PALLAS: PALbociclib CoLlaborative Adjuvant Study: A randomized phase III trial of Palbociclib with standard adjuvant endocrine therapy versus standard adjuvant endocrine therapy alone for hormone receptor positive (HR+) / human epidermal growth factor receptor 2 (HER2)-negative early breast cancer
Clinical Trial Information
Trial Contact: Morales, Leticia; Pelley, Jennifer; Jobson, Gillian S
IRB No: 17.026.03
Protocol Abbrev: NSABP B-57
Principal Investigator: Nikita Chandrakant Shah, MD
Sub Investigators: Baidas, Said MD; Cuesta, Ana MD; Moroose, Rebecca MD; Rostorfer, Regan MD
Phase: Drug: Phase III
Age Group: Adult
Secondary Protocol No: PALLAS
Applicable Disease Sites: Breast Cancer
Therapies Involved: Palbociclib
ClinicalTrials.gov ID: NCT02513394
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).
Pre- and postmenopausal women or men with Stage II (Stage IIA limited to max. 1000 patients) or Stage III early invasive breast cancer
Patients with multicentric and/or multifocal and/or bilateral early invasive breast cancer are eligible if all histopathologically examined tumors meet pathologic criteria for ER+ and/or PR+ and HER2-.
Patients must have histologically confirmed ER+ and/or PR+, HER2-, early invasive breast cancer.
Patients must have undergone breast surgery for the current malignancy. FFPE tumor tissue block must be confirmed to be received at the central sample repository prior to randomization.
ECOG performance status 0-1
Patients who received neo/adjuvant therapy must be after last dose of chemotherapy and/or biologic therapy and must have sufficient resolution of side effects.
Patients who received breast/axilla/post-mastectomy chest wall radiotherapy must be after last dose of radiotherapy and must have sufficient resolution of side effects.
Patients must either be initiating or have already started adjuvant hormonal treatment