“This combination has the potential to become a new standard of care for all patients with HER2-positive breast cancer after treatment with trastuzumab, pertuzumab, and T-DM1.” “Most importantly, tucatinib reduced the risk of death by a third, which is unprecedented in a population of patients who had received extensive prior therapy. “Our results show that for this group of patients, for whom effective standard treatment options are extremely limited, the addition of tucatinib to trastuzumab and capecitabine provided a clinically meaningful reduction in the risk of disease or death,” said Winer, the study’s senior author. The most common adverse effects in the tucatinib group were diarrhea, palmar-plantar erythrodysesthesia (a condition that produces redness, pain, or swelling in the palms of the hand and/or soles of the feet), nausea, fatigue, and vomiting.
The two-year overall survival – the percentage of patients alive two years after the start of treatment – was 45% for the tucatinib group and 27% for the placebo group.Īmong patients whose cancer had metastasized to the brain, 25% of those in the tucatinib group were alive with no advance of the disease a year after beginning treatment, compared to none in the control group. 410 participants were randomly chosen to receive tucatinib combined with trastuzumab and the chemotherapy agent capecitabine 202 patients – the control group – received trastuzumab, capecitabine, and a placebo.Ī year after beginning treatment, 33% of patients in the tucatinib group were alive with no worsening of their disease, compared to 12% in the control group.
T dm1 clinical trials trial#
The trial enrolled 615 patients at 155 sites in 15 countries in North America, Europe, Asia, and Australia. Tucatinib is a targeted compound that binds to a different portion, or domain, of the HER2 protein than other existing drugs. One trial, an international effort called HER2CLIMB, tested the oral agent tucatinib in patients with HER-positive metastatic breast cancer previously treated with trastuzumab, pertuzumab, and T-DM1. International trial of new targeted agent Results from both trials point to the drugs’ clinical effectiveness for many patients. The two trials involve agents that take a new line of attack against HER2 proteins that have become inured to standard therapies. But the development of resistance to these agents ultimately means news and different drugs are needed. Prospects for patients improved markedly with the introduction of drugs such as trastuzumab (Herceptin) and pertuzumab (Perjeta), which target the HER2 protein, and T-DM1, a conjugate drug that uses an antibody to deliver a chemotherapy drug directly to cancer cells. HER2-positive breast cancer, which tests positive for the cancer growth-promoting protein HER2, accounts for 15-20% of breast cancers. “The results of these trials represent significant progress toward this goal, including the first evidence from a clinical trial of a targeted agent that can improve survival for patients with HER2-positive breast cancer that has metastasized to the brain.” Smith Center for Women's Cancers at Dana-Farber and the senior author of one of the studies. “The development of drugs targeting the HER2 protein has dramatically improved outcomes for patients with this form of breast cancer, but nearly all patients with metastatic HER2+ breast cancer eventually become resistant to these drugs, creating a need for new and better therapies,” said Eric Winer, MD, Chief of the Division of Breast Oncology, Susan F. In one trial, the study agent reduced the risk of worsening disease by approximately half and reduced the risk of death by one third. In both cases, the new agents helped halt or reverse the advance of the disease in many patients. The trials tested two new targeted agents in patients whose HER2-positive breast cancer had become resistant to multiple previous therapies. Results of the trials were presented at the San Antonio Breast Cancer Symposium today and are being co-published in the New England Journal of Medicine. One agent is first to show clinical trial effectiveness in patients whose HER2-positive breast cancer has metastasized to the brain.įor patients with HER2-positive breast cancer no longer responding to standard therapies, a pair of clinical trials led by investigators at Dana-Farber Cancer Institute and other institutions offer substantial promise, including for those whose cancer has spread to the brain. In trials led by Dana-Farber Cancer Institute investigators, both agents demonstrate ability to help thwart advance of disease. New targeted drugs show promise in patients with advanced HER2-positive breast cancer in two clinical trials to be presented at SABCS/NEJM