CONFIRM: 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.

• Sponsor: AstraZeneca (Industry)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT00099437
• Collaborator: (none)
• Enrollment: 736
• Locations: 104
• Arms: 2
• Anticipated Duration (Months): 214.5
• Patients Per Site: 7.1
• Patients Per Site Per Month: 0

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the efficacy of a new dose of 500 mg Fulvestrant with the standard dose of 250 mg in postmenopausal women with oestrogen receptor positive advanced breast cancer who have failed on a previous endocrine treatment.

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer	Drug: Fulvestrant	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 736 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Randomised, Double-Blind, Parallel-group, Multicentre, Phase III Study 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
• Actual Study Start Date: Feb 13, 2005
• Actual Primary Completion Date: Feb 27, 2009
• Anticipated Study Completion Date: Dec 30, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 Fulvestrant 500 mg	Drug: Fulvestrant; intramuscular injection; Other Names: Faslodex ZD9238
Experimental: 2 Fulvestrant 250 mg	Drug: Fulvestrant; intramuscular injection; Other Names: Faslodex ZD9238

Outcome Measures

Primary Outcome Measures

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

   Median time (in months) from randomisation until objective disease progression or death (in the absence of objective progression).

Secondary Outcome Measures

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

   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.

2. Clinical Benefit Rate (CBR) [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)]

   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.

3. Duration of Response (DoR) [RECIST tumour assessments carried out every 12 weeks (+/- 2 weeks) from randomisation for study duration (48 months)]

   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)

4. Duration of Clinical Benefit (DoCB) [RECIST tumour assessments carried out every 12 weeks (+/- 2 weeks) from randomisation for study duration (48 months)]

   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

5. Overall Survival (OS) [Overall Survival is equivalent to time to death. For this endpoint, all deaths occurring for study duration (48 months)]

   Median time (in months) from randomisation until death (from any cause) (analysis at 50% deaths )

6. Change From Randomisation in Trial Outcome Index (TOI) Over the Course of the Study [TOI questionnaires were completed every 4 weeks from randomisation until week 24 and then again at treatment discontinuation, for study duration (48 months)]

   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.

7. Overall Survival (OS) - Follow-up [Median time (in months) from randomisation until death (from any cause),up to 80 months]

   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)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 45 Years to 130 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Breast Cancer has continued to grow after having received treatment with an anti-estrogen hormonal treatment such as tamoxifen or an aromatase inhibitor

• Requiring hormonal treatment

• Postmenopausal women defined as a woman who has stopped having menstrual periods

• Evidence of positive estrogen receptor hormone sensitivity

• Written informed consent to participate in the trial

Exclusion Criteria:

• Treatment with an investigational or non-approved drug within one month

• An existing serious disease, illness, or condition that will prevent participation or compliance with study procedures

• A history of allergies to any active or inactive ingredients of Faslodex (i.e. castor oil)

• Treatment with more than one regimen of chemotherapy for advanced breast cancer

• Treatment with more than one regimen of hormonal treatment for advanced breast cancer

