The PEARL study did not demonstrate a statistical superiority in progression-free survival (PFS) for palbociclib + exemestane versus capecitabine in metastatic breast cancer patients who progress to aromatase inhibitors, neither did it demonstrate superiority of palbociclib + exemestane in the luminal subgroup. Treatment with palbociclib + exemestane was generally better tolerated than capecitabine.
Palbociclib is approved for use in combination with endocrine therapy in hormone receptor (HR)-positive, human epidermal growth factor 2 (HER2)-negative metastatic breast cancer patients in first and later lines. However, the relative value of palbociclib plus endocrine therapy versus chemotherapy in pre-treated patients has not been established yet. PEARL is a multinational, open-label, controlled, randomised phase 3 trial comparing the efficacy and safety of palbociclib in combination with endocrine therapy (exemestane or fulvestrant) versus capecitabine in p...
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