Spots Global Cancer Trial Database for Safety and Immunological Response Rate Study of THERATOPE® Vaccine in Metastatic Breast Cancer Patients

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Trial Identification

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

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®

Study ID: NCT00046371

Conditions

Breast Neoplasms

Interventions

THERATOPE® vaccine

Study Description

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 (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.

Detailed Description: