Trastuzumab Emtansine
Information
- Drug Name
- Trastuzumab Emtansine
- Description
- Entry(CIViC)
- 9
CIViC
| Disease | Mutation | EL | ET | ED | CS | VO | TR | Pubmed | Links |
|---|---|---|---|---|---|---|---|---|---|
| lung non-small cell carcinoma |
ERBB2 AMPLIFICATION ( ENST00000269571.10 ) ERBB2 AMPLIFICATION ( ENST00000269571.10 ) |
D |
Predictive
|
Supports
|
Sensitivity/Response | Somatic | 4 | 24898067 | Detail |
| lung adenocarcinoma |
ERBB2 p.Tyr772_Ala775dup (p.Y772_A775dup) ( ENST00000269571.10, ENST00000406381.6, ENST00000445658.6, ENST00000541774.5, ENST00000584450.5, ENST00000584601.5 ) ERBB2 p.Tyr772_Ala775dup (p.Y772_A775dup) ( ENST00000541774.5, ENST00000269571.10, ENST00000445658.6, ENST00000406381.6, ENST00000584450.5, ENST00000584601.5 ) |
C |
Predictive
|
Supports
|
Sensitivity/Response | Somatic | 3 | 25789838 | Detail |
| Her2-receptor positive breast cancer |
ERBB2 AMPLIFICATION ( ENST00000269571.10 ) ERBB2 AMPLIFICATION ( ENST00000269571.10 ) |
B |
Predictive
|
Supports
|
Sensitivity/Response | Somatic | 4 | 24793816 | Detail |
| Her2-receptor positive breast cancer |
ERBB2 AMPLIFICATION ( ENST00000269571.10 ) ERBB2 AMPLIFICATION ( ENST00000269571.10 ) |
B |
Predictive
|
Supports
|
Sensitivity/Response | Somatic | 4 | 23020162 | Detail |
| Her2-receptor positive breast cancer |
ERBB2 AMPLIFICATION ( ENST00000269571.10 ) ERBB2 AMPLIFICATION ( ENST00000269571.10 ) |
B |
Predictive
|
Supports
|
Sensitivity/Response | Somatic | 3 | 23382472 | Detail |
| Her2-receptor positive breast cancer |
ERBB2 AMPLIFICATION ( ENST00000269571.10 ) ERBB2 AMPLIFICATION ( ENST00000269571.10 ) |
B |
Predictive
|
Supports
|
Sensitivity/Response | Somatic | 4 | 21172893 | Detail |
| Her2-receptor positive breast cancer |
PIK3CA p.Glu545Lys (p.E545K) ( ENST00000263967.4, ENST00000643187.1 ) PIK3CA p.Glu545Lys (p.E545K) ( ENST00000263967.4, ENST00000643187.1 ) |
B |
Predictive
|
Supports
|
Sensitivity/Response | Somatic | 26920887 | Detail | |
| Her2-receptor positive breast cancer |
PIK3CA p.His1047Arg (p.H1047R) ( ENST00000263967.4, ENST00000643187.1 ) PIK3CA p.His1047Arg (p.H1047R) ( ENST00000263967.4, ENST00000643187.1 ) |
B |
Predictive
|
Supports
|
Sensitivity/Response | Somatic | 3 | 26920887 | Detail |
| Her2-receptor positive breast cancer | ERBB2 OVEREXPRESSION ERBB2 OVEREXPRESSION | B |
Predictive
|
Supports
|
Sensitivity/Response | Somatic | 4 | 28526536 | Detail |
Annotation
| Description | Associated Genes | Associated Variants | Sensitivity | Supported | Source | Links |
|---|---|---|---|---|---|---|
| Efficacy of trastuzumab in HER2 overexpressing NSC... | ERBB2 |
ERBB2 AMPLIFICATION ( ENST00000269571.10 ) ERBB2 AMPLIFICATION ( ENST00000269571.10 ) |
Sensitivity | true | CIViC Evidence | detail |
| A 51-year old female never smoker with stage IV lu... | ERBB2 |
ERBB2 p.Tyr772_Ala775dup (p.Y772_A775dup) ( ENST00000269571.10, ENST00000406381.6, ENST00000445658.6, ENST00000541774.5, ENST00000584450.5, ENST00000584601.5 ) ERBB2 p.Tyr772_Ala775dup (p.Y772_A775dup) ( ENST00000541774.5, ENST00000269571.10, ENST00000445658.6, ENST00000406381.6, ENST00000584450.5, ENST00000584601.5 ) |
Sensitivity | true | CIViC Evidence | detail |
| The Phase III trial, TH3RESA (NCT01419197), was pe... | ERBB2 |
ERBB2 AMPLIFICATION ( ENST00000269571.10 ) ERBB2 AMPLIFICATION ( ENST00000269571.10 ) |
Sensitivity | true | CIViC Evidence | detail |
| The EMILIA study (NCT00829166) was a Phase II tria... | ERBB2 |
ERBB2 AMPLIFICATION ( ENST00000269571.10 ) ERBB2 AMPLIFICATION ( ENST00000269571.10 ) |
