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

    HER2 inhibitor

    Related drugs:
    Apply
    Testing the Addition of Trastuzumab or Trastuzumab/Pertuzumab to the Usual Chemotherapy for HER2 Positive Endometrial Cancer (NRG-GY026) (NCT05256225)
    Phase 2/3
    National Cancer Institute (NCI)
    Recruiting
    Last update posted :
    02/24/2025
    Initiation :
    11/16/2022
    Primary completion :
    10/31/2027
    Completion :
    10/31/2027
    HER-2 • TP53
    |
    HER-2 positive • HER-2 amplification
    |
    Herceptin (trastuzumab) • carboplatin • paclitaxel • Perjeta (pertuzumab) • Phesgo (pertuzumab/trastuzumab/hyaluronidase-zzxf)
    Trastuzumab + Alpelisib +/- Fulvestrant vs Trastuzumab + CT in Patients With PIK3CA Mutated Previously Treated HER2+ Advanced BrEasT Cancer (ALPHABET) (NCT05063786)
    Phase 3
    Spanish Breast Cancer Research Group
    Active, not recruiting
    Last update posted :
    02/24/2025
    Initiation :
    09/14/2021
    Primary completion :
    06/01/2025
    Completion :
    06/01/2025
    HER-2 • ER • PIK3CA • PGR
    |
    ER positive • PIK3CA mutation
    |
    Herceptin (trastuzumab) • capecitabine • Piqray (alpelisib) • fulvestrant • Halaven (eribulin mesylate) • vinorelbine tartrate • Navelbine oral (vinorelbine tartrate oral)
    A Study of Tucatinib With Trastuzumab and mFOLFOX6 Versus Standard of Care Treatment in First-line HER2+ Metastatic Colorectal Cancer (MOUNTAINEER-03) (NCT05253651)
    Phase 3
    Seagen Inc.
    Recruiting
    Last update posted :
    02/21/2025
    Initiation :
    10/24/2022
    Primary completion :
    04/03/2026
    Completion :
    07/27/2029
    HER-2
    |
    RAS wild-type
    |
    Avastin (bevacizumab) • Herceptin (trastuzumab) • Erbitux (cetuximab) • 5-fluorouracil • oxaliplatin • Tukysa (tucatinib) • leucovorin calcium • levoleucovorin calcium
    Neratinib + Valproate in Advanced Solid Tumors, w/Expansion Cohort in Ras-Mutated Ca (NCT03919292)
    Phase 1/2
    Virginia Commonwealth University
    Recruiting
    Last update posted :
    02/21/2025
    Initiation :
    05/01/2019
    Primary completion :
    05/31/2025
    Completion :
    05/31/2026
    EGFR
    |
    EGFR mutation • RAS mutation
    |
    Nerlynx (neratinib)
    Trial of Pre-operative Neratinib and Endocrine Therapy with Trastuzumab in ER-Positive, HER-2 Positive Breast Cancers (NCT04886531)
    Phase 2
    Ruth O'Regan
    Recruiting
    Last update posted :
    02/21/2025
    Initiation :
    07/21/2022
    Primary completion :
    09/01/2025
    Completion :
    10/01/2025
    HER-2
    |
    HER-2 positive
    |
    Herceptin (trastuzumab) • Nerlynx (neratinib) • letrozole • anastrozole
    A Study of Tucatinib (MK-7119) in Combination With Trastuzumab and Capecitabine in Participants With Previously Treated Locally Advanced Unresectable or Metastatic Human Epidermal Growth Factor Receptor 2 Positive (HER2+) Breast Carcinoma (MK-7119-001) (NCT04721977)
    Phase 2
    Pfizer
    Active, not recruiting
    Last update posted :
    02/20/2025
    Initiation :
    04/08/2021
    Primary completion :
    07/17/2023
    Completion :
    11/25/2025
    HER-2
    |
    Herceptin (trastuzumab) • capecitabine • Tukysa (tucatinib) • Herceptin Hylecta (trastuzumab/hyaluronidase-oysk)
    SPH5030 Tablets in Subjects With Advanced Her2-positive Solid Tumors (NCT05245058)
    Phase 1
    Shanghai Pharmaceuticals Holding Co., Ltd
    Recruiting
    Last update posted :
    02/20/2025
    Initiation :
    01/21/2022
    Primary completion :
    12/21/2025
    Completion :
    12/21/2025
    HER-2
    |
    HER-2 positive
    |
    SPH5030
    A Study of Tucatinib Plus Trastuzumab Deruxtecan in HER2+ Breast Cancer (HER2CLIMB-04) (NCT04539938)
    Phase 2
    Seagen, a wholly owned subsidiary of Pfizer
    Active, not recruiting
    Last update posted :
    02/19/2025
    Initiation :
    12/01/2020
    Primary completion :
    07/15/2024
    Completion :
    07/01/2025
    HER-2
    |
    Enhertu (fam-trastuzumab deruxtecan-nxki) • Tukysa (tucatinib)
    Primary Tumor Resection With EGFR TKI for Stage IV NSCLC (NCT05215548)
    Phase 2
    National Taiwan University Hospital
    Active, not recruiting
    Last update posted :
    02/19/2025
    Initiation :
    09/27/2021
    Primary completion :
    10/01/2026
    Completion :
    10/01/2027
    EGFR
    |
    EGFR mutation • EGFR L858R • EGFR exon 19 deletion
    |
    Gilotrif (afatinib)
    Afatinib in NSCLC With HER2 Mutation (NCT02597946)
    Phase 2
    Boehringer Ingelheim
    Completed
    Last update posted :
    02/19/2025
    Initiation :
    03/18/2016
    Primary completion :
    07/22/2018
    Completion :
    07/22/2018
    HER-2 • KIT
    |
    HER-2 mutation
    |
    Gilotrif (afatinib) • paclitaxel
    A Study of Zanidatamab in Combination With Chemotherapy Plus or Minus Tislelizumab in Patients With HER2-positive Advanced or Metastatic Gastric and Esophageal Cancers (HERIZON-GEA-01) (NCT05152147)
    Phase 3
    Jazz Pharmaceuticals
    Recruiting
    Last update posted :
    02/19/2025
    Initiation :
    12/02/2021
    Primary completion :
    05/15/2025
    Completion :
    05/15/2026
    HER-2
    |
    HER-2 positive • HER-2 expression
    |
    Herceptin (trastuzumab) • cisplatin • 5-fluorouracil • Tevimbra (tislelizumab-jsgr) • capecitabine • oxaliplatin • Ziihera (zanidatamab-hrii)
    Positron Emission Tomography in Women With Advanced HER2-Positive Breast Cancer (NCT01093612)
    Phase N/A
    City of Hope Medical Center
    Active, not recruiting
    Last update posted :
    02/18/2025
    Initiation :
    03/16/2011
    Primary completion :
    10/23/2018
    Completion :
    08/26/2025
    HER-2
    |
    HER-2 negative
    |
    Herceptin (trastuzumab)
    Copper Cu 64-DOTA-Trastuzumab PET in Predicting Response to Treatment With Ado-Trastuzumab Emtansine in Patients With Metastatic HER2 Positive Breast Cancer (NCT02226276)
    Phase N/A
    City of Hope Medical Center
    Active, not recruiting
    Last update posted :
    02/18/2025
    Initiation :
    01/07/2015
    Primary completion :
    12/07/2021
    Completion :
    10/30/2025
    HER-2
    |
    HER-2 positive • HER-2 positive + HER-2 overexpression
    |
    Herceptin (trastuzumab) • Kadcyla (ado-trastuzumab emtansine)
    An Investigational Scan (64Cu-DOTA-Trastuzumab PET/MRI) in Imaging Patients With HER2+ Breast Cancer With Brain Metastasis (NCT05376878)
    Phase 4
    City of Hope Medical Center
    Recruiting
    Last update posted :
    02/18/2025
    Initiation :
    12/21/2022
    Primary completion :
    02/25/2026
    Completion :
    02/25/2026
    HER-2
    |
    HER-2 positive
    |
    Herceptin (trastuzumab) • Enhertu (fam-trastuzumab deruxtecan-nxki) • Trazimera (trastuzumab-qyyp)
    A Study to Evaluate Patient Preference for Home Administration of Fixed-Dose Combination of Pertuzumab and Trastuzumab for Subcutaneous Administration in Participants with Early or Locally Advanced/Inflammatory HER2-Positive Breast Cancer (ProHer) (NCT05415215)
    Phase 3
    Hoffmann-La Roche
    Active, not recruiting
    Last update posted :
    02/17/2025
    Initiation :
    07/05/2022
    Primary completion :
    11/20/2024
    Completion :
    12/31/2025
    HER-2
    |
    HER-2 amplification • EGFR positive
    |
    Herceptin (trastuzumab) • carboplatin • paclitaxel • docetaxel • Perjeta (pertuzumab) • Kadcyla (ado-trastuzumab emtansine) • doxorubicin hydrochloride • cyclophosphamide • Phesgo (pertuzumab/trastuzumab/hyaluronidase-zzxf)
    Neoadjuvant Endocrine Therapy +/- the PI3K Inhibitor Inavolisib in HER2+, HR+, PIK3CA Mutant Early Breast Cancer (GeparPiPPa) (NCT05306041)
    Phase 2
    German Breast Group
