publication date: May. 1, 2014


Breast Cancer

Neratinib Graduates from I-SPY

Phase II Adaptive Trial Regimen

Neratinib combined with standard chemotherapy was found to be a beneficial treatment for some women with newly diagnosed, high-risk breast cancer.

Additionally, researchers learned that an algorithm used in the adaptive, randomized trial known as I-SPY 2 was highly effective at predicting the success of the treatment regimen in the patients who have HER2-positive/HR-negative disease. The finding marks the second drug graduation within the I-SPY 2 trial model.

Data from the phase II trial were presented at the annual meeting of the American Association for Cancer Research.

Launched by UC San Francisco in tandem with a private-public partnership, I-SPY 2 combines personalized medicine with a novel investigational design. Its goals are to improve the efficiency of clinical trials and to streamline the process for developing new drugs and regimens.

“What is so exciting about the graduations is that we’re proving unconditionally that the standing trial mechanism can efficiently evaluate multiple drugs and identify the specific populations for which the agents are most effective,” said Laura Esserman, professor of surgery and director of the Carol Franc Buck Breast Care Center at the UCSF Helen Diller Family Comprehensive Cancer Center.

Esserman is the co-principal investigator of I-SPY 2, which is underway at 20 cancer research centers in the U.S. and Canada.

“We are testing the agents in high-risk patients at a time in their disease (primary breast cancer) when we are most likely to make a difference in survival,” Esserman said. Under the I-SPY 2 model, the costs, time and number of patients required … Continue reading TCCL April – Breast Cancer

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