ONCAlert | 2018 SGO Annual Meeting on Women’s Cancer

An Expanded Access Study of T-DM1 in Previously Treated HER2-Positive Metastatic Breast Cancer

Denise A. Yardley, MD
Published Online: 10:46 AM, Thu September 12, 2013
Denise A. Yardley, MD, Senior Investigator, Sarah Cannon Research Institute, discusses an expanded access study of T-DM1 in previously treated HER2-positive metastatic breast cancer.

This analysis was not as stringent as a conventional clinical trial, Yardley says, and aimed to evaluate patients treated with T-DM1 in the community setting. In this trial, patients received a median of 8 prior therapies and were able to receive T-DM1 before its FDA approval.

The time from initial metastatic diagnosis to receiving T-DM1 in this trial was a mean of 42 months, Yardley says, which is astounding and highlights the benefit of HER2-targeted therapies. Among patients who remained on T-DM1 for over a year, median time from diagnosis to T-DM1 was 60 months. This as well reinforces the advancements of HER2-targeted therapies, Yardley says.

Clinical Pearls

  • This trial looked at T-DM1 in the community setting of patients
  • The patient population received a median of 8 prior therapies for HER2+ metastatic disease
  • Safety profile and activity were similar to previous conventional clinical trials


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