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Effect of SBG in Patients With Breast Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00533364
Recruitment Status : Completed
First Posted : September 21, 2007
Last Update Posted : February 18, 2010
Sponsor:
Information provided by:

Study Description
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.

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: SBG (Soluble beta-glucan) Phase 1 Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 11 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : January 2007
Primary Completion Date : August 2009
Study Completion Date : January 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
U.S. FDA Resources

Arms and Interventions

Intervention Details:
    Drug: SBG (Soluble beta-glucan)
    Oral administration, three dose levels, administered day 1-8 in each 3-weeks treatment cycle, 4 treatments cycles.

Outcome Measures

Primary Outcome Measures :
  1. Asess the safety of SBG in combination with standard antibody and chemotherapy treatment [ Time Frame: 21 weeks ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Women with histologically/cytologically confirmed locally advanced or metastatic breast cancer
  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:

  1. 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
  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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00533364


Locations
Norway
Ullevål University Hospital
Oslo, Norway, 0407
Ålesund Hospital
Ålesund, Norway, 6026
Sponsors and Collaborators
Biotec Pharmacon ASA
Investigators
Principal Investigator: Erik Wist, MD, PhD Ullevaal University Hospital
More Information

Responsible Party: VP Clinical Development, Biotec Pharmacon ASA
ClinicalTrials.gov Identifier: NCT00533364     History of Changes
Other Study ID Numbers: SBG-2-01
First Posted: September 21, 2007    Key Record Dates
Last Update Posted: February 18, 2010
Last Verified: February 2010

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases