Enhertu (fam-trastuzumab deruxtecan-nxki) / Daiichi Sankyo, AstraZeneca  >>  Phase 2
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Trial + Data / EventsStatusPhNRegionInterventionsSponsorConditionsPrimary complStudy compl
Enhertu (fam-trastuzumab deruxtecan-nxki) / Daiichi Sankyo, AstraZeneca
DESTINY-Breast01, NCT03248492 / 2016-004986-18: A Study of DS-8201a in Metastatic Breast Cancer Previously Treated With Trastuzumab Emtansine (T-DM1)

Checkmark Updated OS data from P2 DESTINY-Breast01 trial for HER2 positive metastatic breast cancer at ESMO
Jul 2021 - Jul 2021: Updated OS data from P2 DESTINY-Breast01 trial for HER2 positive metastatic breast cancer at ESMO
Checkmark Updated data from DESTINY-Breast01 trial for HER2 + breast cancer at SABCS 2020
Dec 2020 - Dec 2020: Updated data from DESTINY-Breast01 trial for HER2 + breast cancer at SABCS 2020
Checkmark Data from DESTINY-Breast01 trial for 2L HER2 positive metastatic breast cancer at SABCS 2020
More
Active, not recruiting
2
253
Europe, Canada, Japan, US, RoW
DS-8201a, Experimental product
Daiichi Sankyo, Inc., AstraZeneca, Daiichi Sankyo Co., Ltd.
Breast Cancer
03/19
05/24
2018-004868-57: Phase 2, Open label Study of DS-8201a, an Anti-HER2-AntIbody Drug Conjugate (ADC) for advanced BreaSt Cancer patients, with biomarkers analysis to characterize response/resistance to therapY

Not yet recruiting
2
162
Europe
DS-8201a, Powder for solution for infusion
UNICANCER, Daiichi Sankyo Europe GmbH
Adult patients with advanced breast cancer after at least a first line of chemotherapy in metastatic setting: -if HER2 IHC3+ or IHC2+/ISH+ resistant to trastuzumab and TDM-1 -if HER2 IHC0+ or IHC1+ or IHC2+/ISH- HR+ resistant to endocrine therapy., -, Diseases [C] - Cancer [C04]
 
 
2019-001739-29: Breast cancer patiens with brain metastasi Pacientes con cáncer de mama con metástasis cerebral.

Not yet recruiting
2
39
Europe
DS-8201a, Powder for injection
Medica Scientia Innovation Research S.L. (MEDSIR), Daiichi Sankyo Europe GmbH
Pretreated, unresectable locally advanced or metastatic HumanEpidermal Growth Factor Receptor 2 (HER2)-positive or HER2-lowexpressing breast cancer (BC) with untreated or treated brainmetastases (BMs) or leptomeningeal carcinomatosis (LMC). Cáncer de mama (CM) pretratado, localmente avanzado e irresecableo metastásico con receptor del factor de crecimiento epidérmicohumano 2 (HER2) positivo o baja expresión de HER2 con metástasiscerebrales (MC) no tratadas o tratadas o carcinomatosisleptomeníngea (CLM)., Breast cancer locally advanced and / or brain metastatic. Cáncer de mama localmente avanzado y con metástasis cerebral., Diseases [C] - Cancer [C04]
 
 
2020-002368-30: A study to investigate anti-tumor activity and safety of trastuzumab deruxtecan in patients with solid tumors carrying specific HER2 mutations.

Not yet recruiting
2
100
Europe
Trastuzumab Deruxtecan, DS-8201a, Powder for concentrate for solution for infusion
AstraZeneca AB, ASTRAZENECA AB, AstraZeneca AB
Treatment of unresectable and/or metastatic solid tumors harboring specific HER2 activating mutations regardless of tumor histology., Patients with advanced solid tumors carrying specific HER2 mutations., Diseases [C] - Cancer [C04]
 
 
DESTINY-Lung01, NCT03505710 / 2017-004781-94: DS-8201a in Human Epidermal Growth Factor Receptor 2 (HER2)-Expressing or -Mutated Non-Small Cell Lung Cancer

Hourglass Oct 2023 - Mar 2024 : H2 FY'23 - Approval in EU for HER2 mutant 2L NSCLC (based on DESTINY-Lung01 trial)
Checkmark Presentation of data from DESTINY-Lung01 trial for metastatic NSCLC at ESMO 2022
Sep 2022 - Sep 2022: Presentation of data from DESTINY-Lung01 trial for metastatic NSCLC at ESMO 2022
Checkmark From DESTINY-Lung01 trial for NSCLC
Sep 2021 - Sep 2021: From DESTINY-Lung01 trial for NSCLC
More
Completed
2
181
Europe, Japan, US
Trastuzumab deruxtecan, DS-8201a, Experimental product
Daiichi Sankyo, Daiichi Sankyo Co., Ltd., AstraZeneca
Non-Small Cell Lung Cancer
05/21
04/24
DAISY, NCT04132960: Study of DS-8201a, an Antibody Drug Conjugate for Advanced Breast Cancer Patients, With Biomarkers Analysis

