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NCT06018337Not yet recruiting

A Study of DB-1303 vs Investigator's Choice Chemotherapy in Metastatic Breast Cancer

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)
DualityBio Inc.Phase 3ClinicalTrials.govdrug
Verified
Study focus
Disease/Condition
Metastatic Breast Cancer
Drug/Device/Intervention
DB-1303
Study type
Interventional
Intervention type
drug
Sponsor & location
Primary sponsor
DualityBio Inc.
Location
Dallas, United States of America
Timeline & enrollment
Phase
Phase 3
Start date
Nov 01, 2023
End date
Jun 01, 2027
Enrollment
532 participants
Primary outcome

Progression-free survival (PFS) in the HR+, HER2-low population

Summary

The goal of this clinical trial is to assess the efficacy of DB-1303 compared with
 investigator's choice chemotherapy in terms of progression-free survival (PFS) by blinded
 independent central review (BICR) in the HR+, HER2-low (IHC 2+/ISH- and IHC 1+）population.

ICD-10 classifications
Malignant neoplasm of breastMalignant neoplasm of breastMalignant neoplasm: Breast, unspecifiedMalignant neoplasm: Central portion of breastMalignant neoplasm: Overlapping lesion of breast
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06018337
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT06018337 through Pure Global AI's free database. This Phase 3 trial is sponsored by DualityBio Inc. and is currently Not yet recruiting. The study focuses on Metastatic Breast Cancer. Target enrollment is 532 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.