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Active, not recruiting Phase 3

Trastuzumab Deruxtecan (T-DXd) Alone or in Sequence With THP, Versus Standard Treatment (ddAC-THP), in HER2-positive Early Breast Cancer

NCT05113251 · tracked via the Priya Life Science Italy tracker
Phase
Phase 3
Started
2021-10-25
Last updated
2026-08-11

Condition(s) studied

Breast NeoplasmsBreast CancerHER2-positive Early Breast Cancer

Investigational drug(s) / intervention(s)

Trastuzumab Deruxtecan →Paclitaxel →Trastuzumab →Pertuzumab →Doxorubicin →cyclophosphamide →

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)

FacilityCityRegionStatus
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.

Official registry record

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