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Brief Title: Trial With Eribulin or Eribulin+ Endocrine Therapy in Locally-recurrent or Metastatic Breast Cancer Patients
Official Title: A Multicenter, Randomized, Phase II Trial Evaluating the Efficacy of Eribulin Monotherapy and Eribulin Plus Endocrine Therapy in Locally-recurrent or Metastatic Breast Cancer Patients After Progression on Endocrine Therapy (REVERT)
Study ID: NCT03795012
Brief Summary: Unresectable, ER-positive and/or PR-positive and HER2-negative locally-recurrent or metastatic breast cancer (mBC).
Detailed Description: Pre- and post-menopausal women age ≥ 18 years with unresectable, ER-positive and/or PR-positive and HER2-negative locally-recurrent or metastatic breast cancer (mBC) with no prior line of chemotherapy in the metastatic setting, and that have shown progression while on an aromatase inhibitor-containing regimen in the metastatic setting or within six months from last aromatase inhibitor dose in the adjuvant setting. Patients must have received at least one taxane or anthracycline regimen in either the adjuvant or the neoadjuvant setting. Subjects must have adequate bone marrow and creatinine clearance functions.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Hospital de Jaén, Jaen, Jaén, Spain
Hospital Quiron Dexeus, Barcelona, Please Select, Spain
Institut Català d'Oncologia, Girona, , Spain
Complejo Asistencial Universitario de León, León, , Spain
Hospital Ramón y Cajal, Madrid, , Spain
Hospital Universitario La Paz,, Madrid, , Spain
Hospital Son Llatzer, Palma De Mallorca, , Spain
Hospital Universitario Dr Peset, Valencia, , Spain
Hospital Miguel Servet, Zaragoza, , Spain
Name: Javier Cortés, PhD
Affiliation: MedSIR
Role: PRINCIPAL_INVESTIGATOR