Dr. Pegram on Neoadjuvant Treatments for HER2-Postive Breast Cancer

Mark D. Pegram, MD
Published: Wednesday, Mar 11, 2015



Mark D. Pegram, MD, associate director, clinical research, director, Breast Cancer Program, Stanford Cancer Institute, discusses optimizing neoadjuvant treatments for HER2-positive breast cancer.

Pegram says most progress has been seen in randomized clinical trials involving the addition of pertuzumab to chemotherapy and trastuzumab. For example, in the NeoSphere trial, researchers found an increase in the number of patients who experienced pathological complete response, which correlates with long-term progression-free survival (PFS).

These data sets are sufficient for consideration of an accelerated FDA approval, pending a larger phase III randomized trial in the adjuvant setting, to confirm the addition of pertuzumab would be more impactful than chemotherapy and trastuzumab. An example of this is the AFFINITY trial, Pegram says.

There were also no cardiac safety concerns with the addition of pertuzumab, Pegram reported from a smaller phase II trial.

These three trials will hopefully provide a breakthrough for the early-disease setting, he explains.


Mark D. Pegram, MD, associate director, clinical research, director, Breast Cancer Program, Stanford Cancer Institute, discusses optimizing neoadjuvant treatments for HER2-positive breast cancer.

Pegram says most progress has been seen in randomized clinical trials involving the addition of pertuzumab to chemotherapy and trastuzumab. For example, in the NeoSphere trial, researchers found an increase in the number of patients who experienced pathological complete response, which correlates with long-term progression-free survival (PFS).

These data sets are sufficient for consideration of an accelerated FDA approval, pending a larger phase III randomized trial in the adjuvant setting, to confirm the addition of pertuzumab would be more impactful than chemotherapy and trastuzumab. An example of this is the AFFINITY trial, Pegram says.

There were also no cardiac safety concerns with the addition of pertuzumab, Pegram reported from a smaller phase II trial.

These three trials will hopefully provide a breakthrough for the early-disease setting, he explains.

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