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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02061085
Recruitment Status : Completed
First Posted : February 12, 2014
Last Update Posted : March 22, 2016
Sponsor:
Information provided by (Responsible Party):
MedSIR

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 53 participants
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 : July 2013
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

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



Primary Outcome Measures :
  1. Median time to disease progression and treatment benefit variable [ Time Frame: Up to two years from the last dose ]

Secondary Outcome Measures :
  1. Objective response rate [ Time Frame: Up to one year from the first dose ]
  2. Clinical benefit rate [ Time Frame: Up to one year from the first dose ]
  3. Time until progression after the treatment [ Time Frame: Up to two years from the last dose ]
  4. Median duration of response [ Time Frame: Up to one year from the first dose ]
  5. Safety of eribulin in terms of adverse reactions [ Time Frame: Up to two years form the last dose ]
  6. 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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02061085


Locations
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Spain
Zaragoza, Aragón, Spain
Oviedo, Asturias, Spain
Salamanca, Castilla y León, Spain
Barcelona, Cataluña, Spain
Badajoz, Extremadura, Spain
La Coruña, Galicia, Spain
Palma de Mallorca, Illes Balears, Spain
Gran Canaria, Islas Canarias, Spain
Pamplona, Navarra, Spain
Madrid, Spain
Valencia, Spain
Sponsors and Collaborators
MedSIR
Investigators
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Principal Investigator: Antonio Llombart, MD Valencia

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Responsible Party: MedSIR
ClinicalTrials.gov Identifier: NCT02061085     History of Changes
Other Study ID Numbers: OBU-SW-H-02
First Posted: February 12, 2014    Key Record Dates
Last Update Posted: March 22, 2016
Last Verified: March 2015

Keywords provided by MedSIR:
Breast Neoplasm Metastasis
Receptor,HER-2
Eribulin
Furans, quetones
Antimitotic agent

Additional relevant MeSH terms:
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Neoplasm Metastasis
Breast Neoplasms
Neoplastic Processes
Neoplasms
Pathologic Processes
Neoplasms by Site
Breast Diseases
Skin Diseases