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

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.

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Key information

Conditions

Breast Neoplasms Breast Diseases Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Berkeley, California, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Histopathologically confirmed breast cancer
Documented Stage IV disease
Estrogen and/or progesterone-receptor positive
Stable disease on aromatase inhibitor or Faslodex® treatment begun at least 12 weeks prior to enrolment
Performance status, ECOG = 0 or 1
Life expectancy > 12 weeks
History of freedom from progression for at least 6 months following surgery with a curative intent or for at least 6 months during adjuvant chemotherapy, adjuvant radiotherapy or adjuvant hormonal therapy such as tamoxifen/toremifene treatment
No radiotherapy or major surgery within 4 weeks prior to enrolment

Exclusion criteria

Pregnant or lactating
Known brain metastasis
Bone marrow involvement as the only site of metastasis
First line chemotherapy for Stage IV disease
Past or current cancer other than breast cancer, except for curatively treated basal cell cancer or in situ cancer of the cervix with no evidence of disease
Autoimmune disease, e. g., type I juvenile onset diabetes mellitus, antibody positive rheumatoid arthritis, Grave's disease, lupus, Crohn's disease, IBD, Hashimoto's thyroiditis
Known intercurrent infections (including HBV or HCV) or immunosuppression [human immunodeficiency virus (HIV) or other conditions] or clinical evidence of these conditions
Other significant active infection
Pleural effusions and/or ascites requiring paracentesis every 2 weeks or more frequently
Splenectomy
Concurrent treatment with chemotherapeutic agents other than low-dose cyclophosphamide used in this study
Treatment with interferons (IFNs), cytokines, systemic steroids or other biologicals within 4 weeks prior to enrolment
Receipt of another investigational drug within 30 days of enrolment
Known allergy to shellfish
Known allergy to soy beans or soy products
Known hypersensitivity to polysorbate 80
Known hypersensitivity to the study drugs
Legal incapacity or limited legal capacity

Treatment and study plan

THERATOPE® vaccine

Drug

Sponsors and collaborators

Lead sponsor

Oncothyreon Canada Inc.

Industry

Registry information

Official study 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®

Important dates

Study start: 2002
Study completion: 2005
First posted: Oct 10, 2002
Registry last updated: Jan 23, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed