Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
11 participants
INTERVENTIONAL
2007-01-31
2010-01-31
Brief Summary
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* unfavourable side effects
* beneficial treatment effects when given in combination with standard antibody and chemotherapy to patients with breast cancer.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Interventions
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SBG (Soluble beta-glucan)
Oral administration, three dose levels, administered day 1-8 in each 3-weeks treatment cycle, 4 treatments cycles.
Eligibility Criteria
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Inclusion Criteria
2. Primary tumor or metastases are HER2-ICH3+ or FISH+
3. Measurable or non-measurable disease
4. The patients must not have received treatment with the combination trastuzumab and vinorelbine previously
5. Expected lifetime of more than 12 weeks
6. Age ≥ 18 years
7. Performance status ≤ 2 according to World Health Organization (WHO) scale
8. The patient must be able to comply with the protocol
9. Verbal and written informed consent
Exclusion Criteria
2. Clinical symptoms indicating central nervous system involvement
3. Other current or former malignant disease, with the exception of adequately treated and cured carcinoma in situ cervicis uteri and basocellular skin carcinomas
4. Left ventricular ejection fraction (LVEF) \< 50% of normal range
5. Reduced bone marrow function defined by leukocyte counts \< 3.0 x 109/l and neutrophil counts \< 1.5 x 109/l, or thrombocyte counts ≤ 100 x 109/l
6. Reduced liver function defined by bilirubin \> 3 x upper normal limit and/or ASAT/ALAT \> 3 x upper normal limit and/or alkaline phosphatase \> 3 x upper normal limit.
7. Reduced renal function defined by serum creatinine \> 2 x upper normal limit
18 Years
FEMALE
No
Sponsors
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Biotec Pharmacon ASA
INDUSTRY
Responsible Party
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Biotec Pharmacon ASA
Principal Investigators
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Erik Wist, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Ullevaal University Hospital
Locations
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Ålesund Hospital
Ålesund, , Norway
Ullevål University Hospital
Oslo, , Norway
Countries
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Other Identifiers
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SBG-2-01
Identifier Type: -
Identifier Source: org_study_id
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