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.
Parallel
Trastuzumab deruxtecan
Drugvia IV, protocol determined dosage once per cycle up to eight cycles. Each cycle will last for 21 days (three weeks).
Durvalumab
Drugvia IV, protocol determined dosage once per cycle up to eight cycles. Each cycle will last for 21 days (three weeks).
Pathological complete response (pCR) Rate
pCR rate is the proportion of participants with absent invasive carcinoma in the breast and lymph nodes at time of surgery; in situ disease only is considered pCR; if off-treatment prior to surgery than considered not pCR.
Residual Cancer Burden (RCB) Response
RCB response is the number of participants by RCB category; the RCB calculator used is from M.D Anderson with parameters (see References for link).
Event Free Survival (EFS)
EFS defined from the time of registration until the occurrence of the first of the following events: * Progression of disease that precludes surgery; * Local/regional recurrence: a recurrent or new invasive ipsilateral breast cancer, invasive breast cancer in the axilla, regional lymph nodes, chest wall, or skin of the ipsilateral breast; * Contralateral invasive breast cancer; * Distant recurrence: metastatic disease that has either been biopsy confirmed or clinically diagnosed as recurrent invasive breast cancer; or * Death from any cause. In the absence of an event, EFS is censored at date last disease assessment. t-year EFS to be estimated by Kaplan-Meier method, with time "t" specified according to median follow-up at time of reporting.
Distant progression or distant disease-free survival (DP/DDFS)
DP/DDFS defined from the time of registration until the occurrence of the first of the following events: * Distant progression of disease prior to surgery; * Distant recurrence: metastatic disease that has either been biopsy confirmed or clinically diagnosed as recurrent invasive breast cancer; or * Death from any cause. In the absence of an event, DP/DDFS is censored at date last disease assessment. t-year DP/DDFS to be estimated by Kaplan-Meier method, with time "t" specified according to median follow-up at time of reporting.
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Filipa Lynce, MD
Lead sponsor
Dana-Farber Cancer Institute
Sponsor institution
AstraZeneca
Collaborator
Daiichi Sankyo
Collaborator
