Study Evaluating Trastuzumab Deruxtecan Treatment for Adults with Unresectable or Metastatic HER2-low or HER2 IHC 0 Breast Cancer Including Hormone Receptor-negative and Positive Types

What this Trial Is About

Researchers are evaluating trastuzumab deruxtecan T-DXd for adults with unresectable or metastatic breast cancer that is either HER2-low or HER2 IHC 0. This includes patients with hormone receptor-negative and hormone receptor-positive types. The study aims to assess the safety and effectiveness of T-DXd, focusing on how long patients benefit from this treatment before needing the next anticancer therapy. Participants receive T-DXd intravenously at a dose of 5.4 mgkg on the first day of each 21-day cycle. Treatment continues until disease progression, unacceptable side effects, other criteria for stopping, or two years after the first dose. The study includes four groups based on hormone receptor status and HER2 classification, with participants having had one to two prior treatments for metastatic breast cancer. During the study, participants will have regular assessments including imaging scans to measure tumors, blood tests to monitor organ function, and questionnaires to evaluate quality of life. Researchers will track the time to next treatment, progression-free survival, response rates, adverse events, and changes in patient-reported outcomes for up to 24 months. Safety monitoring and close follow-up will support participant well-being throughout the trial.

Trastuzumab Deruxtecan (T-DXd) in Patients Who Have Hormone Receptor-negative and Hormone Receptor-positive HER2-low or HER2 IHC 0 Metastatic Breast Cancer