Trial started· ClinicalTrials.gov
Trastuzumab Deruxtecan + Stereotactic Radiosurgery (SRS) in HER2+ Breast Cancer Brain Metastases
Trastuzumab Deruxtecan History and Updates
250 events · 2016 – present
Synced daily from openFDA and ClinicalTrials.gov. Last sync: .
16
FDA Approvals
0
Label Revisions
415
Trial Milestones
0
Pivotal Publications
Source: openFDA, ClinicalTrials.gov via AACT, PubMed · Hipa.ai, 2026-06-12Download chart as PNG
This page tracks every FDA action, clinical trial milestone, and major publication for Trastuzumab Deruxtecan since 2016, drawn from openFDA, ClinicalTrials.gov, and PubMed.
All published updates (23)
2026
- Results postedEnhertu Trial Reveals Distinct pCR Rates in HER2-positive Early Breast Cancer· Jun 9, 2026
- FDA approval (supplemental)Enhertu (Trastuzumab Deruxtecan) FDA Approves Supplemental Efficacy· May 15, 2026
- FDA approval (supplemental)Enhertu (Trastuzumab Deruxtecan) Receives FDA Supplemental Efficacy Approval· Apr 27, 2026
- Results postedTrastuzumab Deruxtecan Trial for HER2+ MBC Terminated with Limited Data· Mar 12, 2026
- Results postedTrastuzumab Deruxtecan Shows 81.8% ORR in Metastatic TNBC Trial· Feb 2, 2026
- Primary completionTrastuzumab Deruxtecan Phase 3 Metastatic Breast Cancer Trial Withdrawn· Jan 1, 2026
2025
- FDA approval (supplemental)Enhertu: FDA Approves Supplemental Efficacy Application· Dec 15, 2025
- Results postedTrastuzumab Deruxtecan: Phase 2 NSCLC Umbrella Study Results Posted· Oct 27, 2025
- Results postedTrastuzumab Deruxtecan + Tucatinib Combo Shows 51.4% cORR in HER2+ Breast Cancer· Jul 31, 2025
- Results postedTrastuzumab Deruxtecan Phase 2 Results Posted for HER2+ Breast Cancer with…· Jun 24, 2025
- Results postedTrastuzumab Deruxtecan Shows High Response Rates in HER2+ Breast Cancer· May 16, 2025
- Results postedEnhertu Improves PFS in HER2-low, HR+ Metastatic Breast Cancer Trial· Apr 2, 2025
- Primary completionTrastuzumab Deruxtecan Phase 3 HER2+ Early Breast Cancer Trial Primary…· Mar 12, 2025
- FDA approval (supplemental)Enhertu (Trastuzumab Deruxtecan) Receives FDA Supplemental Efficacy Approval· Jan 27, 2025
2024
- FDA approval (supplemental)Enhertu (Trastuzumab Deruxtecan) FDA Approves Supplemental Efficacy Application· Apr 5, 2024
- FDA approval (supplemental)Enhertu (Trastuzumab Deruxtecan) Receives FDA Supplemental Efficacy Approval· Feb 15, 2024
- Primary completionTrastuzumab Deruxtecan Phase 3 Trial Completes, Shows ORR 62.7% in HER2+…· Feb 8, 2024
2022
- FDA approval (supplemental)Enhertu (Trastuzumab Deruxtecan) Receives FDA Supplemental Efficacy Approval· Nov 4, 2022
- FDA approval (supplemental)FDA Approves Enhertu Supplemental Application for Efficacy· Aug 11, 2022
- FDA approval (supplemental)Trastuzumab Deruxtecan (Enhertu) Gains FDA Supplemental Efficacy Approval· Aug 5, 2022
- FDA approval (supplemental)Enhertu (Trastuzumab Deruxtecan) Gains FDA Supplemental Efficacy Approval· May 4, 2022
2021
- FDA approval (supplemental)Enhertu (Trastuzumab Deruxtecan) Gains Supplemental Efficacy Approval· Jan 15, 2021
2019
- FDA approvalTrastuzumab Deruxtecan Receives Initial FDA Approval· Dec 20, 2019
Upcoming & expected milestones
Primary completion· ClinicalTrials.gov
Neratinib and Fam-Trastuzumab Deruxtecan in Advanced Gastro-esophageal Cancer Patients
Primary completion· ClinicalTrials.gov
Trastuzumab Deruxtecan (T-DXd) With or Without Pertuzumab Versus Taxane, Trastuzumab and Pertuzumab in HER2-positive Metastatic Breast Cance
Primary completion· ClinicalTrials.gov
ELVN-002 in HER2 Mutant Non-Small Cell Lung Cancer
Primary completion· ClinicalTrials.gov
Efficacy of Trastuzumab Deruxtecan in Metastatic Breast Cancer With Different HER2 Expression Patterns
Trial started· ClinicalTrials.gov
Sotorasib in Combination With Trastuzumab Deruxtecan for the Treatment of Locally Advanced and Metastatic Non-small Cell Lung Cancer With a
Primary completion· ClinicalTrials.gov
Trastuzumab Deruxtecan for Subjects With HER2-Positive Gastric Cancer or Gastro-Esophageal Junction Adenocarcinoma After Progression on or A
Trial started· ClinicalTrials.gov
Trastuzumab Deruxtecan and Lovastatin in HER2-low and Ultralow Advanced or Metastatic Breast Cancer
Trial started· ClinicalTrials.gov
Testing the Combination of Anti-Cancer Drugs, Selumetinib and DS-8201a, for Advanced Pancreatic Ductal Adenocarcinoma
Trial started· ClinicalTrials.gov
Phase 1b Study Of TRICK-NK In Combination With T-Dxd In Treatment-Refractory Breast Cancers
Trial started· ClinicalTrials.gov
Testing the Safety of the Combination of Anti-Cancer Drugs CX-5461 (Pidnarulex) and Trastuzumab Deruxtecan (T-DXd) for Human Epidermal Growt
Primary completion· ClinicalTrials.gov
Testing the Combination of Anti-Cancer Drugs, Selumetinib and DS-8201a, for Advanced Pancreatic Ductal Adenocarcinoma
Primary completion· ClinicalTrials.gov
Phase 4 Study to Assess the Safety of Trastuzumab Deruxtecan, in Indian Patients
Trial started· ClinicalTrials.gov
Trastuzumab Deruxtecan to Treat HER2 + Newly Diagnosed Metastatic GI Cancers
Primary completion· ClinicalTrials.gov
