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Breast CancerPhase 2NCT02404506

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

A Phase 2 study testing Eribulin mesilate in people with Breast Cancer and Adenocarcinoma, run by Swiss Cancer Institute at 26 sites in Switzerland.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 70 years and older, women only
Conditions the study is for
Breast Cancer, Adenocarcinoma
What is being tested?
Eribulin mesilate
Could I receive a placebo?
No, everyone receives an active treatment
How many people
78 participants
Where
26 sitesSwitzerland
Study dates
17 Aug 2015to 22 Jul 2021
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 70 years and older
  • Women only
  • No healthy volunteers
  • Older adult

Who may be able to join

  • 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
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  • 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)

Who cannot join

  • 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
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  • 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

Trial locations and contacts

26 sites in 1 country.

26 sites in 1 country

Switzerland26 sites

  • Kantonsspital Aarau

    Aarau, CH-5001

  • Kantonsspital Baden

    Baden, 5404

  • Universitaetsspital-Basel

    Basel, 4031

  • Praxis für ambulante Tumortherapie

    Basel, CH-4052

  • Istituto Oncologico della Svizzera Italiana

    Bellinzona, 6500

  • Klinik Engeried / Oncocare

    Bern, 3012

  • Inselspital, Bern

    Bern, CH-3010

  • Spitalzentrum Biel

    Biel, CH-2501

  • Kantonsspital Graubünden

    Chur, 7000

  • Kantonsspital Frauenfeld / Brustzentrum Thurgau

    Frauenfeld, 8501

  • HFR Fribourg - Hôpital cantonal

    Fribourg, 1708

  • Clinique de Genolier

    Genolier, CH-1272

  • Centre Hospitalier Universitaire Vaudois

    Lausanne, CH-1011

  • Clinica Sant'Anna - Oncologia Varini & Calderoni & Christinat

    Lugano, 6900

  • Kantonsspital Luzern

    Luzerne, CH-6000

  • Onkologie Zentrum Spital Männedorf

    Männedorf, 8708

  • Kantonsspital Olten

    Olten, 4600

  • Onkologiepraxis Dr. med. Isabella Schönenberger

    Sankt Gallen, 9000

  • Tumorzentrum ZeTUP

    Sankt Gallen, 9006

  • Kantonsspital - St. Gallen

    Sankt Gallen, CH-9007

  • Rundum Onkologie am Bahnhofpark

    Sargans, 7320

  • Onkologiezentrum Bürgerspital Solothurn

    Solothurn, CH-4500

  • Regionalspital

    Thun, 3600

  • Kantonsspital Winterthur

    Winterthur, 8401

  • Onkozentrum - Klinik im Park

    Zurich, 8002

  • Brust-Zentrum AG Zürich

    Zurich, 8005

Other trials in Switzerland

About this study

Official title: Eribulin as 1st Line Treatment in Elderly Patients (≥ 70 Years) With Advanced Breast Cancer: a Multicenter Phase II Trial

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.

Read more

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.

Read the detailed description

Due to a rising number of elderly patients, fit for chemotherapy, investigating a well-tolerated and effective first line treatment is warranted. In this specific population often there are contra-indications for the use of standard first line drugs like anthracyclines and taxanes due to comorbidities (e.g. cardiac impairment or Peripheral neuropathy). Response rates in first line treatment with taxanes and anthracyclines usually do not exceed 30%. Eribulin has shown a response rate of 29% and a clinical benefit rate (corresponding to the investigators primary endpoint) of 52% in first line, so the investigators expect similar efficacy, but less toxicity.

Optimal dose, schedule and tolerability of this drug in the first line setting are unknown in the elderly population. No information on dose modifications in this population is available. Based on the data of eribulin in the first line with higher efficacy in those patients with dose reductions, the SAKK 25/14 trial investigates the reduced starting-dose of eribulin of 1.1mg/m2 for this vulnerable population of elderly patients. Growth factors to maintain a certain dose level of eribulin are not recommended, respecting the international guidelines.

SAKK has a tradition in conducting trials in the elderly population, such as SAKK 25/99 in metastatic breast cancer, SAKK 38/08 in aggressive B-cell-Lymphoma, SAKK 41/10 in metastatic colorectal cancer.

Being tested
Eribulin mesilate
Keywords
Eribulin, Breast Cancer, Elderly Patient, Phase II Trial, HER2-neg, adenocarcinoma
Medical subject headings
Breast Neoplasms, Adenocarcinoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Eribulin mesilateDrug

    Also called Halaven

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

Study groups in NCT02404506
Study groupRoleWhat they receive
Arm: Eribulin mesilateExperimentalNot described
Receives: Drug: Eribulin mesilate

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: 24 weeks

Secondary outcomes (6)

  1. Time to treatment failure (TTF)

    time from registration until treatment discontinuation due to any reason or the occurrence of a second tumor. Patients still on treatment will be censored at the date of their last eribulin administration

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

  2. Objective response (OR)

    A patient is defined as having OR, if she has CR or PR according to RECIST v1.1 at any time point during treatment.

    For the primary analysis, all responses (CR, PR) will be considered, including unconfirmed responses. In a sensitivity analysis, only those responses for which a confirmatory measurement at least 4 weeks later is available will be counted as CR or PR

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

  3. Time to progression (TTP)

    TTP is defined as time from registration until documented progression according to RECIST v1.1 or death due to tumor.

    Patients not experiencing an event and patients starting a new anticancer therapy in the absence of an event will be censored at the date of their last available tumor assessment showing non-progression.

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

  4. Overall survival (OS)

    OS is defined as time from registration until death from any cause. Patients not experiencing an event will be censored at the last date they were known to be alive.

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

  5. Adverse events (AEs)

    AEs will be assessed according to NCI CTCAE v4.0.

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

  6. Patient reported neuropathy (PRO Form) and characterization of patients based on cancer-specific geriatric assessment (C-SGA)

    Measured: at the first follow-up visit (at the latest 5 years after registration)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Mar 2015 (estimated)
  2. Study start17 Aug 2015
  3. Primary completion30 Dec 2020
  4. Study completion22 Jul 2021

Why it stopped: The trial was prematurely terminated as of 22.07.2021 as per SAKK board decision board decision from 14th of November 2020. The trial was terminated after the primary endpoint was analyzed, which was the case end of December 2020.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
78 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02404506
Sponsor's protocol ID
SAKK 25/14
Other IDs
000001310
Status last verified
Sep 2021
First submitted
26 Mar 2015
Last updated
29 Sep 2021
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Eribulin mesilate in people with Breast Cancer and Adenocarcinoma, run by Swiss Cancer Institute at 26 sites in Switzerland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 29 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 26 sites in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: The trial was prematurely terminated as of 22.07.2021 as per SAKK board decision board decision from 14th of November 2020. The trial was terminated after the primary endpoint was analyzed, which was the case end of December 2020.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Disease Control (DC) (time frame: 24 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02404506.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2021.

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