Effect of SBG in Patients With Breast Cancer
A Phase I/II Study to Assess the Effect of Soluble Beta-1,3/1,6-glucan in Combination With Standard Therapy in Patients With Breast Cancer
1 other identifier
interventional
11
1 country
2
Brief Summary
This study is set up to determine whether soluble beta-glucan (SBG) has
- unfavourable side effects
- beneficial treatment effects when given in combination with standard antibody and chemotherapy to patients with breast cancer.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1 breast-cancer
Started Jan 2007
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2007
CompletedFirst Submitted
Initial submission to the registry
September 20, 2007
CompletedFirst Posted
Study publicly available on registry
September 21, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2010
CompletedFebruary 18, 2010
February 1, 2010
2.6 years
September 20, 2007
February 17, 2010
Conditions
Outcome Measures
Primary Outcomes (1)
Asess the safety of SBG in combination with standard antibody and chemotherapy treatment
21 weeks
Interventions
Oral administration, three dose levels, administered day 1-8 in each 3-weeks treatment cycle, 4 treatments cycles.
Eligibility Criteria
You may qualify if:
- Women with histologically/cytologically confirmed locally advanced or metastatic breast cancer
- Primary tumor or metastases are HER2-ICH3+ or FISH+
- Measurable or non-measurable disease
- The patients must not have received treatment with the combination trastuzumab and vinorelbine previously
- Expected lifetime of more than 12 weeks
- Age ≥ 18 years
- Performance status ≤ 2 according to World Health Organization (WHO) scale
- The patient must be able to comply with the protocol
- Verbal and written informed consent
You may not qualify if:
- Women who are pregnant or breast-feeding. A negative pregnancy test must be provided during the screening period for fertile women. Fertile women must use effective contraceptive methods
- Clinical symptoms indicating central nervous system involvement
- Other current or former malignant disease, with the exception of adequately treated and cured carcinoma in situ cervicis uteri and basocellular skin carcinomas
- Left ventricular ejection fraction (LVEF) \< 50% of normal range
- 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
- 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.
- Reduced renal function defined by serum creatinine \> 2 x upper normal limit
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Ålesund Hospital
Ålesund, 6026, Norway
Ullevål University Hospital
Oslo, 0407, Norway
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Erik Wist, MD, PhD
Ullevaal University Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
September 20, 2007
First Posted
September 21, 2007
Study Start
January 1, 2007
Primary Completion
August 1, 2009
Study Completion
January 1, 2010
Last Updated
February 18, 2010
Record last verified: 2010-02