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)
Known hypersensitivity to Dato-DXd or any of the drug components
Use of any investigational agent within 28 days prior to initiation of treatment
History of malignancies other than squamous cell carcinoma, basal cell carcinoma of the skin or carcinoma in situ of the cervix within the last 3 years including contralateral breast cancer
Other anticancer therapy, including cytotoxic, targeted agents, immunotherapy, antibody, retinoid, or anti-cancer hormonal treatment with the exception of osteoprotective therapies such as denosumab or bisphosphonates
Medical University of Vienna
Lead sponsor
Daiichi Sankyo
Collaborator