๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2026-05-31

A Study of DB-1303/BNT323 vs Investigator's Choice Chemotherapy in HER2-Low, Hormone Receptor Positive Metastatic Breast Cancer (DYNASTY-Breast02) (NCT06018337)

A Phase 3, Randomized, Multi-center, Open-Label Study of DB-1303 Versus Investigator's Choice Chemotherapy in Human Epidermal Growth Factor Receptor 2 (HER2)-Low, Hormone Receptor Positive (HR+) Metastatic Breast Cancer Patients Whose Disease Has Progressed on Endocrine Therapy (ET) (DYNASTY-Breast02)

๐Ÿ”ต Active, Not Recruiting Phase3 ๐Ÿ’Š Investigational Drug / Biologic Sponsor: DualityBio Inc.

๐Ÿฉบ Plain-English Summary (8th-Grade Level)

The goal of this clinical trial is to assess the efficacy of DB-1303/BNT323 compared with investigator's choice chemotherapy in terms of progression-free survival (PFS) by blinded independent central review (BICR) in the HR+, HER2-low (immunohistochemistry \[IHC\]2+/in situ hybridization \[ISH\]- and IHC 1+) population.

Who can join: Review the eligibility criteria below.

Location: Research Site 1141-0 โ€” Tucson, Arizona

Age range: 18 Years

๐Ÿ“‹ "Do I Qualify?" โ€” 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria โ†—

๐Ÿ“ All Participating Trial Locations (258 Sites)

Showing the first 25 of 258 sites.

  • Research Site 1141-0 โ€” Tucson, Arizona
  • Research Site 1114-0 โ€” Fullerton, California
  • Research Site 1107-0 โ€” Los Angeles, California
  • Research Site 1118-0 โ€” Orange, California
  • Research Site 1143-0 โ€” Sacramento, California
  • Research Site 1132-0 โ€” Santa Barbara, California
  • Research Site 1137-0 โ€” Aurora, Colorado
  • Research Site 1129-0 โ€” Lone Tree, Colorado
  • Research Site 1154-0 โ€” Jacksonville, Florida
  • Research Site 1145-0 โ€” Miami, Florida
  • Research Site 1150-0 โ€” Orange City, Florida
  • Research Site 1125-0 โ€” Palm Bay, Florida
  • Research Site 1155-0 โ€” Athens, Georgia
  • Research Site 1110-0 โ€” Savannah, Georgia
  • Research Site 1147-0 โ€” Chicago, Illinois
  • Research Site 1124-0 โ€” Chicago Ridge, Illinois
  • Research Site 1152-0 โ€” Fort Wayne, Indiana
  • Research Site 1106-0 โ€” Merriam, Kansas
  • Research Site 1104-0 โ€” Louisville, Kentucky
  • Research Site 1122-0 โ€” Silver Spring, Maryland
  • Research Site 8639-0 โ€” Silver Spring, Maryland
  • Research Site 1109-0 โ€” Kansas City, Missouri
  • Research Site 1158-0 โ€” Camden, New Jersey
  • Research Site 1111-0 โ€” Florham Park, New Jersey
  • Research Site 1157-0 โ€” Sante Fe, New Mexico

๐Ÿ’ฐ 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 ยง 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.

๐Ÿ’ก 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.
๐Ÿ›๏ธ View Official NIH Record โ†—