

# events

Injury, poisoning and procedural complications

Ankle fracture¹,^†

# participants affected / at risk

0/228 (0.00%)

1/232 (0.43%)

# events

Injury, poisoning and procedural complications

Fall¹,^†

# participants affected / at risk

0/228 (0.00%)

1/232 (0.43%)

# events

Cardiac disorders

Cardiac failure¹,^†

# participants affected / at risk

0/228 (0.00%)

3/232 (1.29%)

# events

Injury, poisoning and procedural complications

Humerus fracture¹,^†

# participants affected / at risk

1/228 (0.44%)

0/232 (0.00%)

# events

Injury, poisoning and procedural complications

Radius fracture¹,^†

# participants affected / at risk

2/228 (0.88%)

0/232 (0.00%)

# events

Injury, poisoning and procedural complications

Subdural haematoma¹,^†

# participants affected / at risk

1/228 (0.44%)

0/232 (0.00%)

# events

Injury, poisoning and procedural complications

Traumatic spinal cord compression¹,^†

# participants affected / at risk

1/228 (0.44%)

0/232 (0.00%)

# events

Investigations

Alanine aminotransferase increased¹,^†

# participants affected / at risk

0/228 (0.00%)

1/232 (0.43%)

# events

Investigations

Hepatic enzyme increased¹,^†

# participants affected / at risk

0/228 (0.00%)

1/232 (0.43%)

# events

Cardiac disorders

Cardio-respiratory arrest¹,^†

# participants affected / at risk

0/228 (0.00%)

1/232 (0.43%)

# events

Metabolism and nutrition disorders

Dehydration¹,^†

# participants affected / at risk

0/228 (0.00%)

2/232 (0.86%)

# events

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Acoustic neuroma¹,^†

# participants affected / at risk

0/228 (0.00%)

1/232 (0.43%)

# events

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Adenocarcinoma of colon¹,^†

# participants affected / at risk

1/228 (0.44%)

1/232 (0.43%)

# events

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Basal cell carcinoma¹,^†

# participants affected / at risk

0/228 (0.00%)

1/232 (0.43%)

# events

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Colon cancer¹,^†

# participants affected / at risk

1/228 (0.44%)

3/232 (1.29%)

# events

Cardiac disorders

Palpitations¹,^†

# participants affected / at risk

1/228 (0.44%)

0/232 (0.00%)

# events

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Lymphoma¹,^†

# participants affected / at risk

1/228 (0.44%)

0/232 (0.00%)

# events

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Squamous cell carcinoma of the oral cavity¹,^†

# participants affected / at risk

1/228 (0.44%)

0/232 (0.00%)

# events

Nervous system disorders

Brain oedema¹,^†

# participants affected / at risk

1/228 (0.44%)

0/232 (0.00%)

# events

Nervous system disorders

Cerebral haemorrhage¹,^†

# participants affected / at risk

0/228 (0.00%)

1/232 (0.43%)

# events

Nervous system disorders

Cerebral infarction¹,^†

# participants affected / at risk

0/228 (0.00%)

1/232 (0.43%)

# events

Nervous system disorders

Cerebrovascular accident¹,^†

# participants affected / at risk

2/228 (0.88%)

0/232 (0.00%)

# events

Nervous system disorders

Haemorrhagic stroke¹,^†

# participants affected / at risk

1/228 (0.44%)

0/232 (0.00%)

# events

Nervous system disorders

Transient ischaemic attack¹,^†

# participants affected / at risk

1/228 (0.44%)

0/232 (0.00%)

# events

Psychiatric disorders

Anxiety¹,^†

# participants affected / at risk

0/228 (0.00%)

1/232 (0.43%)

# events

Renal and urinary disorders

Acute kidney injury¹,^†

# participants affected / at risk

0/228 (0.00%)

2/232 (0.86%)

# events

Respiratory, thoracic and mediastinal disorders

Acute respiratory failure¹,^†

# participants affected / at risk

0/228 (0.00%)

1/232 (0.43%)

# events

Respiratory, thoracic and mediastinal disorders

Chronic obstructive pulmonary disease¹,^†

# participants affected / at risk

2/228 (0.88%)

0/232 (0.00%)

# events

Respiratory, thoracic and mediastinal disorders

Dyspnoea¹,^†

# participants affected / at risk

0/228 (0.00%)

1/232 (0.43%)

# events

Respiratory, thoracic and mediastinal disorders

Pleural effusion¹,^†

# participants affected / at risk

7/228 (3.07%)

2/232 (0.86%)

# events

Respiratory, thoracic and mediastinal disorders

Pulmonary embolism¹,^†

# participants affected / at risk

3/228 (1.32%)

1/232 (0.43%)

# events

Vascular disorders

Circulatory collapse¹,^†

# participants affected / at risk

0/228 (0.00%)

1/232 (0.43%)

# events

Vascular disorders

Deep vein thrombosis¹,^†

# participants affected / at risk

0/228 (0.00%)

2/232 (0.86%)

# events

Vascular disorders

Hypertensive crisis¹,^†

# participants affected / at risk

2/228 (0.88%)

0/232 (0.00%)

# events

Gastrointestinal disorders

Duodenal stenosis¹,^†

# participants affected / at risk

1/228 (0.44%)

0/232 (0.00%)

