^
    Contact us  to learn more about
    our Premium Content:  News alerts, weekly reports and conference planners
    BIOMARKER:

    HER-2 overexpression

    i
    Entrez ID:
    2064
    Related biomarkers:
    Expression
    Mutation
    CNA
    Fusion
    Others
    Related tests:
    Apply
    QUILT-3.057: NANT Neoadjuvant Triple- Negative Breast Cancer (TNBC) Vaccine (NCT03554109)
    Phase 2
    ImmunityBio, Inc.
    Withdrawn
    Last update posted :
    02/21/2025
    Initiation :
    09/01/2018
    Primary completion :
    06/01/2020
    Completion :
    02/09/2022
    HER-2 • ER • PGR
    |
    HER-2 overexpression • HER-2 amplification
    |
    5-fluorouracil • Bavencio (avelumab) • albumin-bound paclitaxel • cyclophosphamide • leucovorin calcium • Anktiva (nogapendekin alfa inbakicept-pmln) • ETBX-011 • ETBX-051 • ETBX-061 • GI-4000 • GI-6207 • GI-6301 • NK92-CD16-158V • aldoxorubicin (INNO-206)
    Study of Palliative Radiation Combined with Pembrolizumab in Unresectable Metastatic Stage IV Breast Cancer (NCT04990921)
    Phase 2
    University of Louisville
    Recruiting
    Last update posted :
    02/20/2025
    Initiation :
    09/02/2021
    Primary completion :
    07/01/2031
    Completion :
    07/01/2031
    HER-2 • ER
    |
    HER-2 overexpression
    |
    Keytruda (pembrolizumab)
    Heated Intraperitoneal Chemotherapy and Gastrectomy for Gastric Cancer With Positive Peritoneal Cytology (NCT03092518)
    Phase 2
    National Cancer Institute (NCI)
    Completed
    Last update posted :
    02/19/2025
    Initiation :
    06/05/2017
    Primary completion :
    04/05/2024
    Completion :
    07/24/2024
    HER-2
    |
    HER-2 overexpression
    |
    cisplatin • mitomycin • Jelmyto (mitomycin urothelial gel)
    Phase I Trial of Afatinib and Trastuzumab in HER2 Overexpressing Cancer. (NCT01649271)
    Phase 1
    Boehringer Ingelheim
    Completed
    Last update posted :
    02/11/2025
    Initiation :
    07/23/2012
    Primary completion :
    06/23/2016
    Completion :
    06/23/2016
    HER-2
    |
    HER-2 overexpression
    |
    Herceptin (trastuzumab) • Gilotrif (afatinib)
    PLATFORM Study of Precision Medicine for Rare Tumors (NCT04423185)
    Phase 2
    Cancer Institute and Hospital, Chinese Academy ...
    Recruiting
    Last update posted :
    02/11/2025
    Initiation :
    08/15/2020
    Primary completion :
    07/01/2026
    Completion :
    07/01/2028
    EGFR • HER-2 • BRAF • ALK • MET • BRCA1 • BRCA2 • KIT • ROS1 • CDKN2A
    |
    BRCA2 mutation • BRCA1 mutation • EGFR mutation • HER-2 overexpression • BRAF mutation • HER-2 amplification • MET amplification • KIT mutation • ALK fusion • ROS1 fusion • CDKN2A mutation • MET mutation • BRAF amplification
    |
    Xalkori (crizotinib) • Tecentriq (atezolizumab) • Ibrance (palbociclib) • Zelboraf (vemurafenib) • imatinib • Tyvyt (sintilimab) • Alecensa (alectinib) • Zejula (niraparib) • Irene (pyrotinib) • Ameile (aumolertinib) • Vizimpro (dacomitinib)
    Beamion LUNG-1: A Study to Test Different Doses of Zongertinib in People With Different Types of Advanced Cancer (Solid Tumours With Changes in the HER2 Gene) (BEAMION-Lung 1) (NCT04886804)
    Phase 1
    Boehringer Ingelheim
    Recruiting
    Last update posted :
    02/10/2025
    Initiation :
    07/02/2021
    Primary completion :
    03/31/2026
    Completion :
    01/28/2028
    NRG1
    |
    EGFR mutation • HER-2 overexpression • HER-2 amplification • HER-2 mutation
    |
    zongertinib (BI 1810631)
    Vaccine Therapy With Sargramostim (GM-CSF) in Treating Patients With Her-2 Positive Stage III-IV Breast Cancer or Ovarian Cancer (NCT00436254)
    Phase 1
    University of Washington
    Active, not recruiting
    Last update posted :
    02/06/2025
    Initiation :
    10/01/2001
    Primary completion :
    03/01/2010
    Completion :
    04/01/2025
    HER-2 • MUC16
    |
    HER-2 overexpression • HER-2 amplification
    |
    AST-301 • Leukine (sargramostim)
    Tucatinib Plus Trastuzumab and Oxaliplatin-based Chemotherapy or Pembrolizumab-containing Combinations for HER2+ Gastrointestinal Cancers (SGNTUC 024) (NCT04430738)
    Phase 1/2
    Seagen Inc.
