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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Outcome Measures

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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) ]

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2. Secondary:

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

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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. ]

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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 ]

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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 ]

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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. Safety Issue: No

Serious Adverse Events

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Other Adverse Events

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Limitations and Caveats

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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
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