July 6, 2021
TRIO Completes Enrolment For Phase 2 Giredestrant Early Breast Cancer Trial Ahead Of Schedule
Edmonton, AB, July 6, 2021 – Translational Research in Oncology (TRIO), a global academic clinical research organization, announced today enrolment completion in coopERA Breast Cancer (WO42133/TRIO038), a Phase 2 randomized, multi-center, open-label clinical trial of giredestrant (GDC-9545) sponsored by F. Hoffmann-La Roche. This comes shortly after completion of the planned study interim analysis provided encouraging results and supported continuation of the study.
Giredestrant is an oral selective estrogen receptor degrader (SERD) that was shown to be well tolerated with encouraging tumour activity both alone and in combination with palbociclib in estrogen-receptor positive (ER+) metastatic breast cancer patients.
The trial is investigating the ability to expand the safety and efficacy of giredestrant as monotherapy and in combination with palbociclib into the early breast cancer setting. Enrolment of 221 patients was completed three months ahead of schedule. The trial design evaluates the efficacy, safety, and pharmacokinetics of presurgical treatment with giredestrant plus palbociclib compared with anastrozole plus palbociclib for postmenopausal women with ER+ and HER2-negative untreated early breast cancer.
“To have patient enrolment completed three months ahead of schedule, despite the global pandemic, reinforces the strength of commitment of TRIO’s investigator network,” stated Dr. Vanesa Quiroga, a member of the trial’s Steering Committee, GEICAM and Catalan Institute of Oncology. “The scale of interest from patients further underlines the urgency to bring forward new treatment options to treat early stage breast cancer.”
More information on the coopERA Breast Cancer trial (WO42133/TRIO038/coopERA) can be found at clinicaltrials.gov (NCT04436744).
TRIO advances translational cancer research by introducing innovative and novel targeted therapeutic concepts into the clinical trial setting. With international offices in Edmonton (Canada), Paris (France), Montevideo (Uruguay), TRIO’s global reach is expansive. Our goal as an academic clinical research organization is to find the shortest path to saving lives. Additional information on TRIO can be found by visiting https://trioncology.org. Interested parties may also follow TRIO on Twitter (twitter.com/TRIOncology).