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Research Site	Casa Grande	Arizona	United States	85122
2	Research Site	Fountain Valley	California	United States	92708
3	Research Site	New Britain	Connecticut	United States	06052
4	Research Site	Crystal River	Florida	United States	34429
5	Research Site	Fort Lauderdale	Florida	United States	33308
6	Research Site	Urbana	Illinois	United States	61801
7	Research Site	Rosedale	Maryland	United States	21237
8	Research Site	Detroit	Michigan	United States	48202
9	Research Site	Kansas City	Missouri	United States	64131
10	Research Site	Saint Louis	Missouri	United States	63141
11	Research Site	Voorhees	New Jersey	United States	08043
12	Research Site	Greenville	North Carolina	United States	27858
13	Research Site	Pasadena	Texas	United States	77504
14	Research Site	West Bend	Wisconsin	United States	53095
15	Research Site	Brasschaat		Belgium	2930
16	Research Site	Brussels		Belgium	1070
17	Research Site	Brussels		Belgium	1090
18	Research Site	Edegem		Belgium	2650
19	Research Site	Gent		Belgium	9000
20	Research Site	Hasselt		Belgium	3500
21	Research Site	Liège		Belgium	4000
22	Research Site	Turnhout		Belgium	2300
23	Research Site	Barretos		Brazil	14784-400
24	Research Site	Londrina		Brazil	86010-640
25	Research Site	Porto Alegre		Brazil	91350-200
26	Research Site	Recife		Brazil	50670-420
27	Research Site	Salvador		Brazil	40170-070
28	Research Site	Sao Paulo		Brazil	04039-001
29	Research Site	Antofagasta		Chile
30	Research Site	Santiago		Chile	8380455
31	Research Site	Santiago		Chile
32	Research Site	Bogota		Colombia
33	Research Site	Cali		Colombia
34	Research Site	Brno		Czechia	656 53
35	Research Site	Ceske Budejovice		Czechia	370 87
36	Research Site	Pardubice		Czechia	520 03
37	Research Site	Praha 10		Czechia	100 34
38	Research Site	Praha 2		Czechia	128 08
39	Research Site	Praha 8		Czechia	180 00
40	Research Site	Tabor		Czechia	390 03
41	Research Site	V Uvalu 84		Czechia	150 06
42	Research Site	Nyíregyháza		Hungary	4400
43	Research Site	Szombathely		Hungary	9700
44	Research Site	Székesfehérvár		Hungary	8000
45	Research Site	Ansari Nagar		India	110 029
46	Research Site	Bhopal		India	462001
47	Research Site	Hyderabad		India	500082
48	Research Site	Jaipur		India	302013
49	Research Site	Kolkata		India	700054
50	Research Site	Manipal		India	576 104
51	Research Site	Marg Jaipur		India	302004
52	Research Site	Mumbai		India	400012
53	Research Site	Pune		India	411001
54	Research Site	Trivandrum		India	2417
55	Research Site	Vellore		India	632004
56	Research Site	Aviano		Italy	33081
57	Research Site	Bergamo		Italy	24128
58	Research Site	Carpi		Italy	41012
59	Research Site	Genova		Italy	16132
60	Research Site	Prato		Italy	59100
61	Research Site	Reggio Emilia		Italy	42100
62	Research Site	Varese		Italy	21100
63	Research Site	Floriana		Malta	VLT 14
64	Research Site	Mexico City		Mexico	06720
65	Research Site	Mexico		Mexico	01090
66	Research Site	Mexico		Mexico	14140
67	Research Site	Białystok		Poland	15-027
68	Research Site	Poznań		Poland	61-878
69	Research Site	Łódź		Poland	90-553
70	Research Site	Ivanovo		Russian Federation	153040
71	Research Site	Kazan, Tatarstan		Russian Federation	420029
72	Research Site	Kazan, Tatarstan		Russian Federation	420111
73	Research Site	Krasnodar		Russian Federation	350040
74	Research Site	Lipetsk		Russian Federation	398005
75	Research Site	Moscow		Russian Federation	107005
76	Research Site	Moscow		Russian Federation	115478
77	Research Site	Moscow		Russian Federation	121356
78	Research Site	Moscow		Russian Federation	59401
79	Research Site	Nizhniy Novgorod		Russian Federation	603081
80	Research Site	Obninsk		Russian Federation	249020
81	Research Site	Ryazan		Russian Federation	390046
82	Research Site	St-Petersburg		Russian Federation	197758
83	Research Site	St.-Petersburg		Russian Federation	197089
84	Research Site	St.Petersburg		Russian Federation	191014
85	Research Site	Yaroslavl		Russian Federation	150054
86	Research Site	Bardejov		Slovakia	08501
87	Research Site	Bratislava		Slovakia	812 50
88	Research Site	Nitra		Slovakia	949 01
89	Research Site	Trnava		Slovakia	917 75
90	Research Site	A Coruña		Spain	15006
91	Research Site	Madrid		Spain	28040
92	Research Site	Malaga		Spain	29010
93	Research Site	Oviedo		Spain	33011
94	Research Site	Salamanca		Spain	37007
95	Research Site	Sevilla		Spain	41013
96	Research Site	Cherkasy		Ukraine	18009
97	Research Site	Dnipro		Ukraine	49102
98	Research Site	Donetsk		Ukraine	83092
99	Research Site	Kyiv		Ukraine	03022
100	Research Site	Lviv		Ukraine	79031
101	Research Site	Sumy		Ukraine	40022
102	Research Site	Ternopil		Ukraine	46023
103	Research Site	Uzhhorod		Ukraine	88000
104	Research Site	Caracas		Venezuela

Sponsors and Collaborators

• AstraZeneca

Investigators

• Study Director: Faslodex Medical Science Director, MD, AstraZeneca

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• CSP-D6997C00002.PDF
• D6997C00002 Study Report Synopsis

Publications

None provided.

