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Anastrozole Monotherapy Versus Maximal Oestrogen Blockade With Anastrozole and Fulvestrant Combination Therapy (FACT)

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ClinicalTrials.gov Identifier: NCT00256698
Recruitment Status : Completed
First Posted : November 22, 2005
Results First Posted : February 9, 2011
Last Update Posted : August 1, 2012
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 Breast Cancer
Interventions Drug: Fulvestrant
Drug: Anastrozole
Enrollment 514
Recruitment Details 258 patients were randomised to Fulvestrant + Anastrozole and 256 patients were randomised to Anastrozole. In each treatment group, there were 2 patients who did not receive any trial therapy and so have been excluded from the safety summaries.
Pre-assignment Details  
Arm/Group Title Fulvestrant + Anastrozole Anastrozole
Hide Arm/Group Description Fulvestrant 250 mg Loading Dose Regimen + Anastrozole 1 mg Anastrozole 1 mg
Period Title: Overall Study
Started 258 256
Completed 91 84
Not Completed 167 172
Reason Not Completed
Withdrawal by Subject             7             7
Adverse Event             13             6
Protocol Violation             6             5
Lost to Follow-up             1             3
disease progression             97             105
still ongoing at data cut-off             41             46
withdrawn due to osteoporosis             1             0
Prematurely Discontinued             1             0
Arm/Group Title Fulvestrant + Anastrozole Anastrozole Total
Hide Arm/Group Description Fulvestrant 250 mg Loading Dose Regimen + Anastrozole 1 mg Anastrozole 1 mg Total of all reporting groups
Overall Number of Baseline Participants 258 256 514
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 258 participants 256 participants 514 participants
65.2  (9.6) 63.4  (10.3) 64.3  (10.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 258 participants 256 participants 514 participants
Female
258
 100.0%
256
 100.0%
514
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Time to Progression (TTP)
Hide Description RECIST (Response Evaluation Criteria in Solid Tumours) assessments carried out every 8 weeks from randomisation until data cut-off on 30th April 2009. TTP, time in months to worsen 'progression' according to RECIST criteria. (RECIST is a set of published rules that define when cancer patients improve "respond", stay the same "stable"or worsen "progression" during treatments.
Time Frame RECIST assessments carried out every 8 weeks from randomisation until data cut-off on 30th April 2009
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Fulvestrant + Anastrozole Anastrozole
Hide Arm/Group Description:
Fulvestrant 250 mg Loading Dose Regimen + Anastrozole 1 mg
Anastrozole 1 mg
Overall Number of Participants Analyzed 258 256
Median (Full Range)
Unit of Measure: months
10.8
(0 to 49.31)
10.2
(0 to 54.34)
2.Secondary Outcome
Title Percentage of Evaluable Participants With Objective Response Rate (ORR)
Hide Description No. of patients who were objective responders over the no. of patients evaluable for response x100. An objective responder = a patient whose best response is either CR (disappearance of all lesions) or PR (>= 30% shrinkage in the sum of the longest diamemeters of the measurable lesions + no new lesions + no progression of non-measurable lesions)
Time Frame RECIST tumour assessments carried out every 8 weeks from randomisation until data cut-off on 30th April 2009
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Fulvestrant + Anastrozole Anastrozole
Hide Arm/Group Description:
Fulvestrant 250 mg Loading Dose Regimen + Anastrozole 1 mg
Anastrozole 1 mg
Overall Number of Participants Analyzed 129 113
Measure Type: Number
Unit of Measure: Percentage of evaluable participants
31.8 33.6
3.Secondary Outcome
Title Percentage of Clinical Benefit Rate (CBR) Responders
Hide Description No. of patients who were clinical benefit responders over the no. of randomised patients x100. A clinical benefit responder = a patient whose best response is CR, PR or SD>=24 weeks (where a best response of SD = no new lesions and for existing lesions; neither suffient shrinkage to count as PR nor sufficient growth to count as progression)
Time Frame RECIST tumour assessments carried out every 8 weeks from randomisation until data cut-off on 30th April 2009
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Fulvestrant + Anastrozole Anastrozole
Hide Arm/Group Description:
Fulvestrant 250 mg Loading Dose Regimen + Anastrozole 1 mg
Anastrozole 1 mg
Overall Number of Participants Analyzed 258 256
Measure Type: Number
Unit of Measure: Percentage of participants
55.0 55.1
4.Secondary Outcome
Title Duration of Response (DoR)
Hide Description Median time from randomisation until objective progression or death (in the absence of objective progression), measured only in those patients who are objective responders
Time Frame RECIST tumour assessments carried out every 8 weeks from randomisation until data cut-off on 30th April 2009
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Fulvestrant + Anastrozole Anastrozole
Hide Arm/Group Description:
Fulvestrant 250 mg Loading Dose Regimen + Anastrozole 1 mg
Anastrozole 1 mg
Overall Number of Participants Analyzed 129 113
Median (Full Range)
Unit of Measure: months
22.3
(5.55 to 46.95)
18.2
(7.20 to 49.77)
5.Secondary Outcome
Title Duration of Clinical Benefit (DoCB)
Hide Description Median time from randomisation until objective progression or death (in the absence of objective progression), measured only in those patients who are clinical benefit responders
Time Frame RECIST tumour assessments carried out every 8 weeks from randomisation until data cut-off on 30th April 2009
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Fulvestrant + Anastrozole Anastrozole
Hide Arm/Group Description:
Fulvestrant 250 mg Loading Dose Regimen + Anastrozole 1 mg
Anastrozole 1 mg
Overall Number of Participants Analyzed 258 256
Median (Full Range)
Unit of Measure: months
18.5
(1.64 to 46.95)
18.1
(5.19 to 54.34)
6.Secondary Outcome
Title Time to Treatment Failure (TTF)
Hide Description Time from randomisation until the date of discontinuation of randomised treatment for any reason
Time Frame From randomisation until data cut-off on 30th April 2009
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Fulvestrant + Anastrozole Anastrozole
Hide Arm/Group Description:
Fulvestrant 250 mg Loading Dose Regimen + Anastrozole 1 mg
Anastrozole 1 mg
Overall Number of Participants Analyzed 258 256
Median (Full Range)
Unit of Measure: months
12.4
(0 to 46.95)
11.4
(0 to 54.34)
7.Secondary Outcome
Title Overall Survival (OS)
Hide Description Overall survival is equivalent to time to death. Time from randomisation until the date of death
Time Frame All deaths occurring between randomisation and data cut-off on 30th April 2009 are included.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Fulvestrant + Anastrozole Anastrozole
Hide Arm/Group Description:
Fulvestrant 250 mg Loading Dose Regimen + Anastrozole 1 mg
Anastrozole 1 mg
Overall Number of Participants Analyzed 258 256
Median (Full Range)
