This study will look at the efficacy and safety of trastuzumab deruxtecan (T-DXd) in a neoadjuvant setting, in high-risk, HER2-positive early non-metastatic breast cancer.
The target population of interest in this study is participants with high-risk HER2-positive early-stage breast cancer. The purpose of this study is to determine the efficacy and safety of T-DXd neoadjuvant therapy. Participants will be randomised to one of 3 arms: T-DXd monotherapy (Arm A), T-DXd followed by THP (Arm B), or ddAC-THP (Arm C).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
927
administered by intravenous infusion
administered by intravenous infusion
administered by intravenous infusion
Rate of Pathologic Complete Response (pCR).
Proportion of participants who have no evidence by Hematoxylin \& Eosin (H\&E) staining of residual invasive disease in the complete resected breast specimen and all sampled regional lymph nodes (ypT0/Tis ypN0) by central evaluation following completion of neoadjuvant therapy.
Time frame: Through to definitive surgery or discontinuation/withdrawal from study, up to a maximum of approximately 40 months from randomization to primary pCR DCO (12MAR2025)
Event-Free Survival (Count)
Event-free survival (EFS) is defined as the time from date of randomization until disease progression precluding initial surgery, invasive disease recurrence (local, regional, distant, or contralateral), or death from any cause.
Time frame: Up to a maximum of approximately 65 months from randomization to EFS final analysis DCO (Apr 2027)
Event-Free Survival (Duration)
Event-free survival (EFS) is defined as the time from date of randomization until disease progression precluding initial surgery, invasive disease recurrence (local, regional, distant, or contralateral), or death from any cause.
Time frame: Up to a maximum of approximately 65 months from randomization to EFS final analysis DCO (Apr 2027)
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administered by intravenous infusion
administered by intravenous infusion
administered by intravenous infusion
Research Site
Springdale, Arkansas, United States
Research Site
Beverly Hills, California, United States
Research Site
Glendale, California, United States
Research Site
Los Alamitos, California, United States
Research Site
Orange, California, United States
Research Site
New Haven, Connecticut, United States
Research Site
Fort Wayne, Indiana, United States
Research Site
Lexington, Kentucky, United States
Research Site
Louisville, Kentucky, United States
Research Site
Shreveport, Louisiana, United States
...and 135 more locations