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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00305448
Recruitment Status : Completed
First Posted : March 22, 2006
Results First Posted : August 29, 2011
Last Update Posted : February 15, 2012
Information provided by (Responsible Party):

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Advanced Breast Cancer
Metastatic Breast Cancer
Intervention: Drug: Fulvestrant

  Participant Flow

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
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

  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) ]

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

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. ]

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 ]

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 ]

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 reported.   Anticipated Reporting Date:   No text entered.  

  Serious Adverse Events

  Other Adverse Events

  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.

  More Information