    Recruiting
    Last update posted :
    02/17/2025
    Initiation :
    01/02/2023
    Primary completion :
    10/01/2026
    Completion :
    01/01/2027
    HER-2 • PIK3CA • PGR
    |
    HER-2 positive • PIK3CA mutation • PGR positive
    |
    Herceptin (trastuzumab) • tamoxifen • Perjeta (pertuzumab) • Itovebi (inavolisib) • Phesgo (pertuzumab/trastuzumab/hyaluronidase-zzxf)
    A Study to Evaluate the Efficacy and Safety of Inavolisib in Combination With Phesgo Versus Placebo in Combination With Phesgo in Participants With PIK3CA-Mutated HER2-Positive Locally Advanced or Metastatic Breast Cancer (INAVO122) (NCT05894239)
    Phase 3
    Hoffmann-La Roche
    Recruiting
    Last update posted :
    02/14/2025
    Initiation :
    07/28/2023
    Primary completion :
    09/28/2026
    Completion :
    12/28/2032
    HER-2 • PIK3CA
    |
    HER-2 positive • PIK3CA mutation
    |
    tamoxifen • fulvestrant • Itovebi (inavolisib) • Phesgo (pertuzumab/trastuzumab/hyaluronidase-zzxf)
    A Study of Pembrolizumab With Trastuzumab and Chemotherapy in People With Esophagogastric Cancer (NCT06123338)
    Phase 2
    Memorial Sloan Kettering Cancer Center
    Recruiting
    Last update posted :
    02/14/2025
    Initiation :
    02/01/2024
    Primary completion :
    11/30/2027
    Completion :
    11/30/2027
    HER-2
    |
    Keytruda (pembrolizumab) • Herceptin (trastuzumab) • capecitabine • oxaliplatin
    Afatinib in Locally Advanced and Metastatic Chordoma (NCT03083678)
    Phase 2
    Leiden University Medical Center
    Completed
    Last update posted :
    02/13/2025
    Initiation :
    06/21/2018
    Primary completion :
    01/31/2025
    Completion :
    01/31/2025
    EGFR
    |
    EGFR expression
    |
    Gilotrif (afatinib)
    NeoAdjuvant Therapy With Trastuzumab-deruxtecan Versus Chemotherapy+Trastuzumab+Pertuzumab in HER2+ Early Breast Cancer (ADAPTHER2-IV) (NCT05704829)
    Phase 2
    West German Study Group
    Recruiting
    Last update posted :
    02/11/2025
    Initiation :
    02/05/2024
    Primary completion :
    06/01/2026
    Completion :
    06/01/2028
    HER-2
    |
    carboplatin • docetaxel • Perjeta (pertuzumab) • Enhertu (fam-trastuzumab deruxtecan-nxki)
    First in Human Study of BAY2927088 in Participants Who Have Advanced Non-small Cell Lung Cancer (NSCLC) With Mutations in the Genes of Epidermal Growth Factor Receptor (EGFR) and/or Human Epidermal Growth Factor Receptor 2 (HER2) (SOHO-01) (NCT05099172)
    Phase 1/2
    Bayer
    Active, not recruiting
    Last update posted :
    02/11/2025
    Initiation :
    10/25/2021
    Primary completion :
    12/31/2025
    Completion :
    12/31/2026
    HER-2
    |
    EGFR mutation • HER-2 mutation
    |
    BAY 2927088
    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)
    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)
    Adjuvant Trastuzumab, Pertuzumab Plus Docetaxel in the Treatment of Early HER2-positive Breast Cancer (BOLD-1) (NCT02625441)
    Phase 3
    Helsinki University Central Hospital
    Active, not recruiting
    Last update posted :
    02/11/2025
    Initiation :
    12/01/2015
    Primary completion :
    06/01/2025
    Completion :
    06/01/2025
    HER-2
    |
    HER-2 positive
    |
    Herceptin (trastuzumab) • docetaxel • Perjeta (pertuzumab)
    Neratinib and Everolimus, Palbociclib, or Trametinib in Treating Participants With Refractory and Advanced or Metastatic Solid Tumors With EGFR Mutation/Amplification, HER2 Mutation/Amplification, or HER3/4 Mutation or KRAS Mutation (NCI-2018-01218) (NCT03065387)
    Phase 1
    M.D. Anderson Cancer Center
    Active, not recruiting
    Last update posted :
    02/10/2025
    Initiation :
    10/31/2017
    Primary completion :
    10/01/2025
    Completion :
    10/01/2025
    HER-2 • KRAS • ERBB3 • ERBB4
    |
