HER2+ Breast Cancer

A new drug application has been submitted to the FDA for tucatinib for use in combination with trastuzumab and capecitabine for the treatment of patients with unresectable locally advanced or metastatic HER2-positive breast cancer.

Tiffany A. Traina, MD, medical oncologist, Memorial Sloan Kettering Cancer Center, discusses the FDA approval of fam-trastuzumab deruxtecan-nxki (Enhertu; DS-8201) for patients with HER2-positive, locally advanced, or metastatic breast cancer who have been treated with trastuzumab (Herceptin) and pertuzumab (Perjeta) and have disease progression after ado-trastuzumab emtansine (T-DM1; Kadcyla).

The FDA has granted an accelerated approval to fam-trastuzumab deruxtecan-nxki (Enhertu) for the treatment of adult patients with unresectable or metastatic HER2-positive breast cancer who have received ≥2 prior anti–HER2-based regimens in the metastatic setting.

A biologics license application has been submitted to the FDA for margetuximab for use in combination with chemotherapy as a treatment for patients with metastatic HER2-positive breast cancer.

The European Commission has approved ado-trastuzumab emtansine for the adjuvant treatment of adult patients with HER2-positive early breast cancer who have residual invasive disease (breast and/or lymph nodes) following neoadjuvant taxane-based chemotherapy and HER2-targeted therapy.

Lowell L. Hart, MD, FACP, discusses the utility of antibody-drug conjugates in HER2-positive breast cancer.

The FDA has granted tucatinib a breakthrough therapy designation for use in combination with trastuzumab and capecitabine for the treatment of patients with unresectable locally advanced or metastatic HER2-positive breast cancer, including patients with brain metastases, who had prior trastuzumab, pertuzumab, and ado-trastuzumab emtansine.

Nancy Lin, MD, discusses the impact of neratinib on development and progression of central nervous system metastases in patients with HER2-positive metastatic breast cancer.

A pathologic complete response to HER2-directed neoadjuvant therapy reduced the risk of recurrence in early HER2-positive breast cancer but did not eliminate it, supporting the common practice of continued anti-HER2 therapy.

For the past 2 decades, clinical guidelines for the diagnosis and management of breast cancer have sought to clarify the definition of HER2 status, but several key questions remain.

Rashmi K. Murthy, MD, MBE, discusses results of the HER2CLIMB trial in previously treated HER2-positive breast cancer.

The first reported data for adjuvant ado-trastuzumab emtansine in early HER2-positive breast cancer showed high rates of disease control in a randomized trial designed to compare toxicities with trastuzumab and paclitaxel.

Margetuximab continued to show a clear progression-free survival benefit and a trend toward an overall survival benefit versus trastuzumab (Herceptin) when either agent was combined with chemotherapy in patients with HER2-positive metastatic breast cancer who had received prior anti-HER2 therapies.

Adjuvant pertuzumab (Perjeta) with trastuzumab (Herceptin) plus chemotherapy showed a 0.9% improvement in overall survival and continued to reduce the risk of disease recurrence in patients with HER2-positive early breast cancer.

Adding tucatinib to trastuzumab (Herceptin) and capecitabine (Xeloda) reduced the risk of death by 34% in heavily pretreated patients with unresectable locally advanced or metastatic HER2-positive breast cancer.

Trastuzumab deruxtecan (T-DXd; DS-8201) induced a confirmed objective response rate of almost 61% and a durable benefit in heavily pretreated patients with advanced HER2-positive breast cancer.

Erika P. Hamilton, MD, discusses the results of the phase III KATHERINE trial in HER2-positive breast cancer.

Kurt W. Tauer, MD, FACP, discusses encouraging updates across the spectrum of breast cancer subtypes.

Gregory Vidal, MD, PhD, discussed the ways in which currently available and investigational agents are being evaluated in the curative and metastatic settings of HER2-positive breast cancer.

The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended approval of trastuzumab emtansine for the adjuvant treatment of adult patients with HER2-positive early breast cancer who have residual invasive disease (breast and/or lymph nodes) following neoadjuvant taxane-based chemotherapy and HER2-targeted therapy.

Gregory Vidal, MD, PhD, discusses the potential of [fam-] trastuzumab deruxtecan in HER2-positive breast cancer.

Erika P. Hamilton, MD, discussed several studies in the HER2-positive breast cancer space and the sequencing challenges that have emerged.

Keerthi Gogineni, MD, MSHP, discusses the clinical implications of the phase II APT trial in HER2-positive breast cancer.