A Clinical Trial to Compare Efficacy and Tolerability of Faslodex With Arimidex in Patients With Advanced Breast Cancer (FIRST)

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ClinicalTrials.gov Identifier: NCT00274469

Recruitment Status : Completed

First Posted : January 11, 2006

Results First Posted : August 12, 2009

Last Update Posted : September 6, 2019

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Sponsor:

Information provided by (Responsible Party):

AstraZeneca

Study Type	Interventional
Study Design	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
Condition	Metastatic Breast Cancer
Interventions	Drug: fulvestrant Drug: anastrozole
Enrollment	205

Participant Flow

Recruitment Details	Postmenopausal women presenting with advanced breast cancer who had either never received endocrine therapy for advanced disease or had not received endocrine therapy in the previous 12 months in the adjuvant setting were recruited between 6th Feb 2006 and 11th July 2007.
Pre-assignment Details	28 of the 233 enrolled patients were not randomized to treatment groups for the following reasons - 20 patients were incorrectly enrolled (ie did not comply with inclusion / exclusion criteria), 1 died, 1 had an adverse event, 4 voluntarily discontinued, 2 patients were not randomized for other non-specified reasons.


Arm/Group Title	Fulvestrant 500 mg	Anastrozole 1 mg
Arm/Group Description	Fulvestrant 500 mg	Anastrozole 1 mg
Arm/Group Description	Fulvestrant 500 mg	Anastrozole 1 mg
Period Title: Overall Study
Started	102 ^[1]	103 ^[1]
Completed	23 ^[2]	10 ^[2]
Not Completed	79	93
Reason Not Completed
Death	63	74
Did not consent to OS follow-up	16	19
[1] Number of patients randomized [2] Number of patients ongoing study treatment at data cut-off

Baseline Characteristics

Arm/Group Title		Fulvestrant 500 mg	Anastrozole 1 mg	Total
Arm/Group Description		Fulvestrant 500 mg	Anastrozole 1 mg	Total of all reporting groups
Arm/Group Description		Fulvestrant 500 mg	Anastrozole 1 mg	Total of all reporting groups
Overall Number of Baseline Participants		102	103	205
Baseline Analysis Population Description		[Not Specified]
Baseline Analysis Population Description		[Not Specified]
Age, Continuous Mean (Standard Deviation) Unit of measure: Years
	Number Analyzed	102 participants	103 participants	205 participants
		66.6 (9.0)	67.6 (9.3)	67.1 (9.1)
Sex: Female, Male Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	102 participants	103 participants	205 participants
	Female	102 100.0%	103 100.0%	205 100.0%
	Male	0 0.0%	0 0.0%	0 0.0%

Outcome Measures

1.Primary Outcome


Title	Clinical Benefit Rate
Description	A Clinical Benefit (CB) responder is defined as a patient having a bes...
Description	A Clinical Benefit (CB) responder is defined as a patient having a best overall response of either complete response (CR), partial response (PR) or stable disease (SD) for at least 24 weeks evaluated according to modified RECIST. The Clinical Benefit Rate is the percentage of patients with CB.
Time Frame	From randomisation to data cut off (DCO) for primary analysis. The first and the last patients were enrolled on 6 Feb 2006 and 11 Jul 2007 respectively. The DCO for primary analysis was on 10th Jan 2008, 6 months after the last patient was enrolled.

Outcome Measure Data

Analysis Population Description

Full Analysis Set


Arm/Group Title	Fulvestrant 500 mg	Anastrozole 1 mg
Arm/Group Description:	Fulvestrant 500 mg	Anastrozole 1 mg
Arm/Group Description:	Fulvestrant 500 mg	Anastrozole 1 mg
Overall Number of Participants Analyzed	102	103
Measure Type: Number Unit of Measure: Percentage of Participants
	72.5	67.0

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Fulvestrant 500 mg, Anastrozole 1 mg
	Comments	[Not Specified]
	Type of Statistical Test	Non-Inferiority
	Comments	Study is powered basing on 20% deficiency in benefit rate for Fulvestrant compared to Anastrozole.

Statistical Test of Hypothesis	P-Value	0.386
	Comments	Null hypothesis: Fulvestrant has no difference with Anastrozole
	Method	Regression, Logistic
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.302
	Confidence Interval	(2-Sided) 95% 0.717 to 2.380
	Estimation Comments	OR>1 favours Fulvestrant

2.Secondary Outcome


Title	Objective Response Rate
Description	For each patient with measurable disease at baseline, the determinatio...
Description	For each patient with measurable disease at baseline, the determination of the overall response for each visit was carried out using a SAS program per Response Evaluation Criteria in Solid Tumors (RECIST) criteria. Complete Response (CR): Disappearance of all target lesion (TL) and non-target lesions (NTLs) and no new lesions. Partial Response (PR): At least a 30% decrease in the sum of longest diameter of TLs (compared to baseline), no progression of NTLs and no new lesions. Objective response rate is defined as percentage of patients with either CR or PR.
Time Frame	From randomisation to data cut off (DCO) for primary analysis. The first and the last patients were enrolled on 6 Feb 2006 and 11 Jul 2007 respectively. The DCO for primary analysis was on 10th Jan 2008, 6 months after the last patient was enrolled.

