Monotherapy With Eribulin In Her2 Negative Metastatic Breast Cancer as a First Line Treatment (MERIBEL)

A Phase IIa Prospective, Multicenter, Open and Not Controlled of the Efficacy and Tolerability on the First Line Treatment With Eribulin as a Unic Agent on Patients With HER2 Negative Metastatic Breast Cancer Previously Treated With Taxanes

Multicentre, prospective, non-controlled phase II clinical trial to evaluate the efficacy and tolerability of first line single agent Eribulin in patients with HER2-negative metastatic breast carcinoma previously exposed to taxanes for early stage.

The primary objective of the study is to determine the median time to progression achieved with Eribulin. Other secondary objectives will be; overall response rate, clinical benefit rate, time to treatment progression, duration of response and toxicity profile.

Study Overview

• Status: Completed
• Conditions: Breast Neoplasm; Metastasis
• Intervention / Treatment: Drug: Eribulina

• Study Type: Interventional
• Enrollment (Actual): 53
• Phase: Phase 2

Contacts and Locations

Study Locations

• Spain
  • Madrid, Spain
  • Valencia, Spain
  • Aragón
    • Zaragoza, Aragón, Spain
  • Asturias
    • Oviedo, Asturias, Spain
  • Castilla Y León
    • Salamanca, Castilla Y León, Spain
  • Cataluña
    • Barcelona, Cataluña, Spain
  • Extremadura
    • Badajoz, Extremadura, Spain
  • Galicia
    • La Coruña, Galicia, Spain
  • Illes Balears
    • Palma de Mallorca, Illes Balears, Spain
  • Islas Canarias
    • Gran Canaria, Islas Canarias, Spain
  • Navarra
    • Pamplona, Navarra, Spain

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Histologically confirmed metastatic breast cancer HER2 negative, stage IIIb/IV
• Previous history of early disease (stage I-IIIb), surgically resected and treated with standard chemotherapy for at least 12 weeks at which included a taxane or ixabepilone
• Patients must have progressed in the 36 months after treatment with taxanes or ixabepilone.
• Age ≥ 18 years
• Given written informed consent
• Index of Eastern Cooperative Oncology Group (ECOG) of 0 or 1
• Patients must have recovered from toxicities related with previous treatment (CTC ≥ 1)
• Measurable or evaluable disease (RECIST 1.1)
• Adequate bone marrow function
• Adequate hepatic function
• Adequate renal function
• Life expectancy ≥ 3 months

Exclusion Criteria:

• Breast cancer patients initially diagnosed with local disease advanced or metastatic disease.
• Patients who have previously received cytotoxic therapy Hormone therapy permitted if the patients have interrupted it at least two weeks before the start of the study treatment.
• Major surgery or significant traumatic injury during the 4 weeks prior to study treatment or patients who may require major surgery during the assay.
• Brain metastases or leptomeningeal uncontrolled.
• Serious medical condition and / or not properly controlled (unstable angina, lung function severe impaired, uncontrolled diabetes, active serious infection,liver disease, HIV seropositivity, active bleeding diathesis)
• Other malignancies in the last three years, except: cervical carcinoma in situ, basal cell carcinoma or squamous cell skin carcinoma,that have been properly treated
• Patients who are pregnant or breastfeeding, or adults with reproductive capacity wich are not using effective contraception.
• Patients receiving chronic treatment with systemic corticosteroids or other immunosuppressive drugs (except corticosteroids with a daily dose equivalent to prednisone ≤ 20mg on a stable dose regimen one minimum of 4 weeks prior to study entry. Topical and inhaled corticosteroids are allowed
• Active alcoholism or drugs addiction documented.
• Prior history of noncompliance with medical regimens
• Patients who do not want or can not comply with the study protocol

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: monotherapy treatment with Eribulin; Eribulin Dosage: 1.4 mg/m2 Route of administration: IV bolus Schedule of cycle: D1 and D8 every 21 days	Drug: Eribulina

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Median time to disease progression and treatment benefit variable	Up to two years from the last dose

Secondary Outcome Measures

Outcome Measure	Time Frame
Objective response rate	Up to one year from the first dose
Clinical benefit rate	Up to one year from the first dose
Time until progression after the treatment	Up to two years from the last dose
Median duration of response	Up to one year from the first dose
Safety of eribulin in terms of adverse reactions	Up to two years form the last dose
Utility functional hepatic levels as criteria for dose modifications instead of the Child-Pugh classification system for the assessment of liver involvement	Up to one year form the last dose

Collaborators and Investigators

• Sponsor: MedSIR
• Investigators: Principal Investigator: Antonio Llombart, MD, Valencia

Study record dates

Study Major Dates

• Study Start: July 1, 2013
• Primary Completion (Actual): December 1, 2015
• Study Completion (Actual): December 1, 2015

Study Registration Dates

• First Submitted: January 10, 2014
• First Submitted That Met QC Criteria: February 11, 2014
• First Posted (Estimate): February 12, 2014

Study Record Updates

• Last Update Posted (Actual): November 27, 2020
• Last Update Submitted That Met QC Criteria: November 25, 2020
• Last Verified: March 1, 2015

More Information

Terms related to this study

• Keywords: Eribulin; Breast Neoplasm Metastasis; Receptor,HER-2; Furans, quetones; Antimitotic agent
• Additional Relevant MeSH Terms: Pathologic Processes; Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Neoplastic Processes; Breast Neoplasms; Neoplasm Metastasis
• Other Study ID Numbers: OBU-SW-H-02; 2012-004463-41 (EudraCT Number)