CNS-metastasizing HER2-overexpressing breast cancer MedDRA version: 9.1 Level: PT Classification code 10057654 Term: Breast cancer female MedDRA version: 9.1 Level: PT Classification code 10006202 Term: Breast cancer stage IV
Conditions
Interventions
Trade Name: Herceptin
Pharmaceutical Form: Powder for concentrate for solution for infusion
Other descriptive name: Trastuzumab
Concentration unit: mg milligram(s)
Concentration type: equal
Concentrat
Sponsors
Klinikum der Universität München, Standort Großhadern
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Histological proven metastasizing breast cancer in women - HER2-new-overexpression (IHC3+ or IHC2+/FISH+) - Documented CNS metastases and/or Meningeosis carcinomatosa which are (neurosurgical) inoperable - if no irradiation has been performed before study treatment (chemoimmunotherapy) it will be conducted in - If a previous irridiation took place and it is not clinically indicated to be continued, this chemoimmunotherapy will be conducted analog and squentiell to study treatment after previous irradiation - Besides Capecitabine all prior adjuvant /neoadjuvant chemotherapies possible - Patients have to be treated with taxanes and Trastuzumab (not necessarily in combination) before, excluding cases of primary inoperable CNS metastases - Prior hormone therapy is allowed - Age between 18 and 75 years - Performance status (Karnofsky) >= 70% - Life expectancy >= 16 weeks - Signed informed consent after complete information by the investigator before study specific treatment. 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: - Pregnant or breast-feeding women (women with child-bearing potential must use effective contraception) - Missing informed consent - Prior treatment with Capecitabine - opportunity of neurosurgery - Patients, who took part in a clinical trial within 30 days prior to study entry - Psychological, familiar, sociological or geographic circumstances that prevent follow-up medical treatment or treatment according to protocoll - patients with following cardiovascular diseases/risk factors are excluded: - previous congestive heartfailure - high risk of uncontrolled arrhythmia - angina pectoris which needs medical treatment - clinical significant valvular insufficiency - signs of transmural infarction in ECG - not adjustable hypertension
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Determination of response rate;Secondary Objective: Determination of: - Time to progression (TTP) - Overall survival;Primary end point(s): Progression of disease | — |
Countries
Germany
Outcome results
None listed