Phase III Study of Atamestane Plus Toremifene Versus Letrozole in Advanced Breast Cancer
Recruiting in Palo Alto (17 mi)
+62 other locations
Age: 18+
Sex: Female
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Waitlist Available
Sponsor: Intarcia Therapeutics
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 determine whether the first line combination hormonal therapy of an experimental drug, atamestane, plus an FDA-approved drug, toremifene (Fareston®), is more effective than another approved drug, letrozole (Femara®), in delaying the growth of breast cancer in postmenopausal patients with locally advanced or metastatic breast cancer, and whether the side effects of the combination are different from the side effects of letrozole.
Research Team
PG
Paul Goss, M.D.
Principal Investigator
Princess Margaret Hospital, Canada
Eligibility Criteria
Inclusion Criteria
ECOG performance status of 0, 1 or 2 or Karnofsky performance status of 60 or higher
Women age 18 years or older
Pathological or histological confirmation of breast cancer at initial diagnosis or at the time of metastases
See 6 more
Treatment Details
Interventions
- Atamestane (Aromatase Inhibitor)
- Letrozole (Aromatase Inhibitor)
- Toremifene (SERM)
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: Atamestane + toremifeneExperimental Treatment6 Interventions
Group II: Letrozole + placeboActive Control4 Interventions
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Georgia Cancer SpecialistsTucker, GA
Oncology ConsultantsHouston, TX
California Cancer Care, Inc.Greenbrae, CA
Great Falls Clinic-Oncology WestGreat Falls, MT
More Trial Locations
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Who Is Running the Clinical Trial?
Intarcia Therapeutics
Lead Sponsor
Trials
21
Patients Recruited
8,100+