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NCT06018337 · ClinicalTrials.gov registry record · Phase 3
A Study of DB-1303/BNT323 vs Investigator's Choice Chemotherapy in HER2-Low, Hormone Receptor Positive Metastatic Breast Cancer (DYNASTY-Breast02)
A Phase 3 study of Metastatic Breast Cancer, sponsored by DualityBio.
- Active
- Registry status
- Phase 3
- Development phase
- 541
- Enrollment target
- 20
- Study locations
NCT06018337 is a Phase 3 study of Metastatic Breast Cancer that is active but no longer recruiting, run by DualityBio. The registered enrollment target is 541 participants, above the 201-participant average among 139 other Metastatic Breast Cancer trials with a reported enrollment target (169% higher). The trial reports 20 study locations across 10 states.
The verdict
NCT06018337, a Phase 3 study of Metastatic Breast Cancer, is active but no longer recruiting, sponsored by DualityBio.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 541 participants
- Enrollment target
- 20
- Study locations
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 |
Interested in This Trial?
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, categorized as Phase 3. The registered enrollment target is 541 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 201-participant average among 139 other Metastatic Breast Cancer trials with a reported enrollment target (169% higher). The listed sponsor is DualityBio, which has 10 total studies on file at ClinicalTrials.gov.
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.
NCT06018337 reports 20 study locations spanning 10 distinct geographic areas - top geographies include California, Florida, Colorado.
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.
What interventions are being tested in trial NCT06018337?
The interventions under investigation include: Capecitabine (DRUG), Paclitaxel (DRUG), Nab-paclitaxel (DRUG), DB-1303/BNT323 (DRUG).
Who is sponsoring clinical trial NCT06018337?
This trial is sponsored by DualityBio, which has 10 total clinical trials registered on ClinicalTrials.gov.
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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