Phase II study, open label, single arm, evaluating the efficacy of neoadjuvant eribulin mesylate in patients with triple negative breast cancer

A phase II, open label, single arm trial of neoadjuvant therapy in patients with triple negative breast cancer evaluating the efficacy of eribulin mesylate following anthracycline and taxane and correlative science studies attempting to identify predictors of response - Neoadjuvant eribulin

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2012-004956-12-IT

Enrollment

Registered

2013-01-11

Start date

2013-05-17

Completion date

Unknown

Last updated

2018-02-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Triple negative breast cancer, operable or locally advanced MedDRA version: 14.1 Level: SOC Classification code 10029104 Term: Neoplasms benign, malignant and unspecified (incl cysts and polyps) System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Interventions

Trade Name: HALAVEN*EV 6FL 2ML 0,44MG/ML Pharmaceutical Form: Injection INN or Proposed INN: ERIBULIN MESYLATE CAS Number: 441045-17-6 Concentration unit: mg/ml milligram(s)/millilitre Concentration t

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: tumor >= 2 cm N0-2a M0 HER2 negative ER PgR negative Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 48 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 48

Exclusion criteria

Exclusion criteria: prior treatment for breast cancer metastatic cancer bilateral invasive breast cancer multicentric breast cancer pre-existing peripheral neuropathy

Design outcomes

Primary

Measure	Time frame
Main Objective: Pathological complete response in breast and axilla;Secondary Objective: Clinical objective response rate breast conservation rate safety efficacy of eribulin predictive value of PET;Primary end point(s): pCR;Timepoint(s) of evaluation of this end point: 18 months	—

Secondary

Measure	Time frame
Secondary end point(s): ORR metabolic response safety grade 3/4 hematologic toxicity dose reductions and dose delays;Timepoint(s) of evaluation of this end point: 18 months	—

Countries

Italy

Contacts

Public ContactTrial Center

Istututo Nazionale dei tumori di Milano

trialcenter@istitutotumori.mi.it0223903824

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026