Active, not recruiting
2
186
Europe
DS-8201a
UNICANCER, Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company
Breast Tumors
10/21
04/25
DESTINY-Gastric02, NCT04014075 / 2019-001512-34: DS-8201a in HER2-positive Gastric Cancer That Cannot Be Surgically Removed or Has Spread

Checkmark Follow-up data from P2 DESTINY-Gastric02 study in locally advanced or metastatic HER2+ve gastric or gastroesophageal junction adenocarcinoma at ESMO 2022
Sep 2022 - Sep 2022: Follow-up data from P2 DESTINY-Gastric02 study in locally advanced or metastatic HER2+ve gastric or gastroesophageal junction adenocarcinoma at ESMO 2022
Checkmark From DESTINY-Gastric02 trial for gastric cancer at ESMO 2021
Sep 2021 - Sep 2021: From DESTINY-Gastric02 trial for gastric cancer at ESMO 2021
Checkmark Presentation of data from DESTINY-Gastric02 trial for HER2-positive gastric cancer at ESMO 2021
More
Completed
2
79
Europe, US
Trastuzumab deruxtecan, DS-8201a
Daiichi Sankyo, AstraZeneca
Adenocarcinoma Gastric Stage IV With Metastases, Adenocarcinoma - GEJ
11/21
02/24
2021-001246-36: A clinical research study to test different doses of a study drug (ARX788), to see which dose is safest and its effectiveness(shrinks tumor size) in patients with advanced cancer. Estudio de investigación clínica para probar diferentes dosis del fármaco del estudio (ARX788), para ver qué dosis es la más segura y su efectividad (redución tamaño del tumor) en pacientes con cáncer avanzado.

Not yet recruiting
2
210
Europe
ARX788, ARX788, Solution for infusion
Ambrx, Inc., Ambrx, Inc.
Metastatic Breast Cancer Resistant or Refractory Cáncer de mama metastásico resistente o refractario, Advanced Cancer that is metastasic Cáncer avanzado metastásico, Diseases [C] - Cancer [C04]
 
 
DESTINY-CRC02, NCT04744831 / 2020-004782-39: Trastuzumab Deruxtecan in Participants With HER2-overexpressing Advanced or Metastatic Colorectal Cancer

Hourglass Jan 2022 - Dec 2023 : Acceptance of regulatory submission in US for HR +ve/ HER2-low, metastatic breast cancer (based on DESTINY-Breast06 trial)
Hourglass Feb 2023 - Mar 2023 : Data from DESTINY-CRC02 trial for advanced or metastatic colorectal cancer
Active, not recruiting
2
122
Europe, Japan, US, RoW
DS-8201a 5.4 mg/kg Q3W, T-DXd, DS-8201a 6.4 mg/kg Q3W
Daiichi Sankyo, AstraZeneca
Advanced Colorectal Cancer
11/22
07/24
DESTINY-LUNG02, NCT04644237 / 2020-003427-42: Trastuzumab Deruxtecan in Participants With HER2-mutated Metastatic Non-small Cell Lung Cancer (NSCLC)

Hourglass Feb 2023 - Jun 2023 : Data from DESTINY-Lung02 trial for HER2-mutated, unresectable and/or metastatic NSCLC
Hourglass Sep 2022 - Dec 2022 : Approval for treatment of metastatic HER2 +ve breast cancer and metastatic gastric cancer
Checkmark Interim analysis data from DESTINY-Lung02 trial for HER2-mutated, unresectable and/or metastatic NSCLC
Sep 2022 - Sep 2022: Interim analysis data from DESTINY-Lung02 trial for HER2-mutated, unresectable and/or metastatic NSCLC
Checkmark Presentation of data from DESTINY-Lung02 trial for HER2-mutated, unresectable and/or metastatic NSCLC at ESMO 2022
More
Active, not recruiting
2
152
Europe, Canada, Japan, US, RoW
Trastuzumab deruxtecan
Daiichi Sankyo, AstraZeneca
Non-Small Cell Lung Cancer
12/22
08/24
DESTINY-PanTumor01, NCT04639219: A Study of T-DXd for the Treatment of Solid Tumors Harboring HER2 Activating Mutations

Hourglass Feb 2023 - Jun 2023 : Data from DESTINY-PT01 trial for metastatic solid tumors
Active, not recruiting
2
102
Europe, Canada, Japan, US, RoW
Trastuzumab deruxtecan, DS-8201a (T-DXd)
AstraZeneca, Daiichi Sankyo Co., Ltd.
Advanced Solid Tumors With HER2 Mutation,eg:Colorectal,Urothelial,Gastric, Hepatobiliary,Endometrial,Melanoma,Ovarian,Cervical,Salivary Gland,Pancreatic,Breast
01/23
07/26
TUXEDO-1, NCT04752059 / 2020-000981-41: Phase II Study of T-DX in HER2-positive Breast Cancer Brain Metastases

