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

Sponsor

MedSIR (Other)

Overall Status

Completed

CT.gov ID

NCT02061085

Collaborator

(none)

Enrollment

Locations

Arm

Duration (Months)

4.8

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Breast Neoplasm Metastasis	Drug: Eribulina	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

53 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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 Start Date :

Jul 1, 2013

Actual Primary Completion Date :

Dec 1, 2015

Actual Study Completion Date :

Dec 1, 2015

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Median time to disease progression and treatment benefit variable [Up to two years from the last dose]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	City	State	Country
1	Zaragoza	Aragón	Spain
2	Oviedo	Asturias	Spain
3	Salamanca	Castilla Y León	Spain
4	Barcelona	Cataluña	Spain
5	Badajoz	Extremadura	Spain
6	La Coruña	Galicia	Spain
7	Palma de Mallorca	Illes Balears	Spain
8	Gran Canaria	Islas Canarias	Spain
9	Pamplona	Navarra	Spain
10	Madrid		Spain
11	Valencia		Spain