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Clinical Trial Active — Not Recruiting Phase III NCT06018337

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

A Study of DB-1303/BNT323 vs Investigator’s Choice Chemotherapy in HER2-Low, Hormone Receptor Positive Metastatic Breast Cancer (DYNASTY-Breast02) — Active Not Recruiting • Phase III • Oncology • NCT06018337.

📅 02 Jun 2026 ⏱ 1 min read
Active — Not Recruiting
Check the registry for current status and eligibility criteria.
Status
Active — Not Recruiting
Phase
Phase III
NCT ID
NCT06018337
Start
2024-01-18
Completion
2026-06
ClinicaliQ Trial Snapshot
  • A Study of DB-1303/BNT323 vs Investigator’s Choice Chemotherapy in HER2-Low, Hormone Receptor Positive Metastatic Breast Cancer (DYNASTY-Breast02) — Active Not Recruiting • Phase III • Oncology • NCT06018337.
  • DB-1303/BNT323 versus standard chemotherapy for HER2-low, hormone receptor positive advanced breast cancer, measuring time to disease progression.

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What This Trial Is Studying

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: Metastatic Breast Cancer Interventions: DB-1303/BNT323, Capecitabine, Paclitaxel, Nab-paclitaxel Lead Sponsor: DualityBio Inc. Planned Enrollment: 541 participants

Full Trial Details
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Eligibility criteria, protocol, and results when available
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