Nicholas C. Turner, M Click here .D., Ph.D., Jungsil Ro, M.D.D., Ph.D., Sherene Loi, M.D., Ph.D., Sunil Verma, M.D., Hiroji Iwata, M.D., Nadia Harbeck, M.D., Sibylle Loibl, M.D., Cynthia Huang Bartlett, M.D., Ke Zhang, Ph.D., Carla Giorgetti, Ph.D., Sophia Randolph, M.D., Ph.D., Maria Koehler, M.D., Ph.D., and Massimo Cristofanilli, M.D.1 Despite advances in endocrine therapy, a lot of women have a relapse during or after completing adjuvant therapy. The care of these women remains a significant clinical concern. Single-agent treatment with an aromatase inhibitor or tamoxifen shows limited clinical advantage.2,3 The selective estrogen-receptor degrader fulvestrant has modest activity in this population of patients,4,5 and the development of effective therapies that can reverse resistance to endocrine therapy is of clinical importance.
Patients with coexisting illnesses with a high risk of death were excluded. The scientific coordinating center confirmed the eligibility of every patient before randomization.9 percent saline solution. Study-group assignments were concealed from individuals, investigators, dealing with clinicians, and the sponsor. Temporary interruptions of the analysis infusion had been mandated for invasive procedures; in such cases, the infusion was expanded through day time 6 so that the 96-hour infusion could possibly be completed wherever feasible. All other treatments were at the discretion of dealing with clinicians. Evaluation of Patients We assessed baseline demographic characteristics, preexisting circumstances, organ function, sites of infection, microbiology results, and hematologic and laboratory measurements within a day prior to the administration of a scholarly study medication.