Introduction and Exploration of Fulvestrant in Breast Cancer

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Moderator, Adam M. Brufsky, MD, PhD, introduces the panel for an in-depth discussion analyzing recent trials that explored the detection, management, and treatment of metastatic breast cancer. The expert panel includes: Sara Hurvitz, MD, Joyce O’Shaughnessy, MD, Edith A. Perez, MD, Hope S. Rugo, MD, and Andrew D. Seidman, MD.

To begin the conversation, O'Shaughnessy describes the CONFIRM trial, which compared a 250 mg dose of fulvestrant to the now approved 500 mg dose. In this trial, the larger dose of fulvestrant was shown to be superior and is now the standard of care. Additionally, the FALCON trial is comparing the now approved 500 mg dose of fulvestrant to anastrozole in the first-line for patients with advanced breast cancer.

The equivocal findings from a comparison of the 250mg dose of fulvestrant to exemestane and an evaluation of pharmacokinetics raised interests in a higher dose, Perez notes. Initially, Rugo notes, researchers had doubts about whether 250 mg was actually the maximum tolerated dose, which also led to further research and the approval of the 500 mg dose. This stresses the importance of discovering the maximum tolerated dose in clinical trials, Rugo believes.

Seidman believes the 500 mg dose is correct, especially leading into trials exploring combinations.