protocol (ERIBRAIN study) on the evaluation of the efficacy of chemotherapy (called Halaven® or eribulin) in the context of the management of brain metastases secondary to breast cancer that does not overexpress the HER2 protein.

Phase 1

• Conditions: HER2-negative breast cancer with brain metastases; MedDRA version: 20.1Level: PTClassification code 10055113Term: Breast cancer metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2018-001027-40-FR
• Lead Sponsor: Institut Paoli-Calmettes

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-06-27
• Last Update Posted: 24 September 2018

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 95

Inclusion Criteria

1.At least 18 years of age.
2.Life expectancy of 3 months or longer.
3.ECOG performance status of 0, 1, or 2.
4.HER2-negative (IHC 0/1+ or 2+ and in situ hybridization negative) metastatic breast cancer
5.Locally advanced or metastatic breast cancer that have progressed after at least one chemotherapeutic regimen for advanced disease. Prior therapy should have included an anthracycline and a taxane in either the adjuvant or metastatic setting unless pa-tients were not suitable for these treatments. (no limit to the number of previous lines of therapy, no need for extracranial disease)
6.At least 2 weeks washout period post chemotherapy, targeted or biologic therapy, or radiation therapy is required prior to study entry
7.Patient with untreated CNS disease or previous SRS/surgery without WBRT (cohorts A and B)
-At least 1 measurable CNS lesion = 10 mm on T1-weighted gadolinium-enhanced MRI, OR
-At least one CNS tumor measuring 5-9 mm in longest diameter, plus one or two addi-tional CNS tumors measuring = 3 mm in longest diameter, for which the sum of the longest diameters is = 10 mm.
8.Patient with progressive disease harboring brain metastases after previous WBRT (cohort C)
-At least 1 measurable CNS lesion = 10 mm on T1-weighted gadolinium-enhanced MRI, OR
-At least one CNS tumor measuring 5-9 mm in longest diameter, plus one or two addi-tional CNS tumors measuring = 3 mm in longest diameter, for which the sum of the longest diameters is = 10 mm.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 70
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 25

Exclusion Criteria

1.Prior therapy with eribulin.
2.Patients should not have had major surgery or radiotherapy (therapeutic and/or pallia-tive) within 14 days prior to initiation of study treatment, including CNS-directed radia-tion therapy. (Minor procedures, such as tumor biopsy, thoracentesis, or intravenous catheter placement are allowed with no waiting period)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified