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

NCT05302778 | Unknown

• 1 other identifier: HERMIONE-10
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 3

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.

Conditions

Breast Cancer; Metastatic Breast Cancer; Triple Negative Breast Cancer

Keywords

breast cancer; triple negative; second line; eribulin; real world

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Time to progression (TTP)

  Entire study duration, approximately 3 years

• Overall Response Rate (ORR)

  Entire study duration, approximately 3 years

• Disease Control Rate (DCR)

  Entire study duration, approximately 3 years

• Site of progression

  Entire study duration, approximately 3 years

• Duration of response and disease control

  Entire study duration, approximately 3 years

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with metastatic triple negative breast cancer

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Milano Bicocca: lead
• EISAI s.r.l.: collaborator

Study Sites (3)

ASST Monza

Monza, Italy

RECRUITING

Oncologia Medica Policlinico Universitario Palermo

Palermo, Italy

NOT YET RECRUITING

OSPEDALE LA MADDALENA, Palermo

Palermo, Italy

NOT YET RECRUITING

MeSH Terms

Conditions

Breast Neoplasms; Triple Negative Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Marina E. Cazzaniga, MD

CONTACT

+39/0392339037; marina.cazzaniga@asst-monza.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 15, 2022
• First Posted: March 31, 2022
• Study Start: March 22, 2021
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: May 25, 2023

Record last verified: 2023-05

Locations

IT (3)