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

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ClinicalTrials.gov Identifier: NCT02061085
Recruitment Status : Completed
First Posted : February 12, 2014
Last Update Posted : November 27, 2020
Sponsor:
Information provided by (Responsible Party):
MedSIR

Tracking Information
First Submitted Date  ICMJE January 10, 2014
First Posted Date  ICMJE February 12, 2014
Last Update Posted Date November 27, 2020
Study Start Date  ICMJE July 2013
Actual Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 11, 2014)
Median time to disease progression and treatment benefit variable [ Time Frame: Up to two years from the last dose ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 11, 2014)
  • Objective response rate [ Time Frame: Up to one year from the first dose ]
  • Clinical benefit rate [ Time Frame: Up to one year from the first dose ]
  • Time until progression after the treatment [ Time Frame: Up to two years from the last dose ]
  • Median duration of response [ Time Frame: Up to one year from the first dose ]
  • Safety of eribulin in terms of adverse reactions [ Time Frame: 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 [ Time Frame: Up to one year form the last dose ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Monotherapy With Eribulin In Her2 Negative Metastatic Breast Cancer as a First Line Treatment
Official Title  ICMJE 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
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Breast Neoplasm
  • Metastasis
Intervention  ICMJE Drug: Eribulina
Study Arms  ICMJE 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
Intervention: Drug: Eribulina
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 18, 2016)
53
Original Estimated Enrollment  ICMJE
 (submitted: February 11, 2014)
60
Actual Study Completion Date  ICMJE December 2015
Actual Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02061085
Other Study ID Numbers  ICMJE OBU-SW-H-02
2012-004463-41 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party MedSIR
Study Sponsor  ICMJE MedSIR
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Antonio Llombart, MD Valencia
PRS Account MedSIR
Verification Date March 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP