Doxorubicin-loaded anti-EGFR immunoliposomes in patients with advanced triple-negative EGFR-positive breast cancer

Switzerland (ICTRP)

ID di studio ICTRP
NCT02833766 (ICTRP)

Titolo ufficiale (approvato dal comitato etico)
Anti-EGFR-immunoliposomes loaded with doxorubicin in patients with advanced triple negative EGFR positive breast cancer - A multicenter single arm phase II trial (BASEC)

Titolo accademico
Anti-EGFR-immunoliposomes Loaded With Doxorubicin in Patients With Advanced Triple Negative EGFR Positive Breast Cancer - A Multicenter Single Arm Phase II Trial (ICTRP)

Titolo pubblico
Anti-EGFR-immunoliposomes Loaded With Doxorubicin in Patients With Advanced Triple Negative EGFR Positive Breast Cancer (ICTRP)

Malattie studiate
Breast Cancer (ICTRP)

Intervento studiato
Drug: anti-EGFR-IL-dox (ICTRP)

Tipo di studio
Interventional (ICTRP)

Disegno dello studio
Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label). (ICTRP)

Criteri di inclusione/esclusione

Inclusion Criteria:

- Written informed consent according to ICH/GCP regulations before prescreening and
registration and prior to any trial specific procedures, including participation in
mandatory translational research

- Histologically proven diagnosis of TNBC in metastatic or locally advanced non operable
stage

- EGFR expression in primary tumor or metastases of at least (1+) in
immunohistochemistry, assessed by central pathologist

- Measurable or evaluable disease according to RECIST 1.1

- No prior systemic treatment for metastatic or inoperable disease

- Adequate bone marrow function: neutrophils = 1.5 x 109/L, platelets = 100 x 109/L

- Adequate hepatic function: total bilirubin = 1.5 x ULN; AST, ALT and AP = 2.5 x ULN
(AST, ALT and AP = 5 x ULN if hepatic metastases are the only reason for enzyme
elevation)

- Adequate renal function: serum creatinine = 1.5 x ULN and calculated creatinine
clearance > 30 mL/min, according to the formula of Cockcroft-Gault.

- Adequate cardiac function: Left Ventricular Ejection Fraction (LVEF) = 40% as
determined by either echocardiography (ECHO) or radionuclide angiocardiography (MUGA)

Exclusion Criteria:

- Evidence of CNS or leptomeningeal metastases (even if previously treated); CNS imaging
not required in asymptomatic patients

- History of hematologic or primary solid tumor malignancy, unless in remission for at
least 5 years from registration. Inclusion of adequately treated cervical carcinoma in
situ or localized non-melanoma skin cancer is permitted independent of time since
diagnosis

- Previous therapy with more than 240 mg/m2 of doxorubicin or more than 450 mg/m2 of
epirubicin

- Previous radiotherapy for the metastatic disease (palliative radiotherapy of only
non-target lesions is allowed)

- Adjuvant treatment must have been stopped at least 6 months before registration

- Any serious underlying medical condition (at the judgement of the investigator) which
could impair the ability of the patient to participate in the trial (e.g. active
autoimmune disease, uncontrolled diabetes, etc.)

- Breastfeeding

- Participation in any investigational drug trial within 4 weeks preceding treatment
start

- Any concomitant drugs contraindicated when administering Erbitux™ or Caelyx™ according
to the Swissmedic-approved product information

- Known hypersensitivity to trial drug(s) or to any component of the trial drug(s)

- 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.
(ICTRP)

non disponibile

Endpoint primari e secondari
Progression-free survival (PFS) (ICTRP)

Objective response rate (ORR);Duration of response (DOR);Time to Progression (TTP);Adverse events (AEs);Overall survival (OS);PFS (ICTRP)

Data di registrazione
12.07.2016 (ICTRP)

Inclusione del primo partecipante
28.10.2016 (ICTRP)

Sponsor secondari
non disponibile

Contatti aggiuntivi
Ralph Winterhalder, MD, Luzerner Kantonsspital (ICTRP)

ID secondari
SAKK 24/14 (ICTRP)

Risultati-Dati individuali dei partecipanti
non disponibile

Ulteriori informazioni sullo studio
https://clinicaltrials.gov/show/NCT02833766 (ICTRP)