Eribulin as 1st Line Treatment in Elderly Patients With Advanced Breast Cancer

NCT02404506 | Terminated Phase 2 DMC

• 2 other identifiers: SAKK 25/14000001310
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 26

Brief Summary

Breast cancer is the most frequent malignancy in women, world-wide the leading cause of cancer mortality. One of the strongest risk factors for developing breast cancer is age, with a prevalence approaching 7% in women \>70 years; more than 40% of breast cancer patients are older than 65 years. Although the survival rate has increased in the last years, about one third of patients will relapse with distant metastases. Treatment for patients with metastatic breast cancer is palliative, therefore maintaining or improving quality of life. The use of taxanes and anthracyclines as first line chemotherapy regimen for metastatic breast cancer is widely accepted. Both taxanes and anthracyclines have considerable side effects, especially in elderly patients. Eribulin, a synthetic analogue of a chemotherapeutically active compound derived from the sea sponge Halichondria okadai, acts as an inhibitor of microtubule dynamics. It is registered as palliative chemotherapy in advanced breast cancer after anthracyclines and taxanes. Studies with eribulin treatment have shown similar efficacy compared to anthracyclines and taxanes, but less toxicity. Those studies showed that often the dose of eribulin had to be reduced during treatment due to toxicity without compromising the efficacy of the treatment. 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 secondary objective of the trial is to investigate the safety of eribulin in those patients. Eribulin mesilate 1.1mg/m2 i.v. will be administered intravenously every 3 weeks on day 1 and day 8 until progressive disease.

Conditions

Breast Cancer; Adenocarcinoma

Keywords

Eribulin; Breast Cancer; Elderly Patient; Phase II Trial; HER2-neg; adenocarcinoma

Outcome Measures

Primary Outcomes (1)

• Disease Control (DC)

  A patient has DC, if she has complete response (CR) or partial response (PR) at any time point during treatment, or if she has stable disease (SD) for at least 24 weeks (according to RECIST v1.1).

  24 weeks

Secondary Outcomes (6)

• Time to treatment failure (TTF)

  at treatment discontinuation (at the latest 5 years after registration)

• Objective response (OR)

  at treatment discontinuation (at the latest 5 years after registration)

• Time to progression (TTP)

  at time of progression, death or treatment discontinuation (at the latest 5 years after registration)

• Overall survival (OS)

  at time of death (at the latest 5 years after registration)

• Adverse events (AEs)

  until 30 days after last dose of treatment and resolution of all related AEs thereafter (at the latest 5 years after registration)

Study Arms (1)

Arm: Eribulin mesilate

EXPERIMENTAL

Drug: Eribulin mesilate

Interventions

Eribulin mesilate DRUG

Eribulin mesiylate 1.1mg/m2 d1, 8 every 3 weeks until Progressive disease PD

Also known as: Halaven

Arm: Eribulin mesilate

Eligibility Criteria

• Age: 70 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Swiss Cancer Institute: lead

Study Sites (26)

Kantonsspital Aarau

Aarau, CH-5001, Switzerland

Location

Kantonsspital Baden

Baden, 5404, Switzerland

Location

Universitaetsspital-Basel

Basel, 4031, Switzerland

Location

Praxis für ambulante Tumortherapie

Basel, CH-4052, Switzerland

Location

Istituto Oncologico della Svizzera Italiana

Bellinzona, 6500, Switzerland

Location

Klinik Engeried / Oncocare

Bern, 3012, Switzerland

Location

Inselspital, Bern

Bern, CH-3010, Switzerland

Location

Spitalzentrum Biel

Biel, CH-2501, Switzerland

Location

Kantonsspital Graubünden

Chur, 7000, Switzerland

Location

Kantonsspital Frauenfeld / Brustzentrum Thurgau

Frauenfeld, 8501, Switzerland

Location

HFR Fribourg - Hôpital cantonal

Fribourg, 1708, Switzerland

Location

Clinique de Genolier

Genolier, CH-1272, Switzerland

Location

Centre Hospitalier Universitaire Vaudois

Lausanne, CH-1011, Switzerland

Location

Clinica Sant'Anna - Oncologia Varini & Calderoni & Christinat

Lugano, 6900, Switzerland

Location

Kantonsspital Luzern

Luzerne, CH-6000, Switzerland

Location

Onkologie Zentrum Spital Männedorf

Männedorf, 8708, Switzerland

Location

Kantonsspital Olten

Olten, 4600, Switzerland

Location

Onkologiepraxis Dr. med. Isabella Schönenberger

Sankt Gallen, 9000, Switzerland

Location

Tumorzentrum ZeTUP

Sankt Gallen, 9006, Switzerland

Location

Kantonsspital - St. Gallen

Sankt Gallen, CH-9007, Switzerland

Location

Rundum Onkologie am Bahnhofpark

Sargans, 7320, Switzerland

Location

Onkologiezentrum Bürgerspital Solothurn

Solothurn, CH-4500, Switzerland

Location

Regionalspital

Thun, 3600, Switzerland

Location

Kantonsspital Winterthur

Winterthur, 8401, Switzerland

Location

Onkozentrum - Klinik im Park

Zurich, 8002, Switzerland

Location

Brust-Zentrum AG Zürich

Zurich, 8005, Switzerland

Location

MeSH Terms

Conditions

Breast Neoplasms; Adenocarcinoma

Interventions

eribulin

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Study Officials

• Ursula Hasler-Strub, MD

  Cantonal Hospital of St. Gallen

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 26, 2015
• First Posted: March 31, 2015
• Study Start: August 17, 2015
• Primary Completion: December 30, 2020
• Study Completion: July 22, 2021
• Last Updated: September 29, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

CH (26)