Trastuzumab Emtansine
HER2 Positive Breast Carcinoma
Explore 176 assets in HER2 Positive Breast Carcinoma →Floatz Rating
BB66/100
Confidence
Indicative
Sponsor
SWOG Cancer Research Network
Modality
antibody_drug_conjugate
Development Phase
Phase 4 / Approved
Status
Active
Evidence ledger · v0.2
Clinical Evidence
Clinical track record: trial progression, reported outcomes, safety signals, and endpoint quality.
66High confidence
Detailed axis rationale is planned and will be published soon.
| Trial | Phase | Status | N | Primary endpoint | Readout |
|---|---|---|---|---|---|
NCT07578116CT.gov Adding Surgery and Radiation to the Usual Treatment for HER2-Positive Breast Cancer That Had Already Spread at Diagnosis | — | Not Yet Recruiting | — | — | — |
NCT06595563CT.gov 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 | — | Recruiting | — | — | — |
NCT07152782CT.gov T-DXd With or Without Neratinib for HER2 Positive Breast Cancer With Brain Metastasis | — | Not Yet Recruiting | — | — | — |
NCT04419181CT.gov Feasibility of Chemotherapy De-escalation in Early-Stage HER2 Positive Breast Cancer | — | Withdrawn | — | — | — |
NCT06830889CT.gov A Study of BL-M07D1 Versus T-DM1 in the Adjuvant Treatment of HER2-positive Breast Cancer With Residual Invasive Cancer After Neoadjuvant Therapy | — | Recruiting | — | — | — |
NCT06348134CT.gov Assessing the Efficacy and Safety of Anti-HER2 Therapy in Nigerian Women With HER2+ Breast Cancer Before and After Surgery | — | Recruiting | — | — | — |
NCT06846437CT.gov JSKN003 Versus Trastuzumab Emtansine (T-DM1) for HER2-Positive, Advanced Breast Cancer | — | Recruiting | — | — | — |
NCT06439693CT.gov The SAPPHO Study: Sequential Therapy With Curative Intent in de Novo HER2+ Metastatic Breast Cancer | — | Recruiting | — | — | — |
NCT06316531CT.gov A Study Comparing BL-M07D1 With T-DM1 in Patients With Unresectable Locally Advanced or Metastatic HER2-positive Breast Cancer | — | Active Not Recruiting | — | — | — |
NCT06313086CT.gov DP303c Versus Trastuzumab Emtansine in in Patients With HER2-positive Advanced Breast Cancer | — | Recruiting | — | — | — |
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NCT06265428CT.gov A Study to Compare DB-1303/BNT323 Versus T-DM1 in Breast Cancer | — | Active Not Recruiting | — | — | — |
NCT06126640CT.gov 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 | — | Recruiting | — | — | — |
NCT06968585CT.gov 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 | — | Active Not Recruiting | — | — | — |
NCT05323955CT.gov Secondary BRain Metastases Prevention After Isolated Intracranial Progression on Trastuzumab/Pertuzumab or T-DM1 in Patients With aDvanced Human Epidermal Growth Factor Receptor 2+ brEast Cancer With the Addition of Tucatinib | — | Active Not Recruiting | — | — | — |
NCT05650879CT.gov ELVN-002 in HER2 Mutant Non-Small Cell Lung Cancer | — | Active Not Recruiting | — | — | — |
NCT05388149CT.gov Kadcyla And Neratinib for Interception of HER2+ Breast Cancer With Molecular Residual Disease | — | Recruiting | — | — | — |
NCT05560308CT.gov Phase II Clinical Study of T-DM1 and Pyrotinib Maleate in Patients With HER2-positive Metastatic Breast Cancer Who Had Progressed on TKI Therapy | — | Unknown | — | — | — |
NCT05252988CT.gov Three Antidiarrheal Strategies in HER2+/HR+ Early Breast Cancer Patients Treated With Extended Adjuvant Neratinib | — | Active Not Recruiting | — | — | — |
NCT04886531CT.gov Trial of Pre-operative Neratinib and Endocrine Therapy With Trastuzumab in ER-Positive, HER-2 Positive Breast Cancers | — | Recruiting | — | — | — |
NCT06299852CT.gov Stereotactic Radiation Therapy for HE2-positive Oligometastatic Breast Cancer | — | Unknown | — | — | — |
NCT04675827CT.gov De-escalation Adjuvant Chemo in HER2+/ER-/node-neg Early BC Patients Who Achieved PCR After Neoadjuvant Chemo & Dual HER2 Blockade | — | Terminated | — | — | — |
NCT05081609CT.gov A Study to Investigate Safety and Tolerability of TransCon IL-2 β/γ Alone or in Combination With Pembrolizumab and/or TransCon TLR7/8 Agonist or Other Anticancer Therapies in Adult Participants With Locally Advanced or Metastatic Solid Tumor Malignancies | — | Active Not Recruiting | — | — | — |
NCT05154396CT.gov Neratinib Dose Escalation Regimen for HER2 Positive Early Breast Cancer | — | Unknown | — | — | — |
NCT04893109CT.gov ATEMPT 2.0: Adjuvant T-DM1 vs TH | — | Recruiting | — | — | — |
NCT04296942CT.gov BN-Brachyury, Entinostat, Adotrastuzumab Emtansine and M7824 in Advanced Stage Breast Cancer (BrEAsT) | — | Terminated | — | — | — |
NCT04457596CT.gov 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 | — | Active Not Recruiting | — | — | — |
NCT05429684CT.gov Precise Therapy for Refractory HER2 Positive Advanced Breast Cancer | — | Unknown | — | — | — |
NCT04622319CT.gov 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) | — | Active Not Recruiting | — | — | — |
NCT04351230CT.gov T-DM1 With or Without Abemaciclib for the Treatment of HER2-Positive Metastatic Breast Cancer | — | Withdrawn | — | — | — |
NCT05593094CT.gov A Phase 1 Trial of ZN-A-1041 Enteric Capsules or Combination in Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Advanced Solid Tumors | — | Active Not Recruiting | — | — | — |
NCT04366713CT.gov A Study to Characterize Colon Pathology in Patients With HER2 Amplified Breast Cancer Treated With Neratinib | — | Completed | — | — | — |
NCT04158947CT.gov A Study of HER2+ Breast Cancer Patients With Active Brain Metastases Treated With Afatinib & T-DM1 vs. T-DM1 Alone | — | Unknown | — | — | — |
NCT04042051CT.gov Copanlisib in Combination With T-DM1 in Pretreated Unresectable Locally Advanced or Metastatic HER2-positive Breast Cancer | — | Terminated | — | — | — |
NCT03975647CT.gov A Study of Tucatinib vs. Placebo in Combination With Ado-trastuzumab Emtansine (T-DM1) for Patients With Advanced or Metastatic HER2+ Breast Cancer | — | Active Not Recruiting | — | — | — |
NCT03812393CT.gov Evaluating the Efficacy of Neratinib on Live Cell HER2 Signaling Transduction Analysis Positive Triple Negative Breast | — | Unknown | — | — | — |
NCT03894007CT.gov Improving Pre-operative Systemic Therapy for Human Epidermal Growth Factor Receptor 2 (HER2) Amplified Breast Cancer | — | Terminated | — | — | — |
NCT06693024CT.gov Adjuvant Therapy With Neratinib in HER2 Positive Early Breast Cancer | — | Recruiting | — | — | — |
NCT03530696CT.gov T-DM1 and Palbociclib for Metastatic HER2 Breast Cancer | — | Completed | — | — | — |
NCT03709082CT.gov Palbociclib in Estrogen Receptor Positive (ER+) Human Epidermal Growth Factor Receptor 2 Positive (HER2+) Metastatic Breast Cancer | — | Terminated | — | — | — |
NCT03094052CT.gov Incidence and Severity of Diarrhea in Patients With HER2 Positive Breast Cancer Treated With Trastuzumab and Neratinib | — | Completed | — | — | — |
NCT03203616CT.gov Kadcyla In pAtients With bRAin Metastasis | — | Withdrawn | — | — | — |
NCT03364348CT.gov 4-1BB Agonist Monoclonal Antibody PF-05082566 With Trastuzumab Emtansine or Trastuzumab in Treating Patients With Advanced HER2-Positive Breast Cancer | — | Completed | — | — | — |
NCT02673398CT.gov Neratinib in Treating Older Patients With Stage IV HER2-Positive Breast Cancer | — | Completed | — | — | — |
NCT02658734CT.gov 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 | — | Completed | — | — | — |
