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

AstraZeneca

Status and phase: Completed; Phase 2

Conditions: Metastatic Breast Cancer; Advanced Breast Cancer

Treatments: Drug: Fulvestrant

Study type: Interventional

Funder types: Industry

Identifiers

NCT00305448

FINDER I

D6997C00004

Details and patient eligibility

About

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.

Enrollment: 143 patients

Sex: Female

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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143 participants in 3 patient groups

1

Experimental group

Description:

Fulvestrant 250 mg intramuscular injection

Treatment:

Drug: Fulvestrant

Drug: Fulvestrant

2

Experimental group

Description:

Fulvestrant 250mg (Plus 250mg Loading Regimen)

Treatment:

Drug: Fulvestrant

Drug: Fulvestrant

3

Experimental group

Description:

Fulvestrant 500 mg

Treatment:

Drug: Fulvestrant

Drug: Fulvestrant