A randomized phase III trial of palbociclib with adjuvant endocrine therapy versus endocrine therapy alone for hormone receptor positive (HR+)/ human epidermal growth factor receptor 2 (HER2)-negative early breast Cancer
Type of Study: Clinical Trial
Sponsor / Support: ABCSG, ALLIANCE
Primary Objectives: To compare invasive disease-free survival (iDFS) for the combination of at least 5 years of endocrine therapy plus 2 years of palbociclib treatment versus at least 5 years endocrine therapy alone in patients with histologically confirmed HR-positive/HER2-negative early breast cancer (EBC).
Design: This is a prospective, international, multicenter, randomized, open label Phase III study evaluating the addition of 2 years of palbociclib to at least 5 years of standard adjuvant endocrine therapy for patients with HR+/ HER2-negative EBC.
Sample Size: 4.600 patients
Principal Investigator: Gustavo Werutsky (Steering Committee – LACOG)
Countries LATAM: Mexico
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