MedTrace Logo

Treatment and Survival Continuation Study of Atamestane Plus Toremifene vs Letrozole in Advanced Breast Cancer

NCT00267553 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2007-09-10

No results posted yet for this study

Summary

Protocol 777-CLP-32 is the treatment and survival continuation protocol of Biomed 777-CLP-29, and will continue to compare combined hormonal therapy using the experimental aromatase inhibitor (AI) atamestane combined with the FDA-approved anti-estrogen toremifene (Fareston®), to the single agent FDA-approved aromatase inhibitor letrozole (Femara®) for the treatment of advanced breast cancer. The purpose of this study is to determine whether maximal estrogen suppression achieved via the combination of atamestane, plus toremifene (Fareston®), is more effective than letrozole (Femara®) in delaying the growth of breast cancer.

Conditions

  • Breast Neoplasms
  • Neoplasms, Hormone-Dependent

Interventions

DRUG

Atamestane

DRUG

toremifene

DRUG

letrozole

Sponsors & Collaborators

  • Intarcia Therapeutics

    lead INDUSTRY

Principal Investigators

  • Peter Langecker, MD, PhD · Intarcia Therapeutics

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-11-30
Completion
2006-06-30

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 NCT00267553 on ClinicalTrials.gov