Clinical Trials

Title   PALLAS
Principal Investigator/ Physician   Carole Norden, MD
Protocol┬áNo.   PALLAS AFT-05
Open Date   09/01/2016
Cancer Site   Breast
Status   Open
Sponsor   Alliance for Clinical Trials in Oncology
Contact Email   MCI Clinical Trials

Protocol Title:  "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."

Inclusion Criteria: ECOG performance status 0-1; pre and postmenapausal women or men with stage II (Stage IIA limited to a max of 100 patients) or stage III early invasive breast cancer; patients with multicentric and/or multifocal and/or bilateral early invasive breast cancer whose histopathologically examined tumors all meet pathologic criteria for ER+ and/or PR+ and HER2-; patients must have undergone breast surgery for current malignancy; patients must be after last dose of chemotherapy and/or biologic therapy; patients must be after last dose of radiotherapy; patients must have sufficient resolution of any surgical side effects; patients must either be initiating or already started adjuvant hormonal treatment; patients who received neoadjuvant endocrine therapy are eligible as long as they are enrolled within 12 months of initial histological diagnosis and after completing no more than 6 months of adjuvant endocrine therapy

Exclusion Criteria: Prior therapy with any CDK inhibitor; patients with stage I or IV breast cancer; history of allergic reaction attributed to compounds of chemical or biologic composition similar to palbociclib


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