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

Breast Cancer Clinical Trial

— HERMIONE-10  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05302778
• Other study ID #: HERMIONE-10
• Status: Recruiting
• Start date: March 22, 2021
• Est. completion date: December 2023

Study information

• Verified date: May 2023
• Source: University of Milano Bicocca
• Contact: Marina E. Cazzaniga, MD
• Phone: +39/0392339037
• Email: marina.cazzaniga[@]asst-monza.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 2023
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Metastatic Breast Cancer
• Triple Negative Breast Cancer
• Triple Negative Breast Neoplasms

Locations

Country	Name	City	State
Italy	ASST Monza	Monza
Italy	Oncologia Medica Policlinico Universitario Palermo	Palermo
Italy	OSPEDALE LA MADDALENA, Palermo	Palermo

Sponsors (2)

Lead Sponsor	Collaborator
University of Milano Bicocca	EISAI s.r.l.

Country where clinical trial is conducted

Italy, 

Outcome

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