Breast cancer MedDRA version: 8.1 Level: LLT Classification code 10027475 Term: Metastatic breast cancer
Conditions
Interventions
Product Name: SBG
Pharmaceutical Form: Oral liquid
Sponsors
Biotec Pharmacon ASA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 1. Pregnant or breast-feeding women 2. Nervous system involvement 3. Left ventricular ejection fraction (LVEF) 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Define the clinical toxicity and assess the biologic effects of oral SBG when given to breast cancer patients undergoing standard chemo- and antibody treatment;Secondary Objective: Assess clinical response rates;Primary end point(s): | — |
Countries
Norway
Outcome results
None listed