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

AstraZeneca144 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

144

Conditions

Advanced Breast Cancer Metastatic Breast Cancer

Interventions

FulvestrantDRUG

intramuscular injection 250 mg \& 500 mg

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 (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.

Locations (34)

Research Site

Outcomes

Primary Outcomes

Objective Response (ORR)

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).

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.

Secondary Outcomes

Time to Progression (TTP)

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.

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.

Duration of Response (DoR)

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.

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.

Clinical Benefit Rate (CBR)

CBR was defined as the proportion of all randomised patients who had clinical benefit (response of CR, PR or SD\>=24 weeks.

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.

Pharmacokinetic Parameter: Mean Population Clearance, a Measure of the Efficiency With Which Fulvestrant is Eliminated From the Body

Data from ClinicalTrials.gov

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