loaded with in patients with advanced triple negative

Anti-EGFR-immunoliposomes loaded with doxorubicin in patients with
advanced triple negative EGFR positive breast cancer - A multicenter single arm
phase II trial
« Etude SAKK24/14 »
Sponsor : SAKK
CONTACTS AUX HUG :
Investigateur responsable: Dr Alexandre Bodmer, 079 55 32 405
DESIGN DE L’ETUDE :
OBJECTIF DE L’ETUDE
Cette étude a pour but de déterminer l’efficacité de l’anti-EGFR-IL-dox en première ligne
chez des patients atteints d’un cancer du sein triple négatif et EGFR positif.
Un autre objectif est d’investiguer la sélection clonale sous ce traitement anti-EGFR-IL-dox
qui pourrait aboutir au développement d’une résistance au traitement. Pour ce faire des
prélèvements de sangs seront effectués à des temps précis au cours de l’étude.
CRITERES D’INCLUSION / EXCLUSION :
Main Inclusion criteria:
 Metastatic or locally advanced non operable TNBC
 EGFR expression of at least (1+) in immunohistochemistry
 Measurable or evaluable disease
 No prior systemic treatment for metastatic or inoperable disease
 WHO PS of 0-2
 Patient ≥ 18 years
Main Exclusion criteria:
 Evidence of CNS or leptomeningeal metastases (even if previously treated)
 History of hematologic or primary solid tumor malignancy, unless in
remission for at least 5 years. Inclusion of adequately treated cervical
carcinoma in situ or localized non-melanoma skin cancer is permitted
 Previous therapy with more than 240 mg/m2 of doxorubicin or more than
450 mg/m2 of epirubicin
SAKK 24/14 - Anti-EGFR-IL-dox Trial summary, version 1.0, 10.05.2016 Page 2 of 6
 Previous radiotherapy for the metastatic disease (palliative radiotherapy of
only non-target lesions is allowed)
Etude SAKK 24/14
befy 06.12.2016
 Adjuvant treatment must have been stopped at least 6 months before
registration
 Breastfeeding
 Any other serious underlying medical, psychiatric, psychological, familial or geographical
condition, which in the judgment of the investigator may interfere with the planned staging,
treatment and follow-up, affect patient compliance or place the patient at high risk from
treatment-related complications.
Etude SAKK 24/14
befy 06.12.2016