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

This is a randomized phase II adjuvant study for women and men with Stage I HER2-positive invasive breast cancer. At least 500 eligible patients will be randomized 3:1 to trastuzumab emtansine (T-DM1), followed by subcutaneous (SC) trastuzumab (Herceptin Hylecta) (n = 375) or paclitaxel plus trastuzumab SC (TH) (n = 125). Patients may have any hormone receptor status, may be either pre- or post-menopausal, and must be systemic treatment-naïve for this cancer. HER-2 positivity will be confirmed by central testing in all patients. Patients will be stratified by Age (<55, =55) Planned Radiation (Yes/No) and Planned Hormonal therapy (Yes/No). Arm 1 (n=375) TDM1 3.6 mg/kg IV Day 1 of every 3-week cycle for 6 cycles followed by Trastuzumab 600 mg subcutaneously (Herceptin Hylecta) Day 1 of every 3-week cycle for 11 cycles Arm 2 (n=125) Paclitaxel 80 mg/m2 IV weekly for 12 weeks Trastuzumab 600 mg subcutaneously (Herceptin Hylecta) Day 1 of every 3-week cycle for 17 cycles (the first 4 trastuzumab treatments will be administered concurrently with paclitaxel) Patients on both arms will receive additional adjuvant radiation therapy and/or endocrine therapy if deemed necessary, per institutional practice. Endocrine therapy should not be administered concurrently with paclitaxel and should begin after 12 weeks of trastuzumab emtansine. Similarly, radiation therapy, should begin after the conclusion of paclitaxel treatment or after receipt of 12 weeks (4 cycles) of trastuzumab emtansine for patients on Arm 1. Patients will also participate in patient reported outcomes (PRO) assessments including quality of life (QOL) surveys and symptom questionnaires at specified time points throughout the course of the study treatment and during follow-up. This study requires submission of tumor blocks or slides in order to perform biomarker analyses.


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


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