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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 \[ISH\]- and IHC 1+) population.
Study details:
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.
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
Inclusion criteria
Exclusion criteria
Eligibility
Age eligible for study : 18 and older
Healthy volunteers accepted : No
Gender eligible for study: All
Things to know
Study dates
Study start: 2024-01-18
Primary completion: 2025-12-01
Study completion finish: 2028-05-01
Study type
TREATMENT
Phase
PHASE3
Trial ID
NCT06018337
Intervention or treatment
DRUG: DB-1303/BNT323
DRUG: Capecitabine
DRUG: Paclitaxel
DRUG: Nab-paclitaxel
Conditions
- • Metastatic Breast Cancer
Find a site
Closest Location:
Research Site
Research sites nearby
Select from list below to view details:
Research Site
South Brisbane, Queensland, Australia
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Participant Group/Arm | Intervention/Treatment |
---|---|
EXPERIMENTAL: DB-1303/BNT323
| DRUG: DB-1303/BNT323
|
ACTIVE_COMPARATOR: investigator's choice single agent chemotherapy
| DRUG: Capecitabine
|
What is the study measuring?
Primary outcome
Primary Outcome Measure | Primary Outcome Description | Primary Outcome Time Frame |
---|---|---|
Progression-free survival (PFS) in the HR+, HER2-low population | PFS by BICR according to RECIST 1.1 in the HR+, HER2-low population | Up to approximately 51 months |
Secondary outcome
Secondary Outcome Measure | Secondary Outcome Description | Secondary Outcome Time Frame |
---|---|---|
Overall survival (OS) in the HR+, HER2-low population | OS in the HR+, HER2-low population | Up to approximately 51 months |
Objective response rate (ORR) in the HR+, HER2-low population | ORR by BICR and Investigator assessment according to RECIST 1.1 in the HR+, HER2-low population | Up to approximately 51 months |
PFS by Investigator assessment | PFS by Investigator assessment according to RECIST 1.1 in the HR+, HER2-low population | Up to approximately 51 months |
Duration of response (DoR) in the HR+, HER2-low population | DoR by BICR and Investigator assessment according to RECIST 1.1 in the HR+, HER2-low population | Up to approximately 51 months |
Treatment-emergent adverse events (TEAEs) | TEAEs per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 | from the time of the subject signing the informed consent form (ICF) until the follow-up period is completed (35 days after the last doseof study treatment |
Serious adverse events (SAEs) | SAEs per NCI CTCAE v5.0 | from the time of the subject signing the ICF until the follow-up period is completed (35 days after the last doseof study treatment |
Patient reported outcomes (PROs): European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) - C30 | Change from baseline in the functioning/symptom/global quality of life (QoL) subscales of EORTC QLQ-C30. Scale scores range from 0-100. For functioning and global QoL scales, higher scores indicate better functioning or global health status. For symptom scales, higher scores indicate greater symptom burden. | Up to approximately 51 months |
Patient reported outcomes (PROs): EORTC QLQ-BR45 | Change from baseline in the functioning/symptom subscales of EORTC QLQ-BR45. Scale scores range from 0-100. For functioning scales, higher scores indicate better functioning. For symptom scales, higher scores indicate greater symptom burden. | Up to approximately 51 months |
Patient reported outcomes (PROs): European Quality of Life Five Dimension Five Level Scale (EQ-5D-5L) | Change from baseline in EQ-5D-5L health state utility index score and Visual Analogue Scale (VAS) score. VAS score range from 0-100, higher scores indicate better health status. | Up to approximately 51 months |
European Quality of Life Five Dimension Five Level Scale (EQ-5D-5L) | EQ-5D-5L health state utility index score and Visual Analogue Scale (VAS) score. The change from baseline value will be reported. | Up to approximately 51 months |
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