Comparison of Fulvestrant (FASLODEX™) 250 mg and 500 mg in Postmenopausal Women with Oestrogen Receptor positive Advanced Breast Cancer Progressing or Relapsing after Previous Endocrine Therapy. - CONFIRM

Study identifier:D6997C00002

ClinicalTrials.gov identifier:NCT00099437

EudraCT identifier:2004-002371-16

CTIS identifier:N/A

Recruitment Complete

Official Title

A Randomised, Double-Blind, Parallel-group, Multicentre, Phase III Study Comparing the Efficacy and Tolerability of Fulvestrant (FASLODEX™) 500 mg with Fulvestrant (FASLODEX™) 250 mg in Postmenopausal Women with Oestrogen Receptor Positive Advanced Breast Cancer Progressing or Relapsing after Previous Endocrine Therapy

Medical condition

Breast Cancer

Phase

Phase 3

Healthy volunteers

Study drug

Fulvestrant

Sex

Female

Actual Enrollment

736

Study type

Interventional

Age

45 Years - 130 Years

Date

Study Start Date: 13 Feb 2005

Primary Completion Date: 27 Feb 2009

Estimated Study Completion Date: 31 Mar 2025

Study design

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

Verification:

Verified 01 Jan 2025 by AstraZeneca

Collaborators

Inclusion and exclusion criteria

Location

Research Site

Gent, Belgium, 9000

Location

Research Site

Liège, Belgium, 4000

Location

Research Site

Brussels, Belgium, 1090

Location

Research Site

Brussels, Belgium, 1070

Location

Research Site

Edegem, Belgium, 2650

Location

Research Site

Brasschaat, Belgium, 2930

Location

Research Site

Turnhout, Belgium, 2300

Location

Research Site

Hasselt, Belgium, 3500

Arms	Assigned Interventions
Experimental: 1 Fulvestrant 500 mg	Drug: Fulvestrant intramuscular injection Other Name: Faslodex Other Name: ZD9238
Experimental: 2 Fulvestrant 250 mg	Drug: Fulvestrant intramuscular injection Other Name: Faslodex Other Name: ZD9238

Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups

	Description
Fulvestrant 250 mg	Fulvestrant 250 mg Intramuscular Injection every 28 days
Fulvestrant 500 mg	Fulvestrant 500 mg Intramuscular Injection every 28 days plus 500 mg on day 14

Participant Flow: Overall Study

	Fulvestrant 250 mg	Fulvestrant 500 mg
STARTED	374^[1]	362^[2]
COMPLETED	8^[3]	13^[4]
NOT COMPLETED	366	349
Lost to Follow-up	30	33
Death	293	261
Withdrawal by Subject	6	10
Ongoing in FU but not on treatment	37	45

[1]	randomised patients
[2]	randomised patients
[3]	ongoing study treatment at survival follow-up data cut-off
[4]	ongoing study treatment at survival follow-up data cut-off

Baseline Characteristics

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

Reporting Groups

	Description
Fulvestrant 250 mg	Fulvestrant 250 mg Intramuscular Injection every 28 days
Fulvestrant 500 mg	Fulvestrant 500 mg Intramuscular Injection every 28 days plus 500 mg on day 14

Baseline Measures

	Fulvestrant 250 mg	Fulvestrant 500 mg	Total
Number of Participants [units: Participants]	374	362	736
Age Continuous [units: Years] Mean ± Standard Deviation	60.8 ± 11.94	61.0 ± 11.47	60.9 ± 11.71
Sex: Female, Male [units: ]
Female	374	362	736
Male	0	0	0

Outcome Measures

1. Primary Outcome Measure: Time to Progression (TTP) [ Time Frame: RECIST(Response Evaluation Criteria in Solid Tumors ) tumour assessments carried out every 12 weeks (+/- 2 weeks) from randomisation for study duration (48 months) ]

Measure Type	Primary
Measure Name	Time to Progression (TTP)
Measure Description	Median time (in months) from randomisation until objective disease progression or death (in the absence of objective progression).
Time Frame	RECIST(Response Evaluation Criteria in Solid Tumors ) tumour assessments carried out every 12 weeks (+/- 2 weeks) from randomisation for study duration (48 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.

