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Completed Phase 3 Interventional

Phase III Study of Atamestane Plus Toremifene Versus Letrozole in Advanced Breast Cancer

ClinicalTrials.gov ID: NCT00044291

Public ClinicalTrials.gov record NCT00044291. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 3, 2026, 8:55 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT00044291
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Intarcia Therapeutics
Industry
Enrollment
865 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years and older
Sex
Female
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
May 31, 2002
Primary completion
Dec 31, 2005
Completion
Dec 31, 2005
Last update posted
Jul 30, 2015

2002 – 2006

United States locations

U.S. sites
17
U.S. states
14
U.S. cities
17
Facility City State ZIP Site status
Midwest Internal Medicine, PLLC Lake Havasu City Arizona 86403
Arizona Clinical Research Center Tucson Arizona 85712
California Cancer Care, Inc. Greenbrae California 94904-2007
Sharp Memorial Hospital San Diego California 92123
Innovative Medical Research of South Florida Inc. Miami Shores Florida 33138
Georgia Cancer Specialists Tucker Georgia 30084
Maryland Hematology/Oncology Associates Baltimore Maryland 21236
Oncology Care Associates, PLLC Saint Joseph Michigan 49085
Kansas City Oncology and Hematology Group Kansas City Missouri 64131
Great Falls Clinic-Oncology West Great Falls Montana 59405
Slocum-Dickson Medical Group New Hartford New York 13413
Hematology Oncology Consultants, Inc. Columbus Ohio 43235
Oncology Consultants Houston Texas 77024
First Dynamic Healthcare Services, Inc. Killeen Texas 76710
Cache Valley Cancer Treatment & Research Clinic Logan Utah 84341
Virginia Oncology Associates Norfolk Virginia 23502
Western Washington Oncology Inc., P.S. Olympia Washington 98502

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 46 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00044291, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jul 30, 2015 · Synced Sep 3, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT00044291 live on ClinicalTrials.gov.

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