Ignite Creation Date:
2024-05-05 @ 11:27 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00046371
Status:
COMPLETED
Last Update Posted:
2008-01-23
First Post:
2002-09-27
Brief Title:
Safety and Immunological Response Rate Study of THERATOPE Vaccine in Metastatic Breast Cancer Patients
Sponsor:
Oncothyreon Canada Inc
Organization:
Oncothyreon Canada Inc
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2008-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 LHRH-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
Post-menopausal women on aromatase inhibitors or Faslodex alone and pre-menopausal women on aromatase inhibitors plus luteinising hormone-releasing hormone LHRH-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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None