Outcome Measure Data

Analysis Population Description

Evaluable For Response Set


Arm/Group Title	Fulvestrant 500 mg	Anastrozole 1 mg
Arm/Group Description:	Fulvestrant 500 mg	Anastrozole 1 mg
Arm/Group Description:	Fulvestrant 500 mg	Anastrozole 1 mg
Overall Number of Participants Analyzed	89	93
Measure Type: Number Unit of Measure: Percentage of Participants
	36.0	35.5

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Fulvestrant 500 mg, Anastrozole 1 mg
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.947
	Comments	[Not Specified]
	Method	Regression, Logistic
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.021
	Confidence Interval	(2-Sided) 95% 0.556 to 1.874
	Estimation Comments	OR>1 favours Fulvestrant

3.Secondary Outcome


Title	Time to Progression
Description	Time from randomization until earlier of disease progression or death....
Description	Time from randomization until earlier of disease progression or death. Progression was defined according to RECIST: a patient is determined to have progressed if they have progression of target lesions, clear progression of existing non-target lesions, or the appearance of one or more new lesions. Progression of target lesions is defined as at least a 20% increase in the sum of the longest diameter (LD) of target lesions taking as references the smallest sum of LD recorded. Kaplan-Meier estimates of median for each treatment are reported.
Time Frame	From randomisation to data cut off (DCO) for primary analysis. The first and the last patients were enrolled on 6 Feb 2006 and 11 Jul 2007 respectively. The DCO for primary analysis was on 10th Jan 2008, 6 months after the last patient was enrolled.

Outcome Measure Data

Analysis Population Description

Full Analysis Set.


Arm/Group Title	Fulvestrant 500 mg	Anastrozole 1 mg
Arm/Group Description:	Fulvestrant 500 mg	Anastrozole 1 mg
Arm/Group Description:	Fulvestrant 500 mg	Anastrozole 1 mg
Overall Number of Participants Analyzed	102	103
Median (Inter-Quartile Range) Unit of Measure: Day
	NA ^[1] (173 to NA)	381 ^[2] (168 to NA)

[1]

Median and 75% quartile not calculable

[2]

75% quartile not calculable

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Fulvestrant 500 mg, Anastrozole 1 mg
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.0496
	Comments	[Not Specified]
	Method	Log Rank
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.6266
	Confidence Interval	(2-Sided) 95% 0.3929 to 0.9991
	Estimation Comments	HR<1 favours Fulvestrant

4.Secondary Outcome


Title	Time to Treatment Failure
Description	Time from randomization to treatment discontinuation
Description	Time from randomization to treatment discontinuation
Time Frame	From randomisation to data cut off (DCO) for 75% treatment failure. The first and the last patients were enrolled on 6 Feb 2006 and 11 Jul 2007. The DCO for 75% treatment failure was on 26 Mar 2010, 32 months after the last patient was enrolled.

Outcome Measure Data

Analysis Population Description

Full analysis set.


Arm/Group Title	Fulvestrant 500 mg	Anastrozole 1 mg
Arm/Group Description:	Fulvestrant 500 mg	Anastrozole 1 mg
Arm/Group Description:	Fulvestrant 500 mg	Anastrozole 1 mg
Overall Number of Participants Analyzed	102	103
Median (Inter-Quartile Range) Unit of Measure: Day
	536 (166 to 1303)	387 (169 to 838)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Fulvestrant 500 mg, Anastrozole 1 mg
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.05
	Comments	[Not Specified]
	Method	Log Rank
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.73
	Confidence Interval	(2-Sided) 95% 0.54 to 1.00
	Estimation Comments	HR<1 favours Fulvestrant

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Fulvestrant 500 mg, Anastrozole 1 mg
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.04
	Comments	[Not Specified]
	Method	Regression, Cox
	Comments	Cox regression analysis of TTTF controlling for baseline covariates.

Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.72
	Confidence Interval	(2-Sided) 95% 0.52 to 0.98
	Estimation Comments	HR<1 favours Fulvestrant

5.Secondary Outcome


Title	Time to Progression (Investigator Assessed)
Description	Time from randomization to disease progression (investigator assessed)...
Description	Time from randomization to disease progression (investigator assessed) or death from any cause. Progression was defined by investigator opinion, as patients did not have formal RECIST visits in the follow-up period after the data cut off for the primary analysis of the study.
Time Frame	From randomisation to data cut off (DCO) for 75% treatment failure. The first and the last patients were enrolled on 6 Feb 2006 and 11 Jul 2007. The DCO for 75% treatment failure was on 26 Mar 2010, 32 months after the last patient was enrolled.

Outcome Measure Data

Analysis Population Description

Full Analysis Set.


Arm/Group Title	Fulvestrant 500 mg	Anastrozole 1 mg
Arm/Group Description:	Fulvestrant 500 mg	Anastrozole 1 mg
Arm/Group Description:	Fulvestrant 500 mg	Anastrozole 1 mg
Overall Number of Participants Analyzed	102	103
Median (Inter-Quartile Range) Unit of Measure: Day
	712 (173 to 1331)	400 (168 to 908)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Fulvestrant 500 mg, Anastrozole 1 mg
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.01
	Comments	[Not Specified]
	Method	Log Rank
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.66
	Confidence Interval	(2-Sided) 95% 0.47 to 0.92
	Estimation Comments	HR<1 favours Fulvestrant

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Fulvestrant 500 mg, Anastrozole 1 mg
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.01
	Comments	[Not Specified]
	Method	Regression, Cox
	Comments	Cox regression analysis of TTP (investigator assessed) controlling for baseline covariates.

Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.64
	Confidence Interval	(2-Sided) 95% 0.46 to 0.90
	Estimation Comments	HR<1 favours Fulvestrant

6.Post-Hoc Outcome


Title	Overall Survival
Description	Time from randomization to death (any cause)
Description	Time from randomization to death (any cause)
Time Frame	From randomization to data cut off (DCO) for 65% OS analysis. The first and the last patients were enrolled on 6 Feb 2006 and 11 Jul 2007 respectively. The DCO for 65% OS analysis was on 15 Jul 2014, 7 years after the last patient was enrolled.

Outcome Measure Data

Analysis Population Description

Full Analysis Set


Arm/Group Title	Fulvestrant 500 mg	Anastrozole 1 mg
Arm/Group Description:	Fulvestrant 500 mg	Anastrozole 1 mg
Arm/Group Description:	Fulvestrant 500 mg	Anastrozole 1 mg
Overall Number of Participants Analyzed	102	103
Median (Inter-Quartile Range) Unit of Measure: Month
	54.1 ^[1] (29.7 to NA)	48.4 (28.6 to 78.5)

[1]

75% quartile not calculable

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Fulvestrant 500 mg, Anastrozole 1 mg
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.041
	Comments	[Not Specified]
	Method	Log Rank
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.70
	Confidence Interval	(2-Sided) 95% 0.50 to 0.98
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Fulvestrant 500 mg, Anastrozole 1 mg
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.126
	Comments	[Not Specified]
	Method	Regression, Cox
	Comments	Cox regression analysis of OS controlling for baseline covariates

Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.76
	Confidence Interval	(2-Sided) 95% 0.54 to 1.08
	Estimation Comments	HR<1 favours Fulvestrant

Adverse Events

Time Frame	Non-serious adverse events = randomisation upto the point of data cut off for the primary efficacy analysis. Serious adverse events = randomisation up to the point of data cut off for the 65% overall survival analysis.
Adverse Event Reporting Description	First patient was enrolled on 6th Feb 2006. Non-serious AEs are reported from randomisation up to the data cut-off (DCO 10th Jan 2008) for the primary analysis (56 days after last injection and 30 days after last tablet). Serious AEs are reported from randomisation up to DCO for the 65% OS (15th July 2014). Note: All-Mortality is based on full population, while AEs and SAEs are based on safety population (1 less patient in Fulvestrant arm as it never received the randomised drug).

