Erkrankung: | Brustkrebs (Mammakarzinom) |
Start der Studie am Zentrum: | 01.12.2017 |
Status der Studie: | Rekrutierung abgeschlossen |
Studiendesign: | interventionell |
Studienphase: | Phase III |
Studienart: | Medikamentöse Therapie |
Haupteinschlusskritieren: | - Female patients, age at diagnosis 18 years • Histologically confirmed unilateral primary invasive carcinoma of the breast • T1 - T4 (except inflammatory breast cancer) • All N • Patients should be candidates for (neo) adjuvant chemotherapy according to conventional prognostic factors • No clinical evidence for distant metastasis (M0) • Known HR status and HER2 status (local pathology) • Tumor block available for central pathology review • Performance Status ECOG |
Hauptausschlusskritieren: | • Known hypersensitivity reaction to the compounds or incorporated substances • Prior malignancy with a disease-free survival of < 10 years, except curatively treated basalioma of the skin, pTis of the cervix uteri • Non-operable breast cancer including inflammatory breast cancer • Previous or concurrent treatment with cytotoxic agents for any reason after consultation with the sponsor • Concurrent treatment with other experimental drugs. Participation in another interventional clinical trial with or without any investigational non-marketed drug within 30 days prior to study entry (concurrent participation in non-interventional post authorization safety studies not influencing the primary study endpoints is allowed) • Male breast cancer • Concurrent pregnancy; patients of childbearing potential must implement a highly effective (less than 1% failure rate) non-hormonal contraceptive measure during the study treatment • Breast feeding woman • Sequential breast cancer • Reasons indicating risk of poor compliance • Patients not able to consent |
Prüfarzt: | Dr. med. Antje Lehnert |
Weitere Informationen: | Re-Start der Studie im Dezember 2017. Ursprünglich seit 2012 aktiv. Wurde aufgrund von Findings im Monitoring gestoppt und mit neuem Monitoringteam wieder gestartet. |