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| ID | Type | Description | Link |
|---|---|---|---|
| CTR20233403 | Other Identifier | CENTER FOR DRUG EVALUATION, NMPA |
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| Name | Class |
|---|---|
| BioNTech SE | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DB-1303/BNT323 | Experimental | Enrolled patients will receive DB-1303/BNT323 by intravenous (I.V.) infusion |
|
| T-DM1 | Experimental | Enrolled patients will receive T-DM1 by I.V. infusion |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DB-1303/BNT323 | Drug | Administered I.V. |
| |
| T-DM1 |
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival (PFS) by Blinded Independent Central Review (BICR) assessment per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) | Defined as the time from randomization to the first documented disease progression per RECIST 1.1 as assessed by BICR or death due to any cause, whichever occurs first | Up to approximately 24 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) | Defined as the time from randomization to death due to any cause. | Up to approximately 24 months. |
| Progression Free Survival (PFS) by Investigator assessment per RECIST 1.1 |
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Inclusion Criteria:
Exclusion Criteria:
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
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| Name | Affiliation | Role |
|---|---|---|
| Lily Hu | DualityBio Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 015 | Bengbu | Anhui | 233000 | China | ||
| 016 |
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| Drug |
Administered I.V. |
|
Defined as the time from randomization to the first documented disease progression per RECIST 1.1 as assessed by investigator or death due to any cause, whichever occurs first.
| Up to approximately 24 months. |
| Objective response rate (ORR) by BICR and investigator assessment per RECIST 1.1 | Defined as the percentage of patients who have a complete response (CR) or partial response (PR) per RECIST 1.1 as assessed by BICR and investigator assessment. | Up to approximately 24 months. |
| Duration of response (DoR) by BICR and investigator assessment per RECIST 1.1 | Defined as the time from first response (CR or PR) to subsequent disease progression per RECIST 1.1 as assessed by BICR and investigator assessment, or death from any cause, whichever occurs first. | Up to approximately 24 months. |
| PK parameters: maximum observed concentration (Cmax) | Maximum observed concentration (Cmax) of DB-1303/BNT323 Antibody-drug conjugate (ADC) and free toxin P1003, etc. after DB-1303/BNT323 administration | Up to approximately 24 months. |
| PK parameters: time to maximum concentration (Tmax) | Time to maximum concentration (Tmax) of DB-1303/BNT323 ADC and free toxin P1003, etc. after DB-1303/BNT323 administration | Up to approximately 24 months. |
| Adverse events (AEs) | Number and percentage of patients who report serious adverse events (SAEs), treatment-emergent adverse events (TEAEs), TEAEs leading to study drug discontinuation, adverse events of special interest (AESIs) (graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0[NCI-CTCAE v5.0]) | Up to approximately 24 months. |
| 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 24 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 24 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 24 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 24 months. |
| Anti-drug antibodies (ADA) | Number and percentage of patients who develop anti-drug antibody (ADA) for DB-1303/BNT323. | Up to approximately 24 months. |
| Hefei |
| Anhui |
| 230001 |
| China |
| 029 | Hefei | Anhui | 230601 | China |
| 001 | Beijing | Beijing Municipality | 100039 | China |
| 010 | Beijing | Beijing Municipality | 100142 | China |
| 038 | Jilin City | Changchun | 130022 | China |
| 036 | Fuzhou | Fujian | 350014 | China |
| 037 | Xiamen | Fujian | 361003 | China |
| 023 | Guangzhou | Guangdong | 510060 | China |
| 024 | Guangzhou | Guangdong | 510080 | China |
| 026 | Guangzhou | Guangdong | 510120 | China |
| 028 | Huizhou | Guangdong | 516001 | China |
| 017 | Nanning | Guangxi | 530021 | China |
| 022 | Nanning | Guangxi | 530021 | China |
| 043 | Haikou | Hainan | 570102 | China |
| 045 | Baoding | Hebei | 071000 | China |
| 048 | Shijiazhuang | Hebei | 050011 | China |
| 020 | Haerbin | Heilongjiang | 150081 | China |
| 018 | Luoyang | Henan | 471003 | China |
| 006 | Zhengzhou | Henan | 450003 | China |
| 005 | Zhengzhou | Henan | 450052 | China |
| 011 | Wuhan | Hubei | 430030 | China |
| 009 | Wuhan | Hubei | 430079 | China |
| 030 | Changsha | Hunan | 410005 | China |
| 027 | Nanjing | Jiangsu | 210009 | China |
| 004 | Nanjing | Jiangsu | 210029 | China |
| 044 | Xuzhou | Jiangsu | 221006 | China |
| 014 | Nanchang | Jiangxi | 330006 | China |
| 008 | Changchun | Jilin | 130021 | China |
| 032 | Dalian | Liaoning | 116021 | China |
| 040 | Binzhou | Shandong | 256603 | China |
| 031 | Jinan | Shandong | 250013 | China |
| 047 | Jinan | Shandong | 250117 | China |
| 012 | Linyi | Shandong | 276003 | China |
| 039 | Yantai | Shandong | 264001 | China |
| 002 | Shanghai | Shanghai Municipality | 200032 | China |
| 046 | Shanghai | Shanghai Municipality | 200120 | China |
| 035 | Taiyuan | Shanxi | 030013 | China |
| 003 | Xi’an | Shanxi | 710061 | China |
| 007 | Chengdu | Sichuan | 610041 | China |
| 041 | Neijiang | Sichuan | 641100 | China |
| 034 | Yibin | Sichuan | 644000 | China |
| 021 | Tianjin | Tianjin Municipality | 300060 | China |
| 013 | Ürümqi | Xinjiang | 830011 | China |
| 033 | Kunming | Yunnan | 650118 | China |
| 019 | Hangzhou | Zhejaing | 310022 | China |
| 025 | Hangzhou | Zhejiang | 310003 | China |
| 042 | Hangzhou | Zhejiang | 310016 | China |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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