Eribulin as a Second-line Treatment in Triple-negative Advanced Breast Cancer (HERMIONE-10)

May 24, 2023 updated by: University of Milano Bicocca

Observational Study Evaluating the Role of Eribulin as a Second-line Treatment in Triple-negative Advanced Breast Cancer

Multicenter, retrospective and prospective, cohort, observational study evaluating the clinical efficacy and tolerability of Eribulin as second-line treatment in accordance with the indications authorized by AIFA in patients with triple negative advanced breast cancer in a real world setting.

Study Overview

Status

Recruiting

Conditions

Detailed Description

The study, multicenter, retrospective and prospective, cohort, observational, describes the modalities of treatment with Eribulin as a second line therapy for triple negative breast cancer and "clinical outcomes" in a population real-world, evaluating any differences with the results obtained in clinical trials. Therapeutic sequences will also be evaluated with the aim of providing a photograph of the choices made in clinical practice in this historical moment characterized by rapid evolution of new molecules available to clinicians.

A total of at least 200 patients with triple negative advanced breast cancer treated with Eribulin as second line will be enrolled in the retrospective or prospective cohort. Enrollment period will last 2 years.

Pseudoanonymized data will be collected in a electroctronic database (RedCap Cloud); here the list of the main variables collected:

  • Patient Registration
  • Demography
  • Pregnancy test
  • Past history and habits of the patient
  • Previous antineoplastic therapy
  • Anamnesis close to entering the study
  • Vital signs and ECOG performance status (WHO)
  • Blood chemistry tests
  • RECIST 1.1 Baseline and re-evaluations
  • 12 Lead ECG evaluation
  • Eribulin cycles
  • Adverse events
  • Previous and concomitant medications
  • End of study

The retrospective analysis of the choices made in clinical practice and the benefits obtained from the second therapeutic lines could provide important data to favor the definition of prospective randomized studies, and guide the clinician towards a better therapeutic path.

Study Type

Observational

Enrollment (Estimated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Italy
      • Monza, Italy
      • Palermo, Italy
        • Not yet recruiting
        • Oncologia Medica Policlinico Universitario Palermo
        • Contact:
      • Palermo, Italy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Patients with metastatic triple negative breast cancer

Description

Inclusion Criteria:

  • Performance status according to ECOG equal to 0-2
  • Locally advanced or triple negative metastatic breast cancer (HR- and HER2-) confirmed histologically
  • Progressing after first-line chemotherapy for advanced disease
  • Previous anthracyclines and taxanes therapy (in an adjuvant, neoadjuvant or metastatic), unless the patient is ineligible to receive such treatments
  • Treatment with Eribulin mesylate since 2017, in accordance with AIFA indications
  • Adequate haematological, renal and hepatic function, as per clinical practice
  • Written informed consent

Exclusion Criteria:

  • Breast cancer HER2 + or HR +
  • Treatment with Eribulin in the context of clinical studies
  • Patients unsuitable for treatment with Eribulin
  • Diagnosis of other malignancies in the two years prior to enrollment, with one exception of adequately treated localized basal cell or squamous cell carcinomas of the skin o cervical carcinomas undergoing curative treatment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-free survival (PFS)
Time Frame: Entire study duration, approximately 3 years
PFS defined as time from the beginning of treatment to disease progression or death
Entire study duration, approximately 3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to progression (TTP)
Time Frame: Entire study duration, approximately 3 years
TTP defined as the time from the beginning of treatment to disease progression or death
Entire study duration, approximately 3 years
Overall Response Rate (ORR)
Time Frame: Entire study duration, approximately 3 years
OOR defined as the percentage of patients who achieved a partial response (PR) or a complete response (CR) as best response according to RECIST 1.1
Entire study duration, approximately 3 years
Disease Control Rate (DCR)
Time Frame: Entire study duration, approximately 3 years
DCR defined as the percentage of patients who achieved a partial response (PR), a complete response (CR) or a stable disease (SD) as best response according to RECIST 1.1 criteria, according to the site of metastatic disease (bone disease vs visceral disease with or without bone involvement).
Entire study duration, approximately 3 years
Site of progression
Time Frame: Entire study duration, approximately 3 years
Description of sites of progression in patients with first bone relapse
Entire study duration, approximately 3 years
Duration of response and disease control
Time Frame: Entire study duration, approximately 3 years
Duration of response and disease control
Entire study duration, approximately 3 years
Survival after progression
Time Frame: Entire study duration, approximately 3 years
Survival after progression
Entire study duration, approximately 3 years
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time Frame: Entire study duration, approximately 3 years
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Entire study duration, approximately 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Milano Bicocca

Collaborators

EISAI s.r.l.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 22, 2021

Primary Completion (Estimated)

December 1, 2023

Study Completion (Estimated)

December 1, 2023

Study Registration Dates

First Submitted

March 15, 2022

First Submitted That Met QC Criteria

March 29, 2022

First Posted (Actual)

March 31, 2022

Study Record Updates

Last Update Posted (Actual)

May 25, 2023

Last Update Submitted That Met QC Criteria

May 24, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HERMIONE-10

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Breast Cancer

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Suriname

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe