Dr. Yuan on Ongoing Research in Patients With TNBC According to Pathologic Response

Yuan Yuan, MD, PhD, director, Breast Medical Oncology Medicine, medical director, Breast Oncology Disease Research Group, Cedars-Sinai Medical Center, discusses ongoing investigations at Cedars-Sinai of treatment de-escalation in patients with early-stage triple-negative breast cancer (TNBC) according to their pathological response.

Treatment de-escalation has become an increasing focus of research efforts in the breast cancer space. If successful, de-escalation could decrease long-term toxicities without affecting the risk of disease recurrence in patients who respond to a given therapy, Yuan begins.

Several investigator-initiated and large group trials are being conducted at Cedars-Sinai to address this question, including the phase 3 OptimICE-pCR trial (NCT05812807), Yuan states. This randomized comparator study was designed to investigate the de-escalation of treatment with pembrolizumab (Keytruda) in patients with early-stage TNBC who had achieved a pathological complete response (pCR) following neoadjuvant chemotherapy plus pembrolizumab. Patients will be randomly assigned to undergo either observation or continue single-agent pembrolizumab for up to one year, which is the standard of care for patients who achieved a pCR, Yuan adds. The trial provides an opportunity to see if observation after a pCR is a viable strategy for these patients, Yuan says.

For patients with TNBC who do not experience a pCR with neoadjuvant chemotherapy plus pembrolizumab, efforts are being made to bring currently approved antibody-drug conjugates into the post-neoadjuvant setting from the metastatic setting, Yuan continues. One such trial is the phase 3 ASCENT-05 trial (NCT05633654) of sacituzumab govitecan-hziy (Trodelvy) plus pembrolizumab vs investigator’s choice of treatment, Yuan introduces. Additionally, the phase 3 TROPION-Breast03 trial (NCT05629585) is investigating datopotamab deruxtecan (DS-1062a) in combination with durvalumab (Imfinzi) or administered alone vs investigator’s choice of treatment, she details. Both trials are being conducted in patients with TNBC who have residual disease.

All of these trials could address clinical needs for this population by improving the personalization of therapeutic approaches, Yuan concludes.