Could Your Patient Benefit? New Clinical Trials in Breast Cancer

Helen Leask

September 23, 2021

A number of phase 3 studies in breast cancer have opened in recent months. Maybe one of your patients could benefit from being enrolled?

Advanced HER2+ breast cancer. Patients with previously treated advanced or metastatic HER2+ breast cancer with and without brain metastases are sought for the DESTINY-B12 trial of trastuzumab deruxtecan (Enhertu). Patients will be treated for approximately 2.5 years, depending on the time to progression or death. Recruitment began on June 22, with the aim of recruiting 500 patients globally; US sites are in Massachusetts, North Carolina, and Virginia. Overall survival (OS) and quality of life (QoL) will be tracked. More details at clinical

This is an important study, says Medscape contributor Kathy Miller, MD, professor of oncology and medicine at the Indiana University School of Medicine, Indianapolis. "If positive [it] will change the standard of care and expand options for that subgroup of patients," she said.

Locally recurrent or metastatic HR+, HER2- breast cancer. Patients with locally recurrent inoperable or metastatic HR+, HER2- breast cancer eligible for chemotherapy are being recruited for the KEYNOTE-B49 trial, which will look at adding pembrolizumab (Keytruda) onto chemotherapy. Patients will receive therapy for up to 2 years. Progression-free survival is the primary outcome measure, with OS and QoL as secondary measures. More details at clinical

"This study is based more on hope than preliminary data," Miller said. "While immunotherapy has had some benefit in triple negative breast cancer (TNBC), there is little data to support benefit in ER+ disease. It would be great for our patients if I am wrong about this one."

Locally advanced or metastatic HER2+, PD-L1+ breast cancer. Patients with locally advanced or metastatic HER2+, PD-L1+ breast cancer are sought for KATE3, which is testing trastuzumab emtansine (T-DM1, Kadcyla) with atezolizumab (Tecentriq). Study sites are in California, Georgia, Missouri, New Mexico, New York, and Pennsylvania. Patients will be treated "until disease progression, unmanageable toxicity or study termination by the sponsor." This is the only trial in the list for which OS is a primary outcome; clinically meaningful QoL will also be logged. More details at clinical

HR+, HER2- breast cancer. Premenopausal women with HR+, HER2- breast cancer and men with HR+ breast cancer are being sought for the OVELIA trial, which is testing a new subcutaneous formulation of leuprolide acetate, known as TOL2506. All patients will receive the new product for the 48 weeks of this single-arm trial. After that period, patients can get expanded access until the drug is commercially available. Study sites are in Illinois, Kansas, Kentucky, and Michigan. The study outcome is suppression of ovarian function; researchers will not assess QoL or OS. More details at clinical

ER+, HER2- early breast cancer. Patients with medium- or high-risk ER+, HER2- early breast cancer are sought for the lidERA Breast Cancer study. This trial, based in California, Kansas, Montana, and Nevada, is looking at giredestrant, a new selective estrogen receptor downregulator (SERD). This oral therapy is a potential alternative to monthly intramuscular fulvestrant (Faslodex), the only SERD currently available in the United States. Patients will be treated for up to 5 years or until disease recurrence. The trial will measure OS and QoL, as well as the primary outcome of invasive-disease-free survival. More details at clinical

HR+, HER2- metastatic breast cancer. Patients with HR+, HER2- metastatic breast cancer who have not progressed during first-line treatment with an aromatase inhibitor and a CDK4/6 inhibitor are sought for the SERENA-6 trial. The trial is testing a new oral SERD (known only as AZD9833) in a protocol that is described by the sponsors as a "ctDNA-guided early-switch study." Patients will be monitored for the development of an ESR1 mutation, a measure of acquired resistance to hormone therapy, and then switched to the study drug to see if it improves response. Patients will be treated until disease progression or death, whichever occurs first. The trial will also measure OS and QoL. More details at

"[This is a] difficult study and one that will be both challenging to do and challenging to incorporate into practice," Miller said. "The question is simply whether molecular surveillance for development of an ESR1 mutation and then changing therapy on that basis alone [rather than waiting for progression] is helpful."

All trial information is from the National Institutes of Health US National Library of Medicine (online at Trial sponsors were contacted for interview but either declined or did not respond.

Miller has a regular Medscape column, Miller on Oncology. She has disclosed no relevant financial relationships.

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