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CALADRIO

OFFICIAL TITLE: PROSPECTIVE EVALUATION OF MICROBIOME AS A POTENTIAL PREDICTIVE FACTOR FOR IMMUNOTHERAPY IN LUMINAL-LIKE BREAST CANCER WITHIN THE KELLY CLINICAL STUDY.

CLINICAL TRIAL DETAILS

THE CALADRIO PROJECT IS A SUB-STUDY OF THE KELLY TRIAL (MEDOPP127, EUDRACT#: 2016-004513-27, NCT03222856) WITH THE AIM OF CHARACTERIZING THE MICROBIOME AS A POTENTIAL PREDICTIVE FACTOR OF RESPONSE TO ANTI-PD‑1 IMMUNOTHERAPY PEMBROLIZUMAB IN PATIENTS WITH HORMONE RECEPTOR (HR)‑POSITIVE/HUMAN EPIDERMAL GROWTH FACTOR RECEPTOR 2 (HER2)-NEGATIVE METASTATIC BREAST CANCER (MBC) PREVIOUSLY TREATED WITH ANTHRACYCLINES AND TAXANES.

THE CALADRIO SUBSTUDY ASSESSES THE IMPACT OF GUT AND ORAL MICROBIOTA ON THE CLINICAL OUTCOME OF PATIENTS FROM THE KELLY TRIAL.


 
CALADRIO AT CLINICALTRIALS.GOV
 

TUMOR TYPE

PHASE

N

SITES

COUNTRY

STATUS

BREAST

N/A

28

11

Spain

Analysis

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