PADA-1: a randomized, open label, multicentric phase III trial to evaluate the safety and efficacy of palbociclib in combination with hormone therapy driven by circulating DNA ESR1 mutation monitoring in ER-positive, HER2-negative metastatic breast cancer

Congress : ASCO

Authors : Francois-Clement Bidard, Renaud Sabatier, Frederique Berger, Barbara Pistilli, Florence Dalenc, Thibault de la Motte Rouge, Jean-Sébastien Frenel, Coraline Dubot, Sylvain Ladoire, Jean-Marc Ferrero, Laetitia Stefani, Alain Lortholary, Anne-Claire Hardy-Bessard, Julien Grenier, Sibille Everhard, Emmanuelle Jeannot, Charlotte Proudhon, Jerome Lemonnier, Suzette Delaloge, Thomas Bachelot

Experts group or program : French Breast Cancer Intergroup (UCBG)


Palbociclib (Pal) combined with an aromatase inhibitor (AI) is a standard of care as first line therapy in estrogen receptor-positive (ER+) HER2-negative (HER2-) metastatic breast cancer (MBC). The efficacy of Pal+AI may be however limited by the onset of ESR1 mutations during therapy as a mechanism of resistance to AI, while pre-clinical and retrospective clinical data suggest that ESR1-mutated clones remain sensitive to fulvestrant (Ful). Rising ESR1 mutation levels might be detected in ctDNA several months before actual tumor progression. This clinical utility trial tests whether switching from AI-Pal to Ful-Pal after the onset of rising ESR1 mutations will turn into a clinical benefit for patients; the safety of these treatments will also be evaluated.


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