Ana C Garrido-Castro, MD
The purpose of this study is to test the safety and effectiveness of the sequence of two investigational drugs (trastuzumab deruxtecan followed by datopotamab deruxtecan, or datopotamab deruxtecan followed by trastuzumab deruxtecan) to learn whether the treatment works in treating HER2-negative (HER2-low or HER2-0) metastatic breast cancer. The names of the study drugs involved in this study are: * Datopotamab deruxtecan (a type of antibody drug conjugate) * Trastuzumab deruxtecan (a type of antibody drug conjugate)
This is a multi-institutional, open-label, phase 2 trial assessing the efficacy of sequential antibody drug conjugate (ADC) treatment with Dato-DXd or T-DXd in patients with HER2-negative (HER2-low and HER2-0) locally advanced unresectable or metastatic breast cancer (MBC). There are two parts to this study, which has a sequential design. Most participants will enroll in Group 1, which has two different study drugs. A participant will be randomized to receive one of the two study drugs, and if there is progression of disease on the study drug that was originally assigned, a participant will cr…
Inclusion Criteria: * Participants must have histologically or cytologically confirmed invasive breast cancer with unresectable locally advanced or metastatic disease. Participants without pathologic or cytologic confirmation of metastatic disease should have unequivocal evidence of metastasis from physical examination or radiologic evaluation; i.e., visible chest wall disease or metastases on imaging meeting standard radiology criteria (i.e., lymph nodes larger than 1 cm in the short axis diameter). * The most recent pathology results will be considered for enrollment according to local test…
A HER2-directed ADC, 100mg/vial, via intravenous (into the vein) infusion per protocol.
A TROP2-directed antibody drug conjugate, 100mg/vial, via intravenous (into the vein) infusion per protocol.