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

February 14, 2012 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, and determine the dosing regimen as a second line therapy for Japanese postmenopausal women with oestrogen receptor positive advanced breast cancer.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

143

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

  • Japan
      • Chiba, Japan
        • Research Site
      • Fukuoka, Japan
        • Research Site
      • Hiroshima, Japan
        • Research Site
      • Kawasaki, Japan
        • Research Site
      • Kumamoto, Japan
        • Research Site
      • Niigata, Japan
        • Research Site
      • Oita, Japan
        • Research Site
      • Osaka, Japan
        • Research Site
      • Shizuoka, Japan
        • Research Site
    • Aichi
      • Nagoya, Aichi, Japan
        • Research Site
    • Chiba
      • Asahi, Chiba, Japan
        • Research Site
    • Ehime
      • Matsuyama, Ehime, Japan
        • Research Site
    • Fukuoka
      • Kitakyushu, Fukuoka, Japan
        • Research Site
      • Kurume, Fukuoka, Japan
        • Research Site
    • Fukushima
      • Daito, Fukushima, Japan
        • Research Site
      • Koriyama, Fukushima, Japan
        • Research Site
    • Gunma
      • Ota, Gunma, Japan
        • Research Site
    • Hiroshima
      • Fukuyama, Hiroshima, Japan
        • Research Site
      • Kure, Hiroshima, Japan
        • Research Site
    • Hokkaido
      • Sapporo, Hokkaido, Japan
        • Research Site
    • Hyogo
      • Amagasaki, Hyogo, Japan
        • Research Site
    • Kagoshima
      • Matsubaracho, Kagoshima, Japan
        • Research Site
    • Kanagawa
      • Isehara, Kanagawa, Japan
        • Research Site
      • Sagamihara, Kanagawa, Japan
        • Research Site
      • Yokohama, Kanagawa, Japan
        • Research Site
    • Miyagi
      • Sendai, Miyagi, Japan
        • Research Site
    • Okayama
      • Kurashiki, Okayama, Japan
        • Research Site
    • Osaka
      • Izumisano, Osaka, Japan
        • Research Site
      • Sakai, Osaka, Japan
        • Research Site
      • Suita, Osaka, Japan
        • Research Site
    • Saitama
      • Ina, Saitama, Japan
        • Research Site
      • Moroyama, Saitama, Japan
        • Research Site
    • Tochigi
      • Shimotsuke, Tochigi, Japan
        • Research Site
    • Tokyo
      • Chuo, Tokyo, Japan
        • Research Site
      • Koto-ku, Tokyo, Japan
        • 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

  • Child
  • 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 defined as a 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 breast cancer
  • Treatment with more than one previous regimen of endocrine therapy for advanced breast cancer
  • An existing serious disease, illness, or condition that will prevent participation or compliance with study procedures

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
Drug: Fulvestrant
500 mg intramuscular injection
Drug: Fulvestrant
250 intramuscular injection
Other Names:
  • Faslodex
  • ZD9238
Experimental: 2
Fulvestrant 250mg (Plus 250mg Loading Regimen)
Drug: Fulvestrant
500 mg intramuscular injection
Drug: Fulvestrant
250 intramuscular injection
Other Names:
  • Faslodex
  • ZD9238
Experimental: 3
Fulvestrant 500 mg
Drug: Fulvestrant
500 mg intramuscular injection
Drug: Fulvestrant
250 intramuscular injection
Other Names:
  • Faslodex
  • ZD9238

What is the study measuring?

Primary Outcome Measures

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

An objective response (OR) is defined as a patient having a best overall response of either complete response (CR) or partial response (PR). A patient has best overall response of CR if she had overall response of CR or PR on one visit and met the confirmation criteria per RECIST. ORR is defined as percentage of patients with objective response.

Each patient with measurable disease at baseline was assessed for OR from the sequence of Response Evaluation Criteria in Solid Tumors (RECIST) scan data up to data cut-off. RECIST scans were performed every 12 weeks (+/- 2weeks) from randomization
baseline and every 12 weeks (+/- 2weeks) from randomization data up to data cut-off (19th march 2008)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to Progression (TTP)
Time Frame: every 12 weeks from randomization (+/- 2 weeks) until data cut-off (19th march 2008)
Time (in days) from randomization until objective disease progression or death (in the absence of objective progression). RECIST tumour assessments carried out every 12 weeks from randomization (+/- 2 weeks) until data cut-off on 19th March 2008.
every 12 weeks from randomization (+/- 2 weeks) until data cut-off (19th march 2008)
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.
Time from randomisation until objective progression or death (in the absence of objective progression), measured only in those patients who achieved a confirmed Complete Response or confirmed Partial Response.
RECIST tumour assessments carried out every 12 weeks from randomisation (+/- 2 weeks) until data cut-off on19th March 2008.
Clinical Benefit Rate (CBR)
Time Frame: every 12 weeks(+/- 2 weeks) from randomization to data up to data cut-off, 19th March 2008.
A Clinical Benefit (CB) responder is defined as a patient having a best overall response of Complete response (CR), Partial Response (PR) or Stable disease (SD) provided SD (or better) was present = 154 days from randomization (ie SD = 24 weeks with the 2 week RECIST assessment time window allowed). The Clinical Benefit Rate is the percentage of patients with CB.
every 12 weeks(+/- 2 weeks) from randomization to data up to data cut-off, 19th March 2008.
Pharmacokinetic Parameter: Mean Population Clearance, a Measure of the Efficiency With Which Fulvestrant is Eliminated From the Body
Time Frame: Baseline to 12 weeks
The measure of dispersion for mean population clearance is based on the estimated inter-individual variance
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
The measure of dispersion for volume of distribution is based on the inter-individual variance estimated for the apparent volume of plasma into which Fulvestrant distributes
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 Japan Medical Director, MD, AstraZeneca

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

March 1, 2006

Primary Completion (Actual)

March 1, 2008

Study Completion (Actual)

February 1, 2012

Study Registration Dates

First Submitted

March 20, 2006

First Submitted That Met QC Criteria

March 20, 2006

First Posted (Estimate)

March 22, 2006

Study Record Updates

Last Update Posted (Estimate)

February 15, 2012

Last Update Submitted That Met QC Criteria

February 14, 2012

Last Verified

February 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D6997C00004
  • FINDER I

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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