Arm/Group Title	Fulvestrant 500 mg		Anastrozole 1 mg
Arm/Group Description	Fulvestrant 500 mg		Anastrozole 1 mg
Arm/Group Description	Fulvestrant 500 mg		Anastrozole 1 mg
All-Cause Mortality
	Fulvestrant 500 mg		Anastrozole 1 mg
	Affected / at Risk (%)		Affected / at Risk (%)
Total	63/102 (61.76%)		74/103 (71.84%)
Serious Adverse Events Serious Adverse Events
	Fulvestrant 500 mg		Anastrozole 1 mg
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	24/101 (23.76%)		22/103 (21.36%)
Blood and lymphatic system disorders
LYMPHADENOPATHY ^† 1	0/101 (0.00%)	0	1/103 (0.97%)	1
FEBRILE NEUTROPENIA ^† 2	0/101 (0.00%)	0	1/103 (0.97%)	1
Cardiac disorders
ATRIAL FIBRILLATION ^† 1	1/101 (0.99%)	1	1/103 (0.97%)	1
ARRHYTHMIA ^† 2	0/101 (0.00%)	0	1/103 (0.97%)	1
CARDIAC FAILURE ^† 2	2/101 (1.98%)	2	0/103 (0.00%)	0
CARDIAC FAILURE CONGESTIVE ^† 2	0/101 (0.00%)	0	1/103 (0.97%)	2
CORONARY OSTIAL STENOSIS ^† 2	0/101 (0.00%)	0	1/103 (0.97%)	1
Eye disorders
LACRIMAL DISORDER ^† 1	0/101 (0.00%)	0	1/103 (0.97%)	1
BLINDNESS ^† 2	1/101 (0.99%)	1	0/103 (0.00%)	0
Gastrointestinal disorders
GASTRIC ULCER ^† 1	1/101 (0.99%)	1	0/103 (0.00%)	0
NAUSEA ^† 1	1/101 (0.99%)	1	0/103 (0.00%)	0
VOMITING ^† 1	1/101 (0.99%)	1	0/103 (0.00%)	0
ANAL HAEMRROHAGE ^† 2	1/101 (0.99%)	1	0/103 (0.00%)	0
SUBILEUS ^† 2	0/101 (0.00%)	0	1/103 (0.97%)	1
General disorders
ASTHENIA ^† 2	1/101 (0.99%)	1	0/103 (0.00%)	0
DEATH ^† 2	0/101 (0.00%)	0	2/103 (1.94%)	2
GENERAL PHYSICAL HEALTH DETERIORATION ^† 2	0/101 (0.00%)	0	1/103 (0.97%)	1
Infections and infestations
BRONCHITIS ^† 1	1/101 (0.99%)	2	0/103 (0.00%)	0
GASTROENTERITIS VIRAL ^† 1	1/101 (0.99%)	1	0/103 (0.00%)	0
PNEUMONIA ^† 1	0/101 (0.00%)	0	1/103 (0.97%)	1
ARTHRITIS BACTERIAL ^† 2	1/101 (0.99%)	3	0/103 (0.00%)	0
EMPYEMA ^† 2	0/101 (0.00%)	0	1/103 (0.97%)	1
URINARY TRACT INFECTION ^† 2	1/101 (0.99%)	1	0/103 (0.00%)	0
LOWER RESPIRATORY TRACT INFECTION ^† 2	1/101 (0.99%)	1	0/103 (0.00%)	0
Injury, poisoning and procedural complications
FALL ^† 1	1/101 (0.99%)	1	0/103 (0.00%)	0
FEMUR FRACTURE ^† 1	1/101 (0.99%)	1	2/103 (1.94%)	2
HUMERUS FRACTURE ^† 1	0/101 (0.00%)	0	1/103 (0.97%)	1
RADIUS FRACTURE ^† 1	0/101 (0.00%)	0	1/103 (0.97%)	1
FEMORAL NECK FRACTURE ^† 2	1/101 (0.99%)	1	0/103 (0.00%)	0
HIP FRACTURE ^† 2	0/101 (0.00%)	0	1/103 (0.97%)	1
RIB FRACTURE ^† 2	0/101 (0.00%)	0	1/103 (0.97%)	1
ROAD TRAFFIC ACCIDENT ^† 2	0/101 (0.00%)	0	1/103 (0.97%)	1
Metabolism and nutrition disorders
CACHEXIA ^† 2	1/101 (0.99%)	1	0/103 (0.00%)	0
DECREASED APPETITE ^† 2	2/101 (1.98%)	2	0/103 (0.00%)	0
DEHYDRATION ^† 2	2/101 (1.98%)	3	0/103 (0.00%)	0
Musculoskeletal and connective tissue disorders
OSTEOARTHRITIS ^† 1	1/101 (0.99%)	1	0/103 (0.00%)	0
BONE PAIN ^† 2	0/101 (0.00%)	0	1/103 (0.97%)	1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
COLON CANCER ^† 2	0/101 (0.00%)	0	1/103 (0.97%)	1
LUNG CANCERMETASTATIC ^† 2	0/101 (0.00%)	0	1/103 (0.97%)	1
METASTASES TO THORAX ^† 2	1/101 (0.99%)	1	0/103 (0.00%)	0
SARCOMA ^† 2	0/101 (0.00%)	0	1/103 (0.97%)	1
SQUAMOUS CELL CARCINOMA ^† 2	0/101 (0.00%)	0	1/103 (0.97%)	1
TUMOUR HAEMORRAGE ^† 2	1/101 (0.99%)	1	0/103 (0.00%)	0
Nervous system disorders
NEURALGIA ^† 1	1/101 (0.99%)	1	1/103 (0.97%)	1
TRANSIENT ISCHAEMIC ATTACK ^† 1	0/101 (0.00%)	0	2/103 (1.94%)	2
CEREBROVASCULAR ACCIDENT ^† 2	0/101 (0.00%)	0	1/103 (0.97%)	1
SPINAL CORD COMPRESSION ^† 2	1/101 (0.99%)	1	0/103 (0.00%)	0
Psychiatric disorders
CONFUSIONAL STATE ^† 1	1/101 (0.99%)	1	0/103 (0.00%)	0
Respiratory, thoracic and mediastinal disorders
CHRONIC OBSTRUCTIVE PULMONARY DISEASE ^† 1	1/101 (0.99%)	2	0/103 (0.00%)	0
DYSPNOEA ^† 1	2/101 (1.98%)	2	0/103 (0.00%)	0
PLEURITIC PAIN ^† 1	1/101 (0.99%)	1	0/103 (0.00%)	0
PULMONARY EMBOLISM ^† 2	1/101 (0.99%)	1	0/103 (0.00%)	0
Skin and subcutaneous tissue disorders
ANGIOEDEMA ^† 2	1/101 (0.99%)	1	0/103 (0.00%)	0
Surgical and medical procedures
CHOLECYSTECTOMY ^† 2	1/101 (0.99%)	1	0/103 (0.00%)	0
Vascular disorders
HYPERTENSION ^† 2	1/101 (0.99%)	1	0/103 (0.00%)	0
1 Term from vocabulary, MedDRA 10.0 2 Term from vocabulary, MedDRA † Indicates events were collected by systematic assessment
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	0%
	Fulvestrant 500 mg		Anastrozole 1 mg
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	71/101 (70.30%)		70/103 (67.96%)
Blood and lymphatic system disorders
ANAEMIA ^† 3	2/101 (1.98%)	2	1/103 (0.97%)	1
LYMPHADENOPATHY ^† 3	2/101 (1.98%)	2	0/103 (0.00%)	0
Cardiac disorders
ATRIAL FIBRILLATION ^† 3	0/101 (0.00%)	0	1/103 (0.97%)	1
LEFT VENTRICULAR DYSFUNCTION ^† 3	1/101 (0.99%)	1	0/103 (0.00%)	0
PALPITATIONS ^† 3	0/101 (0.00%)	0	1/103 (0.97%)	1
Ear and labyrinth disorders
VERTIGO ^† 3	1/101 (0.99%)	1	3/103 (2.91%)	4
TINNITUS ^† 3	0/101 (0.00%)	0	2/103 (1.94%)	2
EAR PAIN ^† 3	1/101 (0.99%)	1	0/103 (0.00%)	0
Endocrine disorders
GOITRE ^† 3	1/101 (0.99%)	1	0/103 (0.00%)	0
Eye disorders
ACCOMMODATION DISORDER ^† 3	0/101 (0.00%)	0	1/103 (0.97%)	1
CONJUNCTIVAL DISORDER ^† 3	0/101 (0.00%)	0	1/103 (0.97%)	1
DIPLOPIA ^† 3	1/101 (0.99%)	1	0/103 (0.00%)	0
ERYTHEMA OF EYELID ^† 3	1/101 (0.99%)	1	0/103 (0.00%)	0
EXOPHTHALMOS ^† 3	1/101 (0.99%)	1	0/103 (0.00%)	0
EYE PAIN ^† 3	0/101 (0.00%)	0	1/103 (0.97%)	1
EYELID PTOSIS ^† 3	1/101 (0.99%)	1	0/103 (0.00%)	0
MYOPIA ^† 3	0/101 (0.00%)	0	1/103 (0.97%)	1
VISUAL ACUITY REDUCED ^† 3	1/101 (0.99%)	1	0/103 (0.00%)	0
Gastrointestinal disorders
CONSTIPATION ^† 1	10/101 (9.90%)	12	5/103 (4.85%)	5
DIARRHOEA ^† 1	6/101 (5.94%)	7	7/103 (6.80%)	7
NAUSEA ^† 1	10/101 (9.90%)	10	7/103 (6.80%)	8
VOMITING ^† 1	8/101 (7.92%)	10	3/103 (2.91%)	4
DYSPEPSIA ^† 3	2/101 (1.98%)	3	5/103 (4.85%)	5
ABDOMINAL PAIN ^† 3	2/101 (1.98%)	4	2/103 (1.94%)	2
ABDOMINAL PAIN UPPER ^† 3	2/101 (1.98%)	2	2/103 (1.94%)	2
HIATUS HERNIA ^† 3	2/101 (1.98%)	2	2/103 (1.94%)	2
DRY MOUTH ^† 3	2/101 (1.98%)	2	1/103 (0.97%)	1
ANAL DISCOMFORT ^† 3	0/101 (0.00%)	0	2/103 (1.94%)	2
DIVERTICULUM INTESTINAL ^† 3	0/101 (0.00%)	0	2/103 (1.94%)	2
GASTROOESOPHAGEAL REFLUX DISEASE ^† 3	0/101 (0.00%)	0	2/103 (1.94%)	2
STOMATITIS ^† 3	2/101 (1.98%)	2	0/103 (0.00%)	0
ABDOMINAL DISTENSION ^† 3	0/101 (0.00%)	0	1/103 (0.97%)	1
ABDOMINAL PAIN LOWER ^† 3	0/101 (0.00%)	0	1/103 (0.97%)	1
FLATULENCE ^† 3	1/101 (0.99%)	1	0/103 (0.00%)	0
GASTRODUODENITIS ^† 3	1/101 (0.99%)	1	0/103 (0.00%)	0
GASTROINTESTINAL PAIN ^† 3	0/101 (0.00%)	0	1/103 (0.97%)	1
HAEMATEMESIS ^† 3	0/101 (0.00%)	0	1/103 (0.97%)	1
HAEMORRHOIDAL HAEMORRHAGE ^† 3	0/101 (0.00%)	0	1/103 (0.97%)	1
HAEMORRHOIDS ^† 3	0/101 (0.00%)	0	1/103 (0.97%)	1
PROCTITIS ^† 3	0/101 (0.00%)	0	1/103 (0.97%)	1
RETCHING ^† 3	1/101 (0.99%)	1	0/103 (0.00%)	0
General disorders
FATIGUE ^† 1	1/101 (0.99%)	1	8/103 (7.77%)	8
INJECTION SITE PAIN ^† 1	6/101 (5.94%)	14	0/103 (0.00%)	0
