Clinical trial NCT06265428: A Study to Compare DB-1303/BNT323 Versus T-DM1 in Breast Cancer
Official title: A Phase III, Multicenter, Open-label, Randomized Study to Compare DB-1303 Versus T-DM1 in Patients With HER2-positive Unresectable/Metastatic Breast Cancer Who Have Been Treated With Trastuzumab and a Taxane (Dynasty-Breast01)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: HER2-positive Breast Cancer
Keywords: HER2-positive
Breast Cancer
BC
Lead sponsor: DualityBio Inc.
Sponsor class: INDUSTRY
Collaborators: name: BioNTech SE
First posted: 2024-02-20
Enrollment: 224
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Primary outcomes:
measure: Progression Free Survival (PFS) by Blinded Independent Central Review (BICR) assessment per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
timeFrame: Up to approximately 24 months.
Secondary outcomes:
measure: Overall Survival (OS)
timeFrame: Up to approximately 24 months.
measure: Progression Free Survival (PFS) by Investigator assessment per RECIST 1.1
timeFrame: Up to approximately 24 months.
measure: Objective response rate (ORR) by BICR and investigator assessment per RECIST 1.1
timeFrame: Up to approximately 24 months.
measure: Duration of response (DoR) by BICR and investigator assessment per RECIST 1.1
timeFrame: Up to approximately 24 months.
measure: PK parameters: maximum observed concentration (Cmax)
timeFrame: Up to approximately 24 months.
measure: PK parameters: time to maximum concentration (Tmax)
timeFrame: Up to approximately 24 months.
measure: Adverse events (AEs)
timeFrame: Up to approximately 24 months.
measure: Patient reported outcomes (PROs): European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) - C30
timeFrame: Up to approximately 24 months.
measure: Patient reported outcomes (PROs): EORTC QLQ-BR45
timeFrame: Up to approximately 24 months.
measure: Patient reported outcomes (PROs): European Quality of Life Five Dimension Five Level Scale (EQ-5D-5L)
timeFrame: Up to approximately 24 months.
measure: European Quality of Life Five Dimension Five Level Scale (EQ-5D-5L)
timeFrame: Up to approximately 24 months.
measure: Anti-drug antibodies (ADA)
timeFrame: Up to approximately 24 months.
Other outcomes:
Locations:
city: Bengbu
country: China
facility: 015
state: Anhui
city: Hefei
country: China
facility: 016
state: Anhui
city: Hefei
country: China
facility: 029
state: Anhui
city: Beijing
country: China
facility: 001
state: Beijing
city: Beijing
country: China
facility: 010
state: Beijing
city: Jilin
country: China
facility: 038
state: Changchun
city: Fuzhou
country: China
facility: 036
state: Fujian
city: Xiamen
country: China
facility: 037
state: Fujian
city: Guangzhou
country: China
facility: 023
state: Guangdong
city: Guangzhou
country: China
facility: 024
state: Guangdong
city: Guangzhou
country: China
facility: 026
state: Guangdong
city: Huizhou
country: China
facility: 028
state: Guangdong
city: Nanning
country: China
facility: 017
state: Guangxi
city: Nanning
country: China
facility: 022
state: Guangxi
city: Haikou
country: China
facility: 043
state: Hainan
city: Baoding
country: China
facility: 045
state: Hebei
city: Shijiazhuang
country: China
facility: 048
state: Hebei
city: Haerbin
country: China
facility: 020
state: Heilongjiang
city: Luoyang
country: China
facility: 018
state: Henan
city: Zhengzhou
country: China
facility: 006
state: Henan
city: Zhengzhou
country: China
facility: 005
state: Henan
city: Wuhan
country: China
facility: 011
state: Hubei
city: Wuhan
country: China
facility: 009
state: Hubei
city: Changsha
country: China
facility: 030
state: Hunan
city: Nanjing
country: China
facility: 027
state: Jiangsu
city: Nanjing
country: China
facility: 004
state: Jiangsu
city: Xuzhou
country: China
facility: 044
state: Jiangsu
city: Nanchang
country: China
facility: 014
state: Jiangxi
city: Changchun
country: China
facility: 008
state: Jilin
city: Dalian
country: China
facility: 032
state: Liaoning
city: Binzhou
country: China
facility: 040
state: Shandong
city: Jinan
country: China
facility: 031
state: Shandong
city: Jinan
country: China
facility: 047
state: Shandong
city: Linyi
country: China
facility: 012
state: Shandong
city: Yantai
country: China
facility: 039
state: Shandong
city: Shanghai
country: China
facility: 002
state: Shanghai
city: Shanghai
country: China
facility: 046
state: Shanghai
city: Taiyuan
country: China
facility: 035
state: Shanxi
city: Xi'an
country: China
facility: 003
state: Shanxi
city: Chengdu
country: China
facility: 007
state: Sichuan
city: Neijiang
country: China
facility: 041
state: Sichuan
city: Yibin
country: China
facility: 034
state: Sichuan
city: Tianjin
country: China
facility: 021
state: Tianjin
city: Ürümqi
country: China
facility: 013
state: Xinjiang
city: Kunming
country: China
facility: 033
state: Yunnan
city: Hangzhou
country: China
facility: 019
state: Zhejaing
city: Hangzhou
country: China
facility: 025
state: Zhejiang
city: Hangzhou
country: China
facility: 042
state: Zhejiang
Study officials:
affiliation: DualityBio Inc.
name: Lily Hu
role: STUDY_DIRECTOR
References: