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)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00099437
First received: December 13, 2004
Last updated: August 29, 2014
Last verified: August 2014
  Purpose

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 Intervention Phase
Breast Cancer
Drug: Fulvestrant
Phase 3

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: 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

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]
    Median time (in months) from randomisation until objective disease progression or death (in the absence of objective progression).


Secondary Outcome Measures:
  • Objective Response Rate (ORR) [ Time Frame: RECIST tumour assessments carried out every 12 weeks (+/- 2 weeks) from randomisation for study duration (48 months) ] [ Designated as safety issue: No ]
    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.

  • 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) ] [ 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 (stable disease) >=24 weeks. The Clinical Benefit Rate is the percentage of patients with CB.

  • Duration of Response (DoR) [ Time Frame: RECIST tumour assessments carried out every 12 weeks (+/- 2 weeks) from randomisation for study duration (48 months) ] [ 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 achieve a confirmed complete response (CR) or confirmed partial response (PR)

  • Duration of Clinical Benefit (DoCB) [ Time Frame: RECIST tumour assessments carried out every 12 weeks (+/- 2 weeks) from randomisation for study duration (48 months) ] [ 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 achieve a confirmed complete response (CR), confirmed partial response (PR), or stable disease (SD) >=24 weeks

  • Overall Survival (OS) [ Time Frame: Overall Survival is equivalent to time to death. For this endpoint, all deaths occurring for study duration (48 months) ] [ Designated as safety issue: No ]
    Median time (in months) from randomisation until death (from any cause) (analysis at 50% deaths )

  • 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) ] [ Designated as safety issue: No ]
    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.

  • Overall Survival (OS) - Follow-up [ Time Frame: Median time (in months) from randomisation until death (from any cause),up to 80 months ] [ Designated as safety issue: Yes ]
    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)


Enrollment: 834
Study Start Date: February 2005
Estimated Study Completion Date: January 2015
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  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 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
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: NCT00099437

  Show 80 Study Locations
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Faslodex Medical Science Director, MD AstraZeneca
  More Information

Additional Information:
No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00099437     History of Changes
Other Study ID Numbers: D6997C00002
Study First Received: December 13, 2004
Results First Received: February 23, 2010
Last Updated: August 29, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by AstraZeneca:
Advanced Breast Cancer
Metastatic Breast Cancer

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

ClinicalTrials.gov processed this record on October 23, 2014