Checkmark Data from TUXEDO-1 trial for HER2-positive breast cancer brain metastases at ESMO-BC 2022
May 2022 - May 2022: Data from TUXEDO-1 trial for HER2-positive breast cancer brain metastases at ESMO-BC 2022
Completed
2
15
Europe
Trastuzumab deruxtecan, Ds8201a, Enhertu
Medical University of Vienna, Daiichi Sankyo, Inc.
Breast Cancer Stage IV
05/23
05/23
2022-003865-39: Treatment of HER2+ early breast cancer with either trastuzumab-deruxtecan or standard-of-care treatment (chemotherapy + antibodies) Behandlung von frühem, HER2-positiven Brustkrebs mit Trastuzumab-Deruxtecan im Vergleich zu Standardtherapie (Chemotherapie + Antikörper)

Not yet recruiting
2
402
Europe
Trastuzumab-Deruxtecan (T-DXd), Paclitaxel, Docetaxel, Carboplatin, Trastuzumab, Phesgo, Pertuzumab, DS-8201a, Powder for concentrate for solution for infusion, Concentrate for solution for injection/infusion, Solution for injection, Enhertu
Westdeutsche Studiengruppe GmbH, AstraZeneca
HER2+ early breast cancer HER2+ früher Brustkrebs, Breast Cancer Brustkrebs, Diseases [C] - Cancer [C04]
 
 
DESTINY-PanTumor02, NCT04482309 / 2020-001574-29: A Phase 2 Study of T-DXd in Patients With Selected HER2 Expressing Tumors

Calendar Jan 2024 - Dec 2024: Acceptance of regulatory submission for breast cancer (based on DESTINY-Breast11 trial)
Jul 2023 - Dec 2023: Data from DESTINY-PT02 trial for solid tumors
Checkmark Data from DESTINY-PanTumor02 trial for HER2 Expressing Solid Tumors at ESMO 2021
Jul 2021 - Jul 2021: Data from DESTINY-PanTumor02 trial for HER2 Expressing Solid Tumors at ESMO 2021
Recruiting
2
468
Europe, Canada, Japan, US, RoW
Trastuzumab deruxtecan, DS-8201a, T-DXd
AstraZeneca, Daiichi Sankyo Co., Ltd.
Part 1: Bladder, Biliary Tract, Cervical, Endometrial, Ovarian, Pancreatic Cancer, Rare Tumors, Any Tumor Type Excluding Breast, Gastric, Colorectal Cancer, Part 2: HER2 Expressing/Amplified Solid Tumors Excluding Breast, Gastric, Colorectal Cancer
07/27
07/27
DESTINY-Gastric06, NCT04989816: Study of T-DXd Monotherapy in Patients With HER2-expressing Locally Advanced or Metastatic Gastric or GEJ Adenocarcinoma Who Have Received 2 or More Prior Regimens

Hourglass Jul 2023 - Dec 2023 : Data from DESTINY-Gastric06 trial for metastatic gastric or gastroesophageal junction adenocarcinoma
Completed
2
95
RoW
Trastuzumab Deruxtecan, DS8201a; AZD4552; T-DXd
AstraZeneca, Daiichi Sankyo Co., Ltd.
Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma
06/23
02/24
DESTINY-Lung05, NCT05246514: A Single Arm Phase 2 Study to Evaluate Efficacy and Safety of Trastuzumab Deruxtecan for Patients With HER2 Mutant NSCLC

Active, not recruiting
2
72
RoW
Trastuzumab deruxtecan, T-DXd, DS-8201a
AstraZeneca, Daiichi Sankyo
HER2-mutant Non-Small Cell Lung Cancer
09/23
06/24
HER2CLIMB-04, NCT04539938: A Study of Tucatinib Plus Trastuzumab Deruxtecan in HER2+ Breast Cancer

Active, not recruiting
2
70
US
tucatinib, TUKYSA, ARRY-380, ONT-380, trastuzumab deruxtecan, T-DXd, Enhertu, DS-8201
Seagen Inc.
HER2 Positive Breast Cancer
07/24
10/25
ELPIS, NCT06250777: Efficacy and Safety of T-DXd in HER2-mutant Advanced Lung Cancer Patients With Asymptomatic Brain Metastases

Not yet recruiting
2
27
RoW
Trastuzumab deruxtecan
Yonsei University
Non Small Cell Lung Cancer
01/26
04/26
NCT06271837: A Study of T-DXd in Patients With Selected HER2-overexpressing Tumors

Recruiting
2
50
RoW
Trastuzumab deruxtecan, DS-8201a, T-DXd
AstraZeneca, Daiichi Sankyo Co., Ltd.
Advanced Solid Tumors (Excluding Gastric Cancer and Breast Cancer)
10/25
04/26
TRINITY, NCT06253650: Adjuvant TRastuzumab Deruxtecan for HER2-positive Gastroesophageal Cancer With Persistence of miNImal Residual Disease

