Print  |  Close

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

Active: Yes
Cancer Type: Breast Cancer
Unknown Primary 		NCT ID: NCT06018337
Trial Phases: Phase III Protocol IDs: DB-1303-O-3002 (primary)
NCI-2024-02685
CTR20233708
Eligibility: 18 Years and older, Male and Female Study Type: Treatment
Study Sponsor: DualityBio Inc.
NCI Full Details: http://clinicaltrials.gov/show/NCT06018337

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.

Objectives

The study is a Phase III, Randomized, Multi-center, Open-label study in HER2-low, HR+
metastatic breast cancer subjects whose disease has progressed on at least 2 lines of
prior ET or within 6 months of first line ET + Cyclin-dependent kinase (CDK) 4/6
inhibitor in the metastatic setting. The primary purpose of the study is to determine the
efficacy and safety of DB-1303/BNT323 compared with investigator's choice single agent
chemotherapy in the target population. Approximately 532 subjects with HER2 IHC 2+/ISH-
and IHC 1+ (HER2-low] expression will be randomized 1:1 across approximately 230 centers
globally to receive either DB-1303 or investigator's choice single agent chemotherapy
(capecitabine, paclitaxel or nab-paclitaxel) until Response Evaluation Criteria in Solid
Tumors (RECIST) 1.1 defined disease progression (PD), unless there is unacceptable
toxicity, withdrawal of consent, or another criterion for discontinuation is met.

Treatment Sites in Georgia

Nancy N. and J.C. Lewis Cancer Research Pavilion at St. Joseph Candler
225 Candler Drive
Savannah, GA 31405
912-819-5778
www.sjchs.org

**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.