| Erkrankung: | Brustkrebs (Mammakarzinom) Invas. duktales Karzinom |
| Status der Studie: | Studie rekrutiert |
| Studiendesign: | interventionell |
| Studienphase: | Phase III |
| Studienart: | Medikamentöse Therapie |
| Haupteinschlusskritieren: | 1. The patient must have consented to participate and, prior to beginning specific study procedures, must have signed and dated an appropriate IRBapproved consent form that conforms to federal and institutional guidelines for study treatment and for submission of tumor samples as required by NSABP B-59/GBG 96-GeparDouze for baseline correlative science studies (see Section 6.0). 2. The diagnosis of invasive adenocarcinoma of the breast must have been made by core needle biopsy. 3. Local testing on the diagnostic core must have determined the tumor to be ER-negative, PgR-negative, and HER2-negative by current ASCO/CAP guidelines. (If local testing has determined a tumor to be HER2 equivocal or to have a borderline ER/PgR status (% IHC staining 10% for both) and other eligibility criteria are met, material may be submitted for central testing to determine eligibility.) 4. Central testing for ER, PgR, and HER2 will be performed, and the tumor must be determined to be ER-negative, PgR-negative, and HER2-negative by current ASCO/CAP Guidelines Recommendations. Formalin-fixed, paraffin-embedded (FFPE) breast tissue from core biopsy has therefore to be sent to the GBG central pathology laboratory prior to randomization for central confirmation of TNBC status and for correlative science studies. 5. The tumor specimen used for central ER, PgR, and HER2 testing must also be used for central testing of PD-L1 status using the Ventana PD-L1 (SP142) assay kit. Patients will be eligible irrespective of PD-L1 testing result including PD-L1 indeterminate. Patients will be classified as positive, negative, or indeterminate for stratification purposes. 6. Patients must be 18 years old. 7. Patient may be female or male. 8. The ECOG performance status must be 0-1 |
| Hauptausschlusskritieren: | 1. Excisional biopsy or lumpectomy performed prior to study entry. 2. FNA alone to diagnose the breast cancer. 3. Surgical axillary staging procedure prior to randomization. Exception: FNA or core biopsy of an axillary node is permitted for any patient. A pre-neoadjuvant therapy sentinel lymph node biopsy for patients with clinically negative axillary nodes is prohibited. 4. Definitive clinical or radiologic evidence of metastatic disease. 5. Previous history of contralateral invasive breast cancer. (Patients with synchronous and/or previous contralateral DCIS or LCIS are eligible.) 6. Previous history of ipsilateral invasive breast cancer or ipsilateral DCIS. (Patients with synchronous or previous ipsilateral LCIS are eligible.) 7. History of non-breast malignancies (except for in situ cancers treated only by local excision and basal cell and squamous cell carcinomas of the skin) within 5 years prior to study entry. 8. Treatment including radiation therapy, chemotherapy, or targeted therapy, for the currently diagnosed breast cancer prior to randomization. 9. Previous therapy with anthracyclines or taxanes for any malignancy. |
| Prüfarzt: | Dr. med. Antje Lehnert |