• Responsible Party: AstraZeneca
• ClinicalTrials.gov Identifier: NCT00099437
• Other Study ID Numbers: D6997C00002
• First Posted: Dec 14, 2004
• Last Update Posted: Jun 22, 2022
• Last Verified: May 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Keywords provided by AstraZeneca: Advanced Breast Cancer; Metastatic Breast Cancer
• Additional relevant MeSH terms: Breast Neoplasms; Fulvestrant

Study Results

Participant Flow

Arm/Group Title	Fulvestrant 250 mg	Fulvestrant 500 mg
Arm/Group Description	Fulvestrant 250 mg Intramuscular Injection every 28 days	Fulvestrant 500 mg Intramuscular Injection every 28 days plus 500 mg on day 14
Period Title: Overall Study
STARTED	374	362
COMPLETED	8	13
NOT COMPLETED	366	349

Baseline Characteristics

Arm/Group Title	Fulvestrant 250 mg	Fulvestrant 500 mg	Total
Arm/Group Description	Fulvestrant 250 mg Intramuscular Injection every 28 days	Fulvestrant 500 mg Intramuscular Injection every 28 days plus 500 mg on day 14	Total of all reporting groups
Overall Participants	374	362	736
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	60.8 (11.94)	61.0 (11.47)	60.9 (11.71)
Sex: Female, Male (Count of Participants)
Female	374 100%	362 100%	736 100%
Male	0 0%	0 0%	0 0%

Outcome Measures

1. Primary Outcome

Title	Time to Progression (TTP)
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)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Fulvestrant 250 mg	Fulvestrant 500 mg
Arm/Group Description	Fulvestrant 250 mg Intramuscular Injection every 28 days	Fulvestrant 500 mg Intramuscular Injection every 28 days plus 500 mg on day 14
Measure Participants	374	362
Median (Full Range) [months]	5.5	6.5

2. Secondary Outcome

Title	Objective Response Rate (ORR)
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)

Outcome Measure Data

Analysis Population Description

All patients with measurable disease at baseline.

Arm/Group Title	Fulvestrant 250 mg	Fulvestrant 500 mg
Arm/Group Description	Fulvestrant 250 mg Intramuscular Injection every 28 days	Fulvestrant 500 mg Intramuscular Injection every 28 days plus 500 mg on day 14
Measure Participants	261	240
Number [Percentage of patients]	14.6	13.8

3. Secondary Outcome

Title	Clinical Benefit Rate (CBR)
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)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Fulvestrant 250 mg	Fulvestrant 500 mg
Arm/Group Description	Fulvestrant 250 mg Intramuscular Injection every 28 days	Fulvestrant 500 mg Intramuscular Injection every 28 days plus 500 mg on day 14
Measure Participants	374	362
Number [Percentage of patients]	39.6	45.6

4. Secondary Outcome

Title	Duration of Response (DoR)
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)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Fulvestrant 250 mg	Fulvestrant 500 mg
Arm/Group Description	Fulvestrant 250 mg Intramuscular Injection every 28 days	Fulvestrant 500 mg Intramuscular Injection every 28 days plus 500 mg on day 14
Measure Participants	38	33
Median (Full Range) [Time (in months)]	16.4	19.4

5. Secondary Outcome

Title	Duration of Clinical Benefit (DoCB)
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)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Fulvestrant 250 mg	Fulvestrant 500 mg
Arm/Group Description	Fulvestrant 250 mg Intramuscular Injection every 28 days	Fulvestrant 500 mg Intramuscular Injection every 28 days plus 500 mg on day 14
Measure Participants	148	165
Median (Full Range) [Time (in months)]	13.9	16.6

6. Secondary Outcome

Title	Overall Survival (OS)
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)

Outcome Measure Data

Analysis Population Description

All patients with measurable disease at baseline.