Recruiting
2
46
Europe
Experimental, Control
Gruppo Oncologico del Nord-Ovest
Gastric Cancer, HER2-positive Gastric Cancer
03/27
03/28
EPOC2003, NCT05034887: Phase 2 Study of T-DXd in the Neoadjuvant Treatment for Patients With HER2 Positive Gastric and GEJ Adenocarcinoma

Recruiting
2
37
Japan
Trastuzumab Deruxtecan (T-DXd), DS-8201a
National Cancer Center Hospital East, Daiichi Sankyo Co., Ltd.
Gastric Adenocarcinoma, Gastroesophageal Junction Adenocarcinoma
03/24
03/25
DEMETHER, NCT06172127: PHESGO Maintenance After T-DXd Short Induction for HER2+ Unresectable Locally Recurrent or Metastatic Breast Cancer

Not yet recruiting
2
165
NA
Trastuzumab deruxtecan, T-DXd, Phesgo 1,200 MG / 600 MG / 30,000 UNT Per 15 ML Injection, PHESGO, Pertuzumab-Trastuzumab FDC SC, Phesgo 600 MG / 600 MG / 20,000 UNT in 10 mL Injection
MedSIR, Hoffmann-La Roche
HER2-positive Breast Cancer
11/26
05/29
SERIES, NCT06263543: Sequencing Antibody Drug Conjugates in ER+/HER2 LOW MBC

Recruiting
2
75
US
Sacituzumab govitecan, Trodelvy
Reshma L. Mahtani, D.O., Gilead Sciences
Breast Cancer, Metastatic Breast Cancer, Advanced Breast Cancer, Hormone-receptor-positive Breast Cancer, Human Epidermal Growth Factor 2 Low Breast Cancer
06/26
12/26
NCT04986579: Scalp Cooling in MBC

Recruiting
2
120
US
Paxman Scalp Cooling System, Scalp Cooling Cap, Eribulin, Halaven, Sacituzumab govitecan, Trodelvy, IMMU-132, Trastuzumab deruxtecan, Enhertu, DS-8201a
Dana-Farber Cancer Institute, Paxman Coolers Limited, AstraZeneca, Eisai Inc., Daiichi Sankyo, Gilead Sciences
Metastatic Breast Cancer, Chemotherapy-induced Alopecia
06/26
06/28
NCT06088056: A Phase II Study of T-DXd Plus SRT in HER2-positive Breast Cancer Brain Metastases

Not yet recruiting
2
17
RoW
Combination use of SRT with T-DXd
Fudan University
Breast Cancer, Brain Metastases, Radiotherapy
06/24
07/26
NCT06311214: Personalized Antibody-Drug Conjugate Therapy Based on RNA and Protein Testing for the Treatment of Advanced or Metastatic Solid Tumors (The ADC MATCH Screening and Treatment Trial)

Not yet recruiting
2
500
NA
Biopsy, BIOPSY_TYPE, Bx, Biospecimen Collection, Biological Sample Collection, Biospecimen Collected, Specimen Collection, Computed Tomography, CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography, Computerized axial tomography (procedure), Computerized Tomography, Computerized Tomography (CT) scan, CT, CT Scan, tomography, Echocardiography, EC, Electronic Health Record Review, Enfortumab Vedotin, AGS 22ME, AGS-22M6E, Anti-Nectin 4 ADC ASG-22CE, Anti-nectin-4 Monoclonal Antibody-Drug Conjugate AGS-22M6E, ASG-22CE, Enfortumab Vedotin-ejfv, Padcev, Immunohistochemistry Staining Method, Cell/Tissue, Immunohistochemistry, IHC, Immunohistochemistry, Immunohistochemistry (IHC), Magnetic Resonance Imaging, Magnetic Resonance, Magnetic Resonance Imaging (MRI), Magnetic resonance imaging (procedure), Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MR, MR Imaging, MRI, MRI Scan, MRIs, NMR Imaging, NMRI, Nuclear Magnetic Resonance Imaging, sMRI, Structural MRI, Multigated Acquisition Scan, Blood Pool Scan, Equilibrium Radionuclide Angiography, Gated Blood Pool Imaging, Gated Heart Pool Scan, MUGA, MUGA Scan, Multi-Gated Acquisition Scan, Radionuclide Ventriculogram Scan, Radionuclide Ventriculography, RNVG, SYMA Scanning, Synchronized Multigated Acquisition Scanning, Sacituzumab Govitecan, hRS7-SN38 Antibody Drug Conjugate, IMMU-132, RS7-SN38, Sacituzumab Govitecan-hziy, Trodelvy, Trastuzumab Deruxtecan, DS-8201, DS-8201a, Enhertu, Fam-trastuzumab Deruxtecan-nxki, T-DXd, WHO 10516
National Cancer Institute (NCI)
Advanced Malignant Solid Neoplasm, Metastatic Malignant Solid Neoplasm
10/24
10/24
NCT05953168: T-DXd in the First-Line Treatment of Locally Advanced or Metastatic TNBC-LAR HER2-low Patients

