Content - SAKK 25/14

SAKK 25/14 - New therapeutic option for elderly women with advanced breast cancer

Various treatment options are available for women with advanced breast cancer (either with metastases or local progression). The specific treatment selected depends on several factors, including the nature of the tumour tissue, accompanying diseases and the patient's general condition. One therapeutic option is chemotherapy, but this can cause very debilitating side effects. In fact, the side effects not infrequently lead to treatment being suspended. This is particularly the case with elderly women, who are less able to tolerate the side effects compared to their younger counterparts.

The active substance eribulin (Halaven®) has been on the Swiss market for a few years now. Since eribulin usually causes fewer side effects than other chemotherapy drugs, it would, in principle, be especially suitable for treating elderly patients. At present, however, patients in Switzerland may only be treated with eribulin if they have already received a different chemotherapy drug.

The aim of trial SAKK 25/14 is therefore to establish whether eribulin is suitable for treating elderly patients (over 70 years old) with advanced breast cancer without them first having been treated with a different chemotherapy drug. The study will also investigate whether a lower dose of eribulin produces a comparable effect to the standard dose but at the same time with as few side effects as possible.

Study Chair:

Dr. Ursula Hasler-Strub, Cantonal Hospital of St.Gallen, +41 71 494 19 32

  • Contacts at the hospitals

  • Inclusion criteria

    • Patient must give written informed consent according to ICH/GCP regulations before registration
    • Histologically or cytologically confirmed locally advanced or metastatic HER2-neg, hormone receptor positive or negative adenocarcinoma of the breast with measurable or evaluable disease according to RECIST 1.1 criteria
    • At least 6 months since last adjuvant/neoadjuvant chemotherapy administration before registration
    • At least 2 weeks since prior radiotherapy or endocrine therapy and complete recovery from these interventions at time of registration
    • Baseline C-SGA and patient-reported outcome (PRO) forms have been completed
    • Female patient at the age of ≥70 years
    • WHO performance status 0-2
    • Adequate hematological values: hemoglobin ≥80 g/L (transfusions are allowed), neutrophils ≥1.5 x 109/L, platelets ≥ 100 x 109/L
    • Adequate hepatic function: bilirubin ≤1.5 x ULN, AST ≤3 x ULN, alkaline phosphatase (AP) ≤2.5 x ULN (in case of liver metastases ≤5 x ULN or in case of bone metastases ≤10 x ULN)
    • Adequate renal function (calculated creatinine clearance >40 mL/min, according to the formula of Cockcroft-Gault)
  • Exclusion criteria

    • Known CNS metastases
    • Previous malignancy within 3 years with the exception of adequately treated cervical carcinoma in situ or localized non-melanoma skin cancer
    • Prior chemotherapy for advanced disease
    • Concurrent anticancer treatment or treatment in a clinical trial within 30 days prior to registration. Exception: participation in SAKK 96/12
    • Palliative irradiation prior to study entry with more than 30% of marrow-bearing bone irradiated
    • Pre-existing neuropathy ≥G2 (according to CTCAE v4.0) at registration
    • Severe or uncontrolled cardiovascular disease (congestive heart failure NYHA III or IV (see Appendix 4), unstable angina pectoris, history of myocardial infarction within the last three months, significant arrhythmias, congenital long QT-syndrome)
    • Any concomitant drugs contraindicated for use with the trial drugs according to the approved product information
    • Known hypersensitivity to trial drug or to any component of the trial drug
    • Any serious underlying medical condition (at the judgment of the investigator) which could impair the ability of the patient to participate in the trial (e.g. active autoimmune disease, uncontrolled diabetes)
    • Psychiatric disorder precluding understanding of trial information, giving informed consent, taking part in the geriatric assessment, or interfering with compliance/with the trial protocol
    • Any familial, sociological or geographical condition potentially hampering proper staging and compliance with the trial protocol

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
Istituto Oncologico della Svizzera Italiana IOSI
Via Ospedale
0 6500 Bellinzona
Freiburgstrasse 8
3010 Bern
Spitalzentrum Biel
Vogelsang 84
0 2501 Biel
Kantonsspital Graubünden
Loëstrasse 170
7000 Chur
Spital Thurgau, Kantonsspital Frauenfeld
Waldeggstrasse 8A
0 8501 Frauenfeld
Hôpital Fribourgeois HFR
Chemin des Pensionnats 2
1708 1708 Fribourg
Centre Hospitalier Universitaire Vaudois CHUV
Rue du Bugnon 46
0 Lausanne
Kantonsspital Luzern
0 6000 Luzern
Spital Männedorf AG
Asylstrasse 10
0 8708 Männedorf
Kantonsspital Olten
Baslerstrasse 150
0 4600 Olten
rundum Onkologie
Bahnhofpark 2B
0 7320 Sargans
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
Brustzentrum Basel - Bethesda Spital
Gellertstrasse 144
0 4002 Basel
Clinique de Genolier
Route du Muids 3
0 1272 Genolier
Oncologia Varini & Calderoni & Christinat
Via Antonio Fogazzaro 3
0 6900 Lugano
Solothurner Spitäler AG (soH)
Schöngrünstrasse 42
0 4500 Solothurn
Klinik Hirslanden im Park
Seestrasse 259
0 8002 Zürich
Brustzentrum Seefeld
Seefeldstrasse 214
0 8008 Zürich
Tumor- und Brustzentrum ZeTuP St.Gallen
Rorschacher Strasse 150
0 9006 St.Gallen