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

AstraZeneca

Status and phase: Completed; Phase 2

Conditions: Metastatic Breast Cancer; Advanced Breast Cancer

Treatments: Drug: Fulvestrant

Study type: Interventional

Funder types: Industry

Identifiers

NCT00313170

D6997C00006

FINDER II

Details and patient eligibility

About

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

Enrollment: 144 patients

Sex: Female

Ages: 45 to 130 years old

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 (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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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144 participants in 3 patient groups

1

Experimental group

Description:

Fulvestrant 250 mg (intramuscular injection 250 mg)

Treatment:

Drug: Fulvestrant

2

Experimental group

Description:

Fulvestrant 250 mg (+ 250 mg loading regimen)

Treatment:

Drug: Fulvestrant

3

Experimental group

Description:

Fulvestrant 500 mg (intramuscular injection 500 mg)

Treatment:

Drug: Fulvestrant