    Active, not recruiting
    Last update posted :
    02/06/2025
    Initiation :
    09/15/2020
    Primary completion :
    07/31/2024
    Completion :
    10/31/2025
    HER-2
    |
    HER-2 overexpression • HER-2 amplification
    |
    Keytruda (pembrolizumab) • Herceptin (trastuzumab) • 5-fluorouracil • capecitabine • oxaliplatin • Tukysa (tucatinib) • leucovorin calcium
    A Study of Liposomal Doxorubicin+Docetaxel+Trastuzumab+Metformin in Operable and Locally Advanced HER2 Positive Breast Cancer (met-HEReMYTA) (NCT02488564)
    Phase 2
    Istituto Scientifico Romagnolo per lo Studio e ...
    Completed
    Last update posted :
    02/03/2025
    Initiation :
    12/17/2014
    Primary completion :
    10/01/2018
    Completion :
    03/17/2020
    HER-2
    |
    HER-2 overexpression
    |
    Herceptin (trastuzumab) • docetaxel • metformin • Myocet (non-pegylated liposomal doxorubicin) • doxorubicin liposomal
    Intraperitoneal and Intravenous Paclitaxel Chemotherapy With Oral Capecitabine for Gastric Adenocarcinoma With Peritoneal Carcinomatosis (NCT04034251)
    Phase 2
    National Cancer Institute (NCI)
    Completed
    Last update posted :
    02/03/2025
    Initiation :
    06/09/2020
    Primary completion :
    02/25/2023
    Completion :
    09/05/2024
    HER-2
    |
    HER-2 overexpression
    |
    paclitaxel • capecitabine
    Spevatamig (PT886) for Treatment of Patients with Metastatic/Advanced Gastric, Gastroesophageal Junction and Pancreatic Adenocarcinoma (the TWINPEAK Study) (NCT05482893)
    Phase 1/2
    Phanes Therapeutics
    Recruiting
    Last update posted :
    01/31/2025
    Initiation :
    03/15/2023
    Primary completion :
    12/01/2027
    Completion :
    04/01/2028
    CLDN18
    |
    HER-2 overexpression
    |
    Keytruda (pembrolizumab) • gemcitabine • 5-fluorouracil • capecitabine • albumin-bound paclitaxel • oxaliplatin • irinotecan • leucovorin calcium • spevatamig (PT886)
    Detection of Tumor DNA in the Blood of Patients Receiving Standard Therapy for Hormone Receptor-positive (HR+) Non-HER2 Expressing (HER2-) Metastatic Breast Cancer as a Tool to Select Those Who May Benefit From the Next Course of Fulvestrant in Combination With Alpelisib or Ribociclib (SAFIR 03) (NCT05625087)
    Phase 2
    UNICANCER
    Recruiting
    Last update posted :
    01/30/2025
    Initiation :
    10/19/2023
    Primary completion :
    07/01/2028
    Completion :
    06/01/2030
    HER-2 • ER • PIK3CA • PGR
    |
    HR positive • HER-2 overexpression • HER-2 negative • PIK3CA mutation • HER-2 overexpression + HR positive
    |
    Piqray (alpelisib) • Kisqali (ribociclib) • fulvestrant • triptorelin
    Stereotactic Radiation & Abemaciclib in the Management of HR+/HER2- Breast Cancer Brain Metastases (MCC-20899) (NCT04923542)
