Appendix ZOOM Etude pour site internet

Département d’oncologie Doc Nr: UIC-MOP-APP-023
Centre de Thérapies Expérimentales ZOOM Etude pour site Internet
Unité d’Investigation Clinique (UIC)
Version 01 du 16 JUL 2015 Imprimé le 18 Jan 2016 12:32 par De Saab Diane (HOS42042)
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Appendix
ZOOM Etude pour site internet
Indication
Adénocarcinome du sein HER 2 négatif localement avancé ou
métastatique
Title
Eribulin as 1st line treatment in elderly patients (≥ 70 years) with
advanced breast cancer: a multicenter phase II trial
Protocol ID
SAKK 25/14
Phase
II
Sponsor
SAKK (Swiss Group for Clinical Cancer Research)
Principal
Investigator
Dr. K. Zaman
Primary Objective
The main objective of the trial is to explore the efficacy of a reduced starting dose
of eribulin as first-line treatment in elderly metastatic breast cancer patients. The
primary endpoint is disease control.
Inclusion/exclusio
n criteria
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

Département d’oncologie Doc Nr: UIC-MOP-APP-023
Centre de Thérapies Expérimentales ZOOM Etude pour site Internet
Unité d’Investigation Clinique (UIC)
Version 01 du 16 JUL 2015 Imprimé le 18 Jan 2016 12:32 par De Saab Diane (HOS42042)
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Vérifié par:
DBO
Approuvé par:
KEL
Distribué par:
KEL
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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 drug
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