Reporting Groups

	Description
Fulvestrant 250 mg	Fulvestrant 250 mg Intramuscular Injection every 28 days
Fulvestrant 500 mg	Fulvestrant 500 mg Intramuscular Injection every 28 days plus 500 mg on day 14

Measured Values

	Fulvestrant 250 mg	Fulvestrant 500 mg
Number of Participants Analyzed [units:participants]	374	362
Time to Progression (TTP) [units: months] Median (Full Range)	5.5 (0 to NA) ^[1]	6.5 (0 to NA) ^[1]

No statistical analysis provided for Time to Progression (TTP)

2. Secondary Outcome Measure: Objective Response Rate (ORR) [ Time Frame: RECIST tumour assessments carried out every 12 weeks (+/- 2 weeks) from randomisation for study duration (48 months) ]

Measure Type	Secondary
Measure Name	Objective Response Rate (ORR)
Measure Description	Using the RECIST scan data, an objective response (OR) is defined as a patient having a best overall response of either complete response (CR) or partial response (PR) which is subsequently confirmed as per RECIST. ORR is defined as the percentage of patients with OR.
Time Frame	RECIST tumour assessments carried out every 12 weeks (+/- 2 weeks) from randomisation for study duration (48 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.
All patients with measurable disease at baseline.

Reporting Groups

	Description
Fulvestrant 250 mg	Fulvestrant 250 mg Intramuscular Injection every 28 days
Fulvestrant 500 mg	Fulvestrant 500 mg Intramuscular Injection every 28 days plus 500 mg on day 14

Measured Values

	Fulvestrant 250 mg	Fulvestrant 500 mg
Number of Participants Analyzed [units:participants]	261	240
Objective Response Rate (ORR) [units: Percentage of patients]	14.6	13.8

No statistical analysis provided for Objective Response Rate (ORR)

3. Secondary Outcome Measure: Clinical Benefit Rate (CBR) [ Time Frame: Clinical Benefit from the sequence of RECIST scan data for study duration (48 months) . RECIST (Response Evaluation Criteria in Solid Tumours) scans were performed every 12 weeks (+/- 2 weeks) from randomisation for study duration (48 months) ]

Measure Type	Secondary
Measure Name	Clinical Benefit Rate (CBR)
Measure Description	A Clinical Benefit (CB) responder is defined as a patient having a best overall response of CR, PR or SD (stable disease) >=24 weeks. The Clinical Benefit Rate is the percentage of patients with CB.
Time Frame	Clinical Benefit from the sequence of RECIST scan data for study duration (48 months) . RECIST (Response Evaluation Criteria in Solid Tumours) scans were performed every 12 weeks (+/- 2 weeks) from randomisation for study duration (48 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.

Reporting Groups

	Description
Fulvestrant 250 mg	Fulvestrant 250 mg Intramuscular Injection every 28 days
Fulvestrant 500 mg	Fulvestrant 500 mg Intramuscular Injection every 28 days plus 500 mg on day 14

Measured Values

	Fulvestrant 250 mg	Fulvestrant 500 mg
Number of Participants Analyzed [units:participants]	374	362
Clinical Benefit Rate (CBR) [units: Percentage of patients]	39.6	45.6

No statistical analysis provided for Clinical Benefit Rate (CBR)

4. Secondary Outcome Measure: Duration of Response (DoR) [ Time Frame: RECIST tumour assessments carried out every 12 weeks (+/- 2 weeks) from randomisation for study duration (48 months) ]

Measure Type	Secondary
Measure Name	Duration of Response (DoR)
Measure Description	Time from randomisation until objective progression or death (in the absence of objective progression), measured only in those patients who achieve a confirmed complete response (CR) or confirmed partial response (PR)
Time Frame	RECIST tumour assessments carried out every 12 weeks (+/- 2 weeks) from randomisation for study duration (48 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.

Reporting Groups

	Description
Fulvestrant 250 mg	Fulvestrant 250 mg Intramuscular Injection every 28 days
Fulvestrant 500 mg	Fulvestrant 500 mg Intramuscular Injection every 28 days plus 500 mg on day 14

Measured Values

	Fulvestrant 250 mg	Fulvestrant 500 mg
Number of Participants Analyzed [units:participants]	38	33
Duration of Response (DoR) [units: Time (in months)] Median (Full Range)	16.4 (3.7 to NA) ^[1]	19.4 (5.7 to NA) ^[1]

No statistical analysis provided for Duration of Response (DoR)

5. Secondary Outcome Measure: Duration of Clinical Benefit (DoCB) [ Time Frame: RECIST tumour assessments carried out every 12 weeks (+/- 2 weeks) from randomisation for study duration (48 months) ]

Measure Type	Secondary
Measure Name	Duration of Clinical Benefit (DoCB)
Measure Description	Time from randomisation until objective progression or death (in the absence of objective progression), measured only in those patients who achieve a confirmed complete response (CR), confirmed partial response (PR), or stable disease (SD) >=24 weeks
Time Frame	RECIST tumour assessments carried out every 12 weeks (+/- 2 weeks) from randomisation for study duration (48 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.

Reporting Groups

	Description
Fulvestrant 250 mg	Fulvestrant 250 mg Intramuscular Injection every 28 days
Fulvestrant 500 mg	Fulvestrant 500 mg Intramuscular Injection every 28 days plus 500 mg on day 14

Measured Values

	Fulvestrant 250 mg	Fulvestrant 500 mg
Number of Participants Analyzed [units:participants]	148	165
Duration of Clinical Benefit (DoCB) [units: Time (in months)] Median (Full Range)	13.9 (3.7 to NA) ^[1]	16.6 (2.5 to NA) ^[1]

No statistical analysis provided for Duration of Clinical Benefit (DoCB)

6. Secondary Outcome Measure: Overall Survival (OS) [ Time Frame: Overall Survival is equivalent to time to death. For this endpoint, all deaths occurring for study duration (48 months) ]

Measure Type	Secondary
Measure Name	Overall Survival (OS)
Measure Description	Median time (in months) from randomisation until death (from any cause) (analysis at 50% deaths )
Time Frame	Overall Survival is equivalent to time to death. For this endpoint, all deaths occurring for study duration (48 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.
All patients with measurable disease at baseline.

Reporting Groups

	Description
Fulvestrant 250 mg	Fulvestrant 250 mg Intramuscular Injection every 28 days
Fulvestrant 500 mg	Fulvestrant 500 mg Intramuscular Injection every 28 days plus 500 mg on day 14

Measured Values

	Fulvestrant 250 mg	Fulvestrant 500 mg
Number of Participants Analyzed [units:participants]	374	362
Overall Survival (OS) [units: Time (in months)] Median (Full Range)	22.8 (0.2 to NA) ^[1]	25.1 (0.1 to NA) ^[1]

No statistical analysis provided for Overall Survival (OS)

7. Secondary Outcome Measure: Change from randomisation in Trial Outcome Index (TOI) over the course of the study [ Time Frame: TOI questionnaires were completed every 4 weeks from randomisation until week 24 and then again at treatment discontinuation, for study duration (48 months) ]

Measure Type	Secondary
Measure Name	Change from randomisation in Trial Outcome Index (TOI) over the course of the study
Measure Description	Mean (and standard deviation) change from randomisation until treatment discontinuation in TOI (defined as the first visit response of 'worsened' which is a decrease in TOI from baseline of 5 points or more) using the Kaplan-Meier method. If a subject has not shown a reduction of 5 points or more at the time of analysis then the observation will be right censored using the last QOL assessment date. Trial Outcome Index (TOI) is derived from the FACT-B questionnaire (Cella et al, 1993) by adding together the scores from the following 3 subscales; Physical well-being (PWB), Functional well-being (FWB) and Breast cancer subscale (BCS). The TOI score range is 0-92 with the higher scores representing the more favourable outcomes. Data were collected from a subgroup of patients.
Time Frame	TOI questionnaires were completed every 4 weeks from randomisation until week 24 and then again at treatment discontinuation, for study duration (48 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.

