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 deriva...

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
-

Trastuzumab & Pertuzumab Followed by T-DM1 in MBC

First Posted Date
2013-04-18
Last Posted Date
2021-03-30
Lead Sponsor
Swiss Group for Clinical Cancer Research
Target Recruit Count
208
Registration Number
NCT01835236
Locations
🇨🇭

Hirslanden Klinik Aarau, Aarau, Switzerland

🇨🇭

Kantonspital Aarau, Aarau, Switzerland

🇨🇭

Kantonsspital Baden, Baden, Switzerland

and more 68 locations

A Study of Trastuzumab Emtansine Versus Trastuzumab as Adjuvant Therapy in Patients With HER2-Positive Breast Cancer Who Have Residual Tumor in the Breast or Axillary Lymph Nodes Following Preoperative Therapy (KATHERINE)

Phase 3
Completed
Conditions
Interventions
First Posted Date
2013-01-21
Last Posted Date
2024-07-10
Lead Sponsor
Hoffmann-La Roche
Target Recruit Count
1487
Registration Number
NCT01772472
Locations
🇺🇸

Kaiser Permanente - Vallejo, Vallejo, California, United States

🇺🇸

The Cleveland Clinic Foundation, Cleveland, Ohio, United States

🇺🇸

Kaiser Permanente - San Diego, San Diego, California, United States

and more 274 locations

A Prospective, Randomized Multicenter, Open-label Comparison of Preoperative Trastuzumab Emtansine (T-DM1) With or Without Standard Endocrine Therapy vs. Trastuzumab With Standard Endocrine Therapy Given for Twelve Weeks in Patients With Operable HER2+/HR+ Breast Cancer Within the ADAPT Protocol.

Phase 2
Active, not recruiting
Conditions
Interventions
First Posted Date
2012-12-10
Last Posted Date
2024-11-20
Lead Sponsor
West German Study Group
Target Recruit Count
380
Registration Number
NCT01745965
Locations
🇩🇪

Breast Center of the University of Munich (LMU), Munich, Germany

🇩🇪

Ev. Krankenhaus Bethesda Brustzentrum Niederrhien, Mönchengladbach, Germany

A Study of Trastuzumab Emtansine in Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Breast Cancer Who Have Received Prior Anti-HER2 And Chemotherapy-based Treatment

Phase 3
Completed
Conditions
Interventions
First Posted Date
2012-10-08
Last Posted Date
2022-04-04
Lead Sponsor
Hoffmann-La Roche
Target Recruit Count
2185
Registration Number
NCT01702571
Locations
🇦🇺

Mater Hospital; Patricia Ritchie Centre for Cancer Care and Research, North Sydney, New South Wales, Australia

🇦🇷

CEMIC, Buenos Aires, Argentina

🇧🇪

CHU Sart-Tilman, Liège, Belgium

and more 297 locations

A Study of Trastuzumab Emtansine Versus Taxane in Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Advanced Gastric Cancer

Phase 2
Terminated
Conditions
Interventions
First Posted Date
2012-07-17
Last Posted Date
2017-05-12
Lead Sponsor
Hoffmann-La Roche
Target Recruit Count
415
Registration Number
NCT01641939
Locations
🇬🇹

Centro Oncológico Sixtino / Centro Oncológico SA, Guatemala, Guatemala

🇲🇽

Centenario Hospital Miguel Hidalgo, Aguascalientes, Mexico

🇲🇽

Centro Estatal De Cancerologia De Chihuahua; Servicio De Hematologia Banco De Sangre, Chihuahua, Mexico

and more 145 locations

HER2 Imaging Study to Identify HER2 Positive Metastatic Breast Cancer Patient Unlikely to Benefit From T-DM1

Phase 2
Active, not recruiting
Conditions
Interventions
First Posted Date
2012-03-28
Last Posted Date
2023-08-14
Lead Sponsor
Jules Bordet Institute
Target Recruit Count
90
Registration Number
NCT01565200
Locations
🇧🇪

Institut Jules Bordet, Brussels, Belgium

🇳🇱

Vrije Universiteit Amsterdam (VUMC), Amsterdam, Netherlands

🇧🇪

Universitair Ziekenhuis Antwerpen (UZA), Antwerpen, Edegem, Belgium

and more 2 locations

A Study of Trastuzumab Emtansine in Patients With HER2-Positive Metastatic Breast Cancer and Normal or Reduced Hepatic Function

Phase 1
Completed
Conditions
Interventions
First Posted Date
2012-01-20
Last Posted Date
2016-11-02
Lead Sponsor
Hoffmann-La Roche
Target Recruit Count
28
Registration Number
NCT01513083

HKI-272 for HER2-Positive Breast Cancer and Brain Metastases

First Posted Date
2011-12-19
Last Posted Date
2024-05-22
Lead Sponsor
Dana-Farber Cancer Institute
Target Recruit Count
140
Registration Number
NCT01494662
Locations
🇺🇸

University of North Carolina at Chapel Hill - Lineberger Comprehensive Cancer Center, Chapel Hill, North Carolina, United States

🇺🇸

University of Michigan Comprehensive Cancer Center, Ann Arbor, Michigan, United States

🇺🇸

UPMC Passavant Cranberry, Cranberry Township, Pennsylvania, United States

and more 15 locations
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