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

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