T-DXd Therapy for HER2-low Breast Cancer Patients With Brain Metastases
Primary completion· ClinicalTrials.gov
A Study of Trastuzumab DeRuxtecan for Patients With Advanced HER2-pOsitive GaStric or GastroesoPhageal Junction AdEnocarcinoma Who Have Rece
Primary completion· ClinicalTrials.gov
Impact of Genetic Variants on the Toxicity of Antibody-Drug Conjugates in Locally Advanced or Metastatic Breast Cancer: The Role of the UGT1
Primary completion· ClinicalTrials.gov
Anlotinib With Trastuzumab Deruxtecan for Previously Treated HER2-Low Advanced Breast Cancer
Primary completion· ClinicalTrials.gov
Trastuzumab Deruxtecan Alone or in Combination With Anastrozole for the Treatment of Early Stage HER2 Low, Hormone Receptor Positive Breast
Primary completion· ClinicalTrials.gov
Testing the Combination of DS-8201a and Olaparib in HER2-Expressing Cancers With Expansion in Patients With Platinum Resistant Ovarian Cance
Primary completion· ClinicalTrials.gov
Efficacy and Safety of T-DXd in HER2-mutant Advanced Lung Cancer Patients With Asymptomatic Brain Metastases
Primary completion· ClinicalTrials.gov
RADIomics to Predict HER2 Status And T-DXd Efficacy in Metastatic Breast Cancer: the RADIOSPHER2 Study
Primary completion· ClinicalTrials.gov
Heterogeneity of 68Ga-FAPI Uptake As Imaging Biomarker in T-DXd Treatment for Brain Metastasis of HER2 Positive Breast Cancer
Primary completion· ClinicalTrials.gov
A Study of Novel Agents or Combinations as Perioperative Treatment in Participants With Locally Advanced Resectable Gastroesophageal Adenoca
Primary completion· ClinicalTrials.gov
Safety and Efficacy of T-DXd vs. CDK4/6i-based ET as First-line Therapy of HR-positive and HER2-low/Ultralow Advanced Breast Cancer Patients
Primary completion· ClinicalTrials.gov
A Study of Trastuzumab Deruxtecan in People With Non-Small Cell Lung Cancer
Primary completion· ClinicalTrials.gov
Trastuzumab Deruxtecan in Advanced Breast Cancer
Trial started· ClinicalTrials.gov
Adding Surgery and Radiation to the Usual Treatment for HER2-Positive Breast Cancer That Had Already Spread at Diagnosis
Primary completion· ClinicalTrials.gov
A Phase 2 Study of T-DXd in Patients With Selected HER2 Expressing Tumors
Primary completion· ClinicalTrials.gov
Trastuzumab Rezetecan vs Trastuzumab Deruxtecan in the Neoadjuvant Treatment of HER2 Positive Breast Cancer
Primary completion· ClinicalTrials.gov
Testing the Combination of Two Anti-cancer Drugs, DS-8201a and AZD6738, for The Treatment of Advanced Solid Tumors Expressing the HER2 Prote
Primary completion· ClinicalTrials.gov
Sequential Therapies Modeled on Evolutionary Dynamics for Breast Cancer
Primary completion· ClinicalTrials.gov
Trastuzumab Deruxtecan Versus Standard Neoadjuvant Treatment for HER2-positive Breast Cancer
Primary completion· ClinicalTrials.gov
PHESGO Maintenance After T-DXd Short Induction for HER2+ Unresectable Locally Recurrent or Metastatic Breast Cancer
Primary completion· ClinicalTrials.gov
A Phase II Study of HLX22 in Combination With Trastuzumab Deruxtecan in HER2-low, Hormone Receptor Positive Locally Advanced or Metastatic B
Primary completion· ClinicalTrials.gov
Sequencing SG vs. T-DXd in HER2-Low/TROP2-High Metastatic Breast Cancer
Primary completion· ClinicalTrials.gov
Ph1b/2 Study of the Safety and Efficacy of T-DXd Combinations in Advanced HER2-expressing Gastric Cancer (DESTINY-Gastric03)
Primary completion· ClinicalTrials.gov
Sotorasib in Combination With Trastuzumab Deruxtecan for the Treatment of Locally Advanced and Metastatic Non-small Cell Lung Cancer With a
Primary completion· ClinicalTrials.gov
Organoid-based Functional Precision Therapy for Advanced Breast Cancer
Primary completion· ClinicalTrials.gov
Testing the Combination of the Anticancer Drugs Trastuzumab Deruxtecan (DS-8201a) and Azenosertib (ZN-c3) in Patients With Stomach or Other
Primary completion· ClinicalTrials.gov
Real-world Effectiveness and Safety of Trastuzumab Deruxtecan in Patients With Locally Advanced or Metastatic HER2-positive Gastric or Gastr
Primary completion· ClinicalTrials.gov
Trastuzumab Deruxtecan (T-DXd) for People With Brain Cancer
Primary completion· ClinicalTrials.gov
EIS-12656 as Single Agent and in Combination in Patients With Specified Solid Tumors
Primary completion· ClinicalTrials.gov
T-DXd With or Without Bevacizumab for HER2-low Breast Cancer With Brain Metastasis
Primary completion· ClinicalTrials.gov
Neoadjuvant Trastuzumab Deruxtecan (SHR-A1811) + Pertuzumab in HER2+ Breast Cancer
Primary completion· ClinicalTrials.gov
Trastuzumab Deruxtecan (T-DXd) in Patients Who Have Hormone Receptor-negative and Hormone Receptor-positive HER2-low or HER2 IHC 0 Metastati
Primary completion· ClinicalTrials.gov
Basket Study for Oligo-metastatic Breast Cancer
Primary completion· ClinicalTrials.gov
Study of AZD9574 as Monotherapy and in Combination With Anti-cancer Agents in Participants With Advanced Solid Malignancies
Primary completion· ClinicalTrials.gov
Upfront Trastuzumab-Deruxtecan Plus Capecitabine and Bevacizumab for Patients With HER-2 Positive Metastatic Colorectal Cancer.
