A Study of DB-1303/BNT323 vs Investigator's Choice Chemotherapy in HER2-Low, Hormone Receptor Positive Metastatic Breast Cancer (DYNASTY-Breast02)
Public ClinicalTrials.gov record NCT06018337. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT06018337
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 541 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jan 18, 2024 (Actual)
- Primary completion
- Aug 12, 2026 (Actual)
- Completion
- Aug 2028 (Estimated)
- Last update posted
- Sep 24, 2026
2024 – 2028
United States locations
- U.S. sites
- 44
- U.S. states
- 22
- U.S. cities
- 42
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Research Site 1141-0 | Tucson | Arizona | 85704 | — |
| Research Site 1114-0 | Fullerton | California | 92835 | — |
| Research Site 1107-0 | Los Angeles | California | 90095 | — |
| Research Site 1118-0 | Orange | California | 92868-3201 | — |
| Research Site 1143-0 | Sacramento | California | 95814 | — |
| Research Site 1132-0 | Santa Barbara | California | 93105 | — |
| Research Site 1137-0 | Aurora | Colorado | 80045 | — |
| Research Site 1129-0 | Lone Tree | Colorado | 80124 | — |
| Research Site 1154-0 | Jacksonville | Florida | 32256 | — |
| Research Site 1145-0 | Miami | Florida | 33136 | — |
| Research Site 1150-0 | Orange City | Florida | 32763 | — |
| Research Site 1125-0 | Palm Bay | Florida | 32909 | — |
| Research Site 1155-0 | Athens | Georgia | 30607 | — |
| Research Site 1110-0 | Savannah | Georgia | 31405 | — |
| Research Site 1147-0 | Chicago | Illinois | 60611 | — |
| Research Site 1124-0 | Chicago Ridge | Illinois | 60415 | — |
| Research Site 1152-0 | Fort Wayne | Indiana | 46804 | — |
| Research Site 1106-0 | Merriam | Kansas | 66204 | — |
| Research Site 1104-0 | Louisville | Kentucky | 40202 | — |
| Research Site 1122-0 | Silver Spring | Maryland | 20904 | — |
| Research Site 1109-0 | Kansas City | Missouri | 64111 | — |
| Research Site 1158-0 | Camden | New Jersey | 08103 | — |
| Research Site 1111-0 | Florham Park | New Jersey | 07932 | — |
| Research Site 1157-0 | Sante Fe | New Mexico | 87505 | — |
| Research Site 1148-0 | Staten Island | New York | 10314 | — |
| Research Site 1105-0 | Westbury | New York | 11590 | — |
| Research Site 1144-0 | Chapel Hil | North Carolina | 27599 | — |
| Research Site 1138-0 | Akron | Ohio | 44305 | — |
| Research Site 1160-0 | Cincinnati | Ohio | 45220 | — |
| Research Site 1133-0 | Eugene | Oregon | 97401-8122 | — |
| Research Site 1126-0 | Tigard | Oregon | 97223 | — |
| Research Site 1134-0 | Broomall | Pennsylvania | 19008 | — |
| Research Site 1123-0 | Horsham | Pennsylvania | 19044 | — |
| Research Site 1149-0 | Knoxville | Tennessee | 37909 | — |
| Research Site 1102-0 | Nashville | Tennessee | 37203 | — |
| Research Site 1159-0 | Nashville | Tennessee | 37203 | — |
| Research Site 1101-0 | Dallas | Texas | 75246 | — |
| Research Site 1116-0 | Denison | Texas | 75020 | — |
| Research Site 1115-0 | Houston | Texas | 77030 | — |
| Research Site 1117-0 | San Antonio | Texas | 78240 | — |
| Research Site 1130-0 | Salt Lake City | Utah | 84124 | — |
| Research Site 1108-0 | Fairfax | Virginia | 22031 | — |
| Research Site 1131-0 | Fairfax | Virginia | 22031 | — |
| Research Site 1127-0 | Roanake | Virginia | 24014 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 214 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06018337, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Sep 24, 2026 · Synced Oct 20, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT06018337 live on ClinicalTrials.gov.