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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00313170
Recruitment Status : Completed
First Posted : April 12, 2006
Results First Posted : August 29, 2011
Last Update Posted : January 6, 2020
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

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

Condition or disease Intervention/treatment Phase
Advanced Breast Cancer Metastatic Breast Cancer Drug: Fulvestrant Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 144 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Actual Study Start Date : May 30, 2006
Actual Primary Completion Date : June 13, 2008
Actual Study Completion Date : March 13, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
Drug Information available for: Fulvestrant

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




Primary Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 130 Years   (Adult, Older Adult)
Sexes 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00313170


Locations
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Belgium
Research Site
Brussels, Belgium, 1000
Research Site
Leuven, Belgium, 3000
Research Site
Roeselare, Belgium, 8800
Research Site
Wilrijk, Belgium, 2610
Canada, Alberta
Research Site
Edmonton, Alberta, Canada, T6G 1Z2
Canada, British Columbia
Research Site
Vancouver, British Columbia, Canada, V5Z 4E6
Canada, Ontario
Research Site
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, M4C 3E7
Research Site
Toronto, Ontario, Canada, M4N 3M5
Canada, Quebec
Research Site
Montreal, Quebec, Canada, H3T 1E2
Canada
Research Site
Quebec, Canada, G1S 4L8
Czechia
Research Site
Cheb, Czechia, 350 02
Research Site
Jicin, Czechia, 506 43
Research Site
Praha 4, Czechia, 140 00
France
Research Site
Bordeaux, France, 33000
Research Site
Brive, France, 19312
Research Site
Clermont Ferrand cedex 01, France, 63011
Research Site
Poitiers, France, 86000
Hungary
Research Site
Budapest, Hungary, 1062
Research Site
Debrecen, Hungary, 4032
Research Site
Györ, Hungary, 9024
Research Site
Szeged, Hungary, 6720
Research Site
Tatabánya, Hungary, 2800
Poland
Research Site
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
Romania
Research Site
Bucharest, Romania
Research Site
Bucuresti, Romania
Research Site
Cluj Napoca, Romania, 40015
Turkey
Research Site
Istanbul, Turkey
Sponsors and Collaborators
AstraZeneca
Investigators
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Study Director: AstraZeneca Breast Cancer Established Brands Team Medical Science Director, MD AstraZeneca
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00313170    
Other Study ID Numbers: D6997C00006
FINDER II
First Posted: April 12, 2006    Key Record Dates
Results First Posted: August 29, 2011
Last Update Posted: January 6, 2020
Last Verified: December 2019
Keywords provided by AstraZeneca:
oncology
cancer
breast cancer
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Fulvestrant
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Estrogen Receptor Antagonists
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs