Jeroen Bosch Ziekenhuis, Den Bosch
M. F. Ernst, A.C. Voogd, V.C.G. Tjan-Heijnen
J. Ruiterkamp
IKNL Trial Office Zuid S. van Gastel P.O. Box 9101, 6500 HB Nijmegen zuid.trialbureau@iknl.nl
n.a.
IKNL
Funding by KWF
In order to report the objectives of the study, the primary and secondary endpoints are listed and described below.
Primary endpoint:
Secondary endpoints:
Inclusion criteria Newly diagnosed primary distant metastatic breast cancer (M1) Anticipated survival of at least 6 months Histologically proven breast cancer Hormonal and HER2Neu status should be known T1-T3, resectable T4 status, N0-N3 Performance status of the patient should allow surgery / systemic therapy Co-morbidity of the patient should allow surgery / systemic therapy Age ³ 18 years Written informed consent Exclusion criteria Primary invasive breast cancer in medical history Other malignancy within the last 10 years, besides basal cell carcinoma of the skin or early stage cervical cancer Surgical treatment / radiotherapy of this breast tumor before randomization Irresectable T4 breast tumor Synchronous bilateral breast cancer
