Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
A Study of DB-1303/BNT323 vs Investigator's Choice Chemotherapy in HER2-Low, Hormone Receptor Positive Metastatic Breast Cancer (DYNASTY-Breast02)
NCT06018337 · View on ClinicalTrials.gov ↗
Study Summary
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.
Conditions Studied
Interventions
- DRUG Capecitabine
- DRUG Paclitaxel
- DRUG Nab-paclitaxel
- DRUG DB-1303/BNT323
Study Locations (20)
California
- Research Site 1114-0 — Fullerton
- Research Site 1107-0 — Los Angeles
- Research Site 1118-0 — Orange
- Research Site 1143-0 — Sacramento
- Research Site 1132-0 — Santa Barbara
Florida
- Research Site 1154-0 — Jacksonville
- Research Site 1145-0 — Miami
- Research Site 1150-0 — Orange City
- Research Site 1125-0 — Palm Bay
Colorado
- Research Site 1137-0 — Aurora
- Research Site 1129-0 — Lone Tree
Georgia
- Research Site 1155-0 — Athens
- Research Site 1110-0 — Savannah
Illinois
- Research Site 1147-0 — Chicago
- Research Site 1124-0 — Chicago Ridge
Arizona
- Research Site 1141-0 — Tucson
Indiana
- Research Site 1152-0 — Fort Wayne
Kansas
- Research Site 1106-0 — Merriam
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 541 participants |
| Start Date | 2024-01-18 |
| Est. Completion | 2028-07 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06018337
The ClinicalTrials.gov registry entry for NCT06018337 describes a study currently listed as active not recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 541 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is DualityBio, which has 40 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Metastatic Breast Cancer appearing as the primary indexed condition, and to 4 interventions — of which Capecitabine is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06018337 reports 20 study locations spanning 10 distinct geographic areas — top geographies include California, Florida, Colorado. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT06018337 about?
NCT06018337 is a clinical study titled "A Study of DB-1303/BNT323 vs Investigator's Choice Chemotherapy in HER2-Low, Hormone Receptor Positive Metastatic Breast Cancer (DYNASTY-Breast02)". 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 \[ISH\]- an...
What is the current status of trial NCT06018337?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 541 participants. The study started on 2024-01-18. Estimated completion is 2028-07.
What conditions does trial NCT06018337 study?
This clinical trial studies the following conditions: Metastatic Breast Cancer. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06018337?
The interventions under investigation include: Capecitabine (DRUG), Paclitaxel (DRUG), Nab-paclitaxel (DRUG), DB-1303/BNT323 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06018337?
This trial is sponsored by DualityBio, which has 40 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT06018337 being conducted?
This trial has 20 study locations across Arizona, California, Colorado, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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