    Phase 1/2
    H. Lee Moffitt Cancer Center and Research Insti...
    Recruiting
    Last update posted :
    01/29/2025
    Initiation :
    11/30/2021
    Primary completion :
    03/01/2025
    Completion :
    03/01/2026
    HER-2 • ER • PGR
    |
    HER-2 overexpression • HER-2 negative
    |
    Verzenio (abemaciclib) • fulvestrant
    Safety and Efficacy of Trastuzumab BS (NCT04181333)
    Phase N/A
    Pfizer
    Active, not recruiting
    Last update posted :
    01/28/2025
    Initiation :
    08/09/2023
    Primary completion :
    02/14/2025
    Completion :
    02/14/2025
    HER-2
    |
    HER-2 overexpression
    |
    Herceptin (trastuzumab) • Trazimera (trastuzumab-qyyp)
    Clinical Trial of Atezolizumab With Paclitaxel, Trastuzumab, and Pertuzumab in Patients With Metastatic HER-2 Positive Breast Cancer (NCT03125928)
    Phase 2
    Fox Chase Cancer Center
    Active, not recruiting
    Last update posted :
    01/10/2025
    Initiation :
    06/13/2017
    Primary completion :
    12/01/2025
    Completion :
    12/01/2025
    HER-2
    |
    HER-2 overexpression • HER-2 amplification
    |
    Herceptin (trastuzumab) • Tecentriq (atezolizumab) • paclitaxel • Perjeta (pertuzumab)
    Efficacy and Safety of the Proposed Biosimilar Pertuzumab (PERT-IJS) Versus EU-Perjeta® Along With Trastuzumab and Chemotherapy (Carboplatin and Docetaxel) as Neoadjuvant Treatment in Chemotherapy naïve Patients With Early Stage or Locally Advanced HR Negative and HER2 Positive Breast Cancer (NCT06038539)
    Phase 3
    Biocon Biologics UK Ltd
    Not yet recruiting
    Last update posted :
    12/17/2024
    Initiation :
    01/31/2025
    Primary completion :
    03/15/2026
    Completion :
    11/15/2026
    HER-2 • ER • PGR
    |
    HER-2 overexpression • ER negative
    |
    carboplatin • docetaxel • Perjeta (pertuzumab)
    Adjuvant Trastuzumab Deruxtecan (Enhertu) & Nivolumab For Patients Who Are Disease Free After Completion of Trimodality Treatment For HER-2+ Cancers of Esophagus & Gastroesophageal Junction (NCT05480384)
    Phase 2
    Brown University
    Recruiting
    Last update posted :
    11/25/2024
    Initiation :
    07/14/2023
    Primary completion :
    01/01/2025
    Completion :
    01/01/2027
    HER-2
    |
    HER-2 overexpression • HER-2 amplification
    |
    Opdivo (nivolumab) • Enhertu (fam-trastuzumab deruxtecan-nxki)
    Trastuzumab Deruxtecan in Participants With HER2-overexpressing Advanced or Metastatic Colorectal Cancer (DESTINY-CRC02) (NCT04744831)
    Phase 2
    Daiichi Sankyo
    Completed
    Last update posted :
    11/19/2024
    Initiation :
    03/05/2021
    Primary completion :
    11/01/2022
    Completion :
    10/08/2024
    EGFR • HER-2 • BRAF • TMB • MSI
    |
    MSI-H/dMMR • HER-2 overexpression • BRAF wild-type • RAS wild-type • HER-2 positive + RAS wild-type
    |
    Enhertu (fam-trastuzumab deruxtecan-nxki)
    Developing ctDNA Guided Adjuvant Therapy for Gastrooesophageal Cancer (DECIPHER) (NCT05965479)
    Phase 2
    University of Southampton
    Recruiting
    Last update posted :
    11/11/2024
    Initiation :
    04/10/2024
    Primary completion :
    03/31/2026
    Completion :
    04/30/2028
    HER-2
    |
    HER-2 overexpression
    |
    Enhertu (fam-trastuzumab deruxtecan-nxki)
    A First in Human Study of BAY2701439 to Look at Safety, How the Body Absorbs, Distributes and Excretes the Drug, and How Well the Drug Works in Participants With Advanced Cancer Expressing the HER2 Protein (NCT04147819)
    Phase 1
    Bayer
    Completed
    Last update posted :
    09/27/2024
    Initiation :
    07/02/2020
    Primary completion :
    08/21/2023
    Completion :
    09/26/2023
    HER-2
    |
    HER-2 overexpression • HER-2 amplification • HER-2 mutation • HER-2 underexpression
    |
    BAY2701439 • BAY2701438
    My Pathway: A Study Evaluating Herceptin/Perjeta, Tarceva, Zelboraf/Cotellic, Erivedge, Alecensa, and Tecentriq Treatment Targeted Against Certain Molecular Alterations in Participants With Advanced Solid Tumors (NCT02091141)
    Phase 2
    Genentech, Inc.
