Effect of SBG in Patients With Breast Cancer

Biotec Pharmacon

Status and phase

Completed

Phase 2

Phase 1

Conditions

Breast Cancer

Treatments

Drug: SBG (Soluble beta-glucan)

Study type

Interventional

Funder types

Industry

Identifiers

SBG-2-01

Details and patient eligibility

About

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.

Enrollment

11 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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