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)
๐ฉบ 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
๐งช Interventions in This Study
๐ "Do I Qualify?" โ 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria โ
๐ 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
๐ฐ 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.
More studies in Metastatic Breast Cancer
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- Niraparib in Combination With Trastuzumab in Metastatic HER2+ Breast Cancer โ Birmingham, Alabama
- A Phase 1b Study of T-DXd Combinations in HER2-low Advanced or Metastatic Breast Cancer โ Commack, New York
- Palbociclib With Fulvestrant for Metastatic Breast Cancer After Treatment With Palbociclib and an Aromatase Inhibitor โ Washington D.C., District of Columbia
- A Study of Abemaciclib (LY2835219) Plus Tamoxifen or Abemaciclib Alone in Women With Metastatic Breast Cancer โ Tucson, Arizona
- Roll-over Study to Allow Continued Access to Ribociclib โ Chandler, Arizona
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๐ก 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.