Not yet recruiting
2
69
RoW
Trastuzumab Deruxtecan
Fudan University
Triple-Negative Breast Cancer
08/24
08/26
HUDSON, NCT03334617 / 2017-002208-28: Phase II Umbrella Study of Novel Anti-cancer Agents in Patients With NSCLC Who Progressed on an Anti-PD-1/PD-L1 Containing Therapy

Calendar Jan 2024 - Dec 2024: Data from HUDSON trial for NSCLC
Active, not recruiting
2
531
Europe, Canada, US, RoW
Durvalumab, AZD9150, AZD6738, Vistusertib, Olaparib, Oleclumab, trastuzumab deruxtecan, cediranib, AZD6738 (ceralasertib), AZD6738 (ceralasertib) (240 mg or 160 mg), AZD6738 (ceralasertib) 7 days monotherapy
AstraZeneca
Non-Small Cell Lung Cancer
09/24
09/24
NCT06439693: The SAPPHO Study: A Single-Arm, Phase II Study of Sequential Therapy With Curative Intent in de Novo HER2+ Metastatic Breast Cancer

Not yet recruiting
2
72
US
Nab-Paclitaxel, Abraxane, ABI-007, Albumin-bound paclitaxel, Paclitaxel, Taxol, Docetaxel, Taxotere, Phesgo, pertuzumab plus trastuzumab plus hyaluronidase-zzxf, RG6264, RO7198574, T-DM1, ado-trastuzumab emtansine, Kadcyla, Pertuzumab, Trastuzumab Deruxtecan, Enhertu, fam-trastuzumab deruxtecan-nxki, T-DXd, DS-8201a, Trastuzumab Subcutaneous Subcutaneous, Herceptin Hylecta, Trastuzumab and hyaluronidase-oysk, Tucatinib, Trastuzumab
Dana-Farber Cancer Institute, Translational Breast Cancer Research Consortium, Johns Hopkins University
Breast Cancer Female, Breast Cancer, Breast Cancer Metastatic, Estrogen Receptor-positive Breast Cancer, HER2-positive Breast Cancer, Stage IV Breast Cancer
03/30
03/33
BBI-20231001, NCT05954143: Trial of BDC-1001 +/- Pertuzumab in Subjects With HER2-Positive Metastatic Breast Cancer

Active, not recruiting
2
66
Europe, US
BDC-1001, Pertuzumab, Perjeta®
Bolt Biotherapeutics, Inc., Hoffmann-La Roche
Metastatic Breast Cancer, HER2-positive Breast Cancer
12/24
03/25
NCT05480384: Adjuvant Trastuzumab Deruxtecan (Enhertu) & Nivolumab For Patients Who Are Disease Free After Completion of Trimodality Treatment For HER-2+ Cancers of Esophagus & Gastroesophageal Junction

Recruiting
2
25
US
Nivolumab, OPDIVO, Trastuzumab deruxtecan, ENHERTU
Brown University, AstraZeneca
Esophageal Adenocarcinoma, Esophageal Cancer, HER-2 Protein Overexpression, Gastroesophageal-junction Cancer
01/25
01/27
UNICORN, NCT05845450: Pre-operative Targeted Treatments in Molecularly Selected Resectable Colorectal Cancer

Recruiting
2
112
Europe
Trastuzumab deruxtecan, Durvalumab, Panitumumab, Botensilimab, Balstilimab, Sotorasib
Gruppo Oncologico del Nord-Ovest
Colorectal Cancer, Resectable Colorectal Carcinoma
05/25
05/28
DECIPHER, NCT05965479: Developing ctDNA Guided Adjuvant Therapy for Gastrooesophageal Cancer

Recruiting
2
25
Europe
Trastuzumab deruxtecan, Enhertu
University of Southampton, AstraZeneca, Natera, Inc.
Gastrooesophageal Cancer
03/26
04/28
TUXEDO-4, NCT06048718: T-DXd Therapy for HER2-low Breast Cancer Patients With Brain Metastases

Recruiting
2
27
Europe
Trastuzumab-Deruxtecan (T-DXd), DS-8021a, ENHERTU
MedSIR, Daiichi Sankyo
Breast Cancer, Metastatic Breast Cancer
09/25
07/26
DESTINY-Gastric03, NCT04379596: Ph1b/2 Study of the Safety and Efficacy of T-DXd Combinations in Advanced HER2-expressing Gastric Cancer

Jul 2023 - Dec 2023: Data from DESTINY-Gastric03 trial for gastric cancer
Checkmark Presentation of data from DESTINY-Gastric03 study in HER2-overexpressing gastric cancer at ESMO 2020
Jul 2020 - Jul 2020: Presentation of data from DESTINY-Gastric03 study in HER2-overexpressing gastric cancer at ESMO 2020
Recruiting
2
413
Europe, Canada, Japan, US, RoW
Fluorouracil (5-FU), Capecitabine, Durvalumab, MEDI4736, Oxaliplatin, Trastuzumab, Trastuzumab deruxtecan, DS-8201a, Cisplatin, Pembrolizumab, Volrustomig, MEDI5752, Rilvegostomig, AZD2936
AstraZeneca, Daiichi Sankyo Company, Limited 3-5-1 Nihonbashihoncho, Chuo-ku, Tokyo
Gastric Cancer
07/26
07/26
TRIO-US B-12 TALENT, NCT04553770: Trastuzumab Deruxtecan Alone or in Combination With Anastrozole for the Treatment of Early Stage HER2 Low, Hormone Receptor Positive Breast Cancer

