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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)

AstraZeneca logo

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

104

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Data sourced from clinicaltrials.gov

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