September 15, 2020
Translational Research in Oncology (TRIO) Enrolls First Patient in Early Breast Cancer Phase 2 Trial
EDMONTON, Alberta, Sept. 15, 2020 – Translational Research in Oncology (TRIO), a global academic clinical research organization, announced today enrolment of the first patient in a Phase 2 randomized, multi-center, open-label clinical trial of GDC-9545 sponsored by F. Hoffmann-La Roche.
GDC-9545 is a 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+) metastic breast cancer patients.
This current clinical trial will expand the safety and efficacy of GDC-9545 in combination with palbociclib into the early breast cancer setting. Led by Principal Investigator, Dr. Sara Hurvitz, Medical Director of the Jonsson Comprehensive Cancer Center Clinical Research Unit, this 215-patient clinical trial will evaluate the efficacy, safety, and pharmacokinetics of presurgical treatment with GDC-9545 plus palbociclib compared with anastrozole plus palbociclib for postmenopausal women with ER+ and HER2-negative untreated early breast cancer.
“The initiation of enrolment is an important milestone as we aim to better understand the activity and safety of this therapy in early stage breast cancer, the most common cancer affecting women,” stated Dr. Hurvitz. “Although we have effective therapies for hormone receptor positive breast cancer, disease resistance to these therapies occurs in some women, leading to the diagnosis of incurable breast cancer sometimes years later. Innovative therapies, such as GDC9545, will hopefully be shown to improve outcomes for women. My team and I are anxious to explore the use of this investigational therapy in the context of a presurgical trial, where the tumor may be sampled prior to and after treatment is given. Our hope is that we will not only learn about this drug’s anti-tumor activity but will also be able to identify what makes some tumors sensitive and others resistant to this form of therapy.”
More information on trial WO42133/TRIO038 can be found at clinicaltrials.gov (NCT04436744).