A Study of Pertuzumab in Addition to Chemotherapy and Herceptin (Trastuzumab) as Adjuvant Therapy in Patients With HER2-Positive Primary Breast Cancer

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