ASTHENIA ^† 3	8/101 (7.92%)	14	8/103 (7.77%)	9
OEDEMA PERIPHERAL ^† 3	0/101 (0.00%)	0	4/103 (3.88%)	4
PYREXIA ^† 3	2/101 (1.98%)	2	2/103 (1.94%)	2
INFLUENZA LIKE ILLNESS ^† 3	3/101 (2.97%)	3	0/103 (0.00%)	0
INJECTION SITE HAEMATOMA ^† 3	1/101 (0.99%)	3	0/103 (0.00%)	0
INJECTION SITE HAEMORRHAGE ^† 3	1/101 (0.99%)	3	0/103 (0.00%)	0
INJECTION SITE PRURITUS ^† 3	2/101 (1.98%)	3	0/103 (0.00%)	0
APPLICATION SITE PAIN ^† 3	1/101 (0.99%)	2	0/103 (0.00%)	0
GENERAL PHYSICAL HEALTH DETERIORATION ^† 3	1/101 (0.99%)	2	0/103 (0.00%)	0
CHILLS ^† 3	1/101 (0.99%)	1	0/103 (0.00%)	0
GAIT DISTURBANCE ^† 3	1/101 (0.99%)	1	0/103 (0.00%)	0
INJECTION SITE NODULE ^† 3	1/101 (0.99%)	1	0/103 (0.00%)	0
IRRITABILITY ^† 3	0/101 (0.00%)	0	1/103 (0.97%)	1
NON-CARDIAC CHEST PAIN ^† 3	1/101 (0.99%)	1	0/103 (0.00%)	0
Hepatobiliary disorders
HEPATIC PAIN ^† 3	0/101 (0.00%)	0	2/103 (1.94%)	2
CHOLELITHIASIS ^† 3	1/101 (0.99%)	1	0/103 (0.00%)	0
HEPATIC FUNCTION ABNORMAL ^† 3	0/101 (0.00%)	0	1/103 (0.97%)	1
LIVER TENDERNESS ^† 3	0/101 (0.00%)	0	1/103 (0.97%)	1
Immune system disorders
CONTRAST MEDIA ALLERGY ^† 3	1/101 (0.99%)	1	1/103 (0.97%)	1
SEASONAL ALLERGY ^† 3	0/101 (0.00%)	0	2/103 (1.94%)	2
HYPERSENSITIVITY ^† 3	0/101 (0.00%)	0	1/103 (0.97%)	1
Infections and infestations
INFLUENZA ^† 1	1/101 (0.99%)	1	6/103 (5.83%)	6
URINARY TRACT INFECTION ^† 3	4/101 (3.96%)	5	1/103 (0.97%)	3
BRONCHITIS ^† 3	3/101 (2.97%)	3	3/103 (2.91%)	3
UPPER RESPIRATORY TRACT INFECTION ^† 3	3/101 (2.97%)	3	3/103 (2.91%)	3
LOWER RESPIRATORY TRACT INFECTION ^† 3	1/101 (0.99%)	2	3/103 (2.91%)	3
CYSTITIS ^† 3	3/101 (2.97%)	3	1/103 (0.97%)	1
HERPES ZOSTER ^† 3	2/101 (1.98%)	2	0/103 (0.00%)	0
ORAL CANDIDIASIS ^† 3	1/101 (0.99%)	1	1/103 (0.97%)	1
SINUSITIS ^† 3	0/101 (0.00%)	0	2/103 (1.94%)	2
TONSILLITIS ^† 3	1/101 (0.99%)	1	1/103 (0.97%)	1
VIRAL UPPER RESPIRATORY TRACT INFECTION ^† 3	2/101 (1.98%)	2	0/103 (0.00%)	0
WOUND INFECTION STAPHYLOCOCCAL ^† 3	1/101 (0.99%)	1	1/103 (0.97%)	1
ACARIASIS ^† 3	1/101 (0.99%)	1	0/103 (0.00%)	0
BACTERIAL INFECTION ^† 3	0/101 (0.00%)	0	1/103 (0.97%)	1
CANDIDIASIS ^† 3	1/101 (0.99%)	1	0/103 (0.00%)	0
FUNGAL INFECTION ^† 3	0/101 (0.00%)	0	1/103 (0.97%)	1
IMPETIGO ^† 3	0/101 (0.00%)	0	1/103 (0.97%)	1
NASOPHARYNGITIS ^† 3	0/101 (0.00%)	0	1/103 (0.97%)	1
OSTEOMYELITIS ^† 3	1/101 (0.99%)	1	0/103 (0.00%)	0
PNEUMONIA ^† 3	0/101 (0.00%)	0	1/103 (0.97%)	1
RESPIRATORY TRACT INFECTION ^† 3	1/101 (0.99%)	1	0/103 (0.00%)	0
RHINITIS ^† 3	1/101 (0.99%)	1	0/103 (0.00%)	0
VIRAL INFECTION ^† 3	1/101 (0.99%)	1	0/103 (0.00%)	0
WOUND INFECTION ^† 3	1/101 (0.99%)	1	0/103 (0.00%)	0
Injury, poisoning and procedural complications
CONTUSION ^† 3	1/101 (0.99%)	1	1/103 (0.97%)	1
THERMAL BURN ^† 3	2/101 (1.98%)	2	0/103 (0.00%)	0
ANAEMIA POSTOPERATIVE ^† 3	0/101 (0.00%)	0	1/103 (0.97%)	1
CONTRAST MEDIA REACTION ^† 3	0/101 (0.00%)	0	1/103 (0.97%)	1
FALL ^† 3	1/101 (0.99%)	1	0/103 (0.00%)	0
FEMUR FRACTURE ^† 3	1/101 (0.99%)	1	0/103 (0.00%)	0
JOINT INJURY ^† 3	0/101 (0.00%)	0	1/103 (0.97%)	1
LACERATION ^† 3	0/101 (0.00%)	0	1/103 (0.97%)	1
POST PROCEDURAL COMPLICATION ^† 3	1/101 (0.99%)	1	0/103 (0.00%)	0
PUBIC RAMI FRACTURE ^† 3	1/101 (0.99%)	1	0/103 (0.00%)	0
RADIATION SKIN INJURY ^† 3	0/101 (0.00%)	0	1/103 (0.97%)	1
RIB FRACTURE ^† 3	1/101 (0.99%)	1	0/103 (0.00%)	0
SKELETAL INJURY ^† 3	1/101 (0.99%)	1	0/103 (0.00%)	0
Investigations
ALANINE AMINOTRANSFERASE INCREASED ^† 3	1/101 (0.99%)	3	0/103 (0.00%)	0
BLOOD PRESSURE INCREASED ^† 3	1/101 (0.99%)	1	2/103 (1.94%)	2
BLOOD ALKALINE PHOSPHATASE INCREASED ^† 3	1/101 (0.99%)	1	0/103 (0.00%)	0
GAMMA-GLUTAMYLTRANSFERASE INCREASED ^† 3	1/101 (0.99%)	1	0/103 (0.00%)	0
HEPATIC ENZYME INCREASED ^† 3	1/101 (0.99%)	1	0/103 (0.00%)	0
WEIGHT INCREASED ^† 3	1/101 (0.99%)	1	0/103 (0.00%)	0
Metabolism and nutrition disorders
ANOREXIA ^† 3	2/101 (1.98%)	2	3/103 (2.91%)	3
DECREASED APPETITE ^† 3	2/101 (1.98%)	2	1/103 (0.97%)	1
DIABETES MELLITUS ^† 3	1/101 (0.99%)	1	1/103 (0.97%)	2
FLUID RETENTION ^† 3	1/101 (0.99%)	1	0/103 (0.00%)	0
HYPERGLYCAEMIA ^† 3	1/101 (0.99%)	1	0/103 (0.00%)	0
HYPERURICAEMIA ^† 3	1/101 (0.99%)	1	0/103 (0.00%)	0
HYPOALBUMINAEMIA ^† 3	0/101 (0.00%)	0	1/103 (0.97%)	1
HYPOCALCAEMIA ^† 3	0/101 (0.00%)	0	1/103 (0.97%)	1
VITAMIN D DEFICIENCY ^† 3	1/101 (0.99%)	1	0/103 (0.00%)	0
Musculoskeletal and connective tissue disorders
ARTHRALGIA ^† 1	10/101 (9.90%)	14	8/103 (7.77%)	8
BONE PAIN ^† 1	14/101 (13.86%)	19	10/103 (9.71%)	23
MYALGIA ^† 1	3/101 (2.97%)	3	9/103 (8.74%)	10
BACK PAIN ^† 3	4/101 (3.96%)	4	3/103 (2.91%)	3
MUSCULOSKELETAL PAIN ^† 3	2/101 (1.98%)	3	2/103 (1.94%)	2
MUSCLE SPASMS ^† 3	1/101 (0.99%)	1	2/103 (1.94%)	3
PAIN IN EXTREMITY ^† 3	0/101 (0.00%)	0	3/103 (2.91%)	4
JOINT STIFFNESS ^† 3	0/101 (0.00%)	0	1/103 (0.97%)	3
MUSCULOSKELETAL CHEST PAIN ^† 3	0/101 (0.00%)	0	3/103 (2.91%)	3
OSTEOARTHRITIS ^† 3	1/101 (0.99%)	2	1/103 (0.97%)	1
BURSITIS ^† 3	0/101 (0.00%)	0	1/103 (0.97%)	1
GROIN PAIN ^† 3	1/101 (0.99%)	1	0/103 (0.00%)	0
MUSCLE CONTRACTURE ^† 3	1/101 (0.99%)	1	0/103 (0.00%)	0
SYMPATHETIC POSTERIOR CERVICAL SYNDROME ^† 3	1/101 (0.99%)	1	0/103 (0.00%)	0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
CANCER PAIN ^† 3	1/101 (0.99%)	1	0/103 (0.00%)	0
INFECTED NEOPLASM ^† 3	1/101 (0.99%)	1	0/103 (0.00%)	0
METASTASES TO CENTRAL NERVOUS SYSTEM ^† 3	0/101 (0.00%)	0	1/103 (0.97%)	1
TUMOUR PAIN ^† 3	1/101 (0.99%)	1	0/103 (0.00%)	0
Nervous system disorders
DIZZINESS ^† 1	4/101 (3.96%)	4	6/103 (5.83%)	6
HEADACHE ^† 1	4/101 (3.96%)	26	13/103 (12.62%)	16
NEURALGIA ^† 3	1/101 (0.99%)	1	2/103 (1.94%)	2
DYSGEUSIA ^† 3	0/101 (0.00%)	0	2/103 (1.94%)	2
LETHARGY ^† 3	2/101 (1.98%)	2	0/103 (0.00%)	0
SOMNOLENCE ^† 3	0/101 (0.00%)	0	2/103 (1.94%)	2
CEREBRAL ISCHAEMIA ^† 3	0/101 (0.00%)	0	1/103 (0.97%)	1
DIABETIC NEUROPATHY ^† 3	1/101 (0.99%)	1	0/103 (0.00%)	0
DISTURBANCE IN ATTENTION ^† 3	0/101 (0.00%)	0	1/103 (0.97%)	1
MEMORY IMPAIRMENT ^† 3	0/101 (0.00%)	0	1/103 (0.97%)	1
PARKINSON'S DISEASE ^† 3	0/101 (0.00%)	0	1/103 (0.97%)	1
PAROSMIA ^† 3	0/101 (0.00%)	0	1/103 (0.97%)	1
SYNCOPE ^† 3	0/101 (0.00%)	0	1/103 (0.97%)	1
VITH NERVE PARALYSIS ^† 3	1/101 (0.99%)	1	0/103 (0.00%)	0
Psychiatric disorders
DEPRESSION ^† 3	2/101 (1.98%)	2	4/103 (3.88%)	4
ANXIETY ^† 3	3/101 (2.97%)	3	2/103 (1.94%)	2
INSOMNIA ^† 3	2/101 (1.98%)	2	1/103 (0.97%)	1
DEPRESSED MOOD ^† 3	2/101 (1.98%)	2	0/103 (0.00%)	0
CRYING ^† 3	0/101 (0.00%)	0	1/103 (0.97%)	1
LIBIDO DECREASED ^† 3	0/101 (0.00%)	0	1/103 (0.97%)	1
NEUROSIS ^† 3	0/101 (0.00%)	0	1/103 (0.97%)	1
Renal and urinary disorders
DYSURIA ^† 3	0/101 (0.00%)	0	2/103 (1.94%)	2
URINE ODOUR ABNORMAL ^† 3	1/101 (0.99%)	1	0/103 (0.00%)	0
HAEMATURIA ^† 3	0/101 (0.00%)	0	1/103 (0.97%)	1
NEPHROLITHIASIS ^† 3	0/101 (0.00%)	0	1/103 (0.97%)	1
Reproductive system and breast disorders
