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Trial Title:
A Study to Compare DB-1303/BNT323 Versus T-DM1 in Breast Cancer
NCT ID:
NCT06265428
Condition:
HER2-positive Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Conditions: Keywords:
HER2-positive
Breast Cancer
BC
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
DB-1303/BNT323
Description:
Administered I.V.
Arm group label:
DB-1303/BNT323
Intervention type:
Drug
Intervention name:
T-DM1
Description:
Administered I.V.
Arm group label:
T-DM1
Summary:
This study is designed to compare efficacy and safety of DB-1303/BNT323 versus T-DM1 in
HER2-positive, unresectable and/or metastatic breast cancer patients previously treated
with trastuzumab and taxane.
Detailed description:
This is a randomized controlled, 2-arm, open-label, multicenter phase III study to assess
the efficacy and safety of DB-1303/BNT323 versus Trastuzumab Emtansine (T-DM1) in
patients with human epidermal growth factor receptor 2 (HER2) -positive
unresectable/metastatic breast cancer who have been treated with trastuzumab and taxanes.
Approximately 224 patients with unresectable or metastatic HER2-positive breast cancer
will be randomized 1:1 to receive DB-1303/BNT323 or T-DM1, respectively.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Male or female adults ≥ 18 years at the time of voluntary signing of informed
consent.
- Pathologically confirmed unresectable or metastatic HER2 positive breast cancer
previously treated with trastuzumab and taxane
- Eastern Cooperative Oncology Group (ECOG) performance status score is 0 or 1.
- Presence of at least one measurable lesion according to RECIST v1.1
- Expected survival time ≥ 12 weeks.
- Patients must give informed consent to this study and voluntarily sign written
informed consent form prior to the study.
Exclusion Criteria:
- Prior anti-HER2 ADC therapy.
- Previous history of interstitial lung disease/noninfectious pneumonitis/radiation
pneumonitis requiring steroid therapy.
- Known serious hypersensitivity to the active ingredients of the study drug, inactive
ingredients in the formulation, or other antibody drugs.
- Multiple primary malignancies within 3 years, except for adequately resected
non-melanoma skin cancer, curatively treated in situ tumor, or contralateral breast
cancer
- Uncontrolled infection requiring intravenous antibiotics, antiviral or antifungal
agents, autoimmune disease requiring treatment, uncontrolled diabetes, hypertension,
or other systemic disease that makes compliance with study procedures difficult
- Unrecovered toxicity from prior anticancer therapy, defined as toxicity (except for
alopecia) not recovered to ≤Grade 1 (NCI-CTCAE v5.0) or baseline.
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
The Fifth Medical Center of the Chinese People's Liberation Army General Hospital
Address:
City:
Beijing
Zip:
100039
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Zefei Jiang
Facility:
Name:
Fudan University Shanghai Cancer Center
Address:
City:
Shanghai
Zip:
200032
Country:
China
Status:
Recruiting
Contact:
Last name:
Jian Zhang
Start date:
January 29, 2024
Completion date:
February 2026
Lead sponsor:
Agency:
DualityBio Inc.
Agency class:
Industry
Collaborator:
Agency:
BioNTech SE
Agency class:
Industry
Source:
DualityBio Inc.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06265428
