“An Open-Label, Multinational, Multicenter, Phase 3b/4 Study of Trastuzumab Deruxtecan in Patients With or Without Baseline Brain Metastasis With Previously-Treated Advanced/Metastatic HER2-Positive Breast Cancer(DESTINY-Breast12)”
Disease Types: Breast Cancer Research
-Her2+, unresectable advanced or metastatic breast cancer with disease progression on trastuzumab, pertuzumab, or T-DM1
-No more than 2 lines of therapy in metastatic setting, brain metastasis allowed if stable or not needing immediate therapy
-No: leptomeningeal disease; prior tucatinib therapy; chronic GI disease, refractory nausea/vomiting, significant bowel resection; known active HIV, Hep B, or Hep C;
myocardial infarction within previous 6 months, symptomatic congestive heart failure, unstable angina, recent cardiovascular event including stroke within previous 6 months; long QT syndrome,
QT prolongation requiring medication discontinuation or associated with concurrent medication, history of clinically significant arrythmia that is symptomatic or requires treatment, uncontrolled atrial fibrillation, ventricular tachycardia; history of interstitial lung disease that required steroids, current interstitial lung disease, or pneumonitis, clinically significant lung or pulmonary disease or conditions such as severe asthma or severe COPD, autoimmune or connective tissue or inflammatory disorder or disease with pulmonary involvement, prior pneumonectomy.