Checkmark Presentation of data from TALENT trial for HER2 Low, HR+ breast cancer at SABCS 2022
Dec 2022 - Dec 2022: Presentation of data from TALENT trial for HER2 Low, HR+ breast cancer at SABCS 2022
Recruiting
2
88
US
Anastrozole, Anastrazole, Arimidex, ICI D1033, ICI-D1033, ZD-1033, Therapeutic Conventional Surgery, Trastuzumab Deruxtecan, DS-8201, DS-8201a, Enhertu, Fam-trastuzumab Deruxtecan-nxki, WHO 10516
Jonsson Comprehensive Cancer Center, Translational Research in Oncology-U.S, Daiichi Sankyo Co., Ltd.
Early-stage Breast Cancer, Hormone Receptor Positive Breast Carcinoma, Invasive Breast Cancer, Stage II Breast Cancer, Stage IIA Breast Cancer, Stage IIB Breast Cancer, Stage III Breast Cancer
09/25
09/25
SHAMROCK, NCT05710666 / 2022-002485-32: Neoadjuvant Trastuzumab Deruxtecan (T-DXd) With Response-directed Definitive Therapy in Early Stage HER2-positive Breast Cancer ( Study)

Recruiting
2
80
Europe
trastuzumab deruxtecan (T-DXd) (IV)
Cancer Trials Ireland, AstraZeneca Pharmaceuticals, Breast Cancer Ireland
HER2-positive Breast Cancer
09/25
03/28
ARIADNE, NCT05900206: Trastuzumab Deruxtecan Versus Standard Neoadjuvant Treatment for HER2-positive Breast Cancer

Recruiting
2
370
Europe
Trastuzumab deruxtecan, T-DXd, Enhertu, Docetaxel, Paclitaxel, Carboplatin, Trastuzumab, Herceptin, Pertuzumab, PErjeta, Ribociclib, Kisqali, Letrozole, Epirubicin, Cyclophosphamide
Karolinska University Hospital
Breast Cancer
04/27
04/32
ADAPTHER2-IV, NCT05704829: NeoAdjuvant Therapy With Trastuzumab-deruxtecan Versus Chemotherapy+Trastuzumab+Pertuzumab in HER2+ Early Breast Cancer

Not yet recruiting
2
402
Europe
Trastuzumab deruxtecan, ENHERTU, Standard-of-Care, Chemotherapy+T+P
West German Study Group, AstraZeneca
HER2-positive Early Breast Cancer
06/26
06/28
Strata PATH, NCT05097599: ™ (Precision Indications for Approved Therapies)

Active, not recruiting
2
700
US
lorlatinib, encorafenib + binimetinib, talazoparib, sacituzumab govitecan, axitinib
Strata Oncology, Merck Sharp & Dohme LLC, Pfizer, Gilead Sciences
Cancer, Advanced Solid Tumor
11/26
11/29
NCT06100874: A Single-arm Phase II Trial of SAcituzumab Govitecan and Trastuzumab for HER2+ Metastatic Breast Cancer After Trastuzumab dEruxtEcaN (SATEEN)

Recruiting
2
40
US
Sacituzumab Govitecan, Trodelvy, Trastuzumab, Herceptin, Trastuzumab and Hyaluronidase-oysk, Herceptin Hylecta
Adrienne G. Waks, Gilead Sciences
Her 2 Positive Breast Cancer, Breast Cancer Female, Breast Cancer Metastatic
11/26
11/27
ORIENTA, NCT06102824: Organoid-based Functional Precision Therapy for Advanced Breast Cancer

Recruiting
2
252
RoW
Organoid-guided treatment, Taxane, Abraxane, Lipusu, Capecitabine, Xeloda, Gemcitabine, Gemzar, Vinorelbine, Navelbine, Eribulin, Halaven, Anthracycline, Doxil, Lipodox, Carboplatin, Paraplatin, Utidelone, UTD1, Trastuzumab deruxtecan, Enhertu, Sacituzumab govitecan, Trodelvy
Guangdong Provincial People's Hospital, First Affiliated Hospital, Sun Yat-Sen University, Sun Yat-sen University, Shantou Central Hospital
HER2-negative Breast Cancer, Advanced Breast Cancer
06/27
06/28
TRANSCENDER, NCT05744375: Trastuzumab Deruxtecan in First-line HER2-positive Locally Advanced/MBC Patients Resistant to Trastuzumab+Pertuzumab

Recruiting
2
41
Europe
Trastuzumab deruxtecan, Enhertu
Spanish Breast Cancer Research Group, AstraZeneca
Locally Advanced Breast Cancer, Metastatic Breast Cancer
07/27
03/29
NCT06058988: Trastuzumab Deruxtecan (T-DXd) for People With Brain Cancer

Recruiting
2
30
US
Trastuzumab deruxtecan, T-DXd
Memorial Sloan Kettering Cancer Center, AstraZeneca
Brain Cancer, Glioblastoma, Metastatic Cancer, Leptomeningeal Metastasis, Recurrent Glioblastoma
09/27
09/27
ANISE, NCT05982678: Basket Study for Oligo-metastatic Breast Cancer

Recruiting
2
72
Europe
Trastuzumab deruxtecan
The Netherlands Cancer Institute, Daiichi Sankyo, AstraZeneca
HER2-positive Breast Cancer
10/27
10/34
TRUDI, NCT05795101: TDXD+Durva in HER2+/Low IBC

Recruiting
2
63
US
Trastuzumab deruxtecan, Enhertu, Durvalumab
Filipa Lynce, MD, AstraZeneca, Daiichi Sankyo, Inc.
Invasive Breast Cancer, Inflammatory Breast Cancer Stage III, HER2-positive Breast Cancer, HER2 Low Breast Adenocarcinoma, Breast Cancer
12/27
12/32
2018-000764-29: A Phase IB/II Study to determine efficacy and safety of Durvalumab + Paclitaxel and Durvalumab in Combination with Novel Oncology Therapies with or without Paclitaxel for First-line Metastatic Triple Negative Breast Cancer

Not yet recruiting
1/2
320
Europe
durvalumab, Oleclumab, Capivasertib, Trastuzumab Deruxtecan, MEDI4736, MEDI9447, AZD5363, DS-8201a, Concentrate for solution for infusion, Tablet, Powder for concentrate for solution for infusion
AstraZeneca AB, AstraZeneca
First-line (1L) Stage IV Triple Negative Breast Cancer (TNBC) - the subtype of breast cancer characterized by a lack of tumor expression of estrogen receptor, progesterone receptor, and human epidermal growth factor receptor 2., Treatment of first line (1L) metastatic triple negative breast cancer (TNBC)., Diseases [C] - Cancer [C04]
 
 
2019-004483-22: A study of Trastuzumab Deruxtecan to assess its safety, tolerability, immune response, and inhibition of tumor activity when given alone or in combination with other agents in patients with HER2- expressing Gastric Cancer

Not yet recruiting
1/2
357
Europe
Trastuzumab Deruxtecan, Durvalumab, Capecitabine, 5-Fluorouracil, Oxaliplatin, Trastuzumab, Cisplatin, Pembrolizumab, Volrustomig, DS-8201a, MEDI4736, MEDI5752, Powder for concentrate for solution for infusion, Concentrate for solution for infusion, Film-coated tablet, Solution for infusion, Keytruda 25 mg/mL concentrate for solution for infusion
AstraZeneca AB, ASTRAZENECA AB, AstraZenecaAB, AstraZeneca AB
Patients with Human Epidermal Growth Factor Receptor 2 (HER2)-expressing gastric, GEJ and esophageal cancer, Patients with HER2-expressing gastric, GEJ and esophageal cancer, Diseases [C] - Cancer [C04]
 
 
NCT06328387: HCQ+ADC vs ADC in the Treatment of Advanced Breast Cancer

Recruiting
1/2
120
RoW
Hydroxychloroquine, Plaquenil, Sacituzumab Govitecan, IMMU-132, Trodelvy™, GS-0132, Trastuzumab Deruxtecan, DS-8201, Enhertu
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Advanced Breast Cancer, Metastatic Breast Cancer
02/26
03/26
ICARUSBREAST02, NCT06298084: Dose-Expansion Modular Study To Explore the Safety, Tolerability, and Anti-tumor Activity of HER3- DXd Monotherapy and Combinations in Patients With Inoperable Advanced Breast Cancer (ABC) After Progression on T-DXd

Recruiting
1/2
152
Europe
Patritumab deruxtecan, U3-1402, HER3-DXd, Olaparib, Lynparza
Gustave Roussy, Cancer Campus, Grand Paris, Daiichi Sankyo
Breast Cancer Metastatic, HER2-positive Metastatic Breast Cancer, HER2 Low Breast Carcinoma, Advanced Breast Cancer
09/27
06/29
NCT06324357: 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

Recruiting
1/2
240
US
Zongertinib, BI 1810631, Trastuzumab deruxtecan, T-DXd; Enhertu®, Trastuzumab emtansine, T-DM1; Kadcyla®
Boehringer Ingelheim
Metastatic Breast Cancer, Metastatic Gastric Adenocarcinoma, Gastroesophageal Junction Adenocarcinoma, Esophageal Adenocarcinoma
02/27
08/28
BEGONIA, NCT03742102: A Study of Novel Anti-cancer Agents in Patients With Metastatic Triple Negative Breast Cancer

