![]() ![]() If node-negative or if node status unknown (because it was not assessed), tumor must be >5 mm of any hormone receptor subtype (document ER/PR status: if some ER/PR staining is present, ER and PR negative are defined as being positive in 5mm but there are other small foci of disease that are too small to test for ER/PR/HER2 and are felt to be a part of the same tumor or similar tumor, OR (4) at least one tumor meets eligibility and the other foci in the ipsilateral or contralateral breast are HER2-negative and do not meet criteria for adjuvant chemotherapy per provider discretion (e.g.Participants must have histologically or cytologically confirmed Stage I-III breast cancer with the following criteria met:.Age ≥60 years at the time of study registration (men and women eligible).NOTE: DCIS components should not be counted in the determination of HER2 status.Deborah Dillon at Brigham and Women's Hospital, Boston, MA) prior to patient being registered to begin protocol therapy. Participants must have histologically or cytologically confirmed HER2-positive disease by local pathology, defined as immunohistochemistry (IHC) 3+ or amplification by FISH (HER2/CEP17 ratio ≥2 or an average of ≥6 HER2 gene copies per nucleus) AND confirmed by Central Pathology Review (Dr.More specifically, the trastuzumab in T-DM1 first binds to the HER2 protein on the surface of the breast cancer cells and the DM1 then enters the cells and can cause them to die, preventing tumor growth T-DM1 functions as a targeted cancer therapy because it targets HER2-positive breast cancer cells directly, limiting exposure of the rest of the body to chemotherapy. T-DM1 is an antibody-drug conjugate it is made up of an antibody (trastuzumab) linked to a cytotoxic drug, DM1 (chemotherapy). Food and Drug Administration) has not approved T-DM1 for use in patients with stage I, II, or III breast cancer, but it has been approved for use in advanced, previously treated, HER2-positive breast cancer. The purpose of this research study is to examine the long-term benefits of T-DM1 with regard to breast cancer and take a closer look at the side effects experienced by participants receiving T-DM1. "Investigational" means that the drug is being studied and research doctors are trying to find out more about it-such as the safest dose to use and the side effects it may cause. Phase II clinical trials test the safety and effectiveness of an investigational drug to learn whether the drug works in treating a specific disease. This research study is a Phase II clinical trial. Why Should I Register and Submit Results?. ![]()
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