Prospective, multi-center, randomized, open label comparative Phase III study in patients with intermediate to high-risk (as defined in the SURVIVE trial) HER2-positive or HER2-low early breast cancer, who participate in the SURVIVE trial and experience a molecular relapse, as assessed based on a positive circulating tumor DNA (ctDNA) result, with 2:1 allocation to:
* Arm A: Trastuzumab-Deruxtecan (i.v. 5,4 mg/kg, q3w) + endocrine therapy (if hormonal-receptor-positive) for 16 cycles or until relapse, if earlier * Arm B: Continuous treatment of physician's choice (may include endocrine treatment, CDK4/6-Inhibition, T-DM1, Olaparib, Trastuzumab, Pertuzumab, Capecitabine or Neratinib)
Written informed consent for all study procedures according to local regulatory requirements prior to beginning specific protocol procedures.
Females or males, ≥ 18 years and ≤ 75 years of age.
HER2-positive defined as an immunohistochemistry (IHC) score of 3+ and/or positive by in situ hybridization (ISH) in Her2 2+ tumors (as defined in 2018 American Society of Clinical Oncology - College of American Pathologists [ASCO-CAP] guidelines)
HER2-low defined as an immunohistochemistry (IHC) score of 1+ or an IHC score of 2+ with a mandatory negative in situ hybridization (ISH), as defined in 2018 American Society of Clinical Oncology - College of American Pathologists [ASCO-CAP] guidelines.
Stage IV (metastatic) breast cancer.
ipsi- or contralateral non-invasive carcinoma of the breast (DCIS)
other, curatively treated in-situ disease
adequately treated non-melanoma carcinoma of the skin
Prof. Wolfgang Janni
Lead sponsor
University of Ulm
Sponsor institution