For Healthcare Professionals

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.

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About the study

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.
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Who can take part

You may be eligible to participate in the study if you meet the following criteria:

INCLUSION CRITERIA

Inclusion Criteria:


  1. Breast Cancer has continued to grow after having received treatment with an anti-estrogen hormonal treatment such as tamoxifen or an aromatase inhibitor
  2. Requiring hormonal treatment
  3. Postmenopausal women defined as a woman who has stopped having menstrual periods
  4. Evidence of positive estrogen receptor hormone sensitivity
  5. Written informed consent to participate in the trial

EXCLUSION CRITERIA

Exclusion Criteria:


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

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Study Locations

Enter your ZIP code/Postal code/PIN code to locate study sites near you:

How to Apply


Contact the study center to learn if this study is a good match for you.

Study’s details


Contition

Breast Cancer

Age (in years)

45 - 130

Phase

Phase 3

Participants needed

736

Est. Completion Date

Mar 29, 2024

Treatment type

Interventional


Sponsor

AstraZeneca

ClinicalTrials.gov identifier

NCT00099437

Study number

9238IL/0064

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