MedTrace Logo

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

NCT00044291 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 865

Last updated 2015-07-31

No results posted yet for this study

Summary

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.

Conditions

  • Breast Neoplasms
  • Neoplasms, Hormone-dependent

Interventions

DRUG

atamestane

DRUG

toremifene

DRUG

letrozole

DRUG

aromatase inhibition

PROCEDURE

hormone therapy

PROCEDURE

endocrine therapy

PROCEDURE

antiestrogen therapy

Sponsors & Collaborators

  • Intarcia Therapeutics

    lead INDUSTRY

Principal Investigators

  • Paul Goss, M.D. · Princess Margaret Hospital, Canada

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2002-06-30
Primary Completion
2006-01-31
Completion
2006-01-31

Countries

  • United States
  • Canada
  • Russia
  • Ukraine

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00044291 on ClinicalTrials.gov