To evaluate the association of estrogen receptor (ER) status in the untreated primary tumor with pathologic response and with long-term survival outcomes (including RFS, EFS, IDFS, DDFS, DRFS, RFI, OS, and breast cancer-specific survival). until the end of trastuzumab and pertuzumab therapy). To evaluate safety and tolerability for all patients during the pre-operative phase and for patients who attain pCR and de-escalate therapy (Arm A) until the completion of post-surgery protocol assigned therapy (i.e. To determine 3-year EFS (event-free survival) in all patients from time of study registration. To determine 3-year IDFS (invasive disease-free survival), DDFS (distant disease-free survival), DRFS (distant relapse-free survival), RFI (recurrence-free interval), OS (overall survival) and breast cancer-specific survival in patients who achieve pCR (and by pretreatment clinical stage). To determine if 3-year recurrence-free survival (RFS) is greater than 92% among clinical stages II or IIIa patients with HER2-positive breast cancer who achieve pathologic complete response (pCR) (ypT0/is ypN0) after preoperative therapy with 12 weeks of a taxane, trastuzumab (or Food and Drug Administration approved biosimilar) and pertuzumab (THP x 12). Giving paclitaxel, trastuzumab, and pertuzumab may enable fewer chemotherapy drugs to be given without compromising patient outcomes compared to the usual treatment. When these drugs attach to HER2 receptors, the signals that tell the cells to grow are blocked and the tumor cell may be marked for destruction by the body's immune system. Trastuzumab and pertuzumab are both a form of "targeted therapy" because they work by attaching themselves to specific molecules (receptors) on the surface of tumor cells, known as HER2 receptors. Drugs used in chemotherapy, such as paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.
#T DM1 CLINICAL TRIALS TRIAL#
This trial studies how well paclitaxel, trastuzumab, and pertuzumab work in eliminating further chemotherapy after surgery in patients with HER2-positive stage II-IIIa breast cancer who have no cancer remaining at surgery (either in the breast or underarm lymph nodes) after pre-operative chemotherapy and HER2-targeted therapy. NPF is solely responsible for the content.Recruitment Status, Study Status, Contacts/Locations and OversightĬontacts/Locations, Study Status and Eligibility This program is funded by the American Association for Cancer Research. “The gold standard is that by controlling disease, the patient lives longer.” The goal is not merely to develop new treatments, she noted. Korde also detailed the state of breast cancer treatment for various cancer subtypes, including the different treatment options, from surgery to radiation to chemotherapy and immunotherapy. She detailed the three stages of clinical trials: Phase 1, which tests the safety in a small number of people Phase 2, which tests effectiveness and Phase 3, which tests both safety and efficacy in a large group of patients, as well as comparing it against other treatments. Korde used Kadcyla and the KATHERINE trial that tested is as a case study of the drug development process. (The findings, eventually reported in The New England Journal of Medicine, saw fewer deaths in the Kadcyla treatment arm than the other one – a success.) The most promising is for patients with a certain type of cancer – HER2-positive metastatic breast cancer – whose previous treatment had failed. Kadcyla had already been on the market when researchers began exploring additional uses for it. Its coverage was mostly confined to the medical press. The approval of this use of Kadcyla was an important development for breast cancer treatment, but it wasn’t one of those $1 billion drug blockbusters that make it onto the evening news. Larissa Korde, senior investigator for a cancer therapy evaluation program at the National Cancer Institute, which is part of the National Institutes of Health. That process – from idea to approved therapy – was the focus of a session with National Press Foundation fellows by Dr. And they had to enroll nearly 1,500 women to do so. They had to design a clinical trial that compared treatment with T-DM1 against treatment without it. Researchers had to determine which patients might benefit from the drug trastuzumab-DM1, which is now sold as Kadcyla. Before doctors began using a drug known as T-DM1 to treat breast cancer in women whose previous therapy had failed, the drug had to clear hurdle after hurdle.
0 kommentar(er)
