EUCTR2011-004822-85-AT
Active, not recruiting
Phase 1
A prospective, open, randomized, phase-II study of a therapeutic cancer vaccine (L-BLP25, Stimuvax®) in the pre-operative treatment of women with primary breast cancer - ABCSG-34
ABCSG (Austrian Breast & Colorectal Cancer Study Group)0 sitesNovember 30, 2011
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- primary breast cancer
- Sponsor
- ABCSG (Austrian Breast & Colorectal Cancer Study Group)
- Status
- Active, not recruiting
- Last Updated
- 8 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Pre\- and postmenopausal female patients with core\-biopsied, early primary invasive breast cancer of any clinical and/or radiological tumor stage (except T4d, inflammatory breast cancer) scheduled to receive pre\-operative therapy.
- •One core from the biopsy will be dedicated to analyses of a validated gene expression array
- •Patients must fulfill the following criteria:
- •\-Postmenopausal AND E\+\+\+ or \[E\+\+ and ki67\<14%] AND G 1,2,X AND scheduled for endocrine therapy as standard of care (34 A)
- •\-Triple negative OR E\- OR E\+ OR \[E\+\+ and ki67\>14%] OR G3 OR premenopausal status AND scheduled for anthracyclin\-taxan\-based chemotherapy as institutional standard of care (34 B)
- •\*Note: for ki67 status determination any antibody can be used; scores for determination of E/PR receptor status according to institutional standard
- •No distant metastasis (M0\) or secondary carcinoma as assessed clinically and radiologically (X\-Ray or CT or MRI or PET) within 3 months prior randomization
- •Age \= 18
- •WHO performance status 0 or 1
- •No prior chemotherapy, radiotherapy, or endocrine therapy for invasive breast cancer
Exclusion Criteria
- •HER2 overexpression (\+\+\+)
- •Past or current history of other neoplasms in the last 5 years, except basal cell cancer of the skin, non\-melanoma skin cancer and in situ cancer of the cervix
- •Any medical condition rendering the patient unfit for standard of care pre\-operative therapy (chemotherapy or endocrine therapy in the respective SoC treatment group)
- •Concurrent or prior systemic antitumor therapy \< 5 years
- •Patients scheduled for any chemotherapy other than EC\-\>T or T\-\>EC
- •Clinically significant cardiovascular disease (including unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) \< 1 year before randomization
- •Known autoimmune disease (e.g. rheumatoid arthritis, systemic lupus erythematosus, ulcerative colitis, Crohn´s disease, multiple sclerosis, ankylosing spondylitis)
- •Severely compromised haematopoietic function
- •Known immunodeficiency disease (cellular immunodeficiency, hypogammaglobulinaemia, dysgamaglobulinaemia)
- •Known positive test(s) for human immunodeficiency virus (HIV) infection, hepatitis C virus, acute or chronic active hepatitis B infection
Outcomes
Primary Outcomes
Not specified
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