A Phase-3, Open-Label, Randomized Study of Dato-DXd Versus Investigator's Choice of Chemotherapy (ICC) in Participants With Inoperable or Metastatic HR-Positive, HER2-Negative Breast Cancer Who Have Been Treated With One or Two Prior Lines of Systemic Chemotherapy (TROPION-Breast01) (NCT05104866)

🧪 Interventions in This Study

• Dato-DXd (DRUG)
• Capecitabine (DRUG)
• Gemcitabine (DRUG)
• Eribulin (DRUG)
• Vinorelbine (DRUG)

Full eligibility criteria are available on the official NIH protocol. View the criteria ↗

📍 All Participating Trial Locations (167 Sites)

Showing the first 25 of 167 sites.

• Research Site — Duarte, California
• Research Site — Los Angeles, California
• Research Site — Palo Alto, California
• Research Site — San Francisco, California
• Research Site — Jacksonville, Florida
• Research Site — Atlanta, Georgia
• Research Site — Boston, Massachusetts
• Research Site — Boston, Massachusetts
• Research Site — Grand Rapids, Michigan
• Research Site — New York, New York
• Research Site — Cleveland, Ohio
• Research Site — Portland, Oregon
• Research Site — Nashville, Tennessee
• Research Site — Richmond, Virginia
• Research Site — CABA,
• Research Site — Ciudad de Buenos Aires,
• Research Site — La Plata,
• Research Site — Mar del Plata,
• Research Site — Rosario,
• Research Site — Rosario,
• Research Site — Anderlecht,
• Research Site — Leuven,
• Research Site — Liège,
• Research Site — Itajaí,
• Research Site — Jaú,

💰 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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• [177Lu]Lu-NeoB in Combination With Ribociclib and Fulvestrant in Participants With ER+, HER2- and GRPR+ Advanced Breast Cancer — Los Angeles, California
• Evaluation And Risk Assessment For Persistent Postsurgical Pain After Breast Surgery — Durham, North Carolina
• TACTIVE-U: A Study to Learn About the Study Medicine (Vepdegestrant) When Given With Other Medicines in People With Advanced or Metastatic Breast Cancer (Sub-Study B) — Palo Alto, California
• A Multi Modality Surveillance Program for Women At High Risk for Breast Cancer — Chicago, Illinois
• ATOP TRIAL: T-DM1 in HER2 Positive Breast Cancer — Duarte, California

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💡 How to Participate

1. Check the checklist above to see if you may qualify.
2. Review the official NIH record below to find the coordinating site.
3. Ask about the visit schedule, what is covered at no cost, and any travel support.
4. Confirm with your own doctor before making a decision.