Reporting Groups

	Description
Fulvestrant 250 mg	Fulvestrant 250 mg Intramuscular Injection every 28 days
Fulvestrant 500 mg	Fulvestrant 500 mg Intramuscular Injection every 28 days plus 500 mg on day 14

Measured Values

	Fulvestrant 250 mg	Fulvestrant 500 mg
Number of Participants Analyzed [units:participants]	35	34
Change from randomisation in Trial Outcome Index (TOI) over the course of the study [units: Scores on a scale] Mean (Standard Deviation)	-5.9 (9.89)	-7.5 (13.72)

No statistical analysis provided for Change from randomisation in Trial Outcome Index (TOI) over the course of the study

8. Secondary Outcome Measure: Overall Survival (OS) - follow-up [ Time Frame: Median time (in months) from randomisation until death (from any cause),up to 80 months ]

Measure Type	Secondary
Measure Name	Overall Survival (OS) - follow-up
Measure Description	Overall Survival is equivalent to time to death. For this endpoint, all deaths occurring during the study as a whole until the data cut-off for the survival extension (31st October 2011) are presented (analysis at 75% deaths)
Time Frame	Median time (in months) from randomisation until death (from any cause),up to 80 months
Safety Issue?	Yes

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.
All randomised patients

Reporting Groups

	Description
Fulvestrant 250 mg	Fulvestrant 250 mg Intramuscular Injection every 28 days
Fulvestrant 500 mg	Fulvestrant 500 mg Intramuscular Injection every 28 days plus 500 mg on day 14

Measured Values

	Fulvestrant 250 mg	Fulvestrant 500 mg
Number of Participants Analyzed [units:participants]	374	362
Overall Survival (OS) - follow-up [units: months] Median (Full Range)	22.3 (0.2 to NA) ^[1]	26.4 (0.1 to NA) ^[1]

No statistical analysis provided for Overall Survival (OS) - follow-up

Serious Adverse Events

Time Frame	SAE- From baseline up to October 31st 2011; AE- From baseline up to 28th February 2009
Additional Description	1 participant was randomised to fulvestrant 500 mg but did not receive any treatment. AEs have been collected up to primary data cut off. SAEs have been collected up to follow-up phase data cut-off.

Reporting Groups

	Description
Fulvestrant 250 mg	Fulvestrant 250 mg Intramuscular Injection every 28 days
Fulvestrant 500 mg	Fulvestrant 500 mg Intramuscular Injection every 28 days plus 500 mg on day 14

Serious Adverse Events

Fulvestrant 250 mg

Fulvestrant 500 mg

Total, serious adverse events

# participants affected / at risk

27/374 (7.22%)

35/361 (9.70%)

Blood and lymphatic system disorders

Anaemia¹,^†

# participants affected / at risk

1/374 (0.27%)

3/361 (0.83%)

Blood and lymphatic system disorders

Neutropenia¹,^†

# participants affected / at risk

0/374 (0.00%)

1/361 (0.28%)

Blood and lymphatic system disorders

Thrombocytopenia¹,^†

# participants affected / at risk

1/374 (0.27%)

1/361 (0.28%)

Blood and lymphatic system disorders

Febrile Neutropenia¹,^†

# participants affected / at risk

1/374 (0.27%)

0/361 (0.00%)

Cardiac disorders

Cardiopulmonary Failure¹,^†

# participants affected / at risk

0/374 (0.00%)

1/361 (0.28%)

Cardiac disorders

Acute Myocardial Infarction¹,^†

# participants affected / at risk

2/374 (0.53%)

0/361 (0.00%)

Cardiac disorders

Myocardial Ischaemia¹,^†

# participants affected / at risk

1/374 (0.27%)

0/361 (0.00%)

Gastrointestinal disorders

Vomiting¹,^†

# participants affected / at risk

1/374 (0.27%)

3/361 (0.83%)

Gastrointestinal disorders

Abdominal Pain¹,^†

# participants affected / at risk

0/374 (0.00%)

1/361 (0.28%)

Gastrointestinal disorders

Constipation¹,^†

# participants affected / at risk

1/374 (0.27%)

1/361 (0.28%)

Gastrointestinal disorders

Duodenal Ulcer Perforation¹,^†

# participants affected / at risk

0/374 (0.00%)

1/361 (0.28%)