Checkmark Data from arm-6 of BEGONIA trial in combination with durvalumab for locally advanced or metastatic stage IV TNBC at SABCS 2022
Dec 2022 - Dec 2022: Data from arm-6 of BEGONIA trial in combination with durvalumab for locally advanced or metastatic stage IV TNBC at SABCS 2022
Checkmark Data from arm-7 of BEGONIA trial in combination with durvalumab for TNBC at SABCS 2022
Dec 2022 - Dec 2022: Data from arm-7 of BEGONIA trial in combination with durvalumab for TNBC at SABCS 2022
Checkmark Presentation of results from P1b/2 BEGONIA trial for metastatic TNBC at SABCS 2022
More
Recruiting
1/2
240
Europe, Canada, US, RoW
Durvalumab, MEDI4736, Capivasertib, AZD5363, Oleclumab, MEDI9447, Paclitaxel, Trastuzumab deruxtecan, DS-8201a, Datopotamab deruxtecan, Dato-DXd; DS-1062a
AstraZeneca
Triple Negative Breast Neoplasms
11/24
11/24
CERTIS1, NCT05417594 / 2021-006227-17: Study of AZD9574 as Monotherapy and in Combination With Anti-cancer Agents in Participants With Advanced Solid Malignancies

Recruiting
1/2
490
Europe, US, RoW
AZD9574, Temozolomide, [11C]AZ1419 3391, Datopotamab Deruxtecan (Dato-DXd), Trastuzumab Deruxtecan (T-DXd)
AstraZeneca
Advanced Solid Malignancies
01/26
01/26
DESTINY-Breast07, NCT04538742 / 2019-004531-22: A Phase 1b/2 Study of T-DXd Combinations in HER2-positive Metastatic Breast Cancer

Checkmark Preliminary efficacy and additional safety follow-up results from DESTINY-Breast07 trial for HER2 +ve breast cancer at SABCS 2022
Dec 2022 - Dec 2022: Preliminary efficacy and additional safety follow-up results from DESTINY-Breast07 trial for HER2 +ve breast cancer at SABCS 2022
Checkmark Initial efficacy/safety data from P1b/2 DESTINY-Breast07 trial in combination with pertuzumab for HER2-positive metastatic breast cancer at ASCO 2022
Jun 2022 - Jun 2022: Initial efficacy/safety data from P1b/2 DESTINY-Breast07 trial in combination with pertuzumab for HER2-positive metastatic breast cancer at ASCO 2022
Active, not recruiting
1/2
245
Europe, Canada, US, RoW
Trastuzumab deruxtecan, DS-8201a, T-DXd, Durvalumab, MEDI4736, Paclitaxel, Pertuzumab, Tucatinib, ONT-380
AstraZeneca, Daiichi Sankyo Company, Limited
Metastatic Breast Cancer
01/25
01/25
NCT05894824: An Open Label, Single-arm, Multicenter Phase Ib/II Study to Evaluate the Safety and Efficacy of T-Dxd in Combination With Ramucirumab as a 2nd Line in Patients With HER2 Low Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma

Not yet recruiting
1/2
46
NA
T-Dxd(Trastuzmab deruxtecan), Ramucirumab
Yonsei University
Gastric Cancer, Gastroesophageal Junction (GEJ) Cancer
05/25
01/26
NCT06085755: Trastuzumab Deruxtecan(T-DXd) and Afatinib Combination in HER2-low Advanced Gastric Cancer

Not yet recruiting
1/2
61
NA
Trastuzumab deruxtecan, T-DXd, Afatinib, Giotrif
Jeeyun Lee
Stomach Neoplasm
12/25
12/26
Morpheus-TNBC, NCT03424005 / 2017-002038-21: A Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Patients With Metastatic or Locally Advanced Breast Cancer

Recruiting
1/2
242
Europe, US, RoW
Capecitabine, Atezolizumab, Ipatasertib, SGN-LIV1A, Bevacizumab, Chemotherapy (Gemcitabine + Carboplatin or Eribulin), Selicrelumab, Tocilizumab, Nab-Paclitaxel, Sacituzumab Govitecan, Abemaciclib, Fulvestrant, Ribociclib, Inavolisib, GDC-0077, RO7113755, Inavolisib (9 mg), Inavolisib (6 mg), Trastuzumab Deruxtecan
Hoffmann-La Roche, Seagen Inc., Gilead Sciences
Breast Cancer
05/26
05/26
PETRA, NCT04644068: Study of AZD5305 as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Malignancies

Calendar Jan 2024 - Dec 2024: Data from PETRA trial for advanced solid malignancies
Recruiting
1/2
804
Europe, Canada, Japan, US, RoW
AZD5305, Paclitaxel, Carboplatin, T- Dxd, Dato-DXd, Camizestrant
AstraZeneca
Ovarian Cancer, Breast Cancer, Pancreatic Cancer, Prostate Cancer, Additional Indications Below for Module 4 and 5, Non-small Cell Lung Cancer, Colorectal Cancer, Bladder Cancer, Gastric Cancer, Biliary Cancer, Cervical Cancer, Endometrial Cancer, Small Cell Lung Cancer Only in Module 5
12/26
12/26

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