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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 estrog...

Mise à jour : Il y a 4 ans
Référence : EUCTR2016-004360-18

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 estrogen receptor-positive, HER2-negative metastatic breast cancer patients PADA-1 (PAlbociclib and circulating tumor DNA for ESR1 mutation detection)

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Extrait

Population: STEP 1 • To assess the global safety of the combination of palbociclib + endocrine therapy in the whole population of patients, throughout the study, including the potential sequential administration of fulvestrant plus palbociclib, with focus on hematological toxicities. Population: STEP 2 • To assess whether a change of the hormone therapy associated with palbociclib (namely, an early switch from aromatase inhibitor with palbociclib to fulvestrant with palbociclib following ctDNA detection) will benefit patients in which rising ESR1 mutations are detected during treatment with palbociclib and aromatase inhibitor.

Critère d'inclusion

  • HER-2 negative metastatic breast cancer

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