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PALMIRA

OFFICIAL TITLE: PALBOCICLIB RECHALLENGE IN HORMONE RECEPTOR-POSITIVE/HER2-NEGATIVE ADVANCED BREAST CANCER – PALMIRA.

CLINICAL TRIAL DETAILS

INTERNATIONAL, MULTICENTER, RANDOMIZED, OPEN-LABEL, PHASE II CLINICAL TRIAL TO EVALUATE THE EFFICACY AND SAFETY OF CONTINUATION OF PALBOCICLIB IN COMBINATION WITH SECOND-LINE ENDOCRINE THERAPY IN HORMONE RECEPTOR-POSITIVE/HER2-NEGATIVE ADVANCED BREAST CANCER PATIENTS WHO HAVE ACHIEVED CLINICAL BENEFIT DURING FIRST-LINE PALBOCICLIB-BASED TREATMENT.

THE PRIMARY GOAL IS TO COMPARE THE EFFICACY, DEFINED AS PROGRESSION-FREE SURVIVAL (PFS), OF CONTINUATION OF PALBOCICLIB TREATMENT COMBINED WITH SECOND-LINE ENDOCRINE THERAPY (FULVESTRANT OR LETROZOLE) VERSUS ENDOCRINE THERAPY ALONE IN PRE- AND POST-MENOPAUSAL WOMEN WITH HR-POSITIVE/HER2-NEGATIVE ADVANCED BREAST CANCER (ABC).

IN ADDITION, TO EXPLORE POTENTIAL MOLECULAR MARKERS OF SENSITIVITY AND/OR RESISTANCE FOR THE COMBINATION AND ENDOCRINE THERAPY ALONE.

 

PALMIRA AT CLINICALTRIALS.GOV

TUMOR TYPE

PHASE

N

SITES

COUNTRY

STATUS

HER2+ ABC

II

198

54

Spain, France, Italy, UK, Germany, Slovenia

Closing

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