Fulvestrant (FASLODEX™) as a Treatment in Postmenopausal Women With Estrogen Receptor Positive Breast Cancer

AstraZeneca

Status and phase: Completed; Phase 2

Conditions: Breast Cancer

Treatments: Drug: Fulvestrant

Study type: Interventional

Funder types: Industry

Identifiers

NCT00093002

9238IL/0065

D6997C00003

Details and patient eligibility

About

The purpose of this study is to evaluate fulvestrant in the preliminary stage of breast cancer treatment and assess the relationship between dose, exposure, degree of reduction in tumor markers, and efficacy in postmenopausal women with estrogen receptor positive disease.

Enrollment: 179 patients

Sex: Female

Volunteers: No Healthy Volunteers

Inclusion criteria

• Postmenopausal women defined as women who have stopped having menstrual periods
• Written informed consent to participate in the trial
• Biopsy confirmation of invasive breast cancer
• Evidence of hormone sensitivity
• Willingness to undergo biopsies

Exclusion criteria

• Any previous treatment for breast cancer
• Unwillingness to stop taking any drug known to affect sex hormonal status or a patient in which it would be inappropriate to stop.
• Any severe concurrent condition that would preclude surgery or that would jeopardize compliance with the study, e.g., uncontrolled cardiac disease or uncontrolled diabetes mellitus
• The presence of more than one primary tumor
• History of hypersensitivity to castor oil
• History of known bleeding disorders

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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179 participants in 2 patient groups

1

Experimental group

Description:

250 mg fulvestrant

Treatment:

Drug: Fulvestrant

2

Experimental group

Description:

500 mg fulvestrant

Treatment:

Drug: Fulvestrant