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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®
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.
Age
18 - No limit years
Sex
FEMALE
Healthy Volunteers
No
Berkeley, California, United States
San Francisco, California, United States
Santa Monica, California, United States
Jacksonville, Florida, United States
Plantation, Florida, United States
Port Saint Lucie, Florida, United States
Chicago, Illinois, United States
Des Moines, Iowa, United States
Billings, Montana, United States
Morristown, New Jersey, United States
Start Date
August 1, 2002
Completion Date
August 1, 2005
Last Updated
January 23, 2008
THERATOPE® vaccine
DRUG
Lead Sponsor
Oncothyreon Canada Inc.
NCT07191730
NCT06797635
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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