Akihiko Shimomura, MD, PhD
Elderly patients with HER2-positive breast cancer remain a clinical unmet need, according to Akihiko Shimomura, MD, PhD, making the development of clinical trials for this population an important aspect of breast cancer research.
, Shimomura, Department of Breast and Medical Oncology, Department of Experimental Therapeutics, National Cancer Center Hospital, Tokyo, Japan, discussed the rationale for this study of elderly patients with HER2-positive breast cancer.
OncLive: Please give an overview of the HERB TEA study.
: This is a randomized phase III study comparing T-DM1 with combination therapy of HPD in elderly patients with advanced-stage HER2-positive breast cancer. This is a noninferiority study, and the sample size is 330. It is sponsored by the Japan Clinical Oncology Group, and 43 institutes in Japan contributed to this study.
Elderly patients often have comorbidities. Some elderly patients are not fit to undergo toxic therapy, such as HPD. The aim of our study is to develop a less-toxic novel treatment for elderly patients with advanced HER2-positive breast cancer.
How could the findings impact the HER2-positive breast cancer paradigm?
There have been a few studies targeting elderly patients with breast cancer. Only 50% of patients over the age of 65 [with HER2-positive breast cancer] participated in the CLEOPATRA study. In the clinic, we feel that HPD is too toxic for elderly patients. It is unclear how to optimally treat elderly patients with advanced-stage HER2-positive breast cancer, so we planned this study.
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