DEBBRAH

CLINICAL TRIAL DETAILS

THIS IS A MULTICENTER, INTERNATIONAL, OPEN-LABEL, SINGLE-ARM, MULTICOHORT, TWO-STAGE OPTIMAL SIMON’S DESIGN, PHASE II CLINICAL TRIAL.

THE STUDY COHORTS ARE DIVIDED IN:

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•    COHORT 1: HER2-POSITIVE BC WITH NON-PROGRESSING BM (AFTER WBRT AND/OR SRS AND OR SURGERY.);

•    COHORT 2: HER2-POSITIVE OR HER2-LOW BC WITH ASYMPTOMATIC UNTREATED BM;

•    COHORT 3: HER2-POSITIVE BC WITH PROGRESSING BMS AFTER LOCAL TREATMENT;

•    COHORT 4: HER2-LOW EXPRESSING BC WITH PROGRESSING BMS AFTER LOCAL TREATMENT;

•    COHORT 5: HER2-POSITIVE OR HER2-LOW EXPRESSING BC WITH LMC.

PRIMARY OBJECTIVE: COHORT 1

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•    TO ASSESS EFFICACY -DEFINED AS 16 WEEKS PROGRESSION-FREE SURVIVAL (PFS)- OF TRASTUZUMAB DERUXTECAN (DS-8201A) IN PATIENTS WITH PRETREATED UNRESECTABLE LOCALLY ADVANCED OR METASTATIC HER2- POSITIVE BC WITH NON-PROGRESSING BM (AFTER WBRT AND/OR SRS AND OR SURGERY.).

COHORTS 2, 3, AND 4

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•    TO ASSESS EFFICACY -DEFINED AS CNS ORR- OF TRASTUZUMAB DERUXTECAN (DS-8201A) IN PATIENTS WITH PRETREATED UNRESECTABLE LOCALLY ADVANCED OR METASTATIC BC: 1.

COHORT 5

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•    TO ASSESS EFFICACY -DEFINED AS OS- OF TRASTUZUMAB DERUXTECAN (DS-8201A) IN PATIENTS WITH PRETREATED UNRESECTABLE LOCALLY ADVANCED OR METASTATIC HER2-POSITIVE OR HER2-LOW EXPRESSING BC WITH LMC.

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DEBBRAH AT CLINICALTRIALS.GOV