Gastrointestinal disorders

Peritonitis¹,^†

# participants affected / at risk

0/374 (0.00%)

1/361 (0.28%)

Gastrointestinal disorders

Gastrointestinal Haemorrhage¹,^†

# participants affected / at risk

1/374 (0.27%)

0/361 (0.00%)

General disorders and administration site conditions

Adverse Drug Reaction¹,^†

# participants affected / at risk

0/374 (0.00%)

1/361 (0.28%)

General disorders and administration site conditions

Death¹,^†

# participants affected / at risk

0/374 (0.00%)

1/361 (0.28%)

General disorders and administration site conditions

General Physical Health Deterioration¹,^†

# participants affected / at risk

1/374 (0.27%)

0/361 (0.00%)

General disorders and administration site conditions

Pyrexia¹,^†

# participants affected / at risk

1/374 (0.27%)

0/361 (0.00%)

Hepatobiliary disorders

Hyperbilirubinaemia¹,^†

# participants affected / at risk

0/374 (0.00%)

1/361 (0.28%)

Infections and infestations

Bronchitis¹,^†

# participants affected / at risk

0/374 (0.00%)

2/361 (0.55%)

Infections and infestations

Bronchopneumonia¹,^†

# participants affected / at risk

1/374 (0.27%)

1/361 (0.28%)

Infections and infestations

Pneumonia¹,^†

# participants affected / at risk

0/374 (0.00%)

2/361 (0.55%)

Infections and infestations

Urinary Tract Infection¹,^†

# participants affected / at risk

0/374 (0.00%)

1/361 (0.28%)

Infections and infestations

Viral Infection¹,^†

# participants affected / at risk

0/374 (0.00%)

1/361 (0.28%)

Infections and infestations

Meningitis¹,^†

# participants affected / at risk

1/374 (0.27%)

0/361 (0.00%)

Injury, poisoning and procedural complications

Ankle Fracture¹,^†

# participants affected / at risk

0/374 (0.00%)

1/361 (0.28%)

Injury, poisoning and procedural complications

Contrast Media Reaction¹,^†

# participants affected / at risk

0/374 (0.00%)

1/361 (0.28%)

Injury, poisoning and procedural complications

Femur Fracture¹,^†

# participants affected / at risk

2/374 (0.53%)

1/361 (0.28%)

Injury, poisoning and procedural complications

Humerus Fracture¹,^†

# participants affected / at risk

0/374 (0.00%)

1/361 (0.28%)

Injury, poisoning and procedural complications

Rib Fracture¹,^†

# participants affected / at risk

0/374 (0.00%)

1/361 (0.28%)

Injury, poisoning and procedural complications

Facial Bones Fracture¹,^†

# participants affected / at risk

1/374 (0.27%)

0/361 (0.00%)

Injury, poisoning and procedural complications

Head Injury¹,^†

# participants affected / at risk

1/374 (0.27%)

0/361 (0.00%)

Metabolism and nutrition disorders

Hyperglycaemia¹,^†

# participants affected / at risk

0/374 (0.00%)

2/361 (0.55%)

Metabolism and nutrition disorders

Hypercalcaemia¹,^†

# participants affected / at risk

1/374 (0.27%)

0/361 (0.00%)

Musculoskeletal and connective tissue disorders

Arthralgia¹,^†

# participants affected / at risk

0/374 (0.00%)

1/361 (0.28%)

Musculoskeletal and connective tissue disorders

Back Pain¹,^†

# participants affected / at risk

0/374 (0.00%)

1/361 (0.28%)

Musculoskeletal and connective tissue disorders

Muscular Weakness¹,^†

# participants affected / at risk

1/374 (0.27%)

0/361 (0.00%)

Musculoskeletal and connective tissue disorders

Osteoarthritis¹,^†

# participants affected / at risk

1/374 (0.27%)

0/361 (0.00%)

Musculoskeletal and connective tissue disorders

Pathological Fracture¹,^†

# participants affected / at risk

1/374 (0.27%)

0/361 (0.00%)

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

Benign Mediastinal Neoplasm¹,^†

# participants affected / at risk

0/374 (0.00%)

1/361 (0.28%)