Primary completion· ClinicalTrials.gov
Castrate Resistant Prostate Cancer Enhertu Therapy
Past events
2026
Trial started· ClinicalTrials.gov
ASCEND-CRC: Profiling and Targeting Dynamic Tumor Resistance in Patients With Metastatic Colorectal Cancer
Results posted· ClinicalTrials.gov
Trastuzumab Deruxtecan (T-DXd) Alone or in Sequence With THP, Versus Standard Treatment (ddAC-THP), in HER2-positive Early Breast Cancer
Trial registered· ClinicalTrials.gov
Trastuzumab Deruxtecan and Lovastatin in HER2-low and Ultralow Advanced or Metastatic Breast Cancer
Trial registered· ClinicalTrials.gov
Testing the Combination of Anti-Cancer Drugs, Selumetinib and DS-8201a, for Advanced Pancreatic Ductal Adenocarcinoma
Primary completion· ClinicalTrials.gov
Scalp Cooling in MBC
Primary completion· ClinicalTrials.gov
Pre-operative Targeted Treatments in Molecularly Selected Resectable Colorectal Cancer (UNICORN)
Primary completion· ClinicalTrials.gov
An Investigational Scan (64Cu-DOTA-Trastuzumab PET/MRI) in Imaging Patients With HER2+ Breast Cancer With Brain Metastasis
FDA approval (supplemental)· FDA
Sponsor: DAIICHI SANKYO. Class: Efficacy.
FDA approval (supplemental)· FDA
Sponsor: DAIICHI SANKYO. Class: Efficacy.
Trial registered· ClinicalTrials.gov
Impact of Genetic Variants on the Toxicity of Antibody-Drug Conjugates in Locally Advanced or Metastatic Breast Cancer: The Role of the UGT1
Trial registered· ClinicalTrials.gov
Adding Surgery and Radiation to the Usual Treatment for HER2-Positive Breast Cancer That Had Already Spread at Diagnosis
Trial started· ClinicalTrials.gov
Megestrol Acetate for Fatigue Management in T-DXd Treated Breast Cancer
Primary completion· ClinicalTrials.gov
A Study to Investigate the Efficacy and Safety of Trastuzumab Deruxtecan as the First Treatment Option for Unresectable, Locally Advanced/Me
Trial started· ClinicalTrials.gov
A Trial of Trastuzumab Rezetecan in Unresectable Locally Recurrent/Metastatic Breast Cancer
Trial registered· ClinicalTrials.gov
Phase 1b Study Of TRICK-NK In Combination With T-Dxd In Treatment-Refractory Breast Cancers
FDA approval (supplemental)· FDA
Sponsor: DAIICHI SANKYO. Class: Efficacy.
Trial registered· ClinicalTrials.gov
Megestrol Acetate for Fatigue Management in T-DXd Treated Breast Cancer
Trial started· ClinicalTrials.gov
Trastuzumab Rezetecan vs Trastuzumab Deruxtecan in the Neoadjuvant Treatment of HER2 Positive Breast Cancer
Primary completion· ClinicalTrials.gov
Developing ctDNA Guided Adjuvant Therapy for Gastrooesophageal Cancer
Trial registered· ClinicalTrials.gov
A Trial of Trastuzumab Rezetecan in Unresectable Locally Recurrent/Metastatic Breast Cancer
Results posted· ClinicalTrials.gov
Trastuzumab Deruxtecan in First-line HER2-positive Locally Advanced/MBC Patients Resistant to Trastuzumab+Pertuzumab
Trial registered· ClinicalTrials.gov
HERizon-Breast: A ctDNA-Guided Adaptive Study of Sequential Anti-HER2 Therapies and CNS Prophylaxis to Induce Long-Term Remission
Trial registered· ClinicalTrials.gov
Trastuzumab Deruxtecan + Stereotactic Radiosurgery (SRS) in HER2+ Breast Cancer Brain Metastases
Trial started· ClinicalTrials.gov
HERizon-Breast: A ctDNA-Guided Adaptive Study of Sequential Anti-HER2 Therapies and CNS Prophylaxis to Induce Long-Term Remission
Primary completion· ClinicalTrials.gov
Trastuzumab Deruxtecan (T-DXd) With Pyrotinib in First-line HER2-positive Unresectable or Metastatic Breast Cancer Trial
Trial registered· ClinicalTrials.gov
A Study of Trastuzumab Deruxtecan in People With Non-Small Cell Lung Cancer
Trial registered· ClinicalTrials.gov
Trastuzumab Rezetecan vs Trastuzumab Deruxtecan in the Neoadjuvant Treatment of HER2 Positive Breast Cancer
Trial started· ClinicalTrials.gov
A Study of Trastuzumab Deruxtecan in People With Non-Small Cell Lung Cancer
Trial registered· ClinicalTrials.gov
Upfront Trastuzumab-Deruxtecan Plus Capecitabine and Bevacizumab for Patients With HER-2 Positive Metastatic Colorectal Cancer.
