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Completed

NCT Number: NCT00305448

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

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.

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Key information

Conditions

Advanced Breast Cancer Breast Diseases Breast Neoplasms Metastatic Breast Cancer Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Research Site, Nagoya, Aichi-ken, Japan

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fulvestrant

Drug

250 intramuscular injection

Other names: Faslodex, ZD9238

Primary outcomes

  1. 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

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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

  5. 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

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

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

Acronym: FINDER I

Important dates

Study start
2006
Primary completion
2008
Study completion
2012
First posted
Mar 22, 2006
Registry last updated
Feb 15, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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