A Phase III Randomised Study to Evaluate Dato-DXd and Durvalumab for Neoadjuvant/Adjuvant Treatment of Triple-Negative or Hormone Receptor-low/HER2-negative Breast Cancer (NCT06112379)
A Phase III, Open-label, Randomised Study of Neoadjuvant Datopotamab Deruxtecan (Dato-DXd) Plus Durvalumab Followed by Adjuvant Durvalumab With or Without Chemotherapy Versus Neoadjuvant Pembrolizumab Plus Chemotherapy Followed by Adjuvant Pembrolizumab With or Without Chemotherapy for the Treatment of Adult Patients With Previously Untreated Triple-Negative or Hormone Receptor-low/HER2-negative Breast Cancer (D926QC00001; TROPION-Breast04)
🩺 Plain-English Summary (8th-Grade Level)
This is a Phase III, 2-arm, randomised, open-label, multicentre, global study assessing the efficacy and safety of neoadjuvant Dato-DXd plus durvalumab followed by adjuvant durvalumab with or without chemotherapy compared with neoadjuvant pembrolizumab plus chemotherapy followed by adjuvant pembrolizumab with or without chemotherapy in participants with previously untreated TNBC or hormone receptor-low/HER2-negative breast cancer.
Who can join: Review the eligibility criteria below.
Location: Research Site — Daphne, Alabama
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (283 Sites)
Showing the first 25 of 283 sites.
- Research Site — Daphne, Alabama
- Research Site — Prescott, Arizona
- Research Site — Jonesboro, Arkansas
- Research Site — Rogers, Arkansas
- Research Site — Los Angeles, California
- Research Site — Santa Barbara, California
- Research Site — Santa Rosa, California
- Research Site — Torrance, California
- Research Site — Aurora, Colorado
- Research Site — Longmont, Colorado
- Research Site — Bridgeport, Connecticut
- Research Site — New Haven, Connecticut
- Research Site — Fort Myers, Florida
- Research Site — Jacksonville, Florida
- Research Site — St. Petersburg, Florida
- Research Site — West Palm Beach, Florida
- Research Site — Atlanta, Georgia
- Research Site — Des Moines, Iowa
- Research Site — Edgewood, Kentucky
- Research Site — Louisville, Kentucky
- Research Site — Baton Rouge, Louisiana
- Research Site — Annapolis, Maryland
- Research Site — Boston, Massachusetts
- Research Site — Grand Rapids, Michigan
- Research Site — Traverse City, Michigan
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.