# events

Gastrointestinal disorders

Gastric ulcer haemorrhage¹,^†

# participants affected / at risk

0/228 (0.00%)

1/232 (0.43%)

# events

Gastrointestinal disorders

Large intestine perforation¹,^†

# participants affected / at risk

1/228 (0.44%)

0/232 (0.00%)

# events

Gastrointestinal disorders

Oesophageal dilatation¹,^†

# participants affected / at risk

0/228 (0.00%)

1/232 (0.43%)

# events

Gastrointestinal disorders

Small intestinal obstruction¹,^†

# participants affected / at risk

1/228 (0.44%)

0/232 (0.00%)

# events

†	Events were collected by systematic assessment
1	Term from vocabulary, MedDRA 25.0

Other Adverse Events

Time Frame	116 months (duration from first patient enrolled to data cut-off for the final analysis)
Additional 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.

Frequency Threshold

Threshold above which other adverse events are reported	5%

Reporting Groups

Description

Fulvestrant 500 mg

Anastrozole 1 mg

Other Adverse Events

Fulvestrant 500 mg

Anastrozole 1 mg

Total, other (not including serious) adverse events

# participants affected / at risk

125/228 (54.82%)

127/232 (54.74%)

Blood and lymphatic system disorders

Anaemia¹,^†

# participants affected / at risk

9/228 (3.95%)

20/232 (8.62%)

# events

Respiratory, thoracic and mediastinal disorders

Cough¹,^†

# participants affected / at risk

12/228 (5.26%)

9/232 (3.88%)

# events

General disorders and administration site conditions

Fatigue¹,^†

# participants affected / at risk

29/228 (12.72%)

18/232 (7.76%)

# events

General disorders and administration site conditions

Injection site pain¹,^†

# participants affected / at risk

12/228 (5.26%)

10/232 (4.31%)

# events

General disorders and administration site conditions

Oedema peripheral¹,^†

# participants affected / at risk

11/228 (4.82%)

14/232 (6.03%)

# events

Investigations

Alanine aminotransferase increased¹,^†

# participants affected / at risk

16/228 (7.02%)

8/232 (3.45%)

# events

Investigations

Aspartate aminotransferase increased¹,^†

# participants affected / at risk

12/228 (5.26%)

9/232 (3.88%)

# events

Musculoskeletal and connective tissue disorders

Arthralgia¹,^†

# participants affected / at risk

42/228 (18.42%)

31/232 (13.36%)

# events

Musculoskeletal and connective tissue disorders

Back pain¹,^†

# participants affected / at risk

22/228 (9.65%)

18/232 (7.76%)

# events

Musculoskeletal and connective tissue disorders

Myalgia¹,^†

# participants affected / at risk

16/228 (7.02%)

8/232 (3.45%)

# events

Musculoskeletal and connective tissue disorders

Pain in extremity¹,^†

# participants affected / at risk

17/228 (7.46%)

11/232 (4.74%)

# events

Nervous system disorders

Headache¹,^†

# participants affected / at risk

12/228 (5.26%)

12/232 (5.17%)

# events

Psychiatric disorders

Anxiety¹,^†

# participants affected / at risk

12/228 (5.26%)

4/232 (1.72%)

# events

Psychiatric disorders

Insomnia¹,^†

# participants affected / at risk

18/228 (7.89%)

15/232 (6.47%)

# events

Respiratory, thoracic and mediastinal disorders

Dyspnoea¹,^†

# participants affected / at risk

10/228 (4.39%)

15/232 (6.47%)

# events

Vascular disorders

Hot flush¹,^†

# participants affected / at risk

26/228 (11.40%)

24/232 (10.34%)

# events

Vascular disorders

Hypertension¹,^†

# participants affected / at risk

18/228 (7.89%)

22/232 (9.48%)

# events

Gastrointestinal disorders

Constipation¹,^†

# participants affected / at risk

16/228 (7.02%)

11/232 (4.74%)

# events

Gastrointestinal disorders

Diarrhoea¹,^†

# participants affected / at risk

15/228 (6.58%)

15/232 (6.47%)

# events

Gastrointestinal disorders

Nausea¹,^†

# participants affected / at risk

25/228 (10.96%)

25/232 (10.78%)

# events

†	Events were collected by systematic assessment
1	Term from vocabulary, MedDRA 25.0

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.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.

Results Point of Contact

Name/Title:	Global Clinical Lead
Organization:	AstraZeneca
Phone	1-877-240-9479
E-mail:	[email protected]

Documents available

Download
CSP redacted
Download
SAP redacted
Download
CSR Synopsis redacted
Download
FALCON_Clinical_Study_Protocol
Download
Trial Results Summaries
Available here

Contacts

Contact

AstraZeneca Clinical Study Information Center

1-877-240-9479

information.center@astrazeneca.com

Contact Backup

In US and Canada - Cancer Study Locator Service (web link - www.emergingmed.com/networks/AstraZeneca)

1-877-400-4656

astrazeneca@emergingmed.com

Investigators

Principal Investigator

Shankar S

AstraZeneca

Sponsors

Collaborators

Inclusion Criteria

Exclusion Criteria

Research Site

Research Site

Research Site

Research Site

Research Site

Research Site

Research Site

Research Site

CSP redacted

SAP redacted

CSR Synopsis redacted

FALCON_Clinical_Study_Protocol

Trial Results Summaries