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
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Key Inclusion Criteria:
* Patients must be at least 18 years of age.
* Histologically documented HER2-positive early breast cancer (EBC) participants, including clinical stage at presentation (based on mammogram or breast MRI assessment): T0-4 (inclusive of inflammatory breast cancer), N1-3, M0 or ≥ T3, N0, M0 as determined by the AJCC staging system, 8th edition
* ECOG performance status of 0 or 1 at randomization
* Adequate organ and bone marrow function
* LVEF ≥ 50% within 28 days before randomization
* FFPE tissue block (2 cores) or 20 freshly-cut, serial tumor slides for HER2 assessment by central lab. If blocks are incomplete or fewer than 20 slides are available, participants may be eligible following discussion with the AstraZeneca Study Physician
Exclusion Criteria:
* prior history of invasive breast cancer
* stage IV breast cancer (determined by AJCC staging system)
* any primary malignancy within 3 years (except resected non-melanoma skin cancer, curatively treated in situ disease) Note: This includes a second current breast primary malignancy (ie, bilateral breast cancer)
* history of DCIS (except those treated with mastectomy \>5 years prior to current diagnosis)
* History of, or current, ILD/pneumonitis
* Prior systemic therapy for the treatment of breast cancer
* Previous treatment with anthracyclines, cyclophosphamide or taxanes for any malignancy
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.
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.
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