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

December 17, 2019 updated by: AstraZeneca

Phase II Study to Evaluate the Efficacy and Tolerability of Fulvestrant 250mg, 250mg Plus 250mg Loading Regimen and 500mg in Postmenopausal Women With ER +ve Advanced Breast Cancer Progressing or Relapsing After Previous Endocrine Therapy

This study will assess the relationship between fulvestrant dose and efficacy in postmenopausal women with oestrogen receptor positive advanced breast cancer.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

144

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Brussels, Belgium, 1000
        • Research Site
      • Leuven, Belgium, 3000
        • Research Site
      • Roeselare, Belgium, 8800
        • Research Site
      • Wilrijk, Belgium, 2610
        • Research Site
  • Canada
      • Quebec, Canada, G1S 4L8
        • Research Site
    • Alberta
      • Edmonton, Alberta, Canada, T6G 1Z2
        • Research Site
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 4E6
        • Research Site
    • Ontario
      • Cambridge, Ontario, Canada, N1R 3G2
        • Research Site
      • London, Ontario, Canada, N6A 4L6
        • Research Site
      • Oshawa, Ontario, Canada, L1G 2B9
        • Research Site
      • Sault Ste. Marie, Ontario, Canada, P6A 2C4
        • Research Site
      • Toronto, Ontario, Canada, M4N 3M5
        • Research Site
      • Toronto, Ontario, Canada, M4C 3E7
        • Research Site
    • Quebec
      • Montreal, Quebec, Canada, H3T 1E2
        • Research Site
  • Czechia
      • Cheb, Czechia, 350 02
        • Research Site
      • Jicin, Czechia, 506 43
        • Research Site
      • Praha 4, Czechia, 140 00
        • Research Site
  • France
      • Bordeaux, France, 33000
        • Research Site
      • Brive, France, 19312
        • Research Site
      • Clermont Ferrand cedex 01, France, 63011
        • Research Site
      • Poitiers, France, 86000
        • Research Site
  • Hungary
      • Budapest, Hungary, 1062
        • Research Site
      • Debrecen, Hungary, 4032
        • Research Site
      • Györ, Hungary, 9024
        • Research Site
      • Szeged, Hungary, 6720
        • Research Site
      • Tatabánya, Hungary, 2800
        • Research Site
  • Poland
      • Bydgoszcz, Poland, 85-796
        • Research Site
      • Gdańsk, Poland, 80-214
        • Research Site
      • Gdańsk, Poland, 80-462
        • Research Site
      • Kraków, Poland, 31-115
        • Research Site
      • Olsztyn, Poland, 10-228
        • Research Site
  • Romania
      • Bucharest, Romania
        • Research Site
      • Bucuresti, Romania
        • Research Site
      • Cluj Napoca, Romania, 40015
        • Research Site
  • Turkey
      • Istanbul, Turkey
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years to 130 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Breast Cancer has continued to grow after having received treatment with an anti-estrogen hormonal treatment such as tamoxifen or an aromatase inhibitor.
  • Requiring hormonal treatment.
  • Postmenopausal women (woman who has stopped having menstrual periods)

Exclusion Criteria:

  • Treatment with more than one previous regimen of systemic anticancer therapy other than endocrine therapy for advanced BC.
  • Treatment with more than one previous regimen of endocrine therapy for advanced BC.
  • An existing condition that prevents compliance.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Fulvestrant 250 mg (intramuscular injection 250 mg)
Drug: Fulvestrant
intramuscular injection 250 mg & 500 mg
Other Names:
  • Faslodex
  • ZD9238
Experimental: 2
Fulvestrant 250 mg (+ 250 mg loading regimen)
Drug: Fulvestrant
intramuscular injection 250 mg & 500 mg
Other Names:
  • Faslodex
  • ZD9238
Experimental: 3
Fulvestrant 500 mg (intramuscular injection 500 mg)
Drug: Fulvestrant
intramuscular injection 250 mg & 500 mg
Other Names:
  • Faslodex
  • ZD9238

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective Response (ORR)
Time Frame: The planned data cut-off for this study was when all patients, except withdrawals, had been followed up for at least 24 weeks. Patients received treatment up to approximately 2 years.
Objective response rate was defined as percentage of patients with either complete response (CR - disappearance of all target lesions) or partial response (PR - at least 30% decrease in the sum of diameters of target lesions). All patients were to be followed up every 12 weeks for progression, defined by response evaluation criteria in solid tumors (RECIST v1.1).
The planned data cut-off for this study was when all patients, except withdrawals, had been followed up for at least 24 weeks. Patients received treatment up to approximately 2 years.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to Progression (TTP)
Time Frame: The planned data cut-off for this study was when all patients, except withdrawals, had been followed up for at least 24 weeks. Patients received treatment up to approximately 2 years.
Time from randomisation until objective disease progression or death (in the absence of objective progression) using the Kaplan-Meier method. RECIST tumor assessments were carried out every 12 weeks until progression.
The planned data cut-off for this study was when all patients, except withdrawals, had been followed up for at least 24 weeks. Patients received treatment up to approximately 2 years.
Duration of Response (DoR)
Time Frame: The planned data cut-off for this study was when all patients, except withdrawals, had been followed up for at least 24 weeks. Patients received treatment up to approximately 2 years.
DoR was defined as the time from date of first documentation of the response (CR or PR) until the date of disease progression or death from any cause.
The planned data cut-off for this study was when all patients, except withdrawals, had been followed up for at least 24 weeks. Patients received treatment up to approximately 2 years.
Clinical Benefit Rate (CBR)
Time Frame: The planned data cut-off for this study was when all patients, except withdrawals, had been followed up for at least 24 weeks. Patients received treatment up to approximately 2 years.
CBR was defined as the proportion of all randomised patients who had clinical benefit (response of CR, PR or SD>=24 weeks.
The planned data cut-off for this study was when all patients, except withdrawals, had been followed up for at least 24 weeks. Patients received treatment up to approximately 2 years.
Pharmacokinetic Parameter: Mean Population Clearance, a Measure of the Efficiency With Which Fulvestrant is Eliminated From the Body
Time Frame: Baseline to 12 weeks
A 2-compartment model with a 1st order absorption and 1st order elimination process was fitted to the fulvestrant concentration-time data. Relative standard error is reported for the mean.
Baseline to 12 weeks
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
A 2-compartment model with a 1st order absorption and 1st order elimination process was fitted to the fulvestrant concentration-time data. Relative standard error is reported for the mean. The mean estimate of volume of distribution at steady state was reported as the sum of V1/F and V2/F in the clinical study report.
Baseline to 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Investigators

  • Study Director: AstraZeneca Breast Cancer Established Brands Team Medical Science Director, MD, AstraZeneca

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 30, 2006

Primary Completion (Actual)

June 13, 2008

Study Completion (Actual)

March 13, 2019

Study Registration Dates

First Submitted

April 10, 2006

First Submitted That Met QC Criteria

April 11, 2006

First Posted (Estimate)

April 12, 2006

Study Record Updates

Last Update Posted (Actual)

January 6, 2020

Last Update Submitted That Met QC Criteria

December 17, 2019

Last Verified

December 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D6997C00006
  • FINDER II

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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