Trial registered· ClinicalTrials.gov
Neoadjuvant Trastuzumab Deruxtecan (SHR-A1811) + Pertuzumab in HER2+ Breast Cancer
Trial started· ClinicalTrials.gov
Neoadjuvant Trastuzumab Deruxtecan (SHR-A1811) + Pertuzumab in HER2+ Breast Cancer
Results posted· ClinicalTrials.gov
A Study of Novel Anti-cancer Agents in Patients With Metastatic Triple Negative Breast Cancer
Primary completion· ClinicalTrials.gov
HCQ+ADC vs ADC in the Treatment of Advanced Breast Cancer
Trial registered· ClinicalTrials.gov
Sequencing SG vs. T-DXd in HER2-Low/TROP2-High Metastatic Breast Cancer
Trial started· ClinicalTrials.gov
Sequencing SG vs. T-DXd in HER2-Low/TROP2-High Metastatic Breast Cancer
Trial registered· ClinicalTrials.gov
ASCEND-CRC: Profiling and Targeting Dynamic Tumor Resistance in Patients With Metastatic Colorectal Cancer
Primary completion· ClinicalTrials.gov
A Randomised Trial Comparing Trastuzumab Deruxtecan to CDK4/6 Inhibitors in Non-luminal A, ER-positive/HER2-low Metastatic Breast Cancer
Trial started· ClinicalTrials.gov
A Randomised Trial Comparing Trastuzumab Deruxtecan to CDK4/6 Inhibitors in Non-luminal A, ER-positive/HER2-low Metastatic Breast Cancer
2025
Primary completion· ClinicalTrials.gov
Trastuzumab Deruxtecan(T-DXd) and Afatinib Combination in HER2-low Advanced Gastric Cancer
FDA approval (supplemental)· FDA
Sponsor: DAIICHI SANKYO. Class: Efficacy.
FDA approval (supplemental)· FDA
Sponsor: DAIICHI SANKYO. Class: Labeling.
Trial started· ClinicalTrials.gov
T-DXd With or Without Neratinib for HER2 Positive Breast Cancer With Brain Metastasis
Primary completion· ClinicalTrials.gov
A Study of T-DXd as Monotherapy or in Combination With Anti-cancer Agents in Patients With Selected HER2-expressing Tumors
Trial started· ClinicalTrials.gov
ERADICATE: A Phase Ib/II Study of Elacestrant Plus Trastuzumab Deruxtecan in Patients With CDK4/6 Inhibitor and Endocrine-resistant HR+/HER2
Primary completion· ClinicalTrials.gov
A Study to Evaluate the Safety and Therapeutic Activity of GI-102 As a Single Agent and in Combination with Conventional Anti-cancer Drugs,
Trial started· ClinicalTrials.gov
Testing Two Different Drugs (Sacituzumab-govitecan and Trastuzumab-deruxtecan) Combinations Prescribed in an Alterning Pattern to Patients W
Primary completion· ClinicalTrials.gov
A Study of T-DXd as Monotherapy or in Combination With Anti-cancer Agents in Patients With Selected HER2-expressing Tumors
Results posted· ClinicalTrials.gov
Phase II Umbrella Study of Novel Anti-cancer Agents in Participants With NSCLC Who Progressed on an Anti-PD-1/PD-L1 Containing Therapy
Trial started· ClinicalTrials.gov
Study of Trastuzumab Deruxtecan, Pembrolizumab, and Platinum-based Chemotherapy in First-line HER2 Overexpressing Non-small Cell Lung Cancer
Trial started· ClinicalTrials.gov
Upfront Trastuzumab-Deruxtecan Plus Capecitabine and Bevacizumab for Patients With HER-2 Positive Metastatic Colorectal Cancer.
Trial started· ClinicalTrials.gov
T-DXd With or Without Bevacizumab for HER2-low Breast Cancer With Brain Metastasis
Trial registered· ClinicalTrials.gov
ERADICATE: A Phase Ib/II Study of Elacestrant Plus Trastuzumab Deruxtecan in Patients With CDK4/6 Inhibitor and Endocrine-resistant HR+/HER2
Primary completion· ClinicalTrials.gov
Neoadjuvant Trastuzumab Deruxtecan (T-DXd) With Response-directed Definitive Therapy in Early Stage HER2-positive Breast Cancer (SHAMROCK St
Trial started· ClinicalTrials.gov
Study of Trastuzumab Deruxtecan Versus Standard of Care Chemotherapy for HER2-Expressing (IHC 3+/2+) Endometrial Cancer
Trial started· ClinicalTrials.gov
DESTINY-PANTUMOUR04
Trial registered· ClinicalTrials.gov
Trastuzumab Deruxtecan in Advanced Breast Cancer
Primary completion· ClinicalTrials.gov
Testing the Safety and Tolerability of the Anti-cancer Drugs Trastuzumab Deruxtecan and Neratinib for Cancers With Changes in the HER2 Gene
Trial registered· ClinicalTrials.gov
T-DXd With or Without Neratinib for HER2 Positive Breast Cancer With Brain Metastasis
Trial registered· ClinicalTrials.gov
Testing Two Different Drugs (Sacituzumab-govitecan and Trastuzumab-deruxtecan) Combinations Prescribed in an Alterning Pattern to Patients W
Trial registered· ClinicalTrials.gov
T-DXd With or Without Bevacizumab for HER2-low Breast Cancer With Brain Metastasis
Primary completion· ClinicalTrials.gov
Testing the Biological Effects of DS-8201a on Patients With Advanced Cancer
Trial started· ClinicalTrials.gov
Trastuzumab Deruxtecan in Advanced Breast Cancer
Trial registered· ClinicalTrials.gov
Testing the Safety of the Combination of Anti-Cancer Drugs CX-5461 (Pidnarulex) and Trastuzumab Deruxtecan (T-DXd) for Human Epidermal Growt
Trial registered· ClinicalTrials.gov
Trastuzumab Deruxtecan to Treat HER2 + Newly Diagnosed Metastatic GI Cancers
Trial registered· ClinicalTrials.gov
DESTINY-PANTUMOUR04
Results posted· ClinicalTrials.gov
A Study of Tucatinib Plus Trastuzumab Deruxtecan in HER2+ Breast Cancer
Trial started· ClinicalTrials.gov
A Clinical Study of Patritumab Deruxtecan to Treat Breast Cancer (MK-1022-016)
Primary completion· ClinicalTrials.gov
DS8201a and Pembrolizumab in Participants With Locally Advanced/Metastatic Breast or Non-Small Cell Lung Cancer
Trial registered· ClinicalTrials.gov
A Study of Novel Agents or Combinations as Perioperative Treatment in Participants With Locally Advanced Resectable Gastroesophageal Adenoca
Trial started· ClinicalTrials.gov
A Study of Novel Agents or Combinations as Perioperative Treatment in Participants With Locally Advanced Resectable Gastroesophageal Adenoca
Trial started· ClinicalTrials.gov
A Study of Subcutaneous Trastuzumab Deruxtecan in Participants With Metastatic Solid Tumors
Primary completion· ClinicalTrials.gov
Trastuzumab Deruxtecan in First-line HER2-positive Locally Advanced/MBC Patients Resistant to Trastuzumab+Pertuzumab
Trial registered· ClinicalTrials.gov
A Clinical Study of Patritumab Deruxtecan to Treat Breast Cancer (MK-1022-016)
Primary completion· ClinicalTrials.gov
HER-TEMPO - Real World Treatment-related Outcomes on T-DXd in Canada
Trial started· ClinicalTrials.gov
Safety and Efficacy of T-DXd vs. CDK4/6i-based ET as First-line Therapy of HR-positive and HER2-low/Ultralow Advanced Breast Cancer Patients
Results posted· ClinicalTrials.gov
DS-8201a for trEatment of aBc, BRain Mets, And Her2[+] Disease
Trial registered· ClinicalTrials.gov
RADIomics to Predict HER2 Status And T-DXd Efficacy in Metastatic Breast Cancer: the RADIOSPHER2 Study
Trial started· ClinicalTrials.gov
Trial of Trastuzumab Deruxtecan in Previously Treated HER2
Primary completion· ClinicalTrials.gov
NeoAdjuvant Therapy With Trastuzumab-deruxtecan Versus Chemotherapy+Trastuzumab+Pertuzumab in HER2+ Early Breast Cancer
Trial registered· ClinicalTrials.gov
Study of Trastuzumab Deruxtecan Versus Standard of Care Chemotherapy for HER2-Expressing (IHC 3+/2+) Endometrial Cancer
Trial registered· ClinicalTrials.gov
A Study of Subcutaneous Trastuzumab Deruxtecan in Participants With Metastatic Solid Tumors
Trial registered· ClinicalTrials.gov
Sotorasib in Combination With Trastuzumab Deruxtecan for the Treatment of Locally Advanced and Metastatic Non-small Cell Lung Cancer With a
Trial registered· ClinicalTrials.gov
DESTINY-Endometrial01: A Phase III Study of Trastuzumab Deruxtecan Plus Rilvegostomig or Pembrolizumab as First-Line Treatment of HER2-Expre
Results posted· ClinicalTrials.gov
A Study of T-DXd in Participants With or Without Brain Metastasis Who Have Previously Treated Advanced or Metastatic HER2 Positive Breast Ca
Primary completion· ClinicalTrials.gov
Adjuvant Trastuzumab Deruxtecan (Enhertu) & Nivolumab For Patients Who Are Disease Free After Completion of Trimodality Treatment For HER-2+
Trial started· ClinicalTrials.gov
A Randomized Secondary Adjuvant Treatment Intervention Study Comparing Trastuzumab-Deruxtecan to SOC Therapy in eBC Patients With Molecular
Trial started· ClinicalTrials.gov
A Phase II Study of HLX22 in Combination With Trastuzumab Deruxtecan in HER2-low, Hormone Receptor Positive Locally Advanced or Metastatic B
Results posted· ClinicalTrials.gov
Study of Trastuzumab Deruxtecan (T-DXd) vs Investigator's Choice Chemotherapy in HER2-low, Hormone Receptor Positive, Metastatic Breast Canc
Trial registered· ClinicalTrials.gov
Study of Trastuzumab Deruxtecan, Pembrolizumab, and Platinum-based Chemotherapy in First-line HER2 Overexpressing Non-small Cell Lung Cancer
Trial started· ClinicalTrials.gov
DESTINY-Endometrial01: A Phase III Study of Trastuzumab Deruxtecan Plus Rilvegostomig or Pembrolizumab as First-Line Treatment of HER2-Expre
Trial started· ClinicalTrials.gov
Platform Trial Evaluating Treatment of Neoadjuvant Trastuzumab-deruxtecan Containing Combination Therapies for HER2+, Resectable Esophagogas
Trial started· ClinicalTrials.gov
Study of Trastuzumab Deruxtecan With Bevacizumab Versus Bevacizumab Monotherapy for First-line Maintenance in HER2-Expressing Ovarian Cancer
Trial started· ClinicalTrials.gov
Personalized Antibody-Drug Conjugate Therapy Based on RNA and Protein Testing for the Treatment of Advanced or Metastatic Solid Tumors (The
Trial started· ClinicalTrials.gov
Safety and Efficacy of HCB101 in Combination With Multiple Agents in Patients With Advanced Solid Tumors
Primary completion· ClinicalTrials.gov
Trastuzumab Deruxtecan (T-DXd) Alone or in Sequence With THP, Versus Standard Treatment (ddAC-THP), in HER2-positive Early Breast Cancer
Trial started· ClinicalTrials.gov
Castrate Resistant Prostate Cancer Enhertu Therapy