Sensitivity | true | CIViC Evidence | detail |
| In a randomized phase II study, first line treatme... | ERBB2 |
ERBB2 AMPLIFICATION ( ENST00000269571.10 ) ERBB2 AMPLIFICATION ( ENST00000269571.10 ) |
Sensitivity | true | CIViC Evidence | detail |
| In the single arm Phase II study (TDM4258g) breast... | ERBB2 |
ERBB2 AMPLIFICATION ( ENST00000269571.10 ) ERBB2 AMPLIFICATION ( ENST00000269571.10 ) |
Sensitivity | true | CIViC Evidence | detail |
| In a phase 3 clinical trial (NCT00829166), metasta... | PIK3CA |
PIK3CA p.Glu545Lys (p.E545K) ( ENST00000263967.4, ENST00000643187.1 ) PIK3CA p.Glu545Lys (p.E545K) ( ENST00000263967.4, ENST00000643187.1 ) |
Sensitivity | true | CIViC Evidence | detail |
| In a phase 3 clinical trial (NCT00829166), metasta... | PIK3CA |
PIK3CA p.His1047Arg (p.H1047R) ( ENST00000263967.4, ENST00000643187.1 ) PIK3CA p.His1047Arg (p.H1047R) ( ENST00000263967.4, ENST00000643187.1 ) |
Sensitivity | true | CIViC Evidence | detail |
| Trastuzumab emtansine has its indication for patie... | ERBB2 | ERBB2 OVEREXPRESSION ERBB2 OVEREXPRESSION | Sensitivity | true | CIViC Evidence | detail |
| NCT ID | Status | Phase | Summary | Start date | Completion date |
|---|---|---|---|---|---|
| NCT04931342 | Active, not recruiting | Phase 2 | A Study Evaluating the Efficacy and Safety of Biomarker-Driven Therapies in Patients With Persistent or Recurrent Rare Epithelial Ovarian Tumors | October 7, 2021 | December 31, 2028 |
| NCT04740918 | Active, not recruiting | Phase 3 | 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) | June 7, 2021 | April 30, 2024 |
| NCT04439110 | Active, not recruiting | Phase 2 | Testing Ado-Trastuzumab Emtansine as a Potential Targeted Treatment in Cancers With HER2 Genetic Changes (MATCH-Subprotocol Q) | August 12, 2015 | March 7, 2025 |
| NCT01772472 | Active, not recruiting | Phase 3 | 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) | April 3, 2013 | May 15, 2024 |
| NCT02314481 | Active, not recruiting | Phase 2 | Deciphering Antitumour Response and Resistance With INtratumour Heterogeneity | May 12, 2017 | May 2026 |
| NCT02390427 | Active, not recruiting | Phase 1 | Phase Ib Dose-escalation Trial of Taselisib (GDC-0032) in Combination With Anti-HER2 Therapies in Participants With Advanced HER2+ Breast Cancer | April 20, 2015 | May 2024 |
| NCT02465060 | Active, not recruiting | Phase 2 | Targeted Therapy Directed by Genetic Testing in Treating Patients With Advanced Refractory Solid Tumors, Lymphomas, or Multiple Myeloma (The MATCH Screening Trial) | August 17, 2015 | December 31, 2025 |
| NCT04591431 | Active, not recruiting | Phase 2 | The Rome Trial From Histology to Target: the Road to Personalize Target Therapy and Immunotherapy | October 7, 2020 | June 2025 |
| NCT05415215 | Active, not recruiting | Phase 3 | 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 | July 5, 2022 | December 31, 2025 |
| NCT01853748 | Active, not recruiting | Phase 2 | T-DM1 vs Paclitaxel/Trastuzumab for Breast (ATEMPT Trial) | May 2013 | May 2024 |
| NCT02605915 | Completed | Phase 1 | Safety and Pharmacokinetics of Atezolizumab Combination Treatments in Participants With HER2-Positive and HER2-Negative Breast Cancer | December 31, 2015 | November 13, 2019 |
| NCT02658734 | Completed | Phase 4 | 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 | November 1, 2016 | December 14, 2019 |
