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
- Conditions
- Breast cancerMedDRA version: 8.1Level: LLTClassification code 10027475Term: Metastatic breast cancer
- Registration Number
- EUCTR2006-003620-11-NO
- Lead Sponsor
- Biotec Pharmacon ASA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- Not specified
1. Women with locally advanced or metastatic breast cancer
2. Primary tumor or metastases are HER2-ICH3+ or FISH+
3. Have not received Herceptin or Vinorelbine treatment previously
4. Expected lifetime more than 12 weeks
5. Performance status 2 or less according to the WHO scale
6. Age 18 or more
7. Ability to comply with the protocol
8. Ability to consent to participation
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
1. Pregnant or breast-feeding women
2. Nervous system involvement
3. Left ventricular ejection fraction (LVEF) < 50% of normal range
4. Reduced bone marrow function defined by leukocyte counts < 3.0 x 109/l and 5. neutrophil counts < 1.5 x 109/l, or thrombocyte counts = 100 x 109/l
5. Reduced liver function defined by bilirubin > 3 upper normal limit and/or ASAT/ALAT > 3 x upper normal limit and/or alkaline phosphatase > 3 x upper normal limit
6. Reduced renal function defined by serum creatinine > 2 x upper normal limit
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method