MedPath

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 of A166 Versus Trastuzumab Emtansine (T-DM1) in Patients With HER2-Positive Unresectable or Metastatic Breast Cancer Previously Treated With Trastuzumab and Taxane Therapy

Phase 3
Active, not recruiting
Conditions
HER2-positive Breast Cancer
Interventions
First Posted Date
2025-05-13
Last Posted Date
2025-05-13
Lead Sponsor
Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.
Target Recruit Count
365
Registration Number
NCT06968585
Locations
🇨🇳

Fudan University Shanghai Cancer Center, Shanghai, Shanghai, China

A Study of BL-M07D1 Versus T-DM1 in the Adjuvant Treatment of HER2-positive Breast Cancer With Residual Invasive Cancer After Neoadjuvant Therapy

Phase 3
Not yet recruiting
Conditions
HER2-positive Breast Cancer
Interventions
First Posted Date
2025-02-17
Last Posted Date
2025-02-19
Lead Sponsor
Sichuan Baili Pharmaceutical Co., Ltd.
Target Recruit Count
1450
Registration Number
NCT06830889
Locations
🇨🇳

Jiangsu Province Hospital, Nanjing, Jiangsu, China

🇨🇳

Fudan University Shanghai Cancer Center, Shanghai, Shanghai, China

HER2 Molecular Imaging with 89Zr-trastuzumab PET/CT As a Predictive Biomarker for Antibody-drug Conjugate Sequencing in Patients with Advanced HER2-positive Breast Cancer

Phase 2
Not yet recruiting
Conditions
HER2-positive Metastatic Breast Cancer
HER2-positive Advanced Breast Cancer
Interventions
First Posted Date
2024-09-13
Last Posted Date
2024-09-13
Lead Sponsor
Jules Bordet Institute
Target Recruit Count
87
Registration Number
NCT06595563

The SAPPHO Study: Sequential Therapy With Curative Intent in de Novo HER2+ Metastatic Breast Cancer

Phase 2
Recruiting
Conditions
Stage IV Breast Cancer
Breast Cancer Metastatic
Breast Cancer Female
Breast Cancer
Estrogen Receptor-positive Breast Cancer
HER2-positive Breast Cancer
Interventions
First Posted Date
2024-06-03
Last Posted Date
2025-04-03
Lead Sponsor
Dana-Farber Cancer Institute
Target Recruit Count
72
Registration Number
NCT06439693
Locations
🇺🇸

Dana-Farber Cancer Institute, Boston, Massachusetts, United States

Assessing the Efficacy and Safety of Anti-HER2 Therapy in Nigerian Women With HER2+ Breast Cancer Before and After Surgery

Phase 2
Not yet recruiting
Conditions
Human Epidermal Growth Factor 2 Negative Carcinoma of Breast
HER2-positive Breast Cancer
Breast Cancer
Interventions
First Posted Date
2024-04-04
Last Posted Date
2025-05-06
Lead Sponsor
University of Chicago
Target Recruit Count
74
Registration Number
NCT06348134
Locations
🇳🇬

Obafemi Awolowo University Teaching Hospitals Complex (OAUTHC), Ile-Ife, Osun, Nigeria

🇺🇸

University of Chicago, Chicago, Illinois, United States

Beamion BCGC-1: A Study to Find a Suitable Dose of Zongertinib Used Alone and in Combination With Other Treatments to Test Whether it Helps People With Different Types of HER2+ Cancer That Has Spread

Phase 1
Recruiting
Conditions
Metastatic Breast Cancer
Metastatic Gastric Adenocarcinoma
Esophageal Adenocarcinoma
Gastroesophageal Junction Adenocarcinoma
Interventions
First Posted Date
2024-03-21
Last Posted Date
2025-04-30
Lead Sponsor
Boehringer Ingelheim
Target Recruit Count
582
Registration Number
NCT06324357
Locations
🇺🇸

Valkyrie Clinical Trials, Los Angeles, California, United States

🇺🇸

University of California Irvine, Orange, California, United States

🇺🇸

Sharp Memorial Hospital, San Diego, California, United States

and more 47 locations

A Study Comparing BL-M07D1 With T-DM1 in Patients With Unresectable Locally Advanced or Metastatic HER2-positive Breast Cancer

Phase 3
Recruiting
Conditions
HER2-positive Breast Cancer
Interventions
First Posted Date
2024-03-18
Last Posted Date
2024-07-18
Lead Sponsor
Sichuan Baili Pharmaceutical Co., Ltd.
Target Recruit Count
268
Registration Number
NCT06316531
Locations
🇨🇳

Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Guangzhou, Guangdong, China

DP303c Versus Trastuzumab Emtansine in in Patients With HER2-positive Advanced Breast Cancer

Phase 3
Recruiting
Conditions
HER2-positive Breast Cancer
Interventions
First Posted Date
2024-03-15
Last Posted Date
2024-05-10
Lead Sponsor
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Target Recruit Count
442
Registration Number
NCT06313086
Locations
🇨🇳

Fudan University Shanghai Cancer Center, Shanghai, Shanghai, China

Stereotactic Radiation Therapy for HE2-positive Oligometastatic Breast Cancer

Not Applicable
Recruiting
Conditions
Oligometastatic Disease
HER2-positive Metastatic Breast Cancer
Interventions
First Posted Date
2024-03-08
Last Posted Date
2024-03-08
Lead Sponsor
N.N. Petrov National Medical Research Center of Oncology
Target Recruit Count
58
Registration Number
NCT06299852
Locations
🇷🇺

N.N. Petrov National Medical Research Center of Oncology, Saint Petersburg, Russian Federation

Tolerability and Efficacy of Adjuvant T-DM1 in Patients With HER2 Positive Breast Cancer After Incomplete Pathological Response to Neoadjuvant Chemotherapy Including Anti-HER2 Agents. Real-world Multicenter Retrospective-prospective Study

Recruiting
Conditions
Breast Cancer
Interventions
First Posted Date
2024-02-22
Last Posted Date
2024-02-22
Lead Sponsor
Regina Elena Cancer Institute
Target Recruit Count
160
Registration Number
NCT06272799
Locations
🇮🇹

"Regina Elena" National Cancer Institute, Rome, Italy

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