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

Running, not enrolling · Phase 3

Conditions studied: Breast Neoplasms, Breast Cancer, HER2-positive Early Breast Cancer

In brief

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.

Key facts

Study ID

NCT05113251

Run by

AstraZeneca

People needed

927

Starts

2021-10-25

Expected to finish

2027-04-30

Last updated by the study team

2026-06-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• 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

Where it is running

• Research Site — Goiânia, Brazil
• Research Site — Ijuí, Brazil
• Research Site — Natal, Brazil
• Research Site — Springdale, Arkansas, United States
• Research Site — Beverly Hills, California, United States
• Research Site — Glendale, California, United States
• Research Site — Los Alamitos, California, United States
• Research Site — Orange, California, United States
• Research Site — New Haven, Connecticut, United States
• Research Site — Fort Wayne, Indiana, United States
• Research Site — Lexington, Kentucky, United States
• Research Site — Louisville, Kentucky, United States
• Research Site — Shreveport, Louisiana, United States
• Research Site — Minneapolis, Minnesota, United States
• Research Site — Las Vegas, Nevada, United States
• Research Site — East Brunswick, New Jersey, United States
• Research Site — Summit, New Jersey, United States
• Research Site — Commack, New York, United States
• Research Site — Durham, North Carolina, United States
• Research Site — Greenville, South Carolina, United States
• Research Site — Germantown, Tennessee, United States
• Research Site — Nashville, Tennessee, United States
• Research Site — Fort Worth, Texas, United States
• Research Site — Ogden, Utah, United States
• Research Site — Tacoma, Washington, United States

Full record on ClinicalTrials.gov

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