Skip to main content
OpenTrials
Completed

NCT Number: NCT00313170

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 in postmenopausal women with oestrogen receptor positive advanced breast cancer.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

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

Age range

45 year–130 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Research Site, Brussels, Belgium

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 (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.

Treatment and study plan

Fulvestrant

Drug

intramuscular injection 250 mg & 500 mg

Other names: Faslodex, ZD9238

Primary outcomes

  1. 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).

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  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

    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.

  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

    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.

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 II

Important dates

Study start
2006
Primary completion
2008
Study completion
2019
First posted
Apr 12, 2006
Registry last updated
Jan 6, 2020

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.