Trial started· ClinicalTrials.gov
A Phase Ⅲ Study of Rilvegostomig in Combination With Fluoropyrimidine and Trastuzumab Deruxtecan as the First-line Treatment for HER2-positi
Trial started· ClinicalTrials.gov
Study of TDXd, Chemotherapy, Pembrolizumab, and Trastuzumab in First-Line Metastatic HER2-Positive Gastric or Gastroesophageal Junction Canc
Trial started· ClinicalTrials.gov
Real-world Effectiveness and Safety of Trastuzumab Deruxtecan in Patients With Locally Advanced or Metastatic HER2-positive Gastric or Gastr
Trial registered· ClinicalTrials.gov
Real-world Effectiveness and Safety of Trastuzumab Deruxtecan in Patients With Locally Advanced or Metastatic HER2-positive Gastric or Gastr
Trial registered· ClinicalTrials.gov
A Phase II Study of HLX22 in Combination With Trastuzumab Deruxtecan in HER2-low, Hormone Receptor Positive Locally Advanced or Metastatic B
Trial started· ClinicalTrials.gov
Heterogeneity of 68Ga-FAPI Uptake As Imaging Biomarker in T-DXd Treatment for Brain Metastasis of HER2 Positive Breast Cancer
Trial registered· ClinicalTrials.gov
Study of Trastuzumab Deruxtecan With Bevacizumab Versus Bevacizumab Monotherapy for First-line Maintenance in HER2-Expressing Ovarian Cancer
Trial started· ClinicalTrials.gov
Testing the Combination of the Anticancer Drugs Trastuzumab Deruxtecan (DS-8201a) and Azenosertib (ZN-c3) in Patients With Stomach or Other
Primary completion· ClinicalTrials.gov
A Phase 1b/2 Study of T-DXd Combinations in HER2-positive Metastatic Breast Cancer
Primary completion· ClinicalTrials.gov
Efficacy of Trastuzumab Deruxtecan in Metastatic Breast Cancer with Different HER2 Expression Patterns
Trial started· ClinicalTrials.gov
Real-world Study of Trastuzumab Deruxtecan in Patients With Unresectable or Metastatic HER2-low Breast Cancer
Trial registered· ClinicalTrials.gov
Heterogeneity of 68Ga-FAPI Uptake As Imaging Biomarker in T-DXd Treatment for Brain Metastasis of HER2 Positive Breast Cancer
FDA approval (supplemental)· FDA
Sponsor: DAIICHI SANKYO. Class: Labeling.
Results posted· ClinicalTrials.gov
Trastuzumab Deruxtecan With Nivolumab in Advanced Breast and Urothelial Cancer
FDA approval (supplemental)· FDA
Sponsor: DAIICHI SANKYO. Class: Efficacy.
Trial started· ClinicalTrials.gov
Perioperative Therapies in Locally Advanced Unresectable Gastric Cancer
Trial registered· ClinicalTrials.gov
Safety and Efficacy of HCB101 in Combination With Multiple Agents in Patients With Advanced Solid Tumors
Trial registered· ClinicalTrials.gov
A Phase Ⅲ Study of Rilvegostomig in Combination With Fluoropyrimidine and Trastuzumab Deruxtecan as the First-line Treatment for HER2-positi
Trial started· ClinicalTrials.gov
Phase 4 Study to Assess the Safety of Trastuzumab Deruxtecan, in Indian Patients
2024
Trial registered· ClinicalTrials.gov
Trial of Trastuzumab Deruxtecan in Previously Treated HER2
Trial registered· ClinicalTrials.gov
Platform Trial Evaluating Treatment of Neoadjuvant Trastuzumab-deruxtecan Containing Combination Therapies for HER2+, Resectable Esophagogas
Trial registered· ClinicalTrials.gov
Study of TDXd, Chemotherapy, Pembrolizumab, and Trastuzumab in First-Line Metastatic HER2-Positive Gastric or Gastroesophageal Junction Canc
Trial registered· ClinicalTrials.gov
Real-world Study of Trastuzumab Deruxtecan in Patients With Unresectable or Metastatic HER2-low Breast Cancer
Results posted· ClinicalTrials.gov
A Single Arm Phase 2 Study to Evaluate Efficacy and Safety of Trastuzumab Deruxtecan for Patients With HER2 Mutant NSCLC
Primary completion· ClinicalTrials.gov
A Study of Novel Anti-cancer Agents in Patients With Metastatic Triple Negative Breast Cancer
Results posted· ClinicalTrials.gov
Study of T-DXd Monotherapy in Patients With HER2-expressing Locally Advanced or Metastatic Gastric or GEJ Adenocarcinoma Who Have Received 2
Primary completion· ClinicalTrials.gov
A Single Arm Phase 2 Study to Evaluate Efficacy and Safety of Trastuzumab Deruxtecan for Patients With HER2 Mutant NSCLC
Trial started· ClinicalTrials.gov
TReatment of ADC-Refractory Breast CancEr With Dato-DXd or T-DXd: TRADE DXd
Trial registered· ClinicalTrials.gov
A Randomized Secondary Adjuvant Treatment Intervention Study Comparing Trastuzumab-Deruxtecan to SOC Therapy in eBC Patients With Molecular
Trial registered· ClinicalTrials.gov
Perioperative Therapies in Locally Advanced Unresectable Gastric Cancer
Trial started· ClinicalTrials.gov
Organoid-based Functional Precision Therapy for Advanced Breast Cancer
Trial started· ClinicalTrials.gov
Trastuzumab Deruxtecan(T-DXd) and Afatinib Combination in HER2-low Advanced Gastric Cancer
Trial registered· ClinicalTrials.gov
Castrate Resistant Prostate Cancer Enhertu Therapy
Trial registered· ClinicalTrials.gov
