Content - SAKK 24/14

SAKK 24/14 - Efficacy of a new kind of chemotherapy for the treatment of breast cancer

In this trial, we investigate the efficacy of a new kind of chemotherapy that penetrates the tumor cell specifically. As a result, it should improve the prognosis for patients with triple-negative breast cancer. This kind of cancer is different from other breast cancer because it is significantly more aggressive and the prognosis is worse. Moreover, women affected by this disease are rather young.

For this trial, we use so called “Anti-EGFR-Immunoliposome”. Health authorities have not yet approved its usage. However, it was already investigated in an earlier trial with 26 patients with different tumors. Our trial is the first one that investigates its effectiveness in advanced triple-negative breast cancer.  

An anti-EGFR-Immunoliposome composes two main elements, namely chemotherapy (liposomal doxorubicin) and an antibody (cetuximab). Antibodies are protein molecules, which are produced by the human immune system, in order to repel infections. These antibodies are placed on the surface of liposomes (fat molecules that serve as means of transport) and transfer the chemotherapy directly into tumor cells, in order to save the healthy tissue.  

Study Chair:

Dr. med. Ralph Winterhalder, Cantonal Hospital of Lucerne, +41 41 205 58 75

  • Contacts at the hospitals

  • 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.

Locations for this trial:

Kantonsspital Aarau
Tellstrasse 25
0 5001 Aarau
Kantonsspital Baden
Im Ergel 1
4600 Baden
Universitätsspital Basel
Petersgraben 4
0 4031 Basel
Inselspital
Freiburgstrasse 8
3010 Bern
Kantonsspital Graubünden
Loëstrasse 170
7000 Chur
Centre Hospitalier Universitaire Vaudois CHUV
Rue du Bugnon 46
0 Lausanne
Kantonsspital Luzern
Spitalstrasse
0 6000 Luzern
Kantonsspital Olten
Baslerstrasse 150
0 4600 Olten
Kantonsspital St. Gallen
Rorschacher Strasse 95
0 9007 St. Gallen
Spital STS AG Thun
Krankenhausstrasse 12
0 3600 Thun
Kantonsspital Winterthur
Brauerstrasse 15
0 8401 Winterthur
Hôpitaux Universitaires de Genève HUG
Rue Gabrielle-Perret-Gentil 4
0 1205 Genève
Hôpital du Valais Sion
Avenue du Grand-Champsec 80
0 1951 Sion
UniversitätsSpital Zürich
Rämistrasse 100
0 8091 Zürich
Klinik Hirslanden im Park
Seestrasse 259
0 8002 Zürich