Neoadjuvant Response-guided Treatment of HER2 Positive Breast Cancer

Summary

The purpose of this trial is to evaluate efficacy and toxicity of either the combination of docetaxel, trastuzumab sc and pertuzumab (arm A) or trastuzumab emtansin (arm B). Switch of therapy to the opposite treatment alternative is applicable in case of lack of response after two courses of treatment, or for medical reasons under exceptional circumstances (drug reaction, other medical conditions) at any point. After termination of the primary treatment follow-up for five years. A translational subprotocol is a mandatory part of the study protocol, with exception for the use of PET-CT evaluations.

Timeline

Start

2014-11

Primary completion

2019-02

Completion

2029-02

Publications

• Zhu Y, Zerdes I, Matikas A, Cruz IR, Bergqvist M, Elinder E, Bosch A, Lindman H, Einbeigi Z, Andersson A, Carlsson L, Dreifaldt AC, Isaksson-Friman E, Hellstrom M, Johansson H, Wang K, Bergh JCS, Hatschek T, Foukakis T. The role of serum thymidine kinase 1 activity in neoadjuvant-treated HER2-positive breast cancer: biomarker analysis from the Swedish phase II randomized PREDIX HER2 trial. Breast Cancer Res Treat. 2024 Apr;204(2):299-308. doi: 10.1007/s10549-023-07200-x. Epub 2024 Jan 4.
• Matikas A, Johansson H, Gryback P, Bjohle J, Acs B, Boyaci C, Lekberg T, Fredholm H, Elinder E, Margolin S, Isaksson-Friman E, Bosch A, Lindman H, Adra J, Andersson A, Agartz S, Hellstrom M, Zerdes I, Hartman J, Bergh J, Hatschek T, Foukakis T. Survival Outcomes, Digital TILs, and On-treatment PET/CT During Neoadjuvant Therapy for HER2-positive Breast Cancer: Results from the Randomized PREDIX HER2 Trial. Clin Cancer Res. 2023 Feb 1;29(3):532-540. doi: 10.1158/1078-0432.CCR-22-2829.
• Hatschek T, Foukakis T, Bjohle J, Lekberg T, Fredholm H, Elinder E, Bosch A, Pekar G, Lindman H, Schiza A, Einbeigi Z, Adra J, Andersson A, Carlsson L, Dreifaldt AC, Isaksson-Friman E, Agartz S, Azavedo E, Gryback P, Hellstrom M, Johansson H, Maes C, Zerdes I, Hartman J, Brandberg Y, Bergh J. Neoadjuvant Trastuzumab, Pertuzumab, and Docetaxel vs Trastuzumab Emtansine in Patients With ERBB2-Positive Breast Cancer: A Phase 2 Randomized Clinical Trial. JAMA Oncol. 2021 Sep 1;7(9):1360-1367. doi: 10.1001/jamaoncol.2021.1932.

Drugs

Indications