Klinische Studien

Insema

PrüfplancodeISRCTNEudraCTClinicaltrials.govDRKS
GBG-75NCT02466737

Vergleich der axillären Sentinel- Lymphknotenbiopsie versus keiner Axilla- Operation bei Patientinnen mit invasiven Mammakarzinom (Stadium I und II) und brusterhaltender Therapie: Eine prospektiv- randomisierte, operative Studie (INSEMA-Studie)

Status: Aktiv

Studienziel / Fragestellung

Primäres Prüfziel

  • invasive disease-free survival (IDFS) after breast-conserving surgery [ Time Frame: 5 years ]

Diagnose

Comparison of Axillary Sentinel Lymph Node Biopsy Versus no Axillary Surgery

Patientenmerkmale

Einschlusskriterien

  • Written informed consent prior to beginning breast-conserving surgery, including expected cooperation of the patients for follow-up, must be obtained and documented according to the local regulatory requirements
  • Histologically confirmed unilateral primary invasive carcinoma of the breast (core biopsy). Multifocal tumors are allowed if breast-conserving surgery is planned
  • Age at diagnosis at least 35 years
  • Preoperative imaging techniques with estimated tumor size of <5 cm (iT1/iT2 irrespective of hormone sensitivity or HER2 status)
  • Clinically and sonographically tumor-free axilla prior to core biopsy (cN0/iN0)
  • In cases with cN0 and iN+, a negative core biopsy or fine needle aspiration (FNA) biopsy of the sonographically suspected lymph node is required before randomization
  • No clinical evidence for distant metastasis (M0)
  • Planned breast-conserving surgery (R0 resection) with postoperative external whole-breast irradiation (conventional fractionation or hypofractionation)

Ausschlusskriterien

  • Secondary malignancy, except curatively treated basalioma of the skin and carcinoma in situ of the cervix
  • Time since core biopsy >3 months (optimal <1 month)
  • Previous and already (neoadjuvant) treated invasive breast carcinoma
  • Histologically non-invasive breast carcinoma
  • cT3/T4 or iT3/T4 tumors
  • Patients aged <35 years
  • Planned total mastectomy (e.g. multicentric tumors )
  • Planned intraoperative radiotherapy (e.g. Intrabeam) or postoperative partial breast irradiation (e.g. multicatheter technique) alone; both procedures are allowed as boost techniques
  • Male patients

Studiendesign

  • Phase III
  • Multizentrisch
  • Prospektiv
  • Randomisiert
  • Zweiarmig

Intervention

Procedure: no axillary surgery versus SLNB
Procedure: SLNB versus completion ALND

Dokumente (passwortgeschützt)

Zuständigkeiten Gesamtstudie

Universitätsklinikum Rostock

  • Tel. +49 (0)381 494-0

Leiter der klinischen Prüfung

Prof. Dr. med. Peter Reimer

Prüfzentren

Köln

Klinik und Poliklinik für Frauenheilkunde und Geburtshilfe

Studienbüro

Status

Aktiv

Prüfer (Hauptprüfer im Zentrum)

Dr. med. Michael Mallmann

Stellvertretender Prüfer

  • Dr. med. Wolfram Malter
  • Dr. med. Fabinshy Thangarajah

Studienkontakt im Prüfzentrum