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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00313170
First received: April 10, 2006
Last updated: July 14, 2014
Last verified: July 2014
  Purpose

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


Condition Intervention Phase
Advanced Breast Cancer
Metastatic Breast Cancer
Drug: Fulvestrant
Phase 2

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
Official 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

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Objective Response (OR) [ Time Frame: RECIST scans were performed every 12 weeks (+/- 2 weeks) from randomisation to until data cut off on 13th June 2008 ] [ Designated as safety issue: No ]
    Number of participants who were objective responders over the number of participants evaluable for response x100. An objective responder = a patient whose best response is either CR (disappearance of all lesions) or PR (>= 30% shrinkage in the sum of the longest diameters of the measurable lesions + no new lesions + no progression of non-measurable lesions)


Secondary Outcome Measures:
  • Time to Progression (TTP) [ Time Frame: RECIST tumour assessments carried out every 12 weeks (+/- 2 weeks) from randomisation until data cut off on 13th June 2008 ] [ Designated as safety issue: No ]
    Median time (in days) from randomisation until objective disease progression or death (in the absence of objective progression) using the Kaplan-Meier method

  • Duration of Response (DoR) [ Time Frame: RECIST tumour assessments were carried out every 12 weeks (+/- 2 weeks) from randomisation until data cut-off on 13th June 2008 ] [ Designated as safety issue: No ]
    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 (CR) or confirmed Partial Response (PR)

  • Clinical Benefit Rate (CBR) [ Time Frame: Each patient was assessed for Clinical Benefit from the sequence of RECIST (Response Evaluation Criteria in Solid Tumours) scan data up to the data cut-off, 13th June 2008. RECIST scans were performed every 12 weeks (+/- 2 weeks) from randomisation. ] [ Designated as safety issue: No ]
    A Clinical Benefit (CB) responder is defined as a patient having a best overall response of CR, PR or SD, provided that the SD was present at least 154 days from randomisation (ie. SD>=24 weeks - with the 2 week RECIST assessment time window allowed). The Clinical Benefit Rate is the percentage of patients with CB.

  • Pharmacokinetic Parameter: Mean Population Clearance, a Measure of the Efficiency With Which Fulvestrant is Eliminated From the Body [ Time Frame: Baseline to 12 weeks ] [ Designated as safety issue: No ]
    The measure of dispersion for mean population clearance is based on the estimated inter-individual variance.

  • 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 ] [ Designated as safety issue: No ]
    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


Enrollment: 161
Study Start Date: May 2006
Estimated Study Completion Date: December 2014
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Fulvestrant 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
Drug: Fulvestrant
intramuscular injection 250 mg & 500 mg
Other Names:
  • Faslodex
  • ZD9238

  Eligibility

Ages Eligible for Study:   45 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00313170

  Show 33 Study Locations
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: AstraZeneca Breast Cancer Established Brands Team Medical Science Director, MD AstraZeneca
  More Information

Additional Information:
No publications provided by AstraZeneca

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00313170     History of Changes
Other Study ID Numbers: D6997C00006, FINDER II
Study First Received: April 10, 2006
Results First Received: June 10, 2009
Last Updated: July 14, 2014
Health Authority: Belgium: Federal Agency for Medicines and Health Products, FAMHP
Canada: Health Canada
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Hungary: National Institute of Pharmacy
Romania: National Medicines Agency
Poland: Ministry of Health

Keywords provided by AstraZeneca:
oncology
cancer
breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Fulvestrant
Estradiol
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Estrogen Antagonists
Estrogen Receptor Modulators
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Estrogens
Hormones

ClinicalTrials.gov processed this record on July 26, 2014