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.

Phase 3Active Not RecruitingNCT00099437

AstraZeneca736 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

736

Conditions

Breast Cancer

Interventions

FulvestrantDRUG

intramuscular injection

Eligibility

Sex: FEMALEMin age: 45 YearsMax age: 130 Years

Medical Language ↔ Plain English

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

Locations (106)

Outcomes

Primary Outcomes

Time to Progression (TTP)

Median time (in months) from randomisation until objective disease progression or death (in the absence of objective progression).

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)

Secondary Outcomes

Objective Response Rate (ORR)

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.

Time frame: RECIST tumour assessments carried out every 12 weeks (+/- 2 weeks) from randomisation for study duration (48 months)

Clinical Benefit Rate (CBR)

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.

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)

Duration of Response (DoR)

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)

Time frame: RECIST tumour assessments carried out every 12 weeks (+/- 2 weeks) from randomisation for study duration (48 months)

Duration of Clinical Benefit (DoCB)

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

Research Site

Casa Grande, Arizona, United States

Research Site

Fountain Valley, California, United States

Research Site

New Britain, Connecticut, United States

Research Site

Crystal River, Florida, United States

Research Site

Fort Lauderdale, Florida, United States

Research Site

Urbana, Illinois, United States

Research Site

Rosedale, Maryland, United States

Research Site

Detroit, Michigan, United States

Research Site

Kansas City, Missouri, United States

Research Site

St Louis, Missouri, United States

...and 96 more locations

Change From Randomisation in Trial Outcome Index (TOI) Over the Course of the Study

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.

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)