![]() The KATHERINE trial-funded by the manufacturer of T-DM1, Genentech-enrolled nearly 1,500 women with early-stage HER2-positive breast cancer, meaning their cancer was confined to the breast and the axillary lymph nodes. Once the antibody binds to HER2 on cancer cells, emtansine is released into the cells.Īfter showing that T-DM1 improved how long women with metastatic HER2-positive breast cancer live, researchers quickly moved to test the drug in women with early-stage disease. The antibody portion of T-DM1, in addition to blocking the activity of the HER2 protein on cancer cells, serves as a homing device for emtansine. ![]() Known as an antibody–drug conjugate, T-DM1 chemically links the trastuzumab antibody to the chemotherapy drug emtansine (also known as DM1). Trastuzumab latches on to HER2 proteins on the surface of breast cancer cells and prevents HER2 from stimulating cancer cell growth. Trastuzumab, a monoclonal antibody, was among the first FDA-approved targeted cancer therapies and has long been an established therapy for HER2-positive breast cancer. “T-DM1 has now become the standard of care for women with HER2-positive breast cancer and residual invasive cancer following neoadjuvant therapy,” he said. The trial results, and the subsequent FDA approval, have already had an important impact on patient care, Dr. Geyer said, “the majority of women tolerated the drug reasonably well.” As a result, more women taking T-DM1 (29%) did not complete the full course of the adjuvant treatment than women taking trastuzumab (19%).īut many of these women did not have to stop taking the drug until they were near the end of their adjuvant treatment period, explained the study’s lead investigator, Charles Geyer, Jr., M.D., of the Virginia Commonwealth University Massey Cancer Center. Side effects, including serious side effects, were more frequent in women treated with T-DM1. In the trial, women treated with T-DM1 had a 50% reduced risk of their cancer returning or death than women treated with trastuzumab. The new approval, announced on May 3, is based on findings from a large clinical trial called KATHERINE that compared T-DM1 with trastuzumab (Herceptin) as an adjuvant treatment. However, to be eligible to receive the drug under this newly approved use, women must first have undergone presurgical, or neoadjuvant, therapy to shrink their tumors and still have some signs of remaining invasive cancer, called residual cancer, in the breast or nearby lymph nodes. Under the expanded approval, it can now be used when the cancer is far less advanced: as a post-surgical, or adjuvant, treatment in women with early-stage HER2-positive breast cancer. The Food and Drug Administration (FDA) has expanded the approved use of the drug ado-trastuzumab emtansine (Kadcyla) to treat some women with HER2-positive breast cancer.Īdo-trastuzumab, also called T-DM1, was initially approved by FDA more than 6 years ago to treat women with metastatic HER2-positive breast cancer. The CFI MSI Funding will support the CCTG trials operations, assures development of the highly innovative personalized cancer therapies, expand its operations and data platforms to support innovative clinical trials and related research.Credit: Adapted from Breast Can Res. "Through clinical trials and the work of the CCTG, we are defining new standards of care, diagnostic tests, and therapies, having a positive impact on cancer patients worldwide.” “The CCTG has received continuous investment through the MSI program, marking its critical importance in the Canadian research landscape and Queen’s leadership in this area,” says Dr. Also noted were the impressive Canadian network, and success in advancing the full spectrum of cancer clinical trials for researchers and patients across Canada and the world. The MSI review recognized that CCTG central operations at Queen’s as a unique Canadian research facility. “The award acknowledges CCTG as a national resource that is used by leading Canadian researchers who are internationally recognized for their work.” “The continuing investment from CFI will ensure CCTG continues to conduct research of the exceptional caliber and competitive with the best in the world,” acknowledges Dr Janet Dancey, CCTG Director. The funding supports state-of-the-art facilities of national importance to drive innovative research in Canada. Minister of Innovation, Science and Industry, François-Philippe Champagne announced the award at Queen’s University as part of the 19 successful research infrastructure projects receiving $628 million from the Canada Foundation for Innovation (CFI). The Canadian Cancer Trials Group (CCTG) Operations and Statistics Centre will receive full funding of $19,457,683 through The Major Science Initiatives (MSI) Fund. The 2023 Major Science Initiative Fund Competition awarded to The Canadian Cancer Trials Group
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