A Study to Compare DB-1303/BNT323 Versus T-DM1 in Breast Cancer

DualityBio

Status and phase: Active, not recruiting; Phase 3

Conditions: HER2-positive Breast Cancer

Treatments: Drug: T-DM1; Drug: DB-1303/BNT323

Study type: Interventional

Funder types: Industry

Identifiers

NCT06265428

CTR20233403 (Other Identifier)

DB-1303-O-3001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 228 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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228 participants in 2 patient groups

DB-1303/BNT323

Experimental group

Description:

Enrolled patients will receive DB-1303/BNT323 by intravenous (I.V.) infusion

Treatment:

Drug: DB-1303/BNT323

T-DM1

Experimental group

Description:

Enrolled patients will receive T-DM1 by I.V. infusion

Treatment:

Drug: T-DM1