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

Intestinal Adenocarcinoma¹,^†

# participants affected / at risk

0/374 (0.00%)

1/361 (0.28%)

Nervous system disorders

Cerebral Ischaemia¹,^†

# participants affected / at risk

0/374 (0.00%)

1/361 (0.28%)

Nervous system disorders

Cerebrovascular Accident¹,^†

# participants affected / at risk

0/374 (0.00%)

1/361 (0.28%)

Nervous system disorders

Meningorrhagia¹,^†

# participants affected / at risk

0/374 (0.00%)

1/361 (0.28%)

Nervous system disorders

Syncope¹,^†

# participants affected / at risk

1/374 (0.27%)

0/361 (0.00%)

Psychiatric disorders

Completed Suicide¹,^†

# participants affected / at risk

1/374 (0.27%)

0/361 (0.00%)

Renal and urinary disorders

Renal Failure Acute¹,^†

# participants affected / at risk

1/374 (0.27%)

0/361 (0.00%)

Respiratory, thoracic and mediastinal disorders

Dyspnoea¹,^†

# participants affected / at risk

1/374 (0.27%)

2/361 (0.55%)

Respiratory, thoracic and mediastinal disorders

Interstitial Lung Disease¹,^†

# participants affected / at risk

0/374 (0.00%)

1/361 (0.28%)

Respiratory, thoracic and mediastinal disorders

Pleural Effusion¹,^†

# participants affected / at risk

0/374 (0.00%)

1/361 (0.28%)

Respiratory, thoracic and mediastinal disorders

Pulmonary Embolism¹,^†

# participants affected / at risk

1/374 (0.27%)

1/361 (0.28%)

Respiratory, thoracic and mediastinal disorders

Aspiration¹,^†

# participants affected / at risk

1/374 (0.27%)

0/361 (0.00%)

Respiratory, thoracic and mediastinal disorders

Hydrothorax¹,^†

# participants affected / at risk

1/374 (0.27%)

0/361 (0.00%)

Respiratory, thoracic and mediastinal disorders

Pleurisy¹,^†

# participants affected / at risk

1/374 (0.27%)

0/361 (0.00%)

Respiratory, thoracic and mediastinal disorders

Pneumothorax¹,^†

# participants affected / at risk

1/374 (0.27%)

0/361 (0.00%)

Respiratory, thoracic and mediastinal disorders

Respiratory Failure¹,^†

# participants affected / at risk

1/374 (0.27%)

0/361 (0.00%)

Vascular disorders

Hypertension¹,^†

# participants affected / at risk

1/374 (0.27%)

1/361 (0.28%)

Vascular disorders

Venous Thrombosis Limb¹,^†

# participants affected / at risk

0/374 (0.00%)

1/361 (0.28%)

Vascular disorders

Arterial Thrombosis Limb¹,^†

# participants affected / at risk

1/374 (0.27%)

0/361 (0.00%)

Vascular disorders

Deep Vein Thrombosis¹,^†

# participants affected / at risk

1/374 (0.27%)

0/361 (0.00%)

Vascular disorders

Iliac Artery Embolism¹,^†

# participants affected / at risk

1/374 (0.27%)

0/361 (0.00%)

Vascular disorders

Venous Thrombosis¹,^†

# participants affected / at risk

1/374 (0.27%)

0/361 (0.00%)

Cardiac disorders

ATRIAL FIBRILLATION¹,^†

# participants affected / at risk

0/374 (0.00%)

1/361 (0.28%)

General disorders

ASTHENIA¹,^†

# participants affected / at risk

0/374 (0.00%)

1/361 (0.28%)

Infections and infestations

INFECTIOUS PERITONITIS¹,^†

# participants affected / at risk

0/374 (0.00%)

1/361 (0.28%)

Injury, poisoning and procedural complications

FALL¹,^†

# participants affected / at risk

1/374 (0.27%)

0/361 (0.00%)

Musculoskeletal and connective tissue disorders

BONE PAIN¹,^†

# participants affected / at risk

0/374 (0.00%)

1/361 (0.28%)

Respiratory, thoracic and mediastinal disorders

HAEMOTHORAX¹,^†

# participants affected / at risk

0/374 (0.00%)

1/361 (0.28%)

†	Events were collected by systematic assessment
1	Term from vocabulary, MedDRA 11.1

Other Adverse Events

Time Frame	SAE- From baseline up to October 31st 2011; AE- From baseline up to 28th February 2009
Additional Description	1 participant was randomised to fulvestrant 500 mg but did not receive any treatment. AEs have been collected up to primary data cut off. SAEs have been collected up to follow-up phase data cut-off.

