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Clinical trials for HER2

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   44365   clinical trials with a EudraCT protocol, of which   7389   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
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    878 result(s) found for: HER2. Displaying page 1 of 44.
    1  2  3  4  5  6  7  8  9  Next» Last»»
    EudraCT Number: 2018-004247-23 Sponsor Protocol Number: LUMC201811 Start Date*: 2019-03-22
    Sponsor Name:Leiden University Medical Center
    Full Title: [89Zr]trastuzumab PET/CT imaging of HER2 positive breast cancer for predicting pathologic complete response after neoadjuvant chemotherapy; A multicentre study
    Medical condition: HER2+ breast cancer
    Disease:
    Population Age: Adults, Elderly Gender: Female
    Trial protocol: NL (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2006-002766-20 Sponsor Protocol Number: CAUY922A2101 Start Date*: 2009-02-25
    Sponsor Name:Novartis Pharma Services AG
    Full Title: A phase I dose escalation, multi-center, open-label study of AUY922 administered IV on a once-weekly schedule in adult patients with advanced solid malignancies including phase II expansion arms in...
    Medical condition: Dose-expansion study to assess safety, tolerability & efficacy: -One arm (MTD expansion) will enroll advanced cancer patients (other than breast carcinoma). -Two arms (phase II) to assess response ...
    Disease:
    Population Age: Adults, Elderly Gender: Female
    Trial protocol: GB (Completed) DE (Prematurely Ended) NL (Completed)
    Trial results: View results
    EudraCT Number: 2006-000562-36 Sponsor Protocol Number: BIG2-06/N063D/EGF106708 Start Date*: 2007-05-04
    Sponsor Name:Novartis Pharma Services AG
    Full Title: ALTTO (Adjuvant Lapatinib and/or Trastuzumab Treatment Optimisation) study. A randomised, multi-centre, open-label, phase III study of adjuvant lapatinib, trastuzumab, their sequence and their comb...
    Medical condition: Operable primary breast cancer with over expression/ amplification of HER2.
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10006187 Breast cancer PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IE (Completed) HU (Completed) FR (Completed) GB (Completed) SK (Completed) EE (Completed) CZ (Completed) DK (Completed) BE (Completed) DE (Completed) GR (Completed) NL (Completed) IT (Completed) ES (Completed) SI (Completed) BG (Completed) AT (Completed)
    Trial results: View results
    EudraCT Number: 2013-001036-22 Sponsor Protocol Number: SOLTI-1114 Start Date*: 2013-10-15
    Sponsor Name:SOLTI
    Full Title: PAM50 HER2-enriched phenotype as a predictor of early response to neoadjuvant lapatinib plus trastuzumab in Stage I to IIIA HER2-positive breast cancer
    Medical condition: Untreated invasive breast carcinoma eligible for primary definitive surgery (Stage I-IIIA)
    Disease: Version SOC Term Classification Code Term Level
    14.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10065430 HER-2 positive breast cancer PT
    Population Age: Adults, Elderly Gender: Female
    Trial protocol: ES (Completed)
    Trial results: View results
    EudraCT Number: 2021-005646-15 Sponsor Protocol Number: 21-BI-1607-01 Start Date*: 2022-07-06
    Sponsor Name:BioInvent International AB
    Full Title: Phase 1/2a Open-label Clinical Trial of BI-1607, an Fc-Engineered Monoclonal Antibody to CD32b (FcγRIIB), in Combination with Trastuzumab in Subjects with HER2-positive Advanced Solid Tumors - CONT...
    Medical condition: HER2-positive locally Advanced unresectable or metastatic solid tumors in Phase 1 HER2+ breast cancer and subjects with HER2+ metastatic gastric or gastroesophageal junction adenocarcinoma in Pha...
    Disease: Version SOC Term Classification Code Term Level
    23.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10065430 HER2 positive breast cancer PT
    23.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10066896 HER2 positive gastric cancer PT
    23.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10084871 Gastroesophageal junction cancer metastatic LLT
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10065147 Malignant solid tumor LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2006-006619-64 Sponsor Protocol Number: 2006SG005 Start Date*: 2007-07-04
    Sponsor Name:University Hospital of South Manchester NHS Foundation Trust [...]
    1. University Hospital of South Manchester NHS Foundation Trust
    2. University of Manchester
    Full Title: Randomised Controlled Trial of Lapatinib (A Her1/2 Tyrosine Kinase Inhibitor) on Epithelial Proliferation and Apoptosis in Ductal Cancer in Situ.
    Medical condition: Women with a core biopsy diagnosis of histologically proven Her2 positive DCIS (or DCIS and invasive cancer). Women undergoing re-excision of DCIS will be eligible provided residual DCIS is presen...
    Disease: Version SOC Term Classification Code Term Level
    9.1 10065430 HER-2 positive breast cancer LLT
    Population Age: Adults Gender: Female
    Trial protocol: GB (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2011-005219-98 Sponsor Protocol Number: PH3-01 Start Date*: 2012-10-08
    Sponsor Name:Galena Biopharma, Inc
    Full Title: Prevention of Recurrence in Early-Stage, Node-Positive Breast Cancer with Low to Intermediate HER2 Expression with NeuVax™ Treatment (PRESENT)
    Medical condition: Operable early-stage, node-positive breast cancer
    Disease: Version SOC Term Classification Code Term Level
    19.0 100000004864 10071113 Node-positive breast cancer LLT
    Population Age: Adults, Elderly Gender: Female
    Trial protocol: BG (Prematurely Ended) HU (Prematurely Ended) CZ (Prematurely Ended) DE (Prematurely Ended) GB (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2018-004868-57 Sponsor Protocol Number: UC-0105/1815 Start Date*: 2019-09-02
    Sponsor Name:UNICANCER
    Full Title: 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
    Medical condition: 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 IHC...