Unit of Measure: months
37.8
(0.07 to 61.86)
38.2
(0.13 to 60.39)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Fulvestrant + Anastrozole Anastrozole
Hide Arm/Group Description Fulvestrant 250 mg Loading Dose Regimen + Anastrozole 1 mg Anastrozole 1 mg
All-Cause Mortality
Fulvestrant + Anastrozole Anastrozole
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Fulvestrant + Anastrozole Anastrozole
Affected / at Risk (%) Affected / at Risk (%)
Total   40/256 (15.63%)   45/254 (17.72%) 
Blood and lymphatic system disorders     
Anaemia  1  1/256 (0.39%)  1/254 (0.39%) 
Cardiac disorders     
Cardiac Failure  1  3/256 (1.17%)  1/254 (0.39%) 
Pericardial Effusion  1  0/256 (0.00%)  2/254 (0.79%) 
Angina Pectoris  1  0/256 (0.00%)  1/254 (0.39%) 
Arrhythmia  1  0/256 (0.00%)  1/254 (0.39%) 
Atrial Flutter  1  0/256 (0.00%)  1/254 (0.39%) 
Cardiac Arrest  1  0/256 (0.00%)  1/254 (0.39%) 
Atrial Fibrillation  1  1/256 (0.39%)  0/254 (0.00%) 
Bradycardia  1  1/256 (0.39%)  0/254 (0.00%) 
Cardiomyopathy  1  1/256 (0.39%)  0/254 (0.00%) 
Myocardial Infarction  1  1/256 (0.39%)  0/254 (0.00%) 
Ventricular Arrhythmia  1  1/256 (0.39%)  0/254 (0.00%) 
Ear and labyrinth disorders     
Vertigo  1  0/256 (0.00%)  2/254 (0.79%) 
Gastrointestinal disorders     
Nausea  1  2/256 (0.78%)  2/254 (0.79%) 
Diarrhoea  1  2/256 (0.78%)  0/254 (0.00%) 
Constipation  1  0/256 (0.00%)  1/254 (0.39%) 
Abdominal Pain Upper  1  1/256 (0.39%)  0/254 (0.00%) 
Ileus  1  1/256 (0.39%)  0/254 (0.00%) 
Pancreatitis  1  1/256 (0.39%)  0/254 (0.00%) 
Vomiting  1  1/256 (0.39%)  0/254 (0.00%) 
General disorders     
General Physical Health Deterioration  1  0/256 (0.00%)  3/254 (1.18%) 
Chest Pain  1  1/256 (0.39%)  2/254 (0.79%) 
Pain  1  0/256 (0.00%)  2/254 (0.79%) 
Fatigue  1  2/256 (0.78%)  1/254 (0.39%) 
Oedema Peripheral  1  1/256 (0.39%)  0/254 (0.00%) 
Pyrexia  1  1/256 (0.39%)  0/254 (0.00%) 
Foot Amputation  1  0/256 (0.00%)  1/254 (0.39%) 
Infections and infestations     
Pneumonia  1  3/256 (1.17%)  2/254 (0.79%) 
Urinary Tract Infection  1  0/256 (0.00%)  2/254 (0.79%) 
Infection  1  2/256 (0.78%)  0/254 (0.00%) 
Sepsis  1  2/256 (0.78%)  0/254 (0.00%) 
Bronchitis  1  0/256 (0.00%)  1/254 (0.39%) 
Gangrene  1  0/256 (0.00%)  1/254 (0.39%) 
Viral Infection  1  0/256 (0.00%)  1/254 (0.39%) 
Bronchpneumonia  1  1/256 (0.39%)  0/254 (0.00%) 
Erysipelas  1  1/256 (0.39%)  0/254 (0.00%) 
Gastroenteritis  1  1/256 (0.39%)  0/254 (0.00%) 
Injury, poisoning and procedural complications     
Humerus Fracture  1  0/256 (0.00%)  2/254 (0.79%) 
Femur Fracture  1  2/256 (0.78%)  1/254 (0.39%) 
Hip Fracture  1  0/256 (0.00%)  1/254 (0.39%) 
Pelvic Fracture  1  0/256 (0.00%)  1/254 (0.39%) 
Fall  1  1/256 (0.39%)  0/254 (0.00%) 
Femoral Neck Fracture  1  1/256 (0.39%)  0/254 (0.00%) 
Fractured Sacrum  1  1/256 (0.39%)  0/254 (0.00%) 
Head Injury  1  1/256 (0.39%)  0/254 (0.00%) 
Joint Dislocation  1  1/256 (0.39%)  0/254 (0.00%) 
Subdural Haematoma  1  1/256 (0.39%)  0/254 (0.00%) 
Blood Creatinine Increased  1  0/256 (0.00%)  1/254 (0.39%) 
Metabolism and nutrition disorders     
Hypercalcaemia  1  0/256 (0.00%)  2/254 (0.79%) 
Hyperglycaemia  1  0/256 (0.00%)  1/254 (0.39%) 
Hypoglycaemia  1  0/256 (0.00%)  1/254 (0.39%) 
Dehydration  1  1/256 (0.39%)  0/254 (0.00%) 
Musculoskeletal and connective tissue disorders     
Muscular Weakness  1  0/256 (0.00%)  2/254 (0.79%) 
Back Pain  1  2/256 (0.78%)  0/254 (0.00%) 
Musculoskeletal Pain  1  0/256 (0.00%)  1/254 (0.39%) 
Osteoarthritis  1  0/256 (0.00%)  1/254 (0.39%) 
Pain In Extremity  1  0/256 (0.00%)  1/254 (0.39%) 
