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Comparison of Fulvestrant (FASLODEX™) 250 mg and 500 mg in Postmenopausal Women With Oestrogen Receptor Positive Advanced Breast Cancer Progressing or Relapsing After Previous Endocrine Therapy. (CONFIRM)

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: NCT00099437
Recruitment Status : Active, not recruiting
First Posted : December 14, 2004
Results First Posted : June 15, 2010
Last Update Posted : March 21, 2023
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Study Description
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Brief Summary:
The purpose of this study is to evaluate the efficacy of a new dose of 500 mg Fulvestrant with the standard dose of 250 mg in postmenopausal women with oestrogen receptor positive advanced breast cancer who have failed on a previous endocrine treatment.

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: Fulvestrant Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 736 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomised, Double-Blind, Parallel-group, Multicentre, Phase III Study Comparing the Efficacy and Tolerability of Fulvestrant (FASLODEX™) 500 mg With Fulvestrant (FASLODEX™) 250 mg in Postmenopausal Women With Oestrogen Receptor Positive Advanced Breast Cancer Progressing or Relapsing After Previous Endocrine Therapy
Actual Study Start Date : February 13, 2005
Actual Primary Completion Date : February 27, 2009
Estimated Study Completion Date : December 29, 2023

Resource links provided by the National Library of Medicine

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

Arms and Interventions
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Arm Intervention/treatment
Experimental: 1
Fulvestrant 500 mg
 Drug: Fulvestrant
intramuscular injection
Other Names:
  • Faslodex
  • ZD9238
Experimental: 2
Fulvestrant 250 mg
 Drug: Fulvestrant
intramuscular injection
Other Names:
  • Faslodex
  • ZD9238


Outcome Measures
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Primary Outcome Measures :
  1. Time to Progression (TTP) [ Time Frame: RECIST(Response Evaluation Criteria in Solid Tumors ) tumour assessments carried out every 12 weeks (+/- 2 weeks) from randomisation for study duration (48 months) ]
    Median time (in months) from randomisation until objective disease progression or death (in the absence of objective progression).


Secondary Outcome Measures :
  1. Objective Response Rate (ORR) [ Time Frame: RECIST tumour assessments carried out every 12 weeks (+/- 2 weeks) from randomisation for study duration (48 months) ]
    Using the RECIST scan data, an objective response (OR) is defined as a patient having a best overall response of either complete response (CR) or partial response (PR) which is subsequently confirmed as per RECIST. ORR is defined as the percentage of patients with OR.

  2. Clinical Benefit Rate (CBR) [ Time Frame: Clinical Benefit from the sequence of RECIST scan data for study duration (48 months) . RECIST (Response Evaluation Criteria in Solid Tumours) scans were performed every 12 weeks (+/- 2 weeks) from randomisation for study duration (48 months) ]
    A Clinical Benefit (CB) responder is defined as a patient having a best overall response of CR, PR or SD (stable disease) >=24 weeks. The Clinical Benefit Rate is the percentage of patients with CB.

  3. Duration of Response (DoR) [ Time Frame: RECIST tumour assessments carried out every 12 weeks (+/- 2 weeks) from randomisation for study duration (48 months) ]
    Time from randomisation until objective progression or death (in the absence of objective progression), measured only in those patients who achieve a confirmed complete response (CR) or confirmed partial response (PR)

  4. Duration of Clinical Benefit (DoCB) [ Time Frame: RECIST tumour assessments carried out every 12 weeks (+/- 2 weeks) from randomisation for study duration (48 months) ]
    Time from randomisation until objective progression or death (in the absence of objective progression), measured only in those patients who achieve a confirmed complete response (CR), confirmed partial response (PR), or stable disease (SD) >=24 weeks

  5. Overall Survival (OS) [ Time Frame: Overall Survival is equivalent to time to death. For this endpoint, all deaths occurring for study duration (48 months) ]
    Median time (in months) from randomisation until death (from any cause) (analysis at 50% deaths )

  6. Change From Randomisation in Trial Outcome Index (TOI) Over the Course of the Study [ Time Frame: TOI questionnaires were completed every 4 weeks from randomisation until week 24 and then again at treatment discontinuation, for study duration (48 months) ]
    Mean (and standard deviation) change from randomisation until treatment discontinuation in TOI (defined as the first visit response of 'worsened' which is a decrease in TOI from baseline of 5 points or more) using the Kaplan-Meier method. If a subject has not shown a reduction of 5 points or more at the time of analysis then the observation will be right censored using the last QOL assessment date. Trial Outcome Index (TOI) is derived from the FACT-B questionnaire (Cella et al, 1993) by adding together the scores from the following 3 subscales; Physical well-being (PWB), Functional well-being (FWB) and Breast cancer subscale (BCS). The TOI score range is 0-92 with the higher scores representing the more favourable outcomes. Data were collected from a subgroup of patients.

  7. Overall Survival (OS) - Follow-up [ Time Frame: Median time (in months) from randomisation until death (from any cause),up to 80 months ]
    Overall Survival is equivalent to time to death. For this endpoint, all deaths occurring during the study as a whole until the data cut-off for the survival extension (31st October 2011) are presented (analysis at 75% deaths)


Eligibility Criteria
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Information from the National Library of Medicine

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, Learn About Clinical Studies.


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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 defined as a woman who has stopped having menstrual periods
  • Evidence of positive estrogen receptor hormone sensitivity
  • Written informed consent to participate in the trial

Exclusion Criteria:

  • Treatment with an investigational or non-approved drug within one month
  • An existing serious disease, illness, or condition that will prevent participation or compliance with study procedures
  • A history of allergies to any active or inactive ingredients of Faslodex (i.e. castor oil)
  • Treatment with more than one regimen of chemotherapy for advanced breast cancer
  • Treatment with more than one regimen of hormonal treatment for advanced breast cancer
Contacts and Locations
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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): NCT00099437


Locations
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Sponsors and Collaborators
AstraZeneca
Investigators
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Study Director: Faslodex Medical Science Director, MD AstraZeneca
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00099437    
Other Study ID Numbers: D6997C00002
First Posted: December 14, 2004    Key Record Dates
Results First Posted: June 15, 2010
Last Update Posted: March 21, 2023
Last Verified: March 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Time Frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure
Access Criteria: When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure
URL: https://astrazenecagroup-dt.pharmacm.com/DT/Home
Keywords provided by AstraZeneca:
Advanced Breast Cancer
Metastatic 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