| Erkrankung: | Brustkrebs (Mammakarzinom) |
| Start der Studie am Zentrum: | 30.05.2017 |
| Status der Studie: | Rekrutierung abgeschlossen |
| Studiendesign: | interventionell |
| Studienphase: | Phase II |
| Studienart: | Medikamentöse Therapie |
| Haupteinschlusskritieren: | • Female patients, age at diagnosis 18 years and older • Histologically confirmed unilateral primary invasive carcinoma of the breast • Patients must qualify for neoadjuvant treatment as follows: o No clinical evidence for distant metastasis (M0) o Clinical cT1c-T4a-c (participation of patients with tumors > cT2 is strongly recommended) and no evidence for distant metastases (M0) o All clinical N (participation of patients with cN+, also in case of cT1c, is strongly recommended) o Known positive HR-status and centrally confirmed HER2+-status by IHC/FISH o Patients need to fulfill adequate blood count and organ function to receive chemotherapy (see exclusion criteria). • Tumor block available |
| 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 • Concurrent treatment with other experimental drugs and participation in another clinical trial with any investigational drug within 30 days prior to study entry is excluded • Male breast cancer • Concurrent pregnancy • Breastfeeding • Sequential breast cancer • Reasons indicating risk of poor compliance • Known polyneuropathy ≥ grade 2 |
| Prüfarzt: | Dr. med. Antje Lehnert |