    Completed
    Last update posted :
    07/23/2024
    Initiation :
    04/14/2014
    Primary completion :
    05/24/2023
    Completion :
    05/24/2023
    EGFR • HER-2 • BRAF • ALK • TMB • PTCH1 • SMO
    |
    EGFR mutation • HER-2 overexpression • BRAF mutation • HER-2 amplification • BRAF V600 • ALK rearrangement • ALK mutation • SMO mutation
    |
    Herceptin (trastuzumab) • Tecentriq (atezolizumab) • erlotinib • Zelboraf (vemurafenib) • Alecensa (alectinib) • Perjeta (pertuzumab) • Cotellic (cobimetinib) • Erivedge (vismodegib)
    A Study to Evaluate Safety, Efficacy, Pharmacokinetics, and Immunogenicity of Test Pertuzumab (ZRC-3277, Cadila Healthcare Ltd.,) (NCT05283837)
    Phase 3
    Zydus Lifesciences Limited
    Completed
    Last update posted :
    07/18/2024
    Initiation :
    09/26/2022
    Primary completion :
    09/06/2023
    Completion :
    09/06/2023
    HER-2 • ER • PGR
    |
    HER-2 positive • HER-2 overexpression • HER-2 amplification • ER positive + PGR positive • PGR positive
    |
    docetaxel • Perjeta (pertuzumab)
    A Study on Adding Precisely Targeted Radiation Therapy (Stereotactic Body Radiation Therapy) to the Usual Treatment Approach (Drug Therapy) in People With Breast Cancer (NCT05534438)
    Phase 2
    Memorial Sloan Kettering Cancer Center
    Recruiting
    Last update posted :
    07/09/2024
    Initiation :
    09/06/2022
    Primary completion :
    09/06/2025
    Completion :
    09/06/2025
    HER-2 • ER
    |
    HER-2 overexpression • HER-2 expression
    Atezolizumab + Pertuzumab + Trastuzumab In CNS Mets In BC (NCT03417544)
    Phase 2
    Nancy Lin, MD
    Active, not recruiting
    Last update posted :
    07/04/2024
    Initiation :
    05/21/2018
    Primary completion :
    05/20/2020
    Completion :
    12/01/2025
    HER-2
    |
    HER-2 positive • HER-2 overexpression • HER-2 amplification
    |
    Herceptin (trastuzumab) • Tecentriq (atezolizumab) • Perjeta (pertuzumab)
    Vaccine Therapy in Treating Patients With Stage IV HLA-A2 and HER2 Positive Breast or Ovarian Cancer Receiving Trastuzumab (NCT00194714)
    Phase 1/2
    University of Washington
    Completed
    Last update posted :
    06/06/2024
    Initiation :
    05/01/2016
    Primary completion :
    03/31/2021
    Completion :
    05/22/2023
    HER-2 • IFNG
    |
    HER-2 overexpression • HER-2 amplification • HER-2 expression • HLA-A2 positive
    |
    Herceptin (trastuzumab) • HER-2/neu peptide vaccine
    Testing the Safety and Tolerability of the Anti-cancer Drugs Trastuzumab Deruxtecan and Neratinib for Cancers With Changes in the HER2 Gene (NCI-2022-04099) (NCT05372614)
    Phase 1
    National Cancer Institute (NCI)
    Recruiting
    Last update posted :
    06/05/2024
    Initiation :
    10/05/2022
    Primary completion :
    06/17/2024
    Completion :
    06/17/2024
    HER-2 • CD4 • CASP3
    |
    HER-2 positive • HER-2 overexpression • HER-2 amplification • HER-2 mutation • HER-2 L755S • HER-2 A775_G776insYVMA • HER-2 S310F • HER-2 V777L • HER-2 G778_P780dup • HER-2 D769Y • HER-2 L869R • HER-2 V842I • HER-2 H878Y • HER-2 L866M • HER-2 A775 • HER-2 G309A • HER-2 P780-Y781insGSP • HER-2 R678Q • HER-2 R896C • HER-2 T862A • HER-2 YVMA
    |
    Nerlynx (neratinib) • Enhertu (fam-trastuzumab deruxtecan-nxki)
    Adoptive T Cell Therapy Following HER2-Pulsed Dendritic Cell Vaccine & Pepinemab /Trastuzumab in Patients w/ Metastatic HER2+ Breast Cancer (NCT05378464)
