The Evaluation of the Efficacy and Tolerability of FASLODEX (Fulvestrant) and AROMASIN (Exemestane) in Hormone Receptor Positive Postmenopausal Women With Advanced Breast Cancer
(EFECT Trial)
Recruiting in Palo Alto (17 mi)
+116 other locations
Age: 18+
Sex: Female
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Waitlist Available
Sponsor: AstraZeneca
No Placebo Group
Pivotal Trial (Near Approval)
Prior Safety Data
Trial Summary
What is the purpose of this trial?
The purpose of this study is to compare the efficacy of Faslodex (fulvestrant) to Aromasin (exemestane) in hormone receptor positive postmenopausal women with advanced breast cancer. Patients will be treated until disease progression or until the investigator has determined that treatment is not in the best interest of the patient, whichever occurs first.
Eligibility Criteria
Inclusion Criteria
Biopsy confirmation of Breast Cancer
Breast Cancer has continued to grow after having received treatment with an aromatase inhibitor Postmenopausal women defined as a women who has stopped having menstrual periods
Evidence of hormone sensitivity
See 1 more
Treatment Details
Interventions
- Exemestane (Hormone Therapy)
- Fulvestrant (Hormone Therapy)
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: 2Experimental Treatment1 Intervention
Fulvestrant
Group II: 1Active Control1 Intervention
Exemestane
Exemestane is already approved in European Union, United States, Canada, Japan for the following indications:
🇪🇺 Approved in European Union as Aromasin for:
- Early breast cancer
- Advanced breast cancer
🇺🇸 Approved in United States as Aromasin for:
- Early breast cancer
- Advanced breast cancer
🇨🇦 Approved in Canada as Aromasin for:
- Early breast cancer
- Advanced breast cancer
🇯🇵 Approved in Japan as Aromasin for:
- Early breast cancer
- Advanced breast cancer
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Research SiteCanton, OH
Research SiteSan Antonio, TX
Research SiteRichmond, VA
Research SiteHouston, TX
More Trial Locations
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Who Is Running the Clinical Trial?
AstraZenecaLead Sponsor