| NCT01966471 | Completed | Phase 3 | A Study of Trastuzumab Emtansine (Kadcyla) Plus Pertuzumab (Perjeta) Following Anthracyclines in Comparison With Trastuzumab (Herceptin) Plus Pertuzumab and a Taxane Following Anthracyclines as Adjuvant Therapy in Participants With Operable HER2-Positive Primary Breast Cancer | January 31, 2014 | June 4, 2021 |
| NCT00934856 | Completed | Phase 1/Phase 2 | A Study of Trastuzumab Emtansine (T-DM1) in Combination With Docetaxel, and Potentially Pertuzumab, in Participants With Advanced Breast Cancer | July 2009 | October 2013 |
| NCT01120184 | Completed | Phase 3 | A Study of Trastuzumab Emtansine (T-DM1) Plus Pertuzumab/Pertuzumab Placebo Versus Trastuzumab [Herceptin] Plus a Taxane in Participants With Metastatic Breast Cancer (MARIANNE) | July 31, 2010 | September 16, 2016 |
| NCT01196052 | Completed | Phase 2 | A Study of Trastuzumab Emtansine (T-DM1) Sequentially With Anthracycline-based Chemotherapy, as Adjuvant or Neoadjuvant Therapy for Patients With Early Stage Herceptin (HER)2-positive Breast Cancer | October 2010 | June 2013 |
| NCT01419197 | Completed | Phase 3 | A Study of Trastuzumab Emtansine in Comparison With Treatment of Physician's Choice in Participants With HER2-positive Breast Cancer Who Have Received at Least Two Prior Regimens of HER2-directed Therapy | September 2011 | August 2015 |
| NCT01513083 | Completed | Phase 1 | A Study of Trastuzumab Emtansine in Patients With HER2-Positive Metastatic Breast Cancer and Normal or Reduced Hepatic Function | February 2012 | September 2014 |
| NCT01702571 | Completed | Phase 3 | 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 | November 27, 2012 | July 31, 2020 |
| NCT01816035 | Completed | Phase 1 | Trastuzumab Emtansine in Treating Patients With HER2-Positive Metastatic or Locally Advanced Breast Cancer That Cannot Be Removed by Surgery | June 2014 | April 2017 |
| NCT02131064 | Completed | Phase 3 | A Study Evaluating Trastuzumab Emtansine Plus Pertuzumab Compared With Chemotherapy Plus Trastuzumab and Pertuzumab for Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Breast Cancer | June 25, 2014 | May 29, 2018 |
| NCT02289833 | Completed | Phase 2 | A Study of Trastuzumab Emtansine in Participants With Human Epidermal Growth Factor Receptor (HER)2 Immunohistochemistry (IHC)-Positive, Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) | December 15, 2014 | August 20, 2018 |
| NCT02924883 | Completed | Phase 2 | A Study to Evaluate the Efficacy and Safety of Trastuzumab Emtansine in Combination With Atezolizumab or Atezolizumab-Placebo in Participants With Human Epidermal Growth Factor-2 (HER2) Positive Locally Advanced or Metastatic Breast Cancer (BC) Who Received Prior Trastuzumab and Taxane Based Therapy | September 26, 2016 | February 6, 2020 |
| NCT02999672 | Completed | Phase 2 | A Study to Determine Best Tumor Response With Trastuzumab Emtansine in Human Epidermal Growth Factor Receptor 2 (HER2) Overexpressing Solid Tumors | December 23, 2016 | April 10, 2018 |
| NCT03084939 | Completed | Phase 3 | Efficacy and Safety of Trastuzumab Emtansine in Chinese Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Locally Advanced or Metastatic Breast Cancer | April 24, 2017 | March 14, 2023 |
| NCT03153163 | Completed | Phase 1 | Study of the Pharmacokinetics and Safety of Trastuzumab Emtansine in Chinese Participants With Locally Advanced Inoperable or Metastatic HER2+ Breast Cancer | June 20, 2017 | September 27, 2018 |
| NCT03726879 | Completed | Phase 3 | A Study To Evaluate the Efficacy and Safety Of Atezolizumab or Placebo in Combination With Neoadjuvant Doxorubicin + Cyclophosphamide Followed By Paclitaxel + Trastuzumab + Pertuzumab In Early Her2-Positive Breast Cancer | January 11, 2019 | August 24, 2023 |
| NCT04632992 | Completed | Phase 2 | A Study Evaluating Targeted Therapies in Participants Who Have Advanced Solid Tumors With Genomic Alterations or Protein Expression Patterns Predictive of Response | January 13, 2021 | February 27, 2024 |
| NCT00829166 | Completed | Phase 3 | A Study of Trastuzumab Emtansine Versus Capecitabine + Lapatinib in Participants With HER2-positive Locally Advanced or Metastatic Breast Cancer | February 2009 | September 2015 |
| NCT06126640 | Not yet recruiting | Phase 3 | 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 | November 2023 | April 2032 |
| NCT06348134 | Not yet recruiting | Phase 2 | Assessing the Efficacy and Safety of Anti-HER2 Therapy in Nigerian Women With HER2+ Breast Cancer Before and After Surgery | July 1, 2024 | July 1, 2036 |
| NCT05673928 | Recruiting | Phase 2 | 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) | May 16, 2023 | March 1, 2029 |
| NCT05650879 | Recruiting | Phase 1 | ELVN-002 in HER2 Mutant Non-Small Cell Lung Cancer | March 20, 2023 | July 2026 |
| NCT04197687 | Recruiting | Phase 2 | TPIV100 and Sargramostim for the Treatment of HER2 Positive, Stage II-III Breast Cancer in Patients With Residual Disease After Chemotherapy and Surgery | February 20, 2020 | January 15, 2025 |
| NCT04266249 | Recruiting | Phase 2 | CompassHER2-pCR: Decreasing Chemotherapy for Breast Cancer Patients After Pre-surgery Chemo and Targeted Therapy | March 13, 2020 | December 31, 2038 |
| NCT05525858 | Recruiting | KPMNG Study of MOlecular Profiling Guided Therapy Based on Genomic Alterations in Advanced Solid Tumors II | September 28, 2022 | September 2025 | |
| NCT04341181 | Recruiting | Phase 2 | ProTarget - A Danish Nationwide Clinical Trial on Targeted Cancer Treatment Based on Genomic Profiling | August 24, 2020 | April 30, 2025 |
| NCT06313086 | Recruiting | Phase 3 | DP303c Versus Trastuzumab Emtansine in in Patients With HER2-positive Advanced Breast Cancer | March 13, 2024 | February 2028 |
| NCT00781612 | Recruiting | Phase 2 | A Safety Extension Study of Trastuzumab Emtansine in Participants Previously Treated With Trastuzumab Emtansine Alone or in Combination With Other Anti-Cancer Therapy in One of the Parent Studies | October 16, 2008 | September 20, 2029 |
| NCT06324357 | Recruiting | Phase 1/Phase 2 | Beamion BCGC-1: A Study to Find a Suitable Dose of Zongertinib in Combination With Trastuzumab Deruxtecan or With Trastuzumab Emtansine and to Test Whether it Helps People With Different Types of HER2+ Cancer That Has Spread | May 23, 2024 | August 21, 2028 |
| NCT04457596 | Recruiting | Phase 3 | T-DM1 and Tucatinib Compared With T-DM1 Alone in Preventing Relapses in People With High Risk HER2-Positive Breast Cancer, the CompassHER2 RD Trial | January 6, 2021 | May 2035 |
| NCT04486352 | Recruiting | Phase 1/Phase 2 | A Study of Targeted Agents for Patients With Recurrent or Persistent Endometrial Cancer | October 20, 2021 | October 2026 |
| NCT06299852 | Recruiting | N/A | Stereotactic Radiation Therapy for HE2-positive Oligometastatic Breast Cancer | July 1, 2022 | September 1, 2025 |
| NCT04589845 | Recruiting | Phase 2 | Tumor-Agnostic Precision Immuno-Oncology and Somatic Targeting Rational for You (TAPISTRY) Platform Study | January 18, 2021 | September 25, 2032 |
