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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 Nov 5, 2026, 12:07 AM EST

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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
Aug 2002 (Type not available)
Primary completion
Not listed
Completion
Aug 2005 (Actual)
Last update posted
Jan 23, 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 23, 2008 · Synced Nov 5, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT00046371 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →