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

Status Recruiting

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.

Clinical Trial 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

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05302778
Study type	Observational
Source	University of Milano Bicocca
Contact	Marina E. Cazzaniga, MD
Phone	+39/0392339037
Email	marina.cazzaniga@asst-monza.it
Status	Recruiting
Phase
Start date	March 22, 2021
Completion date	December 2023

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms