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)

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-507333-17-00

Acronym

DB-1303-O-3002

Enrollment

Registered

2024-03-11

Start date

2024-04-15

Completion date

Unknown

Last updated

2025-10-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HER2-low, Hormone Receptor Positive, Metastatic Breast Cancer

Brief summary

PFS by BICR according to response evaluation criteria in solid tumors (RECIST) 1.1 in the HR+, HER2-low population

Detailed description

OS in the HR+, HER2-low population, ORR and DoR by BICR and Investigator assessment according to RECIST 1.1 in the HR+, HER2-low population, PFS by Investigator assessment according to RECIST 1.1 in the HR+, HER2-low population, TEAEs and SAEs per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0, physical examinations, changes from baseline in laboratory findings, electrocardiograms (ECGs), ECHO/MUGA and vital signs., The patient reported outcomes (PROs) include: change from baseline in EORTC QLQC30 and EORTC QLQ-BR45 Scale scores, time to deterioration in EORTC QLQ-C30 scores, EQ-5D-5L health state utility index

Interventions

DRUGPACLITAXEL

DRUGCAPECITABINE

DRUGPACLITAXEL ALBUMIN-BOUND

DRUGDB-1303

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
PFS by BICR according to response evaluation criteria in solid tumors (RECIST) 1.1 in the HR+, HER2-low population	—

Secondary

Measure	Time frame
OS in the HR+, HER2-low population, ORR and DoR by BICR and Investigator assessment according to RECIST 1.1 in the HR+, HER2-low population, PFS by Investigator assessment according to RECIST 1.1 in the HR+, HER2-low population, TEAEs and SAEs per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0, physical examinations, changes from baseline in laboratory findings, electrocardiograms (ECGs), ECHO/MUGA and vital signs., The patient reported outcomes (PROs) include: change from baseline in EORTC QLQC30 and EORTC QLQ-BR45 Scale scores, time to deterioration in EORTC QLQ-C30 scores, EQ-5D-5L health state utility index	—

Measure

Time frame

—

Countries

Belgium, France, Germany, Hungary, Italy, Poland, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026