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| Sponsor: | Oncothyreon Canada Inc. |
|---|---|
| Information provided by: | Oncothyreon Canada Inc. |
| ClinicalTrials.gov Identifier: | NCT00046371 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Breast Neoplasms |
Drug: THERATOPE® vaccine |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment |
| 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® |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria
Exclusion Criteria
Contacts and Locations| United States, California | |
| Berkeley, California, United States | |
| San Francisco, California, United States | |
| Santa Monica, California, United States | |
| United States, Florida | |
| Plantation, Florida, United States | |
| Port St. Lucie, Florida, United States | |
| Jacksonville, Florida, United States | |
| United States, Illinois | |
| Chicago, Illinois, United States | |
| United States, Iowa | |
| Des Moines, Iowa, United States | |
| United States, Montana | |
| Billings, Montana, United States | |
| United States, New Jersey | |
| Morristown, New Jersey, United States | |
| United States, North Carolina | |
| Gastonia, North Carolina, United States | |
| Hickory, North Carolina, United States | |
| United States, Ohio | |
| Columbus, Ohio, United States | |
| Cincinnati, Ohio, United States | |
| United States, Texas | |
| Houston, Texas, United States | |
| United States, Virginia | |
| Richmond, Virginia, United States | |
| Norfolk, Virginia, United States | |
More Information
| Study ID Numbers: | STn-BR-105 |
| Study First Received: | September 27, 2002 |
| Last Updated: | January 22, 2008 |
| ClinicalTrials.gov Identifier: | NCT00046371 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Cancer Vaccines Aromatase Receptors, Estrogen Receptors, Progesterone |
|
Neoplasms Neoplasms by Site Skin Diseases Breast Neoplasms Breast Diseases |