The purpose of this study is to test the safety and effectiveness of an investigational drug combination (trastuzumab deruxtecan and durvalumab) to learn whether the intervention works in treating Human Epidermal growth factor Receptor-2 (HER2)-expressing inflammatory breast cancer.
The names of the study drugs involved in this study are:
* Trastuzumab deruxtecan * Durvalumab
Participants must have a histological or cytological diagnosis of invasive breast cancer.
All histologic subtypes are eligible.
Participants must have a clinical diagnosis of stage III inflammatory breast cancer within the past 6 months
HER2-positive status as determined locally by the current ASCO/CAP guidelines or HER2-low tumor expression (IHC 2+/ISH-, IHC 1+/ISH-, or IHC 1+/ISH untested) (note: ISH may be determined by either fluorescence in situ hybridization [FISH] or dual in situ hybridization [DISH])
Has received prior systemic anti-cancer therapy for the current diagnosis of inflammatory breast cancer, including chemotherapy, immunotherapy, or targeted therapy
Has received any radiotherapy or surgery for the current diagnosis of inflammatory breast cancer. Tumor biopsies are not considered surgery for the purpose of enrollment.
Prior hypersensitivity to durvalumab or the excipients of durvalumab or trastuzumab deruxtecan or history of severe hypersensitivity reactions to other monoclonal antibodies.
Major surgery within 4 weeks prior to study treatment initiation. Patients must have recovered from any effects of any major surgery.
Filipa Lynce, MD
Lead sponsor
Dana-Farber Cancer Institute
Sponsor institution
AstraZeneca
Collaborator
Daiichi Sankyo
Collaborator