Have had an anti cancer drug as part of another clinical trial in the last 4 weeks.Have had trastuzumab or lapatinib in the last 3 weeks.Have had hormone therapy in the last week.Have had paclitaxel, docetaxel or a chemotherapy drug from the vinca alkaloids group such as vincristine, vinblastine, vindesine or vinorelbine in the last 6 months.Have had any treatment for breast cancer that has spread or come back after treatment apart from hormone therapy.Are able to have chemotherapy OR another standard treatment with the intent to cure your cancer.Are willing to use reliable contraception during treatment and for 6 months after if there is any chance you or your partner could become pregnant.Are well enough to carry out your normal activities apart from heavy physical work ( performance status 0, 1).Have an area of cancer that can be seen on a scan.Have breast cancer that has come back in the same area of the breast (local recurrence) or has spread to another part of the body and is HER2 positive. You may be able to enter this trial if you Works best for breast cancer that has spread or come back in the same area.The aims of the trial are to find out which combination of drugs In this trial, they will also compare it with a standard combination of trastuzumab and paclitaxel or docetaxel. The researchers think that TDM1 alone, or in combination with pertuzumab may work well for people with HER2 positive breast cancer that has spread or come back in the same area. This type of drug is called a conjugated monoclonal antibody. Trastuzumab finds the cancer cells and delivers the DM1 to them. Trastuzumab emtansine (TDM1) is a combination of trastuzumab and a chemotherapy drug called DM1. We know from research that having both pertuzumab and trastuzumab together may be better than having just one of them alone. It works by targeting the HER2 protein but in a different way to trastuzumab. Pertuzumab is a type of biological therapy called a monoclonal antibody. Paclitaxel and docetaxel are drugs that doctors often use. You may have trastuzumab with chemotherapy. These cancers are ‘HER2 positive’ and can be treated with a drug called trastuzumab which targets the HER2 protein. Some breast cancers have large amounts of a protein called HER2 on the surface of the cells. It is for people who have breast cancer that is HER2 positive. The Royal Marsden NHS Foundation Trust, Fulham Road, London, SW3 6JJ,United KingdomĪbstract: Background: Neo-adjuvant chemotherapy (NAC) can facilitate breast conservation, allowsThis trial is looking at 2 new drugs called trastuzumab emtansine (TDM1) and pertuzumab for breast cancer that has spread to another part of the body ( secondary breast cancer) or has come back in the same area (local recurrence).Title:T-DM1 in the Neo-Adjuvant Treatment of HER2-Positive Breast Cancer: Impact of the KRISTINE (TRIO-021) Trial Keywords: Breast cancer, HER2, pertuzumab, taxane, T-DM1, trastuzumab. T-DM1 could be used to de-escalate NAC for selected patients. Management of HER2 positive breast cancer, further research is needed to determine whether Systemic chemotherapy and provides the potential, if these patients can be identified up-front, toĬonclusion: Although the KRISTINE trial results have not changed the standard of care for the neoadjuvant This suggests that not all HER2 positive early breast cancer patients require Results: T-DM1 with pertuzumab did not improve pCR over standard therapy, although the novelĬombination was better tolerated, and a sub-group of patients (44%) achieved pCR with the systemicĬhemotherapy-free regimen. Of HER2 positive early breast cancer and the impact of the KRISTINE trial results. Methods: This review summarises the data supporting current standards in the neo-adjuvant treatment Of T-DM1 with pertuzumab compared to standard chemotherapy plus trastuzumab and pertuzumab The KRISTINE trial investigated the combination In advancedīreast cancer (ABC), T-DM1 improves survival compared to standard 2nd or 3rd line regimens, but notĬompared to first line chemotherapy plus trastuzumab. With a potent cytotoxic, DM1, a maytansine derivative, via a stable thioether linker. T-DM1 is a novel antibody-drug conjugate, combining trastuzumab In early breast cancer, the addition of pertuzumab to docetaxelĪnd trastuzumab resulted in a higher rate of pathological complete response (pCR), leading to acceleratedĪpproval in many territories. Pertuzumab is an anti-HER2 monoclonal antibody with a distinct binding site to trastuzumab, which In vivo testing of chemotherapy sensitivity and provides a route to accelerated approval of new therapies.įor HER2 positive breast cancer, the anti-HER2 monoclonal antibody, trastuzumab, is a standard Background: Neo-adjuvant chemotherapy (NAC) can facilitate breast conservation, allows
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