PHESGO Maintenance After T-DXd Short Induction for HER2+ Unresectable Locally Recurrent or Metastatic Breast Cancer
Trial Parameters
Brief Summary
DEMETHER is a phase II trial exploring the maintenance of trastuzumab and pertuzumab fixed dose combination (FDC) for subcutaneous administration (SC, PHESGO) following trastuzumab deruxtecan (T-DXd) as induction treatment for HER2-positive unresectable locally recurrent or metastatic breast cancer (MBC) patients.
Eligibility Criteria
Inclusion Criteria: To be eligible to participate in this trial, an individual must meet ALL the following criteria: 1. Patient must be capable to understand the purpose of the study and have signed written informed consent form (ICF) prior to beginning specific protocol procedures. 2. Male or female patients ≥ 18 years of age at the time of signing ICF. 3. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1. 4. Life expectancy of ≥ 12 weeks at screening. 5. Evidence of HER2-overexpressing tumor status confirmed by any MEDSIR's designated central lab or patient has a pathology report confirming HER2-overexpression by local testing, preferably on the most recent available metastatic sample. In the latest case, tumor tissue or blood must be sent to any MEDSIR's designated central lab for confirmation of HER2 status. Analysis of the primary tumor sample will be accepted if the metastatic tissue is inaccessible. 6. Must have known estrogen receptor (ER) and progesterone