Neratinib and the combination of veliparib plus carboplatin improves breast cancer outcomes.
In patients with certain subtypes of breast cancer, neratinib and the combination of veliparib plus carboplatin were found to be more effective eradicating tumors before surgery compared with standard therapy alone.
Researchers conducted 2 studies as part of a nationwide research initiative called I-SPY2 that were published in the New England Journal of Medicine.
“I-SPY2 is employing an exciting new model for testing drugs,” said Kathy S. Albain, MD, FACP, FASCO, co-author of both studies. “Trials have not been run this way before in breast cancer. Now we can determine much sooner which drugs are active, while minimizing patients’ exposure to drugs that do not work — all as the trial progresses from day to day.”
To determine which investigational drug under study is the best fit for a patient’s tumor profile, researchers used biomarker profiles of breast cancer cell genes.
“A patient’s treatment is targeted, in real time, to the tumor’s biology,” Albain said. “I-SPY2 allows us to bring exciting new agents into the curative setting more quickly than the standard way of first testing them extensively in large, multi-year trials.”
For the I-SPY2 studies, the researchers wanted to determine if the experimental treatments could completely eradicate tumors before surgery. Women who have complete tumor eradication before surgery are found to be less likely to relapse or die of breast cancer.
In one study, the drug neratinib was found to be highly active in patients with HER2-positive, hormone-receptor-negative breast cancer. There were 56% of patients treated with neratinib plus standard treatment who had tumor eradication before surgery, compared with 33% of patients who received standard treatment.
In the second study, researchers found that 51% of women with triple negative breast cancer administered veliparib and carboplatin plus standard treatment had tumor eradication before surgery, compared with 26% of women administered standard treatment alone.
“(I-SPY2 is) an important addition to the inventory of trial designs,” wrote David Harrington, PhD, and Giovanni Parmigiani, PhD in an accompanying perspective article. “We applaud the use of I-SPY2 described here and urge continued innovation in trial design, especially in both earlier phase 1 and later phase 3 settings.”
Based on the findings from the 2 studies, the experimental drugs are being fast-tracked to large-scale phase 3 trials.