Trastuzumab emtansine

Generic Name: Trastuzumab emtansine

Brand Names: Kadcyla

Drug Type: Biotech

Chemical Formula: -

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

Associated Therapies: -

Clinical Trials

Trial of Neoadjuvant Trastuzumab Emtansine in Patients With HER2-Equivocal Breast Cancer

Phase 2

Withdrawn

Conditions: Breast Cancer

Interventions: Drug: Trastuzumab emtansine

First Posted Date: 2016-04-01

Last Posted Date: 2016-09-14

Lead Sponsor: Jenny C. Chang, MD

Registration Number: NCT02725541

Locations: 🇺🇸
Houston Methodist Hospital, Houston, Texas, United States

Trial of Ado-Trastuzumab Emtansine for Patients With HER2 Amplified or Mutant Cancers

Phase 2

Recruiting

Conditions: Solid Tumor Cancers
Bladder Cancer
Lung Cancer
Urinary Tract Cancers

Interventions: Drug: ado-trastuzumab emtansine

First Posted Date: 2016-02-05

Last Posted Date: 2024-12-04

Lead Sponsor: Memorial Sloan Kettering Cancer Center

Target Recruit Count: 140

Registration Number: NCT02675829

Locations: 🇺🇸
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities), Basking Ridge, New Jersey, United States
🇺🇸
Memorial Sloan Kettering Monmouth (Limited Protocol Activities), Middletown, New Jersey, United States
🇺🇸
Memorial Sloan Kettering Bergen (Limited Protocol Activities), Montvale, New Jersey, United States

and more 4 locations

A Study of Trastuzumab Emtansine in Indian Patients With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Unresectable Locally Advanced or Metastatic Breast Cancer Who Have Received Prior Treatment With Trastuzumab and a Taxane

Phase 4

Completed

Conditions: HER2 Positive Breast Cancer, Metastatic Breast Cancer, Locally Advanced Breast Cancer

Interventions: Drug: Trastuzumab emtansine

First Posted Date: 2016-01-20

Last Posted Date: 2021-04-02

Lead Sponsor: Hoffmann-La Roche

Target Recruit Count: 70

Registration Number: NCT02658734

Locations: 🇮🇳
Max Super Speciality Hospital; Medical Oncology, North WEST Delhi, Delhi, India
🇮🇳
Manipal Hospital; Department of Oncology, Bangalore, Karnataka, India
🇮🇳
Artemis Health Institute, Gurgaon, India

and more 10 locations

Vinorelbine With Trastuzumab Emtansine in Pre-Treated HER2-Positive Metastatic Breast Cancer

Phase 1

Terminated

Conditions: Breast Cancer
Metastatic Breast Cancer

Interventions: Drug: Vinorelbine
Drug: Trastuzumab Emtansine

First Posted Date: 2016-01-18

Last Posted Date: 2019-04-17

Lead Sponsor: University of Miami

Target Recruit Count: 2

Registration Number: NCT02658084

Locations: 🇺🇸
University of Miami, Miami, Florida, United States

An Open-Label, Phase Ib/II Clinical Trial Of Cdk 4/6 Inhibitor, Ribociclib (Lee011), In Combination With Trastuzumab Or T-Dm1 For Advanced/Metastatic Her2-Positive Breast Cancer.

Phase 1

Completed

Conditions: Breast Cancer

Interventions: Drug: Ribociclib
Drug: T-DM1
Drug: Trastuzumab
Drug: Fulvestrant

First Posted Date: 2016-01-15

Last Posted Date: 2022-08-01

Lead Sponsor: Dana-Farber Cancer Institute

Target Recruit Count: 25

Registration Number: NCT02657343

Locations: 🇺🇸
Massacusetts General Hospital, Boston, Massachusetts, United States
🇺🇸
Dana-Farber Cancer Institute, Boston, Massachusetts, United States

Safety and Pharmacokinetics of Atezolizumab Combination Treatments in Participants With HER2-Positive and HER2-Negative Breast Cancer

Phase 1

Completed

Conditions: HER2-Positive Metastatic Breast Cancer
HER2-Negative Metastatic Breast Cancer
Locally Advanced or Early Breast Cancer

Interventions: Drug: Atezolizumab
Drug: Pertuzumab
Drug: Trastuzumab emtansine
Drug: Doxorubicin
Drug: Docetaxel
Drug: Carboplatin
Drug: Trastuzumab
Drug: Cyclophosphamide

First Posted Date: 2015-11-16

Last Posted Date: 2020-02-05

Lead Sponsor: Hoffmann-La Roche

Target Recruit Count: 98

Registration Number: NCT02605915

Locations: 🇺🇸
HCA Midwest Division, Kansas City, Missouri, United States
🇺🇸
Horizon Oncology Research, Inc., Lafayette, Indiana, United States
🇺🇸
St. Luke's University Health Network, Bethlehem, Pennsylvania, United States

and more 17 locations

Targeted Therapy Directed by Genetic Testing in Treating Patients With Advanced Refractory Solid Tumors, Lymphomas, or Multiple Myeloma (The MATCH Screening Trial)

Phase 2

Active, not recruiting

Conditions: Advanced Malignant Solid Neoplasm
Breast Carcinoma
Cervical Carcinoma
Liver Carcinoma
Malignant Uterine Neoplasm
Recurrent Gastric Carcinoma
Recurrent Head and Neck Carcinoma
Recurrent Ovarian Carcinoma
Recurrent Prostate Carcinoma
Recurrent Rectal Carcinoma

Interventions: Drug: Afatinib
Drug: Binimetinib
Drug: Adavosertib
Drug: Capivasertib
Drug: Afatinib Dimaleate
Procedure: Biospecimen Collection
Other: Cytology Specimen Collection Procedure
Drug: Dabrafenib
Drug: Fexagratinib
Drug: Dasatinib
Drug: Ipatasertib
Drug: Defactinib
Drug: Sapanisertib
Procedure: Biopsy
Drug: Crizotinib
Drug: Dabrafenib Mesylate
Drug: PI3K-beta Inhibitor GSK2636771
Drug: Defactinib Hydrochloride
Drug: Palbociclib
Biological: Nivolumab
Drug: Copanlisib
Drug: Taselisib
Drug: Ulixertinib
Drug: Copanlisib Hydrochloride
Biological: Trastuzumab Emtansine
Biological: Relatlimab
Procedure: Computed Tomography
Drug: Trametinib
Biological: Pertuzumab
Drug: Erdafitinib
Procedure: Radiologic Examination
Procedure: Multigated Acquisition Scan
Drug: Larotrectinib
Drug: Larotrectinib Sulfate
Procedure: Echocardiography
Drug: Osimertinib
Biological: Trastuzumab
Other: Laboratory Biomarker Analysis
Procedure: Magnetic Resonance Imaging
Drug: Vismodegib
Drug: Sunitinib Malate
Procedure: Radionuclide Imaging

First Posted Date: 2015-06-08

Last Posted Date: 2024-12-27

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 6452

Registration Number: NCT02465060

Locations: 🇺🇸
University of Alabama at Birmingham Cancer Center, Birmingham, Alabama, United States
🇺🇸
Thomas Hospital, Fairhope, Alabama, United States
🇺🇸
Mobile Infirmary Medical Center, Mobile, Alabama, United States

and more 1416 locations

Phase Ib Dose-escalation Trial of Taselisib (GDC-0032) in Combination With Anti-HER2 Therapies in Participants With Advanced HER2+ Breast Cancer

Phase 1

Completed

Conditions: Metastatic Breast Cancer
Recurrent Breast Cancer

Interventions: Drug: Taselisib
Drug: Trastuzumab emtansine
Drug: Pertuzumab
Drug: Trastuzumab
Drug: Paclitaxel

First Posted Date: 2015-03-17

Last Posted Date: 2024-10-02

Lead Sponsor: Otto Metzger, MD

Target Recruit Count: 68

Registration Number: NCT02390427

Locations: 🇺🇸
Sarah Cannon Research Institute, Nashville, Tennessee, United States
🇺🇸
Massachusetts General Hospital, Boston, Massachusetts, United States
🇺🇸
Dana Farber Cancer Institute, Boston, Massachusetts, United States

T-DM1+Pertuzumab in Pre-OP Early-Stage HER2+ BRCA

Phase 2

Active, not recruiting

Conditions: HER-2 Positive Breast Cancer
Breast Cancer
Stage II Breast Cancer
Stage III Breast Cancer

Interventions: Drug: T-DM1
Drug: Pertuzumab
Procedure: Excision of tumor/mastectomy

First Posted Date: 2014-12-30

Last Posted Date: 2024-08-07

Lead Sponsor: Dana-Farber Cancer Institute

Target Recruit Count: 164

Registration Number: NCT02326974

Locations: 🇺🇸
Dana Farber Cancer Institute, Boston, Massachusetts, United States
🇺🇸
Tennessee Oncology/Sarah Cannon Research Institute, Nashville, Tennessee, United States
🇺🇸
Vanderbilt-Ingram Cancer Center, Nashville, Tennessee, United States

and more 1 locations

Pembrolizumab and Monoclonal Antibody Therapy in Advanced Cancer

Phase 1

Terminated

Conditions: Breast Cancer
Advanced Cancer
Colorectal Cancer
Gastric Cancer
Esophageal Cancer

Interventions: Drug: Pembrolizumab
Drug: ado-trastuzumab emtansine
Drug: Cetuximab
Drug: Trastuzumab

First Posted Date: 2014-12-17

Last Posted Date: 2019-10-21

Lead Sponsor: Western Regional Medical Center

Target Recruit Count: 16

Registration Number: NCT02318901

Locations: 🇺🇸
Western Regional Medical Center/Cancer Treatment Center of America, Goodyear, Arizona, United States

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