Global Study Comparing Fulvestrant and Arimidex for Certain Breast Cancer Patients

Sponsor: AstraZeneca

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT01602380

Provider View

This study is comparing two treatments, Fulvestrant (FASLODEX) and Anastrozole (ARIMIDEX), to see how they affect the progression of breast cancer in women who have not received hormonal treatment before.

Patient Parameters

Program Overview

The study aims to find out how effective Fulvestrant (FASLODEX) and Anastrozole (ARIMIDEX) are in slowing down the progression of breast cancer in postmenopausal women with locally advanced or metastatic breast cancer. These women have not been treated with hormonal therapy before.

Description

This is a Phase III clinical trial where participants are randomly assigned to receive either Fulvestrant or Anastrozole. The study is double-blind, meaning neither the participants nor the researchers know who is receiving which treatment. It is being conducted at multiple centers and focuses on postmenopausal women with hormone receptor-positive breast cancer that is either locally advanced or has spread to other parts of the body. The goal is to compare how well each treatment works and how tolerable they are for the patients.

Eligibility Criteria

Inclusion Criteria

  • Women who have been diagnosed with breast cancer and are postmenopausal (age 60 or older).
  • The cancer must have hormone receptors (ER positive and/or PgR positive).
  • The cancer is either locally advanced or has spread to other parts of the body (metastatic).
  • Patients may have had one line of chemotherapy if the cancer has progressed further.
  • At least one tumor that can be measured and assessed over time.
  • Postmenopausal status confirmed by:
    • Having had both ovaries removed.
    • Being over 60 years old.
    • Being under 60 but not having periods for over a year without certain treatments, and having hormone levels in the postmenopausal range.

Exclusion Criteria

  • Having life-threatening cancer that has spread.
  • Cancer that has spread extensively to the liver, brain, or meninges, or causing severe lung symptoms.
  • Lung metastases are allowed if they do not severely affect breathing.
  • Previous systemic therapy for breast cancer, except for one line of chemotherapy completed over 28 days before joining the study.
  • Recent radiation therapy unless it was completed over 28 days before joining the study, except for bone pain control.
  • Previous hormonal treatment for breast cancer.
  • Any other cancer within the last 3 years, except for certain skin cancers or cervical cancer that has been treated.

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