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. - Full Text View

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:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

Drug Information available for: Fulvestrant

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

Time to Progression (TTP) [ Time Frame: RECIST 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)
Time to Deterioration in Trial Outcome Index (TOI) [ 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 ]
Median time (in months) from randomisation until deterioration in TOI (defined as the first visit response of 'worsened') using the Kaplan-Meier method. Trial Outcome Index (TOI) is derived from the FACT-B questionnaire. Data were collected from a subgroup of patients.

Enrollment:	834
Study Start Date:	February 2005
Estimated Study Completion Date:	September 2013
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

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00099437

Show 89 Study Locations

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director:

Faslodex Medical Science Director, MD

AstraZeneca

More 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 14, 2012
Health Authority:	United States: Food and Drug Administration

Keywords provided by AstraZeneca:

Advanced Breast Cancer
Metastatic Breast Cancer

Additional relevant MeSH terms:

Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Estrogens
Estradiol
Fulvestrant
Hormones

Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Estrogen Antagonists
Estrogen Receptor Modulators
Hormone Antagonists
Antineoplastic Agents, Hormonal

ClinicalTrials.gov processed this record on June 18, 2013

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)