Breast CancerPhase 1/2NCT00533364
Effect of SBG in Patients With Breast Cancer
A Phase 1/2 study testing SBG (Soluble beta-glucan) in people with Breast Cancer, run by Biotec Pharmacon ASA at 2 sites in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- SBG (Soluble beta-glucan)
- Type of treatment
- Pill or oral medicine
- How many people
- 11 participants
- Where
- 2 sitesNorway
- Study dates
- Jan 2007to Jan 2010
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Norway2 sites
Ålesund Hospital
Ålesund, 6026
Ullevål University Hospital
Oslo, 0407
About this study
Official title: 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
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.
- Conditions
- Breast Cancer
- Being tested
- SBG (Soluble beta-glucan)
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SBG (Soluble beta-glucan)Drug
Oral administration, three dose levels, administered day 1-8 in each 3-weeks treatment cycle, 4 treatments cycles.
What is being measured
The primary outcome is the main question the study is designed to answer.
Asess the safety of SBG in combination with standard antibody and chemotherapy treatment
Measured: 21 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2007 (estimated)
- Study startJan 2007
- Primary completionAug 2009
- Study completionJan 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biotec Pharmacon ASA
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Erik Wist, MD, PhD, Principal investigator, Ullevaal University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00533364
- Sponsor's protocol ID
- SBG-2-01
- Status last verified
- Feb 2010
- First submitted
- 20 Sep 2007
- Last updated
- 18 Feb 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT00533364
- Acronym / sponsor ID
- SBG-2-01
- Conditions
- Breast Cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Biotec Pharmacon ASAIndustry (pharma, biotech, devices)
- Study start
- Jan 2007
- Primary completion
- Aug 2009 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 21 Sep 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SBG (Soluble beta-glucan)Oral administration, three dose levels, administered day 1-8 in each 3-weeks treatment cycle, 4 treatments cycles. | Drug | – |
Primary outcome
Asess the safety of SBG in combination with standard antibody and chemotherapy treatment
Time frame: 21 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Erik Wist, MD, PhD principal investigator
Ullevaal University Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing SBG (Soluble beta-glucan) in people with Breast Cancer, run by Biotec Pharmacon ASA at 2 sites in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Feb 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Asess the safety of SBG in combination with standard antibody and chemotherapy treatment (time frame: 21 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2010.