Effect of SBG in Patients With Breast Cancer

February 17, 2010 updated by: Biotec Pharmacon ASA

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.

Study Overview

Status

Completed

Conditions

Breast Cancer

Intervention / Treatment

Drug: SBG (Soluble beta-glucan)

Study Type

Interventional

Enrollment (Actual)

Phase

Phase 2
Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Norway
- - Oslo, Norway, 0407
    - Ullevål University Hospital
  - Ålesund, Norway, 6026
    - Ålesund Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

Female

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: N/A
Interventional Model: Single Group Assignment
Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Asess the safety of SBG in combination with standard antibody and chemotherapy treatment Time Frame: 21 weeks	21 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Biotec Pharmacon ASA

Investigators

Principal Investigator: Erik Wist, MD, PhD, Ullevaal University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2007

Primary Completion (Actual)

August 1, 2009

Study Completion (Actual)

January 1, 2010

Study Registration Dates

First Submitted

September 20, 2007

First Submitted That Met QC Criteria