Rhabdomyolysis  1  0/256 (0.00%)  1/254 (0.39%) 
Spinal Column Stenosis  1  0/256 (0.00%)  1/254 (0.39%) 
Arthralgia  1  1/256 (0.39%)  0/254 (0.00%) 
Osteonecrosis  1  1/256 (0.39%)  0/254 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Basal Cell Carcinoma  1  0/256 (0.00%)  1/254 (0.39%) 
Meningioma  1  0/256 (0.00%)  1/254 (0.39%) 
Metastases To Meninges  1  0/256 (0.00%)  1/254 (0.39%) 
Ovarian Cancer  1  0/256 (0.00%)  1/254 (0.39%) 
Nervous system disorders     
Dizziness  1  2/256 (0.78%)  2/254 (0.79%) 
Syncope  1  2/256 (0.78%)  1/254 (0.39%) 
Headache  1  1/256 (0.39%)  1/254 (0.39%) 
Intracranial Haematoma  1  0/256 (0.00%)  1/254 (0.39%) 
Peripheral Sensory Neuropathy  1  0/256 (0.00%)  1/254 (0.39%) 
Cerebellar Infarction  1  1/256 (0.39%)  0/254 (0.00%) 
Cerebral Infarction  1  1/256 (0.39%)  0/254 (0.00%) 
Peripheral Motor Neuropathy  1  1/256 (0.39%)  0/254 (0.00%) 
Spinal Cord Compression  1  1/256 (0.39%)  0/254 (0.00%) 
Syncope Vasovagal  1  1/256 (0.39%)  0/254 (0.00%) 
Psychiatric disorders     
Depression  1  0/256 (0.00%)  1/254 (0.39%) 
Schizophrenia  1  0/256 (0.00%)  1/254 (0.39%) 
Confusional State  1  1/256 (0.39%)  0/254 (0.00%) 
Renal and urinary disorders     
Renal Failure  1  2/256 (0.78%)  0/254 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Dyspnoea  1  3/256 (1.17%)  2/254 (0.79%) 
Pleural Effusion  1  3/256 (1.17%)  0/254 (0.00%) 
Pulmonary Embolism  1  2/256 (0.78%)  0/254 (0.00%) 
Pleuritic Pain  1  0/256 (0.00%)  1/254 (0.39%) 
Pneumonitis  1  0/256 (0.00%)  1/254 (0.39%) 
Respiratory Failure  1  1/256 (0.39%)  1/254 (0.39%) 
Skin and subcutaneous tissue disorders     
Angioedema  1  1/256 (0.39%)  0/254 (0.00%) 
Urticaria  1  1/256 (0.39%)  0/254 (0.00%) 
Vascular disorders     
Venous Stasis  1  0/256 (0.00%)  1/254 (0.39%) 
Thrombosis  1  1/256 (0.39%)  0/254 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 10.0
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Fulvestrant + Anastrozole Anastrozole
Affected / at Risk (%) Affected / at Risk (%)
Total   161/256 (62.89%)   178/254 (70.08%) 
Gastrointestinal disorders     
Nausea  1  23/256 (8.98%)  27/254 (10.63%) 
Constipation  1  15/256 (5.86%)  12/254 (4.72%) 
Diarrhoea  1  15/256 (5.86%)  13/254 (5.12%) 
Vomiting  1  13/256 (5.08%)  9/254 (3.54%) 
General disorders     
Fatigue  1  27/256 (10.55%)  33/254 (12.99%) 
Infections and infestations     
Urinary tract infection  1  14/256 (5.47%)  8/254 (3.15%) 
Musculoskeletal and connective tissue disorders     
Arthralgia  1  30/256 (11.72%)  27/254 (10.63%) 
Musculoskeletal pain  1  8/256 (3.13%)  20/254 (7.87%) 
Back pain  1  11/256 (4.30%)  15/254 (5.91%) 
Respiratory, thoracic and mediastinal disorders     
Cough  1  10/256 (3.91%)  13/254 (5.12%) 
Dyspnoea  1  13/256 (5.08%)  9/254 (3.54%) 
Vascular disorders     
Hot flush  1  21/256 (8.20%)  19/254 (7.48%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 10.0
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 only disclosure restriction on the PI is that they cannot disclose or publish any information to do with the trial without consent from AstraZeneca
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Gerard Lynch
Organization: AstraZeneca
EMail: aztrial_results_posting@astrazeneca.com
Layout table for additonal information
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00256698    
Other Study ID Numbers: D6997L00002
9238SW/0001
FACT
First Submitted: November 20, 2005
First Posted: November 22, 2005
Results First Submitted: April 29, 2010
Results First Posted: February 9, 2011
Last Update Posted: August 1, 2012