Dr. von Minckwitz on the Rationale of PENELOPE

Gunter von Minckwitz, MD, PhD, Chairman, German Breast Group, Professor of Gynecology, University of Frankfurt, Germany, discusses the rationale behind the phase III PENELOPE trial.

It has been known for a while that patients who do not reach pathologic complete response (pCR) after neoadjuvant chemotherapy have a worse prognosis compared with those who do achieve pCR.

The NATAN study had investigated the use of a bisphosphonate in this setting, though improvement in event-free survival could not be achieved. This further proved the need for new treatment options.

Upon the announcement of progression-free survival benefit in a phase II study of palbociclib plus letrozole, von Minckwitz says oncologists believed the combination should be moved to an early disease setting. A conclusion was then reached to identify patients who have not achieved pCR to be candidates for a “post-neoadjuvant” study investigating palbociclib.