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

Breast Neoplasms Clinical Trial

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®

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00046371
• Other study ID #: STn-BR-105
• Status: Completed
• Phase: Phase 2
• First received: September 27, 2002
• Last updated: January 22, 2008
• Start date: August 2002
• Est. completion date: August 2005

Study information

• Verified date: January 2008
• Source: Oncothyreon Canada Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: August 2005
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Neoplasms

Intervention

Drug:
• THERATOPE® vaccine

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Oncothyreon Canada Inc.

Country where clinical trial is conducted

United States,