Trastuzumab emtansine
- Generic Name
- Trastuzumab emtansine
- Brand Names
- Kadcyla
- Drug Type
- Biotech
- CAS Number
- 1018448-65-1
- Unique Ingredient Identifier
- SE2KH7T06F
- Background
Trastuzumab emtansine, formerly called Trastuzumab-DM1 (T-DM1) is a first-in-class HER2 antibody drug conjugate (ADC) comprised of Genentech's trastuzumab antibody linked to ImmunoGen's cell-killing agent, DM1. T-DM1 combines two strategies-- anti-HER2 activity and targeted intracellular delivery of the potent anti-microtubule agent, DM1 (a maytansine derivative)--to produce cell cycle arrest and apoptosis. Trastuzumab emtansine is marketed under the brand name Kadcyla and is indicated for use in HER2-positive, metastatic breast cancer patients who have already used taxane and/or trastuzumab for metastatic disease or had their cancer recur within 6 months of adjuvant treatment. The FDA label has two precautions. First that trastuzumab emtansine and trastuzumab cannot be interchanged. Second that there is a black box warning of serious side effects such as hepatotoxicity, embryo-fetal toxicity, and cardiac toxicity.
- Indication
Used in HER2-positive, metastatic breast cancer patients who have already used taxane and/or trastuzumab for metastatic disease or had their cancer recur within 6 months of adjuvant treatment.
- Associated Conditions
- HER2-Positive Early Stage Breast Cancer, HER2-positive, Metastatic Breast Cancer
A Study to Compare DB-1303/BNT323 Versus T-DM1 in Breast Cancer
- First Posted Date
- 2024-02-20
- Last Posted Date
- 2024-12-12
- Lead Sponsor
- DualityBio Inc.
- Target Recruit Count
- 224
- Registration Number
- NCT06265428
- Locations
- 🇨🇳
015, Bengbu, Anhui, China
🇨🇳029, Hefei, Anhui, China
🇨🇳001, Beijing, Beijing, China
A Phase III, Active-Controlled Study of SHR-A1811 Versus Trastuzumab Emtansine (T-DM1) in HER2-Positive Primary Breast Cancer Participants With Residual Invasive Disease Following Neoadjuvant Therapy
- Conditions
- HER2-Positive Primary Breast Cancer Participants With Residual Invasive Disease Following Neoadjuvant Therapy
- Interventions
- First Posted Date
- 2023-11-13
- Last Posted Date
- 2025-05-02
- Lead Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Target Recruit Count
- 1600
- Registration Number
- NCT06126640
- Locations
- 🇨🇳
Fudan University Shanghai Cancer Center, Shanghai, Shanghai, China
🇨🇳Tianjin Medical University Cancer Institute & Hospital, Tianjin, Tianjin, China
A Study to Evaluate the Safety and Effectiveness of Trastuzumab Emtansine (T-DM1) as Therapy in Chinese Participants With HER2 Positive Advanced Breast Cancer
- First Posted Date
- 2023-07-14
- Last Posted Date
- 2025-04-11
- Lead Sponsor
- Hoffmann-La Roche
- Target Recruit Count
- 178
- Registration Number
- NCT05945927
- Locations
- 🇨🇳
Union Hospital of Tongji Medical College, Dept. of Cancer Center, Wuhan, China
🇨🇳Beijing Hospital, Beijing, China
🇨🇳Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Guangzhou City, China
Observational Study of Effectiveness and Safety of Trastuzumab Emtansine (T-DM1) in HER2-positive Breast Cancer Patients With Residual Invasive Disease Following Neoadjuvant Chemotherapy and Anti-HER2 Target Therapy
- Conditions
- Breast Cancer
- First Posted Date
- 2023-03-03
- Last Posted Date
- 2023-03-03
- Lead Sponsor
- Consorzio Oncotech
- Target Recruit Count
- 300
- Registration Number
- NCT05754502
- Locations
- 🇮🇹
Nuovo ospedale di Prato - S. Stefano, Prato, Firenze, Italy
🇮🇹IRCCS Istituto Tumori "Giovanni Paolo II", Bari, Italy
🇮🇹A.O.U. Ospedali Riuniti Umberto I, Ancona, Italy
A Phase II Study of Tucatinib and Ado-trastuzumab Emtansine (T-DM1) in Patients With HER2-positive Metastatic Solid Tumors and Metastases to Brain (TUCATEMEB)
- Conditions
- Brain MetastasesMetastatic Solid Tumor
- Interventions
- First Posted Date
- 2023-01-06
- Last Posted Date
- 2025-04-06
- Lead Sponsor
- M.D. Anderson Cancer Center
- Target Recruit Count
- 30
- Registration Number
- NCT05673928
- Locations
- 🇺🇸
M D Anderson Cancer Center, Houston, Texas, United States
ELVN-002 in HER2 Mutant Non-Small Cell Lung Cancer
- Conditions
- HER2 Mutant Non-small Cell Lung CancerHER2-positive Metastatic Breast CancerHER2 Gene MutationHER2 Amplification
- Interventions
- First Posted Date
- 2022-12-14
- Last Posted Date
- 2025-01-09
- Lead Sponsor
- Enliven Therapeutics
- Target Recruit Count
- 198
- Registration Number
- NCT05650879
- Locations
- 🇺🇸
University of Colorado - Anschutz Medical Campus - PPDS, Aurora, Colorado, United States
🇺🇸Advent Health Orlando, Orlando, Florida, United States
🇺🇸BRCR Medical Center Inc, Plantation, Florida, United States
KPMNG Study of MOlecular Profiling Guided Therapy Based on Genomic Alterations in Advanced Solid Tumors II
- Conditions
- Solid TumorAdvanced Solid TumorMetastatic Cancer
- Interventions
- First Posted Date
- 2022-09-02
- Last Posted Date
- 2025-04-27
- Lead Sponsor
- Seoul National University Bundang Hospital
- Target Recruit Count
- 1000
- Registration Number
- NCT05525858
- Locations
- 🇰🇷
Soonchunhyang University Hospital Bucheon, Bucheon, Korea, Republic of
🇰🇷Chungbuk National University Hospital, Chungju, Korea, Republic of
🇰🇷Keimyung University Dongsan Hospital, Daegu, Korea, Republic of
Precise Therapy for Refractory HER2 Positive Advanced Breast Cancer
- Conditions
- HER2+ Breast Cancer
- Interventions
- Drug: Anti-PD-1 monoclonal antibodyDrug: CDK4/6 inhibitorDrug: AI
- First Posted Date
- 2022-06-23
- Last Posted Date
- 2022-06-23
- Target Recruit Count
- 120
- Registration Number
- NCT05429684
- Locations
- 🇨🇳
The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, Shaanxi, China
🇨🇳Jin Yang, Xi'an, Shaanxi, China
A Study to Evaluate Patient Preference for Home Administration of Fixed-Dose Combination of Pertuzumab and Trastuzumab for Subcutaneous Administration in Participants With Early or Locally Advanced/Inflammatory HER2-Positive Breast Cancer
- Conditions
- Early Breast CancerLocally Advanced Breast CancerInflammatory Breast Cancer
- Interventions
- Drug: Investigator's Choice of ChemotherapyProcedure: SurgeryRadiation: Radiotherapy
- First Posted Date
- 2022-06-13
- Last Posted Date
- 2025-05-18
- Lead Sponsor
- Hoffmann-La Roche
- Target Recruit Count
- 347
- Registration Number
- NCT05415215
- Locations
- 🇦🇷
Centro Oncologico Korben, Ciudad Autonoma Buenos Aires, Argentina
🇧🇦Cantonal Hospital Zenica, Zenica, Bosnia and Herzegovina
🇧🇷Hospital Araujo Jorge, Goiania, Goiás, Brazil
Testing the Use of Ado-Trastuzumab Emtansine Compared to the Usual Treatment (Chemotherapy With Docetaxel Plus Trastuzumab) or Trastuzumab Deruxtecan for Recurrent, Metastatic, or Unresectable HER2-Expressing Salivary Gland Cancers
- Conditions
- Unresectable Salivary Gland CarcinomaRecurrent Salivary Gland CarcinomaStage IV Major Salivary Gland Cancer AJCC v8Stage III Major Salivary Gland Cancer AJCC v8Metastatic Salivary Gland Carcinoma
- Interventions
- Procedure: Biopsy ProcedureProcedure: Biospecimen CollectionProcedure: Computed TomographyProcedure: Echocardiography TestProcedure: Magnetic Resonance ImagingOther: Questionnaire AdministrationProcedure: Multigated Acquisition Scan
- First Posted Date
- 2022-06-07
- Last Posted Date
- 2025-05-09
- Lead Sponsor
- NRG Oncology
- Target Recruit Count
- 146
- Registration Number
- NCT05408845
- Locations
- 🇺🇸
Kaiser Permanente-Roseville, Roseville, California, United States
🇺🇸University of Alabama at Birmingham Cancer Center, Birmingham, Alabama, United States
🇺🇸City of Hope Comprehensive Cancer Center, Duarte, California, United States
Drug Development Updates
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