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Completed Phase 2 Interventional

Safety and Immunological Response Rate Study of THERATOPE® Vaccine in Metastatic Breast Cancer Patients

ClinicalTrials.gov ID: NCT00046371

Public ClinicalTrials.gov record NCT00046371. 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 18, 2026, 11:17 AM EDT

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

Official title

Open-Label, Phase II Trial of Immunological Response Rate, Safety, and Tolerability of THERATOPE® Vaccine in Subjects With Metastatic Breast Cancer Undergoing Treatment With Aromatase Inhibitors or Faslodex®

Brief summary

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

The purpose of this study is to examine the immunological response rate to administration of the THERATOPE® vaccine in women with stable metastatic breast cancer who are being treated with aromatase inhibitors or Faslodex® and who do not require chemotherapy. Post-menopausal women on aromatase inhibitors or Faslodex® alone and pre-menopausal women on aromatase inhibitors plus luteinising hormone-releasing hormone (LH/RH)-agonist may be eligible to be enrolled. Patients must not have had radiotherapy or major surgery within four (4) weeks prior to entering the study. Information about the safety and tolerability of administration of the THERATOPE® vaccine will also be gathered during the course of the study.

Study identification

NCT ID
NCT00046371
Recruitment status
Completed
Study type
Interventional
Phase
Phase 2
Lead sponsor
Oncothyreon Canada Inc.
Industry
Enrollment
Not listed

Conditions and interventions

Interventions

Drug

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
Jul 31, 2002
Primary completion
Not listed
Completion
Jul 31, 2005
Last update posted
Jan 22, 2008

2002 – 2005

United States locations

U.S. sites
17
U.S. states
10
U.S. cities
17
Facility City State ZIP Site status
Not listed Berkeley California
Not listed San Francisco California
Not listed Santa Monica California
Not listed Jacksonville Florida
Not listed Plantation Florida
Not listed Port Saint Lucie Florida
Not listed Chicago Illinois
Not listed Des Moines Iowa
Not listed Billings Montana
Not listed Morristown New Jersey
Not listed Gastonia North Carolina
Not listed Hickory North Carolina
Not listed Cincinnati Ohio
Not listed Columbus Ohio
Not listed Houston Texas
Not listed Norfolk Virginia
Not listed Richmond Virginia

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

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00046371, 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 Jan 22, 2008 · Synced Sep 18, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT00046371 live on ClinicalTrials.gov.

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