This study will evaluate the safety and efficacy of trastuzumab deruxtecan (T-DXd) in participants with human epidermal growth factor receptor 2 (HER2)-low or HER2 immunohistochemistry (IHC) 0 (who are both hormone receptor \[HR\]-negative and HR-positive) unresectable and/or metastatic breast cancer.
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Must agree to provide a newly obtained or archival baseline biopsy from primary and/or metastatic lesion.
Pathologically documented Breast Cancer (BC) tumor
Is unresectable and/or metastatic.
Prior treatment with an antibody drug conjugate (ADC).
Uncontrolled or significant cardiovascular disease.
Has a corrected QT interval prolongation.
Has a history of (non-infectious) interstitial lung disease (ILD)/pneumonitis that required steroids, has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at Screening.
Parallel
Trastuzumab Deruxtecan
DrugIntravenous administration, 5.4 mg/kg on Day 1 of each 21-day cycle until radiographic disease progression as assessed by the investigator, unacceptable toxicity, other discontinuation criteria are met, or 2 years after first dose of study drug
Time From the Start of T-DXd to Initiation of Subsequent Anticancer Treatment (TTNT)
TTNT is defined as the time interval from the date of first dose of T-DXd to the initiation of the next anticancer treatment or death due to any cause.
Real-World Progression Free Survival (PFS)
Real-world PFS is defined as time from date of first dose of T-DXd to time of disease progression per investigator assessment based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 or death due to any cause.
Time From Start of T-DXd to Discontinuation of T-DXd or Death (TTD)
TTD is defined as the time interval from the date of first dose of T-DXd to the date of discontinuation of T-DXd or death due to any cause.
Objective Response Rate (ORR)
ORR is defined as the proportion of participants with a best overall response (BOR) of confirmed complete response (CR) or confirmed partial response (PR) according to the investigator and per RECIST version 1.1 criteria.
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
TEAEs are graded according to National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) v5.0. A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after initiating the study drug until 47 days after the last dose of the study drug.
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Daiichi Sankyo
Lead sponsor
AstraZeneca
Collaborator