A Randomised Trial Comparing Trastuzumab Deruxtecan to CDK4/6 Inhibitors in Non-luminal A, ER-positive/HER2-low Metastatic Breast Cancer
Primary completion· ClinicalTrials.gov
Phase II Umbrella Study of Novel Anti-cancer Agents in Participants With NSCLC Who Progressed on an Anti-PD-1/PD-L1 Containing Therapy
Trial started· ClinicalTrials.gov
EIS-12656 as Single Agent and in Combination in Patients With Specified Solid Tumors
Primary completion· ClinicalTrials.gov
T-DXd in the First-Line Treatment of Locally Advanced or Metastatic TNBC-LAR HER2-low Patients
Trial started· ClinicalTrials.gov
Sequential Therapies Modeled on Evolutionary Dynamics for Breast Cancer
Trial registered· ClinicalTrials.gov
Efficacy of Trastuzumab Deruxtecan in Metastatic Breast Cancer with Different HER2 Expression Patterns
Trial started· ClinicalTrials.gov
Phase 3 Study of T-DXd and Rilvegostomig Versus SoC in Advanced HER2-expressing Biliary Tract Cancer
Trial started· ClinicalTrials.gov
The SAPPHO Study: Sequential Therapy With Curative Intent in de Novo HER2+ Metastatic Breast Cancer
Trial registered· ClinicalTrials.gov
TReatment of ADC-Refractory Breast CancEr With Dato-DXd or T-DXd: TRADE DXd
Trial started· ClinicalTrials.gov
Anlotinib With Trastuzumab Deruxtecan for Previously Treated HER2-Low Advanced Breast Cancer
Trial registered· ClinicalTrials.gov
EIS-12656 as Single Agent and in Combination in Patients With Specified Solid Tumors
Trial started· ClinicalTrials.gov
PHESGO Maintenance After T-DXd Short Induction for HER2+ Unresectable Locally Recurrent or Metastatic Breast Cancer
Primary completion· ClinicalTrials.gov
A Study of Tucatinib Plus Trastuzumab Deruxtecan in HER2+ Breast Cancer
Trial started· ClinicalTrials.gov
Efficacy and Safety of T-DXd in HER2-mutant Advanced Lung Cancer Patients With Asymptomatic Brain Metastases
Trial registered· ClinicalTrials.gov
Safety and Efficacy of T-DXd vs. CDK4/6i-based ET as First-line Therapy of HR-positive and HER2-low/Ultralow Advanced Breast Cancer Patients
Primary completion· ClinicalTrials.gov
Real-world Effectiveness and Safety Study of T-Dxd in Chinese Metastatic Breast Cancer
Trial registered· ClinicalTrials.gov
Phase 3 Study of T-DXd and Rilvegostomig Versus SoC in Advanced HER2-expressing Biliary Tract Cancer
Primary completion· ClinicalTrials.gov
StrataPATH™ (Precision Indications for Approved Therapies)
Trial started· ClinicalTrials.gov
T-DXd Therapy for HER2-low Breast Cancer Patients With Brain Metastases
Trial registered· ClinicalTrials.gov
The SAPPHO Study: Sequential Therapy With Curative Intent in de Novo HER2+ Metastatic Breast Cancer
Trial started· ClinicalTrials.gov
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
Trial registered· ClinicalTrials.gov
Phase 4 Study to Assess the Safety of Trastuzumab Deruxtecan, in Indian Patients
Trial registered· ClinicalTrials.gov
Sequential Therapies Modeled on Evolutionary Dynamics for Breast Cancer
Trial started· ClinicalTrials.gov
Basket Study for Oligo-metastatic Breast Cancer
Trial registered· ClinicalTrials.gov
HER-TEMPO - Real World Treatment-related Outcomes on T-DXd in Canada
Trial started· ClinicalTrials.gov
HER-TEMPO - Real World Treatment-related Outcomes on T-DXd in Canada
Trial registered· ClinicalTrials.gov
Testing the Combination of the Anticancer Drugs Trastuzumab Deruxtecan (DS-8201a) and Azenosertib (ZN-c3) in Patients With Stomach or Other
Trial started· ClinicalTrials.gov
Developing ctDNA Guided Adjuvant Therapy for Gastrooesophageal Cancer
FDA approval (supplemental)· FDA
Sponsor: DAIICHI SANKYO. Class: Efficacy.
Trial registered· ClinicalTrials.gov
Anlotinib With Trastuzumab Deruxtecan for Previously Treated HER2-Low Advanced Breast Cancer
Primary completion· ClinicalTrials.gov
Trastuzumab-deruxtecan in Patients With Triple-negative Metastatic HER2-Low Breast Cancer: Real-world Experience in Brazil
Trial registered· ClinicalTrials.gov
HCQ+ADC vs ADC in the Treatment of Advanced Breast Cancer
Trial registered· ClinicalTrials.gov
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
Primary completion· ClinicalTrials.gov
Study of Trastuzumab Deruxtecan (T-DXd) vs Investigator's Choice Chemotherapy in HER2-low, Hormone Receptor Positive, Metastatic Breast Canc
Trial registered· ClinicalTrials.gov
Personalized Antibody-Drug Conjugate Therapy Based on RNA and Protein Testing for the Treatment of Advanced or Metastatic Solid Tumors (The
Trial registered· ClinicalTrials.gov
A Study of T-DXd as Monotherapy or in Combination With Anti-cancer Agents in Patients With Selected HER2-expressing Tumors
Trial started· ClinicalTrials.gov
A Study of T-DXd as Monotherapy or in Combination With Anti-cancer Agents in Patients With Selected HER2-expressing Tumors
FDA approval (supplemental)· FDA
Sponsor: DAIICHI SANKYO. Class: Efficacy.
