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Dr Tolaney on Ongoing Clinical Trials in Early-Stage HER2+ Breast Cancer

Sara M. Tolaney, MD, MPH discusses ongoing clinical trials investigating the addition of HER2-directed therapies to existing treatment regimens for HER2-positive breast cancer.

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Sara M. Tolaney, MD, MPH, chief, Division of Breast Oncology, Susan F. Smith Center for Women's Cancers, associate director, Susan F. Smith Center for Women's Cancers, senior physician, Dana-Farber Cancer Institute, associate professor of Medicine, Harvard Medical School, discusses ongoing clinical trials investigating novel approaches and combination therapies for patients with early-stage HER2-positive breast cancer.

During a presentation on the treatment of early-stage HER2-positive breast cancer given at the 23rd Annual International Congress on the Future of Breast Cancer® East, Tolaney underscored how ongoing trials investigating the sequencing of antibody-drug conjugates (ADCs) and adding HER2-directed therapies to existing treatment regimens could help inform and shape treatment strategies for this patient population in the future.

Tolaney highlights the phase 3 CompassHER2 RD trial (NCT04457596), which is an ongoing prospective, multicenter study investigating the addition of tucatinib (Tukysa) to ado-trastuzumab emtansine (T-DM1; Kadcyla) in patients who presented with T1 to T4, N0 to N3, HER2-positive breast cancer and had residual disease following surgery. In this setting, 14 doses of T-DM1 has been the standard of care, Tolaney explains. In CompassHER2 RD, patients are being randomly assigned to receive T-DM1 plus placebo or T-DM1 plus tucatinib for up to 14 cycles or until disease progression or unacceptable toxicity. Tolaney notes that tucatinib, a HER2-directed TKI, has demonstrated the ability to penetrate the blood-brain barrier, highlighting its potential to prevent recurrent metastases in the brain.

Tolaney also mentions fam-trastuzumab deruxtecan-nxki (T-DXd; Enhertu) as another agent being investigated in the early-stage setting after replacing T-DM1 as the standard-of-care in the second-line setting for patients with metastatic HER2-positive breast cancer. Although T-DXd outperformed T-DM1 in the metastatic setting, clinical trials will determine if it can improve outcomes in the adjuvant setting, Tolaney says.

The phase 3 DESTINY-Breast05 study (NCT04622319) is assessing T-DXd vs T-DM1 in patients with HER2-positive breast cancer who have residual invasive disease in the breast or axillary lymph nodes with a higher risk of recurrence. These studies highlight the effort to bring new HER2-directed therapies to the early-stage setting, Tolaney concludes.