    KRAS mutation • EGFR mutation • HER-2 amplification • EGFR amplification
    |
    Mekinist (trametinib) • Ibrance (palbociclib) • everolimus • Nerlynx (neratinib)
    Phase I Open Label Trial to Assess Safety of BIBW 2992 (Afatinib) in Combination With Herceptin® in Patients With HER2-positive Advanced Breast Cancer. (NCT00950742)
    Phase 1
    Boehringer Ingelheim
    Completed
    Last update posted :
    02/10/2025
    Initiation :
    08/01/2009
    Primary completion :
    10/01/2013
    Completion :
    10/01/2013
    HER-2
    |
    HER-2 amplification
    |
    Herceptin (trastuzumab) • Gilotrif (afatinib)
    Radiation Therapy With or Without Trastuzumab in Treating Women With Ductal Carcinoma In Situ Who Have Undergone Lumpectomy (NCT00769379)
    Phase 3
    National Cancer Institute (NCI)
    Active, not recruiting
    Last update posted :
    02/06/2025
    Initiation :
    11/10/2008
    Primary completion :
    12/31/2019
    Completion :
    03/07/2025
    HER-2 • PGR
    |
    HER-2 positive • HR positive
    |
    Herceptin (trastuzumab) • Herzuma (trastuzumab-pkrb) • Ontruzant (trastuzumab-dttb) • Ogivri (trastuzumab-dkst) • Trazimera (trastuzumab-qyyp) • Herwenda (trastuzumab biosimilar) • GB221 (coprelotamab)
    Paclitaxel and Trastuzumab With or Without Lapatinib in Treating Patients With Stage II or Stage III Breast Cancer That Can Be Removed by Surgery (CALGB-40601) (NCT00770809)
    Phase 3
    National Cancer Institute (NCI)
    Active, not recruiting
    Last update posted :
    02/06/2025
    Initiation :
    12/01/2008
    Primary completion :
    01/31/2014
    Completion :
    07/10/2025
    HER-2 • ER • PGR
    |
    HER-2 positive • HER-2 amplification
    |
    Herceptin (trastuzumab) • paclitaxel • lapatinib • Herzuma (trastuzumab-pkrb) • Ontruzant (trastuzumab-dttb) • Ogivri (trastuzumab-dkst) • Trazimera (trastuzumab-qyyp) • Herwenda (trastuzumab biosimilar) • GB221 (coprelotamab) • SIBP-01 (trastuzumab biosimilar)
    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
    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)
    A Study of Atezolizumab and Trastuzumab in Combination With Capecitabine and Oxaliplatin in Patients With HER2 Positive Locally Advanced Resectable Gastric Cancer of Adenocarcinoma of Gastroesophageal Junction (NCT04661150)
    Phase 2
    Hoffmann-La Roche
    Active, not recruiting
    Last update posted :
    02/06/2025
    Initiation :
    03/12/2021
    Primary completion :
    05/08/2023
    Completion :
    06/30/2026
    HER-2
    |
    HER-2 positive
    |
    Herceptin (trastuzumab) • Tecentriq (atezolizumab) • capecitabine • oxaliplatin
    Classifying for HER2 Dependence to De-Escalate Neoadjuvant Chemotherapy in Patients With HER2+ Early Breast Cancer Undergoing HER2 Double-Blockade (CHERRY-PICK) (NCT06068985)
    Phase 2
    Latin American Cooperative Oncology Group
    Recruiting
    Last update posted :
    02/05/2025
    Initiation :
    09/05/2024
    Primary completion :
    10/01/2026
    Completion :
    10/01/2031
    HER-2
    |
    HER-2 positive • HER-2 negative
    |
    Perjeta (pertuzumab) • Phesgo (pertuzumab/trastuzumab/hyaluronidase-zzxf)
    Tucatinib Together with Pembrolizumab and Trastuzumab (TUGETHER) (NCT04789096)
    Phase 2
    Breast Cancer Trials, Australia and New Zealand
    Recruiting
    Last update posted :
    02/05/2025
    Initiation :
    03/07/2023
    Primary completion :
    09/30/2025
    Completion :
    09/01/2026
    HER-2 • PD-L1
    |
    PD-L1 expression • HER-2 positive • HER-2 amplification • HER-2 expression • PD-L1 negative
    |
    Keytruda (pembrolizumab) • Herceptin (trastuzumab) • capecitabine • Tukysa (tucatinib)
    Early Access Program Providing HER2/HER3 Bispecific Antibody, MCLA-128, for a Patient With Advanced NRG1-Fusion Positive Solid Tumor (NCT04100694)
    Phase N/A
    Merus N.V.
