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

Sponsor

University of Milano Bicocca (Other)

Overall Status

Recruiting

CT.gov ID

NCT05302778

Collaborator

EISAI s.r.l. (Other)

200

Enrollment

Locations

23.3

Anticipated Duration (Months)

66.7

Patients Per Site

2.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer Metastatic Breast Cancer Triple Negative Breast Cancer

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 Design

Study Type:

Observational

Anticipated Enrollment :

200 participants

Observational Model:

Cohort

Time Perspective:

Cross-Sectional

Official Title:

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

Actual Study Start Date :

Mar 22, 2021

Anticipated Primary Completion Date :

Mar 1, 2023

Anticipated Study Completion Date :

Mar 1, 2023

Outcome Measures

Primary Outcome Measures

Progression-free survival (PFS) [Entire study duration, approximately 3 years]
PFS defined as time from the beginning of treatment to disease progression or death

Secondary Outcome Measures

Time to progression (TTP) [Entire study duration, approximately 3 years]
TTP defined as the time from the beginning of treatment to disease progression or death
Overall Response Rate (ORR) [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
Disease Control Rate (DCR) [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).
Site of progression [Entire study duration, approximately 3 years]
Description of sites of progression in patients with first bone relapse
Duration of response and disease control [Entire study duration, approximately 3 years]
Duration of response and disease control
Survival after progression [Entire study duration, approximately 3 years]
Survival after progression
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 [Entire study duration, approximately 3 years]
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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