Phase II Study of Datopotamab-Deruxtecan (Dato-DXd; DS-1026a) in Triple-negative Breast Cancer Patients With Newly Diagnosed or Progressing Brain Metastases
Datopotamab-deruxtecan in triple-negative breast cancer patients with newly diagnosed or progressing brain metastases.
• Histologically confirmed breast cancer
• Triple-negative disease as defined by immunohistochemistry (IHC) and/or c-erb-B2 gene amplification status. For the definition of hormone-receptor negative disease, a cut-off of \<10% tumour cells with positive staining of oestrogen- and progresteron-receptors is required
• Newly diagnosed untreated brain metastases or brain metastases progressing after prior local therapy
• Measurable disease (RANO-BM criteria)
• No indication for immediate local treatment
• Accompanying type II leptomeningeal disease allowed (suspected LMD by clinical findings and neuroimaging)
• KPS ≥70%, ECOG ≤2 Indication for systemic anti-cancer treatment
• Prior exposure to PD-1, PD-L1 inhibitors and TROP-2 targeted agents allowed
• Life expectancy of at least 3 months
• Age ≥18 years
• Patient must be able to tolerate therapy
• Adequate bone-marrow, liver and kidney function
• Adequate treatment washout period before enrolment, defined as:
• Major Surgery: ≥3 weeks
• Radiation therapy to the chest: ≥4 weeks
• Palliative radiation therapy to other areas: ≥2 weeks
• Chemotherapy, small-molecule targeted agents: ≥3 weeks
• Antibody-based treatment: ≥4 weeks (concurrent therapy with denosumab allowed)
• Patient must be capable of understanding the purpose of the study and have given written informed consent