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REVERT

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).

CLINICAL TRIAL DETAILS

THE PRIMARY ENDPOINT IS THE OVERALL RESPONSE RATE IN THE ARM CORRESPONDING TO THE PATIENTS TREATED WITH ERIBULIN IN COMBINATION WITH AROMATASE INHIBITOR THERAPY BASED ON LOCAL INVESTIGATOR’S ASSESSMENT ACCORDING TO RECIST V.1.1

REVERT IS A SIMON’S TWO-STAGE ADMISSIBLE DESIGN CLINICAL TRIAL, 60 PATIENTS WILL BE INCLUDED, 22 IN STAGE I AND 38 IN STAGE II.

PATIENTS WILL RECEIVE ERIBULIN INJECTIONS INTRAVENOUSLY ON DAYS 1 AND 8 OF EVERY 21- DAY CYCLE, ALONE OR IN COMBINATION WITH ENDOCRINE THERAPY (AROMATASE INHIBITOR).

 

REVERT AT CLINICALTRIALS.GOV

TUMOR TYPE

PHASE

BREAST

II

60

9

Spain

N

SITES

COUNTRY

STATUS

Closing

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REVERT SITES

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SPAIN

Hospital Universitario Miguel Servet

SPAIN

Complejo Hospitalario de Jaén

SPAIN

Hospital Universitario Ramón y Cajal

SPAIN

Hospital Universitario La Paz

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Hospital Universitario de León

SPAIN

Hospital Son Llatzer

SPAIN

Hospital Universitari Dexeus

SPAIN

Hospital Universitario Dr. Peset

SPAIN

Institut Català d' Oncologia Girona (ICO)

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