HER2-negative Metastatic Breast Cancer MedDRA version: 20.0 Level: PT Classification code 10073100 Term: Metaplastic breast carcinoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 20.1 Level: PT Classification code 10055113 Term: Breast cancer metastatic System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: HALAVEN - 0.44MG/ML - SOLUZIONE INIETTABILE - USO ENDOVENOSO - FLACONCINO(VETRO) 2ML 6 FLACONCINI
Product Name: HALAVEN
Product Code: [Eribulina]
Pharmaceutical Form: Solution for injectio
Sponsors
CONSORZIO ONCOTECH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Written informed consent (both for clinical and blood biomarker study); 2. Histological diagnosis of HER2 negative MBC; 3. Females >= 18; 4. Measurable disease (according RECIST criteria version 1.1) 5. Prior Anthracyclines and Taxanes 6. 1 prior cytotoxic regimen for advanced or MBC (not including adjuvant or neo-adjuvant therapy). Patients with no prior cytotoxic regimens for advanced or metastatic disease will only be allowed if they relapsed during or within 6 months of (neo-) adjuvant cytotoxic therapy that included anathracyclines and taxanes; 7. Prior hormonotherapy and Cyclines inhibitors are allowed, so as indicated in the international guidelines for the management of hormone positive breast cancer (ER and/or PR positive); 8. ECOG Performance Status = 9.0 g/dl; absolute neutrophil count >= 1.5x103/mm3; plateled count >= 100x103/mm3; bilirubin levels =65 years) yes F.1.3.1 Number of subjects for this age range 15
Exclusion criteria
Exclusion criteria: 1. Unability to give informed consent; 2. Absence of measurable disease; 3. Concurrent active malignancies (except of in situ carcinoma of the cervix and inactive non-melanoma skin cancer); 4. Current active infection; 5. Serious pre-existing medical conditions or serious concomitant diseases; 6. Systemic disorders that would compromise the safety of the patient or her ability to complete the study, at the discretion of the investigator (for example, unstable angina pectoris, or a clinically significant history of cardiac disease or uncontrolled diabetes mellitus); 7. Known immunodeficiency virus infection; 8. Pregnant or breastfeeding women; 9. Unable to undergo medical test for geographical, social or psychological reason 10. Active or symptomatic brain metastases.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Verify: - What is the correct placement of Eribulin in the context of a long term treatment strategy - if an early use of Eribulin is the best approach for MBC pts treatment - if early use of Eribulin can impact on subsequent treatment outcomes;Secondary Objective: - Survival assessment - Quality of life - Exploratory evaluations (liquid biopsies and ctDNA evaluation could help to monitor the course of the disease and to identify novel biomarkers of drug resistance);Primary end point(s): Total Progression-Free Survival (PFS-T);Timepoint(s) of evaluation of this end point: Between randomization and the first event among the following: • the date of progression after the second treatment on study – whichever the second treatment will be according to intention-to-treat (eventual departures from treatments planned in the protocol will be described) • the date of death if death occurs before second progression | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Overall Survival from the date of randomization - Health-related Quality of Life (QoL) - Disease Control Rate (DCR: proportion of patients obtaining complete response or partial response or stable disease >= 6 months): in second line; In third line; In second and/or third line - Post Progression Survival (PPS);Timepoint(s) of evaluation of this end point: - At disease progression/death - At screening /at tumor assessment / at progression | — |
Countries
Italy
Contacts
Public ContactCRO
Clinical Research Technology
Outcome results
None listed