    Phase 1
    H. Lee Moffitt Cancer Center and Research Insti...
    Recruiting
    Last update posted :
    06/05/2024
    Initiation :
    05/31/2022
    Primary completion :
    07/01/2024
    Completion :
    07/01/2026
    HER-2 • PGR • CD4
    |
    HER-2 positive • HER-2 overexpression • HER-2 amplification • ER positive + PGR positive • PGR positive
    |
    Herceptin (trastuzumab) • Trazimera (trastuzumab-qyyp) • pepinemab (VX15)
    Xenogeneic HER2/Neu DNA Immunization for Patients With Metastatic and High Risk Breast Cancer: A Phase I Study to Assess Safety and Immunogenicity (NCT00393783)
    Phase 1
    Memorial Sloan Kettering Cancer Center
    Active, not recruiting
    Last update posted :
    06/05/2024
    Initiation :
    05/01/2006
    Primary completion :
    05/01/2025
    Completion :
    05/01/2025
    HER-2
    |
    HER-2 overexpression
    |
    Herceptin (trastuzumab)
    A Prospective Study of Breast Cancer Patients With Abnormal Strain Imaging (NCT02993198)
    Phase 2
    Northwestern University
    Active, not recruiting
    Last update posted :
    06/03/2024
    Initiation :
    04/01/2015
    Primary completion :
    12/01/2025
    Completion :
    12/01/2025
    HER-2 • PGR
    |
    HER-2 overexpression
    |
    Herceptin (trastuzumab) • Perjeta (pertuzumab)
    A Study of Anti-PD-L1 Checkpoint Antibody (LY3300054) Alone and in Combination in Participants With Advanced Refractory Solid Tumors (NCT02791334)
    Phase 1
    Eli Lilly and Company
    Active, not recruiting
    Last update posted :
    05/31/2024
    Initiation :
    06/29/2016
    Primary completion :
    05/22/2020
    Completion :
    07/01/2024
    HER-2 • ER • PGR • MSI
    |
    MSI-H/dMMR • HER-2 overexpression • HER-2 negative
    |
    Verzenio (abemaciclib) • Cyramza (ramucirumab) • merestinib (LY2801653) • lodapolimab (LY3300054) • LY3321367
    "neoBREASTIM": Atezolizumab Plus RP1 Oncolytic Immunotherapy in the NeoAdjuvant Setting of Triple-Negative Breast Cancer (NCT06067061)
    Phase 1/2
    Institut Curie
    Recruiting
    Last update posted :
    05/30/2024
    Initiation :
    04/05/2024
    Primary completion :
    04/05/2026
    Completion :
    04/05/2031
    HER-2
    |
    HER-2 overexpression
    |
    Tecentriq (atezolizumab) • vusolimogene oderparepvec (RP1)
    To Evaluate the Safety and Tolerability of JSKN003 in Chinese Subjects With Advanced Solid Tumors (JSKN003-102) (NCT05744427)
    Phase 1/2
    Jiangsu Alphamab Biopharmaceuticals Co., Ltd
    Recruiting
    Last update posted :
    05/29/2024
    Initiation :
    03/15/2023
    Primary completion :
    12/31/2024
    Completion :
    12/31/2025
    HER-2
    |
    HER-2 positive • HER-2 overexpression • HER-2 amplification • HER-2 expression
    |
    JSKN003
    Clinical Trial of SOT102 Antibody Drug Conjugate in Patients With Advanced Gastric and Pancreatic Adenocarcinoma (CLAUDIO-01) (NCT05525286)
    Phase 1/2
    SOTIO Biotech a.s.
    Recruiting
    Last update posted :
    05/27/2024
    Initiation :
    03/31/2022
    Primary completion :
    12/01/2027
    Completion :
    06/01/2028
    CLDN18
    |
    HER-2 overexpression • HER-2 negative • CLDN18.2 expression
    |
    SOT102
    HER2 Expression Detection and Radionuclide Therapy in Breast Cancer Using 99mTc/188Re Labeled Single Domain Antibody (NCT04674722)
    Phase 1
    Shanghai General Hospital, Shanghai Jiao Tong U...
    Recruiting
    Last update posted :
    05/17/2024
    Initiation :
    08/24/2020
    Primary completion :
    03/08/2024
    Completion :
    09/30/2024
    HER-2
    |
    HER-2 overexpression • HER-2 expression
    Study of ORIC-114 in Patients With Advanced Solid Tumors Harboring an EGFR or HER2 Alteration (ORIC-114-01) (NCT05315700)
    Phase 1/2
    ORIC Pharmaceuticals
    Recruiting
    Last update posted :
    05/10/2024
    Initiation :
    03/10/2022
    Primary completion :
    03/01/2025
    Completion :
    03/01/2026
    EGFR • HER-2
    |
    EGFR mutation • HER-2 overexpression • HER-2 amplification • EGFR exon 20 insertion • HER-2 exon 20 insertion • EGFR exon 20 mutation • HER-2 exon 23 mutation
    |
    carboplatin • pemetrexed • ORIC-114
    GDC-0084 in Combination With Trastuzumab for Patients With HER2-Positive Breast Cancer Brain Metastases (NCT03765983)
    Phase 2
    Dana-Farber Cancer Institute
    Recruiting
    Last update posted :
    05/07/2024
    Initiation :
    02/11/2019
    Primary completion :
    11/30/2024
    Completion :
    11/30/2025
    HER-2 • EIF4EBP1
    |
    HER-2 positive • HER-2 overexpression • HER-2 amplification
    |
    Herceptin (trastuzumab) • paxalisib (GDC-0084)
    First-in-human Trial of PhOx430, a First-in-class Acetylglucosaminyltransferase V Inhibitor, in Advanced Solid Tumours (PhAST) (NCT05495295)
    Phase 1
    Phost'In Therapeutics
    Recruiting
    Last update posted :
    05/06/2024
    Initiation :
    07/18/2022
    Primary completion :
    07/08/2024
    Completion :
    07/31/2027
    HER-2 • ER • PGR
    |
    HER-2 overexpression • HER-2 negative
    |
    PhOx430
    Neratinib In Combination With Chemotherapy/Trastuzumab/Pembrolizumab In HER2 Gastroesophageal Cancer (NCT06109467)
    Phase 2
    H. Lee Moffitt Cancer Center and Research Insti...
    Recruiting
    Last update posted :
    05/03/2024
    Initiation :
    01/12/2024
    Primary completion :
    04/01/2028
    Completion :
    04/01/2028
    HER-2
    |
    HER-2 overexpression • HER-2 amplification
    |
    Keytruda (pembrolizumab) • Herceptin (trastuzumab) • 5-fluorouracil • Nerlynx (neratinib) • oxaliplatin • leucovorin calcium
    Study of the Monoclonal Antibody IMT-009 in Patients With Advanced Solid Tumors or Lymphomas (NCT05565417)
    Phase 1/2
    Immunitas Therapeutics
    Recruiting
    Last update posted :
    05/03/2024
    Initiation :
    11/28/2022
    Primary completion :
    04/01/2025
    Completion :
    04/01/2025
    KRAS • BRAF • ALK • PIK3CA • MET • MSI
    |
    BRAF V600E • KRAS mutation • HR positive • MSI-H/dMMR • HER-2 overexpression • PIK3CA mutation
    |
    Fruzaqla (fruquintinib) • IMT-009
    A Study of Tucatinib Given Before Surgery to People With HER2+ Cancers That Have Spread to the Brain (NCT05892068)
    Phase 2
    Memorial Sloan Kettering Cancer Center
    Recruiting
    Last update posted :
    04/30/2024
    Initiation :
    05/09/2023
    Primary completion :
    05/09/2028
    Completion :
    05/09/2028
    HER-2
    |
    HER-2 overexpression • HER-2 amplification
    |
    Tukysa (tucatinib)