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

AstraZeneca143 enrolled

Overview

This study will assess the relationship between fulvestrant dose and efficacy, and determine the dosing regimen as a second line therapy for Japanese postmenopausal women with oestrogen receptor positive advanced breast cancer.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

143

Conditions

Advanced Breast Cancer Metastatic Breast Cancer

Interventions

FulvestrantDRUG

250 intramuscular injection

FulvestrantDRUG

500 mg intramuscular injection

Eligibility

Sex: FEMALE

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 Exclusion Criteria: * Treatment with more than one previous regimen of systemic anticancer therapy other than endocrine therapy for advanced breast cancer * Treatment with more than one previous regimen of endocrine therapy for advanced breast cancer * An existing serious disease, illness, or condition that will prevent participation or compliance with study procedures

Locations (35)

Research Site

Outcomes

Primary Outcomes

Objective Response Rate (ORR)

An objective response (OR) is defined as a patient having a best overall response of either complete response (CR) or partial response (PR). A patient has best overall response of CR if she had overall response of CR or PR on one visit and met the confirmation criteria per RECIST. ORR is defined as percentage of patients with objective response. Each patient with measurable disease at baseline was assessed for OR from the sequence of Response Evaluation Criteria in Solid Tumors (RECIST) scan data up to data cut-off. RECIST scans were performed every 12 weeks (+/- 2weeks) from randomization

Time frame: baseline and every 12 weeks (+/- 2weeks) from randomization data up to data cut-off (19th march 2008)

Secondary Outcomes

Time to Progression (TTP)

Time (in days) from randomization until objective disease progression or death (in the absence of objective progression). RECIST tumour assessments carried out every 12 weeks from randomization (+/- 2 weeks) until data cut-off on 19th March 2008.

Time frame: every 12 weeks from randomization (+/- 2 weeks) until data cut-off (19th march 2008)

Duration of Response (DoR)

Time from randomisation until objective progression or death (in the absence of objective progression), measured only in those patients who achieved a confirmed Complete Response or confirmed Partial Response.

Time frame: RECIST tumour assessments carried out every 12 weeks from randomisation (+/- 2 weeks) until data cut-off on19th March 2008.

Clinical Benefit Rate (CBR)

A Clinical Benefit (CB) responder is defined as a patient having a best overall response of Complete response (CR), Partial Response (PR) or Stable disease (SD) provided SD (or better) was present = 154 days from randomization (ie SD = 24 weeks with the 2 week RECIST assessment time window allowed). The Clinical Benefit Rate is the percentage of patients with CB.

Time frame: every 12 weeks(+/- 2 weeks) from randomization to data up to data cut-off, 19th March 2008.

Data from ClinicalTrials.gov

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