Effect of SBG in Patients With Breast Cancer

Breast Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00533364
• Other study ID #: SBG-2-01
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: September 20, 2007
• Last updated: February 17, 2010
• Start date: January 2007
• Est. completion date: January 2010

Study information

• Verified date: February 2010
• Source: Biotec Pharmacon ASA
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway: Norwegian Medicines Agency
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: January 2010
• Est. primary completion date: August 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

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

Locations

Country	Name	City	State
Norway	Ålesund Hospital	Ålesund
Norway	Ullevål University Hospital	Oslo

Sponsors (1)

Lead Sponsor	Collaborator
Biotec Pharmacon ASA

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Asess the safety of SBG in combination with standard antibody and chemotherapy treatment		21 weeks	Yes