Frequency Threshold

Threshold above which other adverse events are reported	5%

Reporting Groups

	Description
Fulvestrant 250 mg	Fulvestrant 250 mg Intramuscular Injection every 28 days
Fulvestrant 500 mg	Fulvestrant 500 mg Intramuscular Injection every 28 days plus 500 mg on day 14

Other Adverse Events

Fulvestrant 250 mg

Fulvestrant 500 mg

Total, other (not including serious) adverse events

# participants affected / at risk

235/374 (62.83%)

241/361 (66.76%)

Gastrointestinal disorders

Nausea¹,^†

# participants affected / at risk

51/374 (13.64%)

35/361 (9.70%)

Gastrointestinal disorders

Vomiting¹,^†

# participants affected / at risk

20/374 (5.35%)

21/361 (5.82%)

Gastrointestinal disorders

Injection Site Pain¹,^†

# participants affected / at risk

34/374 (9.09%)

42/361 (11.63%)

Gastrointestinal disorders

Fatigue¹,^†

# participants affected / at risk

24/374 (6.42%)

27/361 (7.48%)

Gastrointestinal disorders

Asthenia¹,^†

# participants affected / at risk

23/374 (6.15%)

21/361 (5.82%)

Metabolism and nutrition disorders

Anorexia¹,^†

# participants affected / at risk

14/374 (3.74%)

22/361 (6.09%)

Musculoskeletal and connective tissue disorders

Back Pain¹,^†

# participants affected / at risk

40/374 (10.70%)

26/361 (7.20%)

Musculoskeletal and connective tissue disorders

Bone Pain¹,^†

# participants affected / at risk

28/374 (7.49%)

34/361 (9.42%)

Musculoskeletal and connective tissue disorders

Arthralgia¹,^†

# participants affected / at risk

29/374 (7.75%)

29/361 (8.03%)

Musculoskeletal and connective tissue disorders

Pain In Extremity¹,^†

# participants affected / at risk

26/374 (6.95%)

25/361 (6.93%)

Musculoskeletal and connective tissue disorders

Musculoskeletal Pain¹,^†

# participants affected / at risk

12/374 (3.21%)

20/361 (5.54%)

Nervous system disorders

Headache¹,^†

# participants affected / at risk

25/374 (6.68%)

28/361 (7.76%)

Respiratory, thoracic and mediastinal disorders

Cough¹,^†

# participants affected / at risk

20/374 (5.35%)

19/361 (5.26%)

Vascular disorders

Hot Flush¹,^†

# participants affected / at risk

22/374 (5.88%)

24/361 (6.65%)

†	Events were collected by systematic assessment
1	Term from vocabulary, MedDRA 11.1

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS 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.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days . The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: The only disclosure restriction on the PI is that they cannot publish any information to do with the trial without written consent from Quintiles.

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
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Results Point of Contact

Name/Title:	Gerard Lynch
Organization:	AstraZeneca
E-mail:	[email protected]

Documents available

CSP-D6997C00002.PDF
Download
D6997C00002 Study Report Synopsis
Download
Trial Results Summaries
Available here

Contacts

Contact

AstraZeneca Clinical Study Information Center

1-877-240-9479

information.center@astrazeneca.com

Contact Backup

AstraZeneca Cancer Locator Service

877-400-4656

astrazeneca@emergingmed.com

Investigators

Principal Investigator

Faslodex Medical Science Director

AstraZeneca

Sponsors

Collaborators

Inclusion Criteria

Exclusion Criteria

Research Site

Research Site

Research Site

Research Site

Research Site

Research Site

Research Site

Research Site

CSP-D6997C00002.PDF

D6997C00002 Study Report Synopsis

Trial Results Summaries