For Healthcare Professionals

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


About the study

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.

Who can take part

You may be eligible to participate in the study if you meet the following criteria:


Key Inclusion Criteria:

  1. Patients must be at least 18 years of age.
  2. 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
  3. ECOG performance status of 0 or 1 at randomization
  4. Adequate organ and bone marrow function
  5. LVEF ≥ 50% within 28 days before randomization
  6. 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:

  1. prior history of invasive breast cancer
  2. stage IV breast cancer (determined by AJCC staging system)
  3. 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)
  4. history of DCIS (except those treated with mastectomy >5 years prior to current diagnosis)
  5. History of, or current, ILD/pneumonitis
  6. Prior systemic therapy for the treatment of breast cancer
  7. Previous treatment with anthracyclines, cyclophosphamide or taxanes for any malignancy
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Study Locations

Enter your ZIP code/Postal code/PIN code to locate study sites near you:

How to Apply

Contact the study center to learn if this study is a good match for you.

Study’s details


Breast Neoplasms,Breast Cancer,HER2-positive Early Breast Cancer

Age (in years)



Phase 3

Participants needed


Est. Completion Date

Apr 30, 2027

Treatment type



AstraZeneca identifier


Study number


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