Objectives: The phase III THERESA trial continues the exploration of dual HER2 blockade by adding novel pertuzumab to trastuzumab (Herceptin). The primary outcome measure is invasive disease-free survival.
Key entry or exclusion criteria: Patients must have nonmetastatic primary invasive HER2-positive breast cancer that is adequately excised, and either node positive or node negative with at least one protocol-defined risk factor.
Locations: 566 sites.
Goal: 3,806 patients.
Study sponsor: Hoffmann-La Roche in collaboration with the Breast International Group and Genentech
Link for more information: clinicaltrials.gov/ct2/show/NCT01358877
NIH clinical trials identifier: NCT01358877