A randomized phase II trial of adjuvant trastuzumab emtansine (T-DM1) followed by subcutaneous trastuzumab versus paclitaxel in combination with subcutaneous trastuzumab for Stage I HER2-positive breast cancer (ATEMPT 2.0)

Brief description of study

In stage 1 (early) HER2+ breast cancer, lesser chemotherapy is needed to achieve excellent long-term survival. The current standard therapy is TH (paclitaxel plus trastuzumab) and this study evaluates if a different treatment (trastuzumab emtansine (T-DM1)) is even less toxic than TH (while maintaining excellent long-term survival). The purpose of the study is to compare the incidence of clinically relevant toxicity between the two arms. The two arms are the following : trastuzumab emtansine (T-DM1), followed by subcutaneous (SC) trastuzumab (Herceptin Hylecta) or paclitaxel plus trastuzumab SC. Randomization is 3:1. Radiation therapy and/or endocrine therapy can be added as clinically indicated.


Clinical Study Identifier: s21-00934
ClinicalTrials.gov Identifier: NCT04893109
Principal Investigator: Sylvia Adams.
Other Investigators: Yelena Novik, Maryann J Kwa, Caitlin Elizabeth Ryan, Nina D'Abreo, Marleen I Meyers, Thomas B. Daniels, Amanda Marie Talmadge, Jagdeep Raince, Ruth Oratz, Danielle Seidman, Gregory Edward Totero, Anastasiya Apanasyuk, Alexander A Hindenburg, Natalie Jill Klar, Douglas K Marks.


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