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

• Status: Recruiting
• Trial end date: 2026-06-26
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AstraZeneca
• Collaborator: Daiichi Sankyo, Inc.
• Treatments: Cyclophosphamide; Doxorubicin; Paclitaxel; Pertuzumab; Trastuzumab

Criteria

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

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)

• 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