NSABP Agreement: B-57-I PALLAS

Grants and Contracts Details

Description

Although many patients with HR+/HER2- breast cancer may be cured of their disease with optimal local and systemic therapy, a significant number of patients with stage II and III disease will experience disease recurrence. Adjuvant endocrine therapy for breast cancer can be extremely effective, particularly with extension beyond 5 years, however disease recurrence can occur, with risk distributed over the decades following initial diagnosis. Methods to improve the efficacy of endocrine therapy, and delay the onset of resistance, are needed. HR+ breast cancer biologically may demonstrate features suggestive of sensitivity to CDK4/6 inhibition with agents such as palbociclib. Given the demonstrated activity and safety of palbociclib in the first-line treatment of metastatic HR+/ HER2- breast cancer, supporting FDA approval, there is interest in whether the benefits of CDK4/6 inhibition may translate into the adjuvant setting. The purpose of the PALLAS study is to determine whether the addition of palbociclib to adjuvant endocrine therapy will improve outcomes over endocrine therapy alone for HR+/HER2- early breast cancer. Assessment of a variety of correlative analysis, including evaluation of the effect of palbociclib in genomically defined tumor subgroups, is planned. Primary Objective: To compare invasive disease-free survival (iDFS) for the combination of at least 5 years endocrine therapy and 2-year palbociclib treatment versus at least 5 years endocrine therapy alone in patients with histologically confirmed HR+/HER2- invasive early breast cancer (EBC).
StatusActive
Effective start/end date4/1/1610/10/24

Funding

  • NSABP Foundation: $138,800.00

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