NCT02605915CT.gov Safety and Pharmacokinetics of Atezolizumab Combination Treatments in Participants With HER2-Positive and HER2-Negative Breast Cancer | — | Completed | — | — | — |
NCT02400476CT.gov An Open-Label Study to Characterize the Incidence and Severity of Diarrhea in Patients With Early-Stage HER2+ Breast Cancer Treated With Neratinib and Loperamide | — | Completed | — | — | — |
NCT02226276CT.gov Copper Cu 64-DOTA-Trastuzumab PET in Predicting Response to Treatment With Ado-Trastuzumab Emtansine in Patients With Metastatic HER2 Positive Breast Cancer | — | Active Not Recruiting | — | — | — |
NCT02038010CT.gov BYL719 + T-DM1 in HER2(+) Metastatic Breast Cancer Pts Who Progress on Prior Trastuzumab & Taxane Tx | — | Completed | — | — | — |
NCT01983501CT.gov A Study of Tucatinib (ONT-380) Combined With Ado-trastuzumab Emtansine (T-DM1) in Patients With HER2+ Breast Cancer | — | Completed | — | — | — |
NCT01904903CT.gov Cardiac Safety Study in Patients With HER2 + Breast Cancer | — | Completed | — | — | — |
NCT01808573CT.gov A Study of Neratinib Plus Capecitabine Versus Lapatinib Plus Capecitabine in Patients With HER2+ Metastatic Breast Cancer Who Have Received Two or More Prior HER2 Directed Regimens in the Metastatic Setting | — | Completed | — | — | — |
NCT01042379CT.gov I-SPY TRIAL: Neoadjuvant and Personalized Adaptive Novel Agents to Treat Breast Cancer | — | Recruiting | — | — | — |
Competitive Position
Competitive setting: how crowded the indication is, class-level failures, and timing against rivals.
65High confidence
Detailed axis rationale is planned and will be published soon.
Same indication · HER2 Positive Breast Carcinoma
| Asset | Sponsor | Phase | Rating |
|---|---|---|---|
| Trastuzumab Emtansine (this asset) | SWOG Cancer Research Network | Approved | BB · 66 |
| Trastuzumab | SWOG Cancer Research Network | P4 | BB |
| Pertuzumab | SWOG Cancer Research Network | P4 | BB |
| Ribociclib | Danish Breast Cancer Cooperative Group | P3 | BB |
| Cyclophosphamide | National University Hospital, Singapore | P3 | BB |
| Vinorelbine Ditartrate | Fudan University | P3 | BB |
| Docetaxel | Ohio State University Comprehensive Cancer Center | P3 | BB |
| Capecitabine | MedSIR | P4 | BB |
| gb221 | Genor Biopharma Co., Ltd. | P3 | BB |
+42 more in the HER2 Positive Breast Carcinoma cohort
Other indications for Trastuzumab Emtansine
| Indication | Sponsor | Phase | Rating |
|---|---|---|---|
| Breast Cancer | — | P3 | BB · 66 |
| Breast Carcinoma | — | P3 | BB · 66 |
| Inflammatory Breast Carcinoma | — | P3 | B · 63 |
Scientific Foundation
Strength of the underlying biology: target validation, tractability, modality fit, and how related mechanisms have fared.
NR
Planned for methodology v0.2.
Development Feasibility
How realistically the program can be executed, drawing on modality precedent, enrollment dynamics, and sponsor delivery.
NR
Planned for methodology v0.2.
Commercial Opportunity
Commercial prize: addressable population, unmet need, and the value case for the indication.
NR
Planned for methodology v0.2.
IP & Exclusivity
Exclusivity position, covering patent protection and freedom-to-operate runway.
NR
Planned for methodology v0.2.
Manufacturing & Supply
Manufacturing and supply readiness, driven by modality process and scale-up risk.
NR
Planned for methodology v0.2.
Related assets
Citation
Floatz Terminal. Trastuzumab Emtansine in HER2 Positive Breast Carcinoma. Methodology v0.2. Rated under v0.2 effective July 8, 2026. Last refreshed July 8, 2026. Accessed July 14, 2026. https://terminal.floatz.ai/assets/trastuzumab-emtansine-her2-positive-breast-carcinoma
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