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A Clinical Trial to Compare Efficacy and Tolerability of Fulvestrant 250mg, 250mg (Plus 250mg Loading Regimen) and 500mg (FINDER I)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00305448
First received: March 20, 2006
Last updated: February 14, 2012
Last verified: February 2012
History of Changes
Results First Received: March 17, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Advanced Breast Cancer
Metastatic Breast Cancer
Intervention: Drug: Fulvestrant

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Postmenopausal women with oestrogen receptor positive advanced breast cancer progressing or relapsing after previousendocrine therapy were randomized between 7th March 2006 and 4th September 2007. The trial was conducted in Japan only. One patient randomised to Fulvestrant 500mg was not dosed, so the Safety population has 46 patients for that arm.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
8 of the 151 enrolled patients were not randomized to treatment groups for the following reasons - 8 patients were incorrectly enrolled (ie did not comply with one or more inclusion / exclusion criteria).

Reporting Groups
  Description
Fulvestrant 250 mg Fulvestrant 250 mg
Fulvestrant 250 mg + Loading Dose Fulvestrant 250 mg + Loading Dose
Fulvestrant 500 mg Fulvestrant 500 mg

Participant Flow:   Overall Study
    Fulvestrant 250 mg     Fulvestrant 250 mg + Loading Dose     Fulvestrant 500 mg  
STARTED     45     51     47  
COMPLETED     14     17     14  
NOT COMPLETED     31     34     33  
Protocol Violation                 0                 1                 0  
Withdrawal by Subject                 2                 0                 1  
Adverse Event                 1                 0                 1  
Disease Progression                 27                 31                 28  
Subjective Disease Progression                 1                 2                 2  
Tumor Marker Elevation                 0                 0                 1  



  Baseline Characteristics
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Reporting Groups
  Description
Fulvestrant 250 mg Fulvestrant 250 mg
Fulvestrant 250 mg + Loading Dose Fulvestrant 250 mg + Loading Dose
Fulvestrant 500 mg Fulvestrant 500 mg
Total Total of all reporting groups

Baseline Measures
    Fulvestrant 250 mg     Fulvestrant 250 mg + Loading Dose     Fulvestrant 500 mg     Total  
Number of Participants  
[units: participants]
 		  45     51     47     143  
Age  
[units: Years]
Mean ± Standard Deviation 		  62.5  ± 7.4     62.4  ± 9.5     62.7  ± 9.1     62.5  ± 8.7  
Gender  
[units: Participants]
 		       
Female     45     51     47     143  
Male     0     0     0     0  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Objective Response Rate (ORR)   [ Time Frame: baseline and every 12 weeks (+/- 2weeks) from randomization data up to data cut-off (19th march 2008) ]
  Show Outcome Measure 1

2.  Secondary:   Time to Progression (TTP)   [ Time Frame: every 12 weeks from randomization (+/- 2 weeks) until data cut-off (19th march 2008) ]
  Show Outcome Measure 2

3.  Secondary:   Clinical Benefit Rate (CBR)   [ Time Frame: every 12 weeks(+/- 2 weeks) from randomization to data up to data cut-off, 19th March 2008. ]
  Show Outcome Measure 3

4.  Secondary:   Pharmacokinetic Parameter: Mean Population Clearance, a Measure of the Efficiency With Which Fulvestrant is Eliminated From the Body   [ Time Frame: Baseline to 12 weeks ]
  Show Outcome Measure 4

5.  Secondary:   Pharmacokinetic Parameter: Mean Volume of Distribution at Steady State, a Measure of the Apparent Volume in the Body Into Which Fulvestrant Distributes   [ Time Frame: Baseline to 12 weeks ]
  Show Outcome Measure 5

6.  Secondary:   Duration of Response (DoR)   [ Time Frame: RECIST tumour assessments carried out every 12 weeks from randomisation (+/- 2 weeks) until data cut-off on19th March 2008. ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events
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  Other Adverse Events
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Time Frame No text entered.
Additional Description No text entered.

Frequency Threshold
Threshold above which other adverse events are reported   5%  

Reporting Groups
  Description
Fulvestrant 250 mg Fulvestrant 250 mg
Fulvestrant 250 mg + Loading Dose Fulvestrant 250 mg + Loading Dose
Fulvestrant 500 mg Fulvestrant 500 mg

