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Effect of SBG in Patients With Breast Cancer

This study has been completed.
Sponsor:
Information provided by:
Biotec Pharmacon ASA
ClinicalTrials.gov Identifier:
NCT00533364
First received: September 20, 2007
Last updated: February 17, 2010
Last verified: February 2010
History of Changes
  Purpose

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 Intervention Phase
Breast Cancer
 Drug: SBG (Soluble beta-glucan)
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Biotec Pharmacon ASA:

Primary Outcome Measures:
  • Asess the safety of SBG in combination with standard antibody and chemotherapy treatment [ Time Frame: 21 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 11
Study Start Date: January 2007
Study Completion Date: January 2010
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: VP Clinical Development, Biotec Pharmacon ASA
ClinicalTrials.gov Identifier: NCT00533364     History of Changes
Other Study ID Numbers: SBG-2-01
Study First Received: September 20, 2007
Last Updated: February 17, 2010
Health Authority: Norway: Norwegian Medicines Agency

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

ClinicalTrials.gov processed this record on May 21, 2013