BREAST PAIN ^† 3	1/101 (0.99%)	1	2/103 (1.94%)	2
VULVOVAGINAL DRYNESS ^† 3	0/101 (0.00%)	0	2/103 (1.94%)	2
BREAST HAEMORRHAGE ^† 3	1/101 (0.99%)	1	0/103 (0.00%)	0
BREAST TENDERNESS ^† 3	0/101 (0.00%)	0	1/103 (0.97%)	1
CERVICAL POLYP ^† 3	0/101 (0.00%)	0	1/103 (0.97%)	1
DYSPAREUNIA ^† 3	0/101 (0.00%)	0	1/103 (0.97%)	1
GENITAL DISCHARGE ^† 3	1/101 (0.99%)	1	0/103 (0.00%)	0
GENITAL RASH ^† 3	0/101 (0.00%)	0	1/103 (0.97%)	1
METRORRHAGIA ^† 3	1/101 (0.99%)	1	0/103 (0.00%)	0
Respiratory, thoracic and mediastinal disorders
COUGH ^† 1	5/101 (4.95%)	6	8/103 (7.77%)	9
DYSPNOEA ^† 1	7/101 (6.93%)	8	7/103 (6.80%)	7
DYSPHONIA ^† 3	1/101 (0.99%)	1	5/103 (4.85%)	5
PHARYNGOLARYNGEAL PAIN ^† 3	2/101 (1.98%)	2	1/103 (0.97%)	1
EPISTAXIS ^† 3	1/101 (0.99%)	1	1/103 (0.97%)	1
NASAL CONGESTION ^† 3	1/101 (0.99%)	1	1/103 (0.97%)	1
ALLERGIC SINUSITIS ^† 3	1/101 (0.99%)	1	0/103 (0.00%)	0
BRONCHOSPASM ^† 3	1/101 (0.99%)	1	0/103 (0.00%)	0
DYSPNOEA EXERTIONAL ^† 3	0/101 (0.00%)	0	1/103 (0.97%)	1
LARYNGEAL DISORDER ^† 3	0/101 (0.00%)	0	1/103 (0.97%)	1
LUNG INFILTRATION ^† 3	0/101 (0.00%)	0	1/103 (0.97%)	1
NASAL DRYNESS ^† 3	0/101 (0.00%)	0	1/103 (0.97%)	1
PLEURAL EFFUSION ^† 3	0/101 (0.00%)	0	1/103 (0.97%)	1
RALES ^† 3	1/101 (0.99%)	1	0/103 (0.00%)	0
UPPER RESPIRATORY TRACT INFLAMMATION ^† 3	0/101 (0.00%)	0	1/103 (0.97%)	1
Skin and subcutaneous tissue disorders
ALOPECIA ^† 3	3/101 (2.97%)	3	2/103 (1.94%)	2
RASH ^† 3	2/101 (1.98%)	2	1/103 (0.97%)	3
HYPERHIDROSIS ^† 3	4/101 (3.96%)	4	0/103 (0.00%)	0
DERMATITIS CONTACT ^† 3	2/101 (1.98%)	3	0/103 (0.00%)	0
PRURITUS ^† 3	2/101 (1.98%)	2	1/103 (0.97%)	1
DRY SKIN ^† 3	1/101 (0.99%)	1	1/103 (0.97%)	1
NIGHT SWEATS ^† 3	1/101 (0.99%)	1	1/103 (0.97%)	1
COLD SWEAT ^† 3	1/101 (0.99%)	1	0/103 (0.00%)	0
DERMATITIS ALLERGIC ^† 3	0/101 (0.00%)	0	1/103 (0.97%)	1
ECZEMA ^† 3	0/101 (0.00%)	0	1/103 (0.97%)	1
SCAR ^† 3	1/101 (0.99%)	1	0/103 (0.00%)	0
SUBCUTANEOUS NODULE ^† 3	1/101 (0.99%)	1	0/103 (0.00%)	0
Vascular disorders
HOT FLUSH ^† 2	8/101 (7.92%)	8	14/103 (13.59%)	15
HYPERTENSION ^† 1	6/101 (5.94%)	6	2/103 (1.94%)	5
HAEMATOMA ^† 3	2/101 (1.98%)	2	0/103 (0.00%)	0
HYPERAEMIA ^† 3	2/101 (1.98%)	2	0/103 (0.00%)	0
PHLEBITIS ^† 3	1/101 (0.99%)	1	1/103 (0.97%)	1
HYPOTENSION ^† 3	1/101 (0.99%)	1	0/103 (0.00%)	0
1 Term from vocabulary, MedDRA 10.0 2 Term from vocabulary, MedDRA 10. 3 Term from vocabulary, MedDRA † Indicates events were collected by systematic assessment

Limitations and Caveats

One patient in the ITT population was randomized to Fulvestrant 500 but did not receive drug and was excluded from the safety population. Hence, the safety population for Fulvestrant contained 101 patients.

More Information

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.

Results Point of Contact

Layout table for Results Point of Contact information

Name/Title:	Jasmine Lichfield
Organization:	AstraZeneca
Phone:	07585404954
EMail:	jasmine.lichfield@astrazeneca.com

Layout table for additonal information

Responsible Party:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00274469
Other Study ID Numbers:	D6995C00006 FIRST
First Submitted:	January 10, 2006
First Posted:	January 11, 2006
Results First Submitted:	January 27, 2009
Results First Posted:	August 12, 2009
Last Update Posted:	September 6, 2019

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