    Available
    Last update posted :
    02/05/2025
    NRG1
    |
    NRG1 fusion
    |
    Bizengri (zenocutuzumab-zbco)
    First-line Trastuzumab, Gemcitabine, Cisplatin and Nivolumab in Advanced HER2- Positive Biliary Tract Cancer: a Multicenter, Open-label, Single-arm Phase Ib/II Trial (HERBOT) (NCT05749900)
    Phase 1/2
    Yonsei University
    Recruiting
    Last update posted :
    02/05/2025
    Initiation :
    05/12/2023
    Primary completion :
    02/28/2026
    Completion :
    02/28/2027
    HER-2
    |
    HER-2 positive
    |
    Opdivo (nivolumab) • Herceptin (trastuzumab) • cisplatin • gemcitabine
    An Expanded Access Treatment Protocol of Zanidatamab (ZW25) in Patients With HER2-Positive Advanced Biliary Tract Cancer (NCT04578444)
    Phase N/A
    Jazz Pharmaceuticals
    Available
    Last update posted :
    02/04/2025
    HER-2
    |
    HER-2 positive
    |
    Ziihera (zanidatamab-hrii)
    Niraparib in Combination With Trastuzumab in Metastatic HER2+ Breast Cancer (TBCRC 050) (NCT03368729)
    Phase 1/2
    University of Alabama at Birmingham
    Active, not recruiting
    Last update posted :
    02/04/2025
    Initiation :
    09/06/2019
    Primary completion :
    11/01/2026
    Completion :
    12/30/2026
    PGR
    |
    PGR positive • EGFR positive
    |
    Herceptin (trastuzumab) • Zejula (niraparib)
    Study Evaluating Zenocutuzumab in Patients With or Without Molecularly Defined Cancers (NCT05588609)
    Phase 2
    Merus N.V.
    Active, not recruiting
    Last update posted :
    02/04/2025
    Initiation :
    11/17/2022
    Primary completion :
    10/01/2025
    Completion :
    03/01/2026
    NRG1
    |
    NRG1 fusion
    |
    Gilotrif (afatinib) • Xtandi (enzalutamide) • abiraterone acetate • Bizengri (zenocutuzumab-zbco)
    A Study to Evaluate the Efficacy and Safety of Giredestrant in Combination With Phesgo (Pertuzumab, Trastuzumab, and Hyaluronidase-zzxf) Versus Phesgo in Participants With Locally Advanced or Metastatic Breast Cancer (heredERA Breast Cancer) (NCT05296798)
    Phase 3
    Hoffmann-La Roche
    Recruiting
    Last update posted :
    02/04/2025
    Initiation :
    07/04/2022
    Primary completion :
    03/31/2027
    Completion :
    12/31/2030
    HER-2 • ER
    |
    ER positive • EGFR positive
    |
    paclitaxel • docetaxel • tamoxifen • Perjeta (pertuzumab) • giredestrant (GDC-9545) • Phesgo (pertuzumab/trastuzumab/hyaluronidase-zzxf)
    Radiation Therapy Followed by Intrathecal Trastuzumab/Pertuzumab in HER2+ Breast Leptomeningeal Disease (NCT04588545)
    Phase 1/2
    H. Lee Moffitt Cancer Center and Research Insti...
    Recruiting
    Last update posted :
    02/03/2025
    Initiation :
    12/10/2020
    Primary completion :
    07/29/2025
    Completion :
    07/29/2025
    HER-2
    |
    HER-2 positive
    |
    Herceptin (trastuzumab) • Perjeta (pertuzumab)