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

AstraZeneca logo

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)

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

Trial contacts and locations

32

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Data sourced from clinicaltrials.gov

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