Phase I/II Study of AZD2014 given in combination with palbociclib on a background of fulvestrant for treatment of advanced ER + breast cancer that is locally advanced or has spread to other parts of t...

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Référence : EUCTR2015-003320-30

Phase I/II Study of AZD2014 given in combination with palbociclib on a background of fulvestrant for treatment of advanced ER + breast cancer that is locally advanced or has spread to other parts of the body

Femme Homme

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Extrait

PARTS A, B1, B2: To investigate the safety and tolerability of the triplet combination (AZD2014 and palbociclib on a background of fulvestrant) in the patient groups. PART B3: To investigate the impact on exposure to AZD2014 and palbociclib when administered in the triplet combination compared to each drug without the other in the Part B3 patient group. PART C: To assess the efficacy of the triplet combination compared to the doublet combination through assessment of Progression Free Survival in the Part C patient group.


Critère d'inclusion

  • Locally advanced or metastatic estrogen receptor positive breast cancer