Spots Global Cancer Trial Database for Eribulin as a Second-line Treatment in Triple-negative Advanced Breast Cancer

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Trial Identification

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

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

Study ID: NCT05302778

Conditions

Breast Cancer

Metastatic Breast Cancer

Triple Negative Breast Cancer

Interventions

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.

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.