Comparison of Fulvestrant (FASLODEX™) 250 mg and 500 mg in Postmenopausal Women With Oestrogen Receptor Positive Advanced Breast Cancer Progressing or Relapsing After Previous Endocrine Therapy. (CONFIRM)

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AstraZeneca

Status and phase

Active, not recruiting
Phase 3

Conditions

Breast Cancer

Treatments

Drug: Fulvestrant

Study type

Interventional

Funder types

Industry

Identifiers

NCT00099437
2004-002371-16 (EudraCT Number)
D6997C00002

Details and patient eligibility

About

The purpose of this study is to evaluate the efficacy of a new dose of 500 mg Fulvestrant with the standard dose of 250 mg in postmenopausal women with oestrogen receptor positive advanced breast cancer who have failed on a previous endocrine treatment.

Enrollment

736 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 defined as a woman who has stopped having menstrual periods
  • Evidence of positive estrogen receptor hormone sensitivity
  • Written informed consent to participate in the trial

Exclusion criteria

  • Treatment with an investigational or non-approved drug within one month
  • An existing serious disease, illness, or condition that will prevent participation or compliance with study procedures
  • A history of allergies to any active or inactive ingredients of Faslodex (i.e. castor oil)
  • Treatment with more than one regimen of chemotherapy for advanced breast cancer
  • Treatment with more than one regimen of hormonal treatment for advanced breast cancer

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

736 participants in 2 patient groups

1
Experimental group
Description:
Fulvestrant 500 mg
Treatment:
Drug: Fulvestrant
2
Experimental group
Description:
Fulvestrant 250 mg
Treatment:
Drug: Fulvestrant

Trial contacts and locations

103

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Data sourced from clinicaltrials.gov

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