Doxorubicin-loaded anti-EGFR immunoliposomes in patients with advanced triple-negative EGFR-positive breast cancer
Zusammenfassung der Studie
Study Objectives We want to investigate whether it is possible to improve the prognosis of patients with triple-negative breast cancer by administering a chemotherapeutic agent packaged in anti-EGFR immunoliposomes. Study Drug The anti-EGFR immunoliposome is an investigational product. This means that the anti-EGFR immunoliposome has not yet been approved by health authorities. However, the drug has already been studied in a previous study involving 26 patients with various tumors. Our study is now the first to use the drug in advanced triple-negative breast cancer. Study Design This is a multicenter, single-arm Phase II study, meaning that all patients will receive the study drug. This study will be conducted at several (approximately 15) hospitals (i.e., multicenter) in Switzerland. A total of 49 patients are to be treated in the study. Duration of the Study The drug will be administered every 4 weeks as long as it is tolerated well enough and the patients benefit from it. The first study results are expected when all 49 patients have been enrolled and all participants have been observed for one year after enrollment regarding the tolerability and efficacy of the treatment. This is expected to be the case by early 2020. The end of the study is anticipated for the first half of 2023.
(BASEC)
Untersuchte Intervention
The anti-EGFR immunoliposomes consist of two essential components, namely a chemotherapy (liposomal doxorubicin) and an antibody (Cetuximab). Antibodies are protein molecules produced by the human immune system to defend against infections. The antibodies attached to the surface of the liposomes direct the chemotherapy directly into the tumor cells and are intended to spare healthy tissue. We hope that this will improve the ratio of efficacy to side effects. In this way, it is also achieved that the doxorubicin stored inside the immunoliposomes enters the tumor cells in increased concentration.
(BASEC)
Untersuchte Krankheit(en)
Patients with advanced breast cancer exhibiting the following characteristics may participate in this study: a) the breast cancer must be "triple-negative", meaning that neither of the two hormone receptor proteins for estrogen and progesterone nor the HER2 protein were found on the surface of the tumor cells at diagnosis; b) the so-called EGFR protein must be detected on the tumor cells, against which the immunoliposomes are directed; c) the breast cancer has either formed metastases or appears inoperable.
(BASEC)
Patients with advanced breast cancer exhibiting the following characteristics may participate in this study: a) the breast cancer must be "triple-negative", meaning that neither of the two hormone receptor proteins for estrogen and progesterone nor the HER2 protein were found on the surface of the tumor cells at diagnosis; b) the so-called EGFR protein must be detected on the tumor cells, against which the immunoliposomes are directed; c) the breast cancer has either formed metastases or appears inoperable. Additionally, you must not have any other serious illnesses and you must be over 18 years old. (BASEC)
Ausschlusskriterien
Individuals who have already received another chemotherapy for advanced tumor disease may not participate. However, preventive chemotherapies performed immediately after surgery are allowed. (BASEC)
Studienstandort
Aarau, Basel, Bern, Chur, Genf, Lausanne, Luzern, Sion, St Gallen, Winterthur, Zürich, Andere
(BASEC)
Olten, Baden, Thun
(BASEC)
Sponsor
Swiss Cancer Institute
(BASEC)
Kontakt für weitere Auskünfte zur Studie
Kontaktperson Schweiz
Corinne Schär
+41 31 389 91 91
trials@clutterswisscancerinstitute.chSwiss Cancer Institute
(BASEC)
Allgemeine Auskünfte
Luzerner Kantonsspital
(ICTRP)
Wissenschaftliche Auskünfte
Luzerner Kantonsspital
(ICTRP)
Name der bewilligenden Ethikkommission (bei multizentrischen Studien nur die Leitkommission)
Ethikkommission Nordwest- und Zentralschweiz EKNZ
(BASEC)
Datum der Bewilligung durch die Ethikkommission
23.09.2016
(BASEC)
ICTRP Studien-ID
NCT02833766 (ICTRP)
Offizieller Titel (Genehmigt von der Ethikkommission)
Anti-EGFR-immunoliposomes loaded with doxorubicin in patients with advanced triple negative EGFR positive breast cancer - A multicenter single arm phase II trial (BASEC)
Wissenschaftlicher Titel
Anti-EGFR-immunoliposomes Loaded With Doxorubicin in Patients With Advanced Triple Negative EGFR Positive Breast Cancer - A Multicenter Single Arm Phase II Trial (ICTRP)
Öffentlicher Titel
Anti-EGFR-immunoliposomes Loaded With Doxorubicin in Patients With Advanced Triple Negative EGFR Positive Breast Cancer (ICTRP)
Untersuchte Krankheit(en)
Breast Cancer (ICTRP)
Untersuchte Intervention
Drug: anti-EGFR-IL-dox (ICTRP)
Studientyp
Interventional (ICTRP)
Studiendesign
Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label). (ICTRP)
Ein-/Ausschlusskriterien
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)
nicht verfügbar
Primäre und sekundäre Endpunkte
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)
Registrierungsdatum
12.07.2016 (ICTRP)
Einschluss des ersten Teilnehmers
28.10.2016 (ICTRP)
Sekundäre Sponsoren
nicht verfügbar
Weitere Kontakte
Ralph Winterhalder, MD, Luzerner Kantonsspital (ICTRP)
Sekundäre IDs
SAKK 24/14 (ICTRP)
Angaben zur Verfügbarkeit von individuellen Teilnehmerdaten
nicht verfügbar
Weitere Informationen zur Studie
https://clinicaltrials.gov/show/NCT02833766 (ICTRP)
Ergebnisse der Studie
Zusammenfassung der Ergebnisse
nicht verfügbar
Link zu den Ergebnissen im Primärregister
nicht verfügbar