CCS Associates, Inc. (CCSA) is proud to be a partner to Alliance for Clinical Trials in Oncology Foundation, LLC (AFT), a non-profit foundation, in support of the foundation’s mission to help answer important treatment questions through large-scale oncology clinical trials. Across many projects, CCSA provides regulatory and clinical monitoring and management support for the AFT and Austrian Breast & Colorectal Cancer Study Group (ABCSG) largest global Phase 3 trial of targeted therapy, IBRANCE® (Palbociclib), for patients with hormone receptor-positive early breast cancer.
IBRANCE® has received accelerated approved in February 2015 by the U.S. Food and Drug Administration for the treatment of postmenopausal women with estrogen receptor-positive (ER+)/HER2- advanced breast cancer as initial endocrine-based therapy for their metastatic disease.
The 10-year AFT/ABCSG-sponsored trial 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”) started in August 2015 to determine whether the addition of Palbociclib to adjuvant endocrine therapy will improve outcomes over endocrine therapy alone for HR+/HER2- Stage 2 and Stage 3 breast cancer. The trial is open and enrolling (NCT02513394) in several states in United States and Austria and opening in other countries in 2016–2017. The estimated study completion date is September 2025.