Back to results

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

Primary Purpose

Breast Neoplasm, Metastasis

Status

Completed

Phase

Phase 2

Locations

Spain

Study Type

Interventional

Intervention

Eribulina

About this trial

This is an interventional treatment trial for Breast Neoplasm focused on measuring Breast Neoplasm Metastasis, Receptor,HER-2, Eribulin, Furans, quetones, Antimitotic agent

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

monotherapy treatment with Eribulin

Arm Description

Eribulin Dosage: 1.4 mg/m2 Route of administration: IV bolus Schedule of cycle: D1 and D8 every 21 days

Outcomes

Primary Outcome Measures

Median time to disease progression and treatment benefit variable

Secondary Outcome Measures

Objective response rate

Clinical benefit rate

Time until progression after the treatment

Median duration of response

Safety of eribulin in terms of adverse reactions

Utility functional hepatic levels as criteria for dose modifications instead of the Child-Pugh classification system for the assessment of liver involvement

Full Information

NCT ID

NCT02061085

First Posted

January 10, 2014

Last Updated

November 25, 2020

Sponsor

MedSIR

1. Study Identification

Unique Protocol Identification Number

NCT02061085

Brief Title

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

Acronym

MERIBEL

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2015

Overall Recruitment Status

Completed

Study Start Date

July 2013 (undefined)

Primary Completion Date

December 2015 (Actual)

Study Completion Date

December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

MedSIR

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Breast Neoplasm, Metastasis

Keywords

Breast Neoplasm Metastasis, Receptor,HER-2, Eribulin, Furans, quetones, Antimitotic agent

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

53 (Actual)

8. Arms, Groups, and Interventions

Arm Title

monotherapy treatment with Eribulin

Arm Type

Experimental

Arm Description

Eribulin Dosage: 1.4 mg/m2 Route of administration: IV bolus Schedule of cycle: D1 and D8 every 21 days

Intervention Type

Drug

Intervention Name(s)

Eribulina

Primary Outcome Measure Information:

Title

Median time to disease progression and treatment benefit variable

Time Frame

Up to two years from the last dose

Secondary Outcome Measure Information:

Title

Objective response rate

Time Frame

Up to one year from the first dose

Title

Clinical benefit rate

Time Frame

Up to one year from the first dose

Title

Time until progression after the treatment

Time Frame

Up to two years from the last dose

Title

Median duration of response

Time Frame

Up to one year from the first dose

Title

Safety of eribulin in terms of adverse reactions

Time Frame

Up to two years form the last dose

Title

Utility functional hepatic levels as criteria for dose modifications instead of the Child-Pugh classification system for the assessment of liver involvement

Time Frame

Up to one year form the last dose

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Antonio Llombart, MD

Organizational Affiliation

Valencia

Official's Role

Principal Investigator

Facility Information:

City

Zaragoza

State/Province

Aragón

Country

Spain

City

Oviedo

State/Province

Asturias

Country

Spain

City

Salamanca

State/Province

Castilla Y León

Country

Spain

City

Barcelona

State/Province

Cataluña

Country

Spain

City

Badajoz

State/Province

Extremadura

Country

Spain

City

La Coruña

State/Province

Galicia

Country

Spain

City

Palma de Mallorca

State/Province

Illes Balears

Country

Spain

City

Gran Canaria

State/Province

Islas Canarias

Country

Spain

City

Pamplona

State/Province

Navarra

Country

Spain

City

Madrid

Country

Spain

City

Valencia

Country

Spain

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs