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
Adjuvant Chemoradiation and Biomarkers of Response in High-risk Breast Cancer
- Conditions
- Breast Cancer Stage IIIBreast CancerBreast Cancer Stage IBreast Cancer Stage II
- Interventions
- Radiation: External Beam Radiation Therapy 1Radiation: External Beam Radiation Therapy 0
- First Posted Date
- 2022-03-21
- Last Posted Date
- 2025-04-18
- Lead Sponsor
- University of Virginia
- Target Recruit Count
- 45
- Registration Number
- NCT05288777
- Locations
- 🇺🇸
University of Virginia, Charlottesville, Virginia, United States
A Study Evaluating the Efficacy and Safety of Biomarker-Driven Therapies in Patients With Persistent or Recurrent Rare Epithelial Ovarian Tumors
- Conditions
- Ovarian Cancer
- Interventions
- Drug: Luteinizing Hormone-Releasing Hormone (LHRH) Agonists
- First Posted Date
- 2021-06-18
- Last Posted Date
- 2025-03-18
- Lead Sponsor
- Hoffmann-La Roche
- Target Recruit Count
- 176
- Registration Number
- NCT04931342
- Locations
- 🇫🇷
Institut Claudius Regaud, Toulouse, France
🇫🇷Gustave Roussy, Villejuif CEDEX, France
🇺🇸UCSF Helen Diller Family CCC, San Francisco, California, United States
A Study Evaluating the Efficacy and Safety of Adjuvant Atezolizumab or Placebo and Trastuzumab Emtansine for Participants With HER2-Positive Breast Cancer at High Risk of Recurrence Following Preoperative Therapy
- Conditions
- Breast Cancer
- Interventions
- First Posted Date
- 2021-05-05
- Last Posted Date
- 2025-03-14
- Lead Sponsor
- Hoffmann-La Roche
- Target Recruit Count
- 1188
- Registration Number
- NCT04873362
- Locations
- 🇨🇳
Guangdong Provincial People's Hospital, Guangzhou City, China
🇨🇳Sun Yat-sen Memorial Hospital, Guangzhou, China
🇨🇳The First Affilicated Hospital, Sun Yat-sen University, Guangzhou, China
Dynamic Observational Study With PET of 68Ga-HER2-affibody in Anti-HER2 Treatment
- Conditions
- Breast Cancer
- Interventions
- First Posted Date
- 2021-02-24
- Last Posted Date
- 2022-04-20
- Lead Sponsor
- Fudan University
- Target Recruit Count
- 50
- Registration Number
- NCT04769050
- Locations
- 🇨🇳
Fudan University Shanghai Cancer Center, Shanghai, Shanghai, China
A Study of Trastuzumab Emtansine in Combination With Atezolizumab or Placebo as a Treatment for Participants With Human Epidermal Growth Factor 2 (HER2)-Positive and Programmed Death-ligand 1 (PD-L1)-Positive Locally Advanced (LABC) or Metastatic Breast Cancer (MBC)
- Conditions
- Metastatic Breast Cancer
- Interventions
- First Posted Date
- 2021-02-05
- Last Posted Date
- 2025-02-17
- Lead Sponsor
- Hoffmann-La Roche
- Target Recruit Count
- 96
- Registration Number
- NCT04740918
- Locations
- 🇹🇷
Bakirkoy Dr. Sadi Konuk Egitim ve Arastirma Hastanesi, Tibbi Onkoloji, Bakirkoy / Istanbul, Turkey
🇹🇷Acibadem University School of Medicine Altunizade Hospital Oncology Service, Istanbul, Turkey
🇹🇷Kayseri Acibadem Hospital, Kayseri, Turkey
Safety of Continuing HER-2 Directed Therapy in Overt Left Ventricular Dysfunction
- Conditions
- Breast CancerHeart Failure
- Interventions
- First Posted Date
- 2020-12-23
- Last Posted Date
- 2025-04-06
- Lead Sponsor
- Population Health Research Institute
- Target Recruit Count
- 130
- Registration Number
- NCT04680442
- Locations
- 🇧🇷
Hospital de Clínicas de Porto Alegre, Porto Alegre, Rio Grande do Sul, Brazil
🇧🇷Irmandade Da Santa Casa De Misericórdia De Porto Alegre, Porto Alegre, Rio Grande do Sul, Brazil
🇧🇷Hospital Alemão Oswaldo Cruz, São Paulo, Brazil
De-escalation Adjuvant Chemo in HER2+/ER-/Node-neg Early BC Patients Who Achieved pCR After Neoadjuvant Chemo & Dual HER2 Blockade
- Conditions
- HER2-positive Breast CancerER-Negative Breast CancerPR-Negative Breast CancerNode-negative Breast Cancer
- Interventions
- First Posted Date
- 2020-12-19
- Last Posted Date
- 2024-12-04
- Lead Sponsor
- Jules Bordet Institute
- Target Recruit Count
- 139
- Registration Number
- NCT04675827
- Locations
- 🇫🇷
Institut Curie - Paris, Paris, France
🇫🇷CH Perpignan, Perpignan, France
🇫🇷CHU Poitiers, Poitiers, France
A Study Evaluating Targeted Therapies in Participants Who Have Advanced Solid Tumors With Genomic Alterations or Protein Expression Patterns Predictive of Response
- Conditions
- Advanced Unresectable or Metastatic Solid Malignancy
- Interventions
- Drug: Pertuzumab, Trastuzumab, and Hyaluronidase-zzxfDrug: Investigator's Choice of Chemotherapy
- First Posted Date
- 2020-11-17
- Last Posted Date
- 2025-01-08
- Lead Sponsor
- Genentech, Inc.
- Target Recruit Count
- 252
- Registration Number
- NCT04632992
- Locations
- 🇺🇸
Sarah Cannon Research Institute / Tennessee Oncology, Chattanooga, Tennessee, United States
🇺🇸SCRI Oncology Partners, Nashville, Tennessee, United States
🇺🇸Alaska Oncology and Hematology, Anchorage, Alaska, United States
A Study of Trastuzumab Deruxtecan (T-DXd) Versus Trastuzumab Emtansine (T-DM1) in High-risk HER2-positive Participants With Residual Invasive Breast Cancer Following Neoadjuvant Therapy (DESTINY-Breast05)
- Conditions
- HER2-Positive Primary Breast CancerResidual Invasive Breast Cancer
- Interventions
- First Posted Date
- 2020-11-09
- Last Posted Date
- 2025-05-09
- Lead Sponsor
- Daiichi Sankyo
- Target Recruit Count
- 1600
- Registration Number
- NCT04622319
- Locations
- 🇦🇺
Peter MacCallum Cancer Centre, Melbourne, Australia
🇦🇺Breast Cancer Research Centre - WA, Nedlands, Australia
🇦🇺Genesis Care Northern Cancer, Saint Leonards, Australia
Post-op T-DM1 in HER-2+ Salivary Gland Carcinomas
- Conditions
- Salivary Gland CancerHER2 Gene Mutation
- Interventions
- Radiation: Standard of Care RadiotherapyDrug: Standard of Care Chemotherapy
- First Posted Date
- 2020-11-06
- Last Posted Date
- 2025-02-18
- Lead Sponsor
- Dana-Farber Cancer Institute
- Target Recruit Count
- 55
- Registration Number
- NCT04620187
- Locations
- 🇺🇸
David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer Center, New York, New York, United States
🇺🇸Memorial Sloan Kettering Commack, Commack, New York, United States
🇺🇸Memorial Sloan Kettering Nassau, Uniondale, New York, United States
Drug Development Updates
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