Trastuzumab Deruxtecan (T-DXd) Alone or in Sequence With THP, Versus Standard Treatment (ddAC-THP), in HER2-positive Early Breast Cancer
Condition(s) studied
Investigational drug(s) / intervention(s)
Trastuzumab Deruxtecan: administered by intravenous infusion
Paclitaxel: administered by intravenous infusion
Trastuzumab: administered by intravenous infusion
Pertuzumab: administered by intravenous infusion
Doxorubicin: administered by intravenous infusion
cyclophosphamide: administered by intravenous infusion
Study summary
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.
Eligibility
Primary outcome measure(s)
- Rate of Pathologic Complete Response (pCR). — Through to definitive surgery or discontinuation/withdrawal from study, up to a maximum of approximately 40 months from randomization to primary pCR DCO (12MAR2025)
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.
Trial sites (145)
| Facility | City | Region | Status |
|---|---|---|---|
| Research Site | Springdale | Arkansas | |
| Research Site | Beverly Hills | California | |
| Research Site | Glendale | California | |
| Research Site | Los Alamitos | California | |
| Research Site | Orange | California | |
| Research Site | New Haven | Connecticut | |
| Research Site | Fort Wayne | Indiana | |
| Research Site | Lexington | Kentucky | |
| Research Site | Louisville | Kentucky | |
| Research Site | Shreveport | Louisiana | |
| Research Site | Minneapolis | Minnesota | |
| Research Site | Las Vegas | Nevada | |
| Research Site | East Brunswick | New Jersey | |
| Research Site | Summit | New Jersey | |
| Research Site | Commack | New York | |
| Research Site | Durham | North Carolina | |
| Research Site | Greenville | South Carolina | |
| Research Site | Germantown | Tennessee | |
| Research Site | Nashville | Tennessee | |
| Research Site | Fort Worth | Texas | |
| Research Site | Ogden | Utah | |
| Research Site | Tacoma | Washington | |
| Research Site | Goiânia | Brazil | |
| Research Site | Ijuí | Brazil | |
| Research Site | Natal | Brazil | |
| Research Site | Porto Alegre | Brazil | |
| Research Site | Porto Alegre | Brazil | |
| Research Site | São Paulo | Brazil | |
| Research Site | São Paulo | Brazil | |
| Research Site | Panagyurishte | Bulgaria | |
| Research Site | Sofia | Bulgaria | |
| Research Site | Edmonton | Alberta | |
| Research Site | Toronto | Ontario | |
| Research Site | Montreal | Quebec | |
| Research Site | Québec | Quebec | |
| Research Site | Sherbrooke | Quebec | |
| Research Site | Montreal | Canada | |
| Research Site | Beijing | China | |
| Research Site | Changsha | China | |
| Research Site | Changsha | China |
+ 105 more sites — see the full list on the official registry below.
On this site
📄 Enhertu (trastuzumab deruxtecan) drug profile → 📄 Herceptin (trastuzumab) drug profile →More AstraZeneca trials in Italy
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT05113251 on ClinicalTrials.gov ↗ ← All trials in Italy