| NCT05408845 | Recruiting | Phase 2 | Testing the Use of Ado-Trastuzumab Emtansine Compared to the Usual Treatment (Chemotherapy With Docetaxel Plus Trastuzumab) for Recurrent, Metastatic, or Unresectable HER2-Positive Salivary Gland Cancer | September 30, 2022 | July 31, 2028 |
| NCT04873362 | Recruiting | Phase 3 | 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 | May 4, 2021 | October 2, 2034 |
| NCT05945927 | Recruiting | A Study to Evaluate the Safety and Effectiveness of Trastuzumab Emtansine (T-DM1) as Therapy in Chinese Participants With HER2 Positive Advanced Breast Cancer | September 13, 2023 | March 31, 2025 | |
| NCT04680442 | Recruiting | Phase 2 | Safety of Continuing HER-2 Directed Therapy in Overt Left Ventricular Dysfunction | July 1, 2021 | June 1, 2025 |
| NCT05754502 | Recruiting | 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 | July 27, 2021 | May 2, 2025 | |
| NCT04419181 | Suspended | Phase 2 | Feasibility of Chemotherapy De-escalation in Early-Stage HER2 Positive Breast Cancer | August 11, 2024 | June 1, 2026 |
| NCT04675827 | Suspended | Phase 2 | De-escalation Adjuvant Chemo in HER2+/ER-/Node-neg Early BC Patients Who Achieved pCR After Neoadjuvant Chemo & Dual HER2 Blockade | January 17, 2022 | March 2029 |
| NCT01641939 | Terminated | Phase 2/Phase 3 | A Study of Trastuzumab Emtansine Versus Taxane in Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Advanced Gastric Cancer | September 3, 2012 | April 30, 2016 |
| NCT03878524 | Terminated | Phase 1 | Serial Measurements of Molecular and Architectural Responses to Therapy (SMMART) PRIME Trial | April 1, 2020 | December 10, 2020 |
| NCT03784599 | Terminated | Phase 2 | T-DM1 and Osimertinib Combination Treatment to Target HER2 Bypass Track Resistance in EGFR Mutation Positive NSCLC | December 18, 2018 | May 17, 2021 |
| NCT02658084 | Terminated | Phase 1/Phase 2 | Vinorelbine With Trastuzumab Emtansine in Pre-Treated HER2-Positive Metastatic Breast Cancer | April 12, 2017 | October 11, 2018 |
| NCT02144012 | Terminated | Phase 3 | A Study to Evaluate the Efficacy and Safety of Trastuzumab Emtansine Versus the Combination of Trastuzumab Plus Docetaxel in Patients With HER2-positive Breast Cancer | June 2014 | January 2016 |
| NCT04298918 | Terminated | Phase 1/Phase 2 | A Study Evaluating the Safety and Efficacy of Venetoclax in Combination With Trastuzumab Emtansine in Patients With Previously Treated HER2-Positive Locally Advanced or Metastatic Breast Cancer | September 23, 2020 | February 4, 2021 |
| NCT04042051 | Terminated | Phase 1 | Copanlisib in Combination With T-DM1 in Pretreated Unresectable Locally Advanced or Metastatic HER2-positive Breast Cancer | November 12, 2019 | November 2, 2020 |
| NCT03894007 | Terminated | Phase 2 | Improving Pre-operative Systemic Therapy for Human Epidermal Growth Factor Receptor 2 (HER2) Amplified Breast Cancer | May 23, 2019 | June 30, 2021 |
| NCT03418558 | Unknown status | Phase 2 | Study of Trastuzumab-emtansine in Patients With HER2-positive Metastatic Colorectal Cancer Progressing After Trastuzumab and Lapatinib. | July 8, 2015 | June 2019 |
| NCT04351230 | Withdrawn | Phase 2 | T-DM1 With or Without Abemaciclib for the Treatment of HER2-Positive Metastatic Breast Cancer | November 11, 2020 | February 16, 2022 |
| NCT02725541 | Withdrawn | Phase 2 | Trial of Neoadjuvant Trastuzumab Emtansine in Patients With HER2-Equivocal Breast Cancer | March 2016 | May 2019 |
| NCT05238831 | Withdrawn | Early Phase 1 | SMMART Adaptive Clinical Treatment (ACT) Trial | January 30, 2023 | May 31, 2026 |