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
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
This is a prospective, two arm, international, multicenter, randomized, open-label Phase III study evaluating the addition of 2 years of palbociclib to standard adjuvant endocrine therapy for patients with HR+ / HER2- early breast cancer (EBC).
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.
Inclusion Criteria:
FFPE tumor tissue block must be confirmed to be received at the central sample repository prior to randomization.
-Patients must either be initiating or have already started adjuvant hormonal treatment. -
Exclusion Criteria:
Long Beach, California 90806, United States
South San Francisco, California 94080, United States
New Britain, Connecticut 06053, United States
Washington D.C., District of Columbia 20037, United States
Miami, Florida 33136, United States
Indianapolis, Indiana 46202, United States
Bangor, Maine 04401, United States
Baltimore, Maryland 21237, United States
Baltimore, Maryland 21701, United States
Plymouth, Massachusetts 02360, United States
Saint Louis Park, Minnesota 55416, United States
East Syracuse, New York 13057, United States
Pinehurst, North Carolina 28374, United States
Philadelphia, Pennsylvania 19104, United States
Pittsburgh, Pennsylvania 15232, United States
Rapid City, South Dakota 57701, United States
Houston, Texas 77030, United States
Kelowna, British Columbia V1Y5L3, Canada
Kingston, Ontario K7L5P9, Canada
Budapest, 1122, Hungary
Budapest, 1145, Hungary
Szeged, 6720, Hungary
Florence, 50134, Italy
Meldola, 47014, Italy
Parma, 43100, Italy
Nagoya, Aichi-ken 467-8601, Japan
Sapporo, Hokkaido 003-0804, Japan
Warsaw, 02-781, Poland
Seoul, 06351, South Korea
Madrid, 28050, Spain
Sant Joan Despì, 08970, Spain
Tainan, 704, Taiwan