Other Adverse Events
    Fulvestrant 250 mg     Fulvestrant 250 mg + Loading Dose     Fulvestrant 500 mg  
Total, other (not including serious) adverse events        
# participants affected / at risk     44/45     49/51     44/46  
Blood and lymphatic system disorders        
Leukopenia † 2      
# participants affected / at risk     4/45 (8.89%)     2/51 (3.92%)     1/46 (2.17%)  
Neutropenia † 2      
# participants affected / at risk     3/45 (6.67%)     1/51 (1.96%)     2/46 (4.35%)  
Ear and labyrinth disorders        
Vertigo † 2      
# participants affected / at risk     1/45 (2.22%)     0/51 (0.00%)     3/46 (6.52%)  
Gastrointestinal disorders        
Abdominal Pain Upper † 1      
# participants affected / at risk     3/45 (6.67%)     2/51 (3.92%)     2/46 (4.35%)  
Constipation † 2      
# participants affected / at risk     4/45 (8.89%)     7/51 (13.73%)     5/46 (10.87%)  
Diarrhoea † 2      
# participants affected / at risk     4/45 (8.89%)     2/51 (3.92%)     1/46 (2.17%)  
Nausea † 2      
# participants affected / at risk     11/45 (24.44%)     9/51 (17.65%)     6/46 (13.04%)  
Stomatitis † 2      
# participants affected / at risk     2/45 (4.44%)     3/51 (5.88%)     5/46 (10.87%)  
Vomiting † 2      
# participants affected / at risk     1/45 (2.22%)     3/51 (5.88%)     3/46 (6.52%)  
General disorders        
Fatigue † 2      
# participants affected / at risk     7/45 (15.56%)     7/51 (13.73%)     7/46 (15.22%)  
Injection Site Erythema † 2      
# participants affected / at risk     3/45 (6.67%)     2/51 (3.92%)     1/46 (2.17%)  
Injection Site Induration † 2      
# participants affected / at risk     9/45 (20.00%)     6/51 (11.76%)     10/46 (21.74%)  
Injection Site Pain † 2      
# participants affected / at risk     14/45 (31.11%)     11/51 (21.57%)     14/46 (30.43%)  
Injection Site Pruritus † 2      
# participants affected / at risk     4/45 (8.89%)     2/51 (3.92%)     4/46 (8.70%)  
Pyrexia † 2      
# participants affected / at risk     2/45 (4.44%)     4/51 (7.84%)     5/46 (10.87%)  
Infections and infestations        
Nasopharyngitis † 2      
# participants affected / at risk     17/45 (37.78%)     15/51 (29.41%)     16/46 (34.78%)  
Injury, poisoning and procedural complications        
Contusion † 2      
# participants affected / at risk     1/45 (2.22%)     3/51 (5.88%)     3/46 (6.52%)  
Investigations        
Weight Decreased † 2      
# participants affected / at risk     3/45 (6.67%)     1/51 (1.96%)     1/46 (2.17%)  
Metabolism and nutrition disorders        
Anorexia † 2      
# participants affected / at risk     2/45 (4.44%)     4/51 (7.84%)     3/46 (6.52%)  
Musculoskeletal and connective tissue disorders        
Arthralgia † 2      
# participants affected / at risk     2/45 (4.44%)     7/51 (13.73%)     2/46 (4.35%)  
Back Pain † 2      
# participants affected / at risk     3/45 (6.67%)     5/51 (9.80%)     3/46 (6.52%)  
Musculoskeletal Stiffness † 2      
# participants affected / at risk     2/45 (4.44%)     3/51 (5.88%)     1/46 (2.17%)  
Pain In Extremity † 2      
# participants affected / at risk     0/45 (0.00%)     0/51 (0.00%)     3/46 (6.52%)  
Nervous system disorders        
Headache † 2      
# participants affected / at risk     3/45 (6.67%)     8/51 (15.69%)     4/46 (8.70%)  
Hypoaesthesia † 2      
# participants affected / at risk     1/45 (2.22%)     3/51 (5.88%)     2/46 (4.35%)  
Somnolence † 2      
# participants affected / at risk     3/45 (6.67%)     1/51 (1.96%)     1/46 (2.17%)  
Psychiatric disorders        
Insomnia † 2      
# participants affected / at risk     4/45 (8.89%)     3/51 (5.88%)     1/46 (2.17%)  
Respiratory, thoracic and mediastinal disorders        
Cough † 2      
# participants affected / at risk     2/45 (4.44%)     3/51 (5.88%)     1/46 (2.17%)  
Skin and subcutaneous tissue disorders        
Pruritus † 2      
# participants affected / at risk     2/45 (4.44%)     3/51 (5.88%)     4/46 (8.70%)  
Rash † 2      
# participants affected / at risk     1/45 (2.22%)     3/51 (5.88%)     2/46 (4.35%)  
Vascular disorders        
Hot Flush † 2      
# participants affected / at risk     8/45 (17.78%)     11/51 (21.57%)     7/46 (15.22%)  
Hypertension † 2      
# participants affected / at risk     4/45 (8.89%)     0/51 (0.00%)     0/46 (0.00%)  
† Events were collected by systematic assessment
1 Term from vocabulary, MedDRA 11.0
2 Term from vocabulary, MedDRA 11



  More Information
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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:
unchecked 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.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


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


Results Point of Contact:  
Name/Title: Gerard Lynch
Organization: Astrazeneca
e-mail: AZTrial_Results_Posting@astrazeneca.com


No publications provided


Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00305448     History of Changes
Other Study ID Numbers: D6997C00004, FINDER I
Study First Received: March 20, 2006
Results First Received: March 17, 2009
Last Updated: February 14, 2012
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency