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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®


Phase 2
18 Years
N/A
Not Enrolling
Female
Breast Neoplasms

Thank you

Trial Information

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®

Inclusion Criteria


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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Authority:

United States: Food and Drug Administration

Study ID:

STn-BR-105

NCT ID:

NCT00046371

Start Date:

August 2002

Completion Date:

August 2005

Related Keywords:

  • Breast Neoplasms
  • Cancer Vaccines
  • Aromatase
  • Receptors, Estrogen
  • Receptors, Progesterone
  • Breast Neoplasms
  • Neoplasms

Name

Location

Hinsdale, Illinois  60521
Bettendorf, Iowa  52722
Great Falls, Montana  59405
Fountain Valley, California  92708
Miami, Florida  33176
Cleveland, Ohio  44195
Austin, Texas  78705
McLean, Virginia  22101
Hackensack, New Jersey  07601
Charlotte, North Carolina