Arm/Group Title	Fulvestrant 250 mg	Fulvestrant 500 mg
Arm/Group Description	Fulvestrant 250 mg Intramuscular Injection every 28 days	Fulvestrant 500 mg Intramuscular Injection every 28 days plus 500 mg on day 14
Measure Participants	374	362
Median (Full Range) [Time (in months)]	22.8	25.1

7. Secondary Outcome

Title	Change From Randomisation in Trial Outcome Index (TOI) Over the Course of the Study
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)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Fulvestrant 250 mg	Fulvestrant 500 mg
Arm/Group Description	Fulvestrant 250 mg Intramuscular Injection every 28 days	Fulvestrant 500 mg Intramuscular Injection every 28 days plus 500 mg on day 14
Measure Participants	35	34
Mean (Standard Deviation) [Scores on a scale]	-5.9 (9.89)	-7.5 (13.72)

8. Secondary Outcome

Title	Overall Survival (OS) - Follow-up
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

Outcome Measure Data

Analysis Population Description

All randomised patients

Arm/Group Title	Fulvestrant 250 mg	Fulvestrant 500 mg
Arm/Group Description	Fulvestrant 250 mg Intramuscular Injection every 28 days	Fulvestrant 500 mg Intramuscular Injection every 28 days plus 500 mg on day 14
Measure Participants	374	362
Median (Full Range) [months]	22.3	26.4

Adverse Events

Time Frame	SAE- From baseline up to October 31st 2011; AE- From baseline up to 28th February 2009
Adverse Event Reporting 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.
Arm/Group Title	Fulvestrant 250 mg		Fulvestrant 500 mg
Arm/Group Description	Fulvestrant 250 mg Intramuscular Injection every 28 days		Fulvestrant 500 mg Intramuscular Injection every 28 days plus 500 mg on day 14
All Cause Mortality
	Fulvestrant 250 mg		Fulvestrant 500 mg
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Fulvestrant 250 mg		Fulvestrant 500 mg
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	27/374 (7.2%)		35/361 (9.7%)
Blood and lymphatic system disorders
Anaemia	1/374 (0.3%)		3/361 (0.8%)
Neutropenia	0/374 (0%)		1/361 (0.3%)
Thrombocytopenia	1/374 (0.3%)		1/361 (0.3%)
Febrile Neutropenia	1/374 (0.3%)		0/361 (0%)
Cardiac disorders
Cardiopulmonary Failure	0/374 (0%)		1/361 (0.3%)
Acute Myocardial Infarction	2/374 (0.5%)		0/361 (0%)
Myocardial Ischaemia	1/374 (0.3%)		0/361 (0%)
ATRIAL FIBRILLATION	0/374 (0%)		1/361 (0.3%)
Gastrointestinal disorders
Vomiting	1/374 (0.3%)		3/361 (0.8%)
Abdominal Pain	0/374 (0%)		1/361 (0.3%)
Constipation	1/374 (0.3%)		1/361 (0.3%)
Duodenal Ulcer Perforation	0/374 (0%)		1/361 (0.3%)
Peritonitis	0/374 (0%)		1/361 (0.3%)
Gastrointestinal Haemorrhage	1/374 (0.3%)		0/361 (0%)
General disorders
Adverse Drug Reaction	0/374 (0%)		1/361 (0.3%)
Death	0/374 (0%)		1/361 (0.3%)
General Physical Health Deterioration	1/374 (0.3%)		0/361 (0%)
Pyrexia	1/374 (0.3%)		0/361 (0%)
ASTHENIA	0/374 (0%)		1/361 (0.3%)
Hepatobiliary disorders
Hyperbilirubinaemia	0/374 (0%)		1/361 (0.3%)
Infections and infestations
Bronchitis	0/374 (0%)		2/361 (0.6%)
Bronchopneumonia	1/374 (0.3%)		1/361 (0.3%)
Pneumonia	0/374 (0%)		2/361 (0.6%)
Urinary Tract Infection	0/374 (0%)		1/361 (0.3%)
Viral Infection	0/374 (0%)		1/361 (0.3%)
Meningitis	1/374 (0.3%)		0/361 (0%)
INFECTIOUS PERITONITIS	0/374 (0%)		1/361 (0.3%)
Injury, poisoning and procedural complications
Ankle Fracture	0/374 (0%)		1/361 (0.3%)
Contrast Media Reaction	0/374 (0%)		1/361 (0.3%)
Femur Fracture	2/374 (0.5%)		1/361 (0.3%)
Humerus Fracture	0/374 (0%)		1/361 (0.3%)
Rib Fracture	0/374 (0%)		1/361 (0.3%)
Facial Bones Fracture	1/374 (0.3%)		0/361 (0%)
Head Injury	1/374 (0.3%)		0/361 (0%)
FALL	1/374 (0.3%)		0/361 (0%)
Metabolism and nutrition disorders
Hyperglycaemia	0/374 (0%)		2/361 (0.6%)
Hypercalcaemia	1/374 (0.3%)		0/361 (0%)
Musculoskeletal and connective tissue disorders
Arthralgia	0/374 (0%)		1/361 (0.3%)
Back Pain	0/374 (0%)		1/361 (0.3%)
Muscular Weakness	1/374 (0.3%)		0/361 (0%)
Osteoarthritis	1/374 (0.3%)		0/361 (0%)
Pathological Fracture	1/374 (0.3%)		0/361 (0%)
BONE PAIN	0/374 (0%)		1/361 (0.3%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign Mediastinal Neoplasm	0/374 (0%)		1/361 (0.3%)
Intestinal Adenocarcinoma	0/374 (0%)		1/361 (0.3%)
Nervous system disorders
Cerebral Ischaemia	0/374 (0%)		1/361 (0.3%)
Cerebrovascular Accident	0/374 (0%)		1/361 (0.3%)
Meningorrhagia	0/374 (0%)		1/361 (0.3%)
Syncope	1/374 (0.3%)		0/361 (0%)
Psychiatric disorders
Completed Suicide	1/374 (0.3%)		0/361 (0%)
Renal and urinary disorders
Renal Failure Acute	1/374 (0.3%)		0/361 (0%)
Respiratory, thoracic and mediastinal disorders
Dyspnoea	1/374 (0.3%)		2/361 (0.6%)
Interstitial Lung Disease	0/374 (0%)		1/361 (0.3%)
Pleural Effusion	0/374 (0%)		1/361 (0.3%)
Pulmonary Embolism	1/374 (0.3%)		1/361 (0.3%)
Aspiration	1/374 (0.3%)		0/361 (0%)
Hydrothorax	1/374 (0.3%)		0/361 (0%)
Pleurisy	1/374 (0.3%)		0/361 (0%)
Pneumothorax	1/374 (0.3%)		0/361 (0%)
Respiratory Failure	1/374 (0.3%)		0/361 (0%)
HAEMOTHORAX	0/374 (0%)		1/361 (0.3%)
Vascular disorders
Hypertension	1/374 (0.3%)		1/361 (0.3%)
Venous Thrombosis Limb	0/374 (0%)		1/361 (0.3%)
Arterial Thrombosis Limb	1/374 (0.3%)		0/361 (0%)
Deep Vein Thrombosis	1/374 (0.3%)		0/361 (0%)
Iliac Artery Embolism	1/374 (0.3%)		0/361 (0%)
Venous Thrombosis	1/374 (0.3%)		0/361 (0%)
Other (Not Including Serious) Adverse Events
	Fulvestrant 250 mg		Fulvestrant 500 mg
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	235/374 (62.8%)		241/361 (66.8%)
Gastrointestinal disorders
Nausea	51/374 (13.6%)		35/361 (9.7%)
Vomiting	20/374 (5.3%)		21/361 (5.8%)
Injection Site Pain	34/374 (9.1%)		42/361 (11.6%)
Fatigue	24/374 (6.4%)		27/361 (7.5%)
Asthenia	23/374 (6.1%)		21/361 (5.8%)
Metabolism and nutrition disorders
Anorexia	14/374 (3.7%)		22/361 (6.1%)
Musculoskeletal and connective tissue disorders
Back Pain	40/374 (10.7%)		26/361 (7.2%)
Bone Pain	28/374 (7.5%)		34/361 (9.4%)
Arthralgia	29/374 (7.8%)		29/361 (8%)
Pain In Extremity	26/374 (7%)		25/361 (6.9%)
Musculoskeletal Pain	12/374 (3.2%)		20/361 (5.5%)
Nervous system disorders
Headache	25/374 (6.7%)		28/361 (7.8%)
Respiratory, thoracic and mediastinal disorders
Cough	20/374 (5.3%)		19/361 (5.3%)
Vascular disorders
Hot Flush	22/374 (5.9%)		24/361 (6.6%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

The only disclosure restriction on the PI is that they cannot publish any information to do with the trial without written consent from Quintiles.