Results posted· ClinicalTrials.gov
A Study of T-DXd for the Treatment of Solid Tumors Harboring HER2 Activating Mutations
Trial registered· ClinicalTrials.gov
Efficacy and Safety of T-DXd in HER2-mutant Advanced Lung Cancer Patients With Asymptomatic Brain Metastases
Primary completion· ClinicalTrials.gov
A Study of T-DXd in Participants With or Without Brain Metastasis Who Have Previously Treated Advanced or Metastatic HER2 Positive Breast Ca
Trial registered· ClinicalTrials.gov
Trastuzumab Deruxtecan (T-DXd) With Pyrotinib in First-line HER2-positive Unresectable or Metastatic Breast Cancer Trial
Trial started· ClinicalTrials.gov
NeoAdjuvant Therapy With Trastuzumab-deruxtecan Versus Chemotherapy+Trastuzumab+Pertuzumab in HER2+ Early Breast Cancer
Trial started· ClinicalTrials.gov
RADIomics to Predict HER2 Status And T-DXd Efficacy in Metastatic Breast Cancer: the RADIOSPHER2 Study
Trial started· ClinicalTrials.gov
Trastuzumab Deruxtecan (T-DXd) With Pyrotinib in First-line HER2-positive Unresectable or Metastatic Breast Cancer Trial
Trial registered· ClinicalTrials.gov
Trastuzumab-deruxtecan in Patients With Triple-negative Metastatic HER2-Low Breast Cancer: Real-world Experience in Brazil
Results posted· ClinicalTrials.gov
Trastuzumab Deruxtecan in Participants With HER2-mutated Metastatic Non-small Cell Lung Cancer (NSCLC)
Trial started· ClinicalTrials.gov
HCQ+ADC vs ADC in the Treatment of Advanced Breast Cancer
Trial registered· ClinicalTrials.gov
A Study to Assess the Effectiveness of Trastuzumab Deruxtecan in Chinese Breast Cancer Patients (REFRESH)
Trial started· ClinicalTrials.gov
A Study to Assess the Effectiveness of Trastuzumab Deruxtecan in Chinese Breast Cancer Patients (REFRESH)
2023
Trial started· ClinicalTrials.gov
Trastuzumab Deruxtecan (T-DXd) in Patients Who Have Hormone Receptor-negative and Hormone Receptor-positive HER2-low or HER2 IHC 0 Metastati
Trial registered· ClinicalTrials.gov
PHESGO Maintenance After T-DXd Short Induction for HER2+ Unresectable Locally Recurrent or Metastatic Breast Cancer
Trial started· ClinicalTrials.gov
A Study of Trastuzumab DeRuxtecan for Patients With Advanced HER2-pOsitive GaStric or GastroesoPhageal Junction AdEnocarcinoma Who Have Rece
Trial started· ClinicalTrials.gov
Trastuzumab-deruxtecan in Patients With Triple-negative Metastatic HER2-Low Breast Cancer: Real-world Experience in Brazil
Primary completion· ClinicalTrials.gov
EUropean Real-world Experience Of Previously Treated Advanced/Metastatic HER2-positive Breast Cancer Patients Accessing Trastuzumab Deruxtec
Trial registered· ClinicalTrials.gov
Precision Treatment of Recurrent/Metastatic Salivary Gland Carcinoma Guided by Molecular Typing
Trial started· ClinicalTrials.gov
Neoadjuvant Trastuzumab Deruxtecan (T-DXd) With Response-directed Definitive Therapy in Early Stage HER2-positive Breast Cancer (SHAMROCK St
Trial started· ClinicalTrials.gov
Trastuzumab Deruxtecan Versus Standard Neoadjuvant Treatment for HER2-positive Breast Cancer
Trial registered· ClinicalTrials.gov
Organoid-based Functional Precision Therapy for Advanced Breast Cancer
Trial started· ClinicalTrials.gov
DESTINY Breast Respond HER2-low Europe
Trial registered· ClinicalTrials.gov
Trastuzumab Deruxtecan(T-DXd) and Afatinib Combination in HER2-low Advanced Gastric Cancer
Trial registered· ClinicalTrials.gov
Trastuzumab Deruxtecan (T-DXd) for People With Brain Cancer
Trial started· ClinicalTrials.gov
Trastuzumab Deruxtecan in First-line HER2-positive Locally Advanced/MBC Patients Resistant to Trastuzumab+Pertuzumab
Primary completion· ClinicalTrials.gov
A Single Arm Phase 2 Study to Evaluate Efficacy and Safety of Trastuzumab Deruxtecan for Patients With HER2 Mutant NSCLC
Trial started· ClinicalTrials.gov
Trastuzumab Deruxtecan (T-DXd) for People With Brain Cancer
Trial registered· ClinicalTrials.gov
T-DXd Therapy for HER2-low Breast Cancer Patients With Brain Metastases
Trial started· ClinicalTrials.gov
T-DXd in the First-Line Treatment of Locally Advanced or Metastatic TNBC-LAR HER2-low Patients
Primary completion· ClinicalTrials.gov
A Phase 1b Study of T-DXd Combinations in HER2-low Advanced or Metastatic Breast Cancer
Trial started· ClinicalTrials.gov
Precision Treatment of Recurrent/Metastatic Salivary Gland Carcinoma Guided by Molecular Typing
Trial registered· ClinicalTrials.gov
A Study of Trastuzumab DeRuxtecan for Patients With Advanced HER2-pOsitive GaStric or GastroesoPhageal Junction AdEnocarcinoma Who Have Rece
Trial registered· ClinicalTrials.gov
Basket Study for Oligo-metastatic Breast Cancer
Sources
FDA approvals, label revisions, and recalls come from the public openFDA APIs (Drugs@FDA, Drug Label, Drug Enforcement). Drug-safety communications come from the FDA RSS feed. Trial milestones come from ClinicalTrials.gov via the AACT pg dump. Pivotal-publication events come from PubMed, filtered to high-impact journals linked to a Phase 3 trial in our inventory.