Prospective phase II trial using Capecitabine and Trastuzumab for therapy of female patients with cerebral metastasizing, HER2-overexpressing breast cancer - HERXE

Conditions: CNS-metastasizing HER2-overexpressing breast cancer
MedDRA version: 9.1Level: PTClassification code 10057654Term: Breast cancer female
MedDRA version: 9.1Level: PTClassification code 10006202Term: Breast cancer stage IV

Registration Number: EUCTR2007-003634-42-DE

Lead Sponsor: Klinikum der Universität München, Standort Großhadern

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: Female

Target Recruitment: Not specified

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

- 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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Determination of response rate;Secondary Objective: Determination of:<br>- Time to progression (TTP)<br>- Overall survival;Primary end point(s): Progression of disease

Secondary Outcome Measures