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004864 10072737 Advanced breast cancer LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Completed)
    Trial results: (No results available)
    EudraCT Number: 2020-000954-86 Sponsor Protocol Number: 107CS-5 Start Date*: 2020-08-17
    Sponsor Name:Daehwa Pharmaceutical Co., Ltd.
    Full Title: A Multinational, Multicenter, Open-label, Phase II/III Clinical Trial to Evaluate the Efficacy and Safety of Oral Paclitaxel (DHP107) Compared to IV Paclitaxel as First-line Therapy in Patients wit...
    Medical condition: Recurrent or metastatic HER2 negative Breast Cancer
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10027475 Metastatic breast cancer LLT
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10006198 Breast cancer recurrent PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: HU (Trial now transitioned) BG (Completed)
    Trial results: (No results available)
    EudraCT Number: 2017-004415-39 Sponsor Protocol Number: TO-TAS0728-101 Start Date*: 2019-02-05
    Sponsor Name:Taiho Oncology, Inc.
    Full Title: A PHASE 1/2, OPEN-LABEL, MULTICENTER STUDY TO INVESTIGATE THE SAFETY, PHARMACOKINETICS, AND EFFICACY OF TAS0728, AN ORAL COVALENT BINDING INHIBITOR OF HER2, IN SUBJECTS WITH ADVANCED SOLID TUMORS W...
    Medical condition: Urothelial cancer with HER2 or HER3 mutation Biliary tract cancer with HER2 or HER3 mutation Breast cancer with HER2 or HER3 mutation Breast cancer with HER2 amplification/overexpression as per AS...
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10061451 Colorectal cancer PT
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10057654 Breast cancer female PT
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10004593 Bile duct cancer PT
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10077840 Urothelial cancer of renal pelvis LLT
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10079440 Non-squamous non-small cell lung cancer LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) FR (Completed) ES (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2004-000753-30 Sponsor Protocol Number: PM0259CA219B0 Start Date*: 2004-11-08
    Sponsor Name:Pierre Fabre Ibérica S.A. as legal representative of Pierr Fabre Mèdicament
    Full Title: Phase II trial of oral vinorelbine in combination with capecitabine as first line therapy in women with previously untreated HER2 negative metastatic breast cancer.
    Medical condition: Treatment in women with previously untreated HER2 negative metastatic breast cancer.
    Disease:
    Population Age: Adults, Elderly Gender: Female
    Trial protocol: ES (Completed)
    Trial results: View results
    EudraCT Number: 2004-000748-26 Sponsor Protocol Number: PM0259CA215B0 Start Date*: 2004-11-08
    Sponsor Name:Pierre Fabre Ibérica, S.A. en representación de Pierre Fabre Mèdicament
    Full Title: Phase II trial of oral vinorelbine in combination with capecitabine and trastuzumab as first line therapy in women with previously untreated HER2 positive metastatic breast cancer.
    Medical condition: Treatment in women with previously untreated HER2 positive metastatic breast cancer.
    Disease:
    Population Age: Adults, Elderly Gender: Female
    Trial protocol: ES (Completed)
    Trial results: View results
    EudraCT Number: 2017-004190-13 Sponsor Protocol Number: TX05-03 Start Date*: 2018-02-08
    Sponsor Name:Tanvex Biologics Corp.
    Full Title: A randomized, double-blind, parallel group, Phase III trial to compare the efficacy, safety, and immunogenicity of TX05 with Herceptin® in subjects with HER2 positive early breast cancer
    Medical condition: HER-2 positive breast cancer
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10065430 HER-2 positive breast cancer PT
    Population Age: Adults, Elderly Gender: Female
    Trial protocol: HU (Completed) BG (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2005-003098-26 Sponsor Protocol Number: 3144A1-201-WW Start Date*: 2006-06-06
    Sponsor Name:Wyeth Research Division of Wyeth Pharmaceuticals Inc.
    Full Title: Phase 2 Study of HKI-272 in Subjects with Advanced Breast Cancer
    Medical condition: Breast cancer is the most frequently diagnosed malignancy and the second most common cause of cancer related deaths in women. HER2 is a member of the epidermal growth factor receptor (EGFR) family ...
    Disease:
    Population Age: Adults, Elderly Gender: Female
    Trial protocol: BE (Completed) FR (Completed)
    Trial results: View results
    EudraCT Number: 2016-002365-63 Sponsor Protocol Number: GS-US-350-1937 Start Date*: 2017-04-19
    Sponsor Name:Gilead Sciences, Inc.
    Full Title: A Phase 1b Study Followed by an Open label, Parallel, Randomized Phase 2 Study Evaluating the Safety, Tolerability and Efficacy of GS-5829 in Combination with Exemestane or Fulvestrant Comparing wi...
    Medical condition: Advanced Estrogen Receptor Positive HER2-Breast Cancer
    Disease: Version SOC Term Classification Code Term Level
    19.1 100000004864 10070575 Estrogen receptor positive breast cancer LLT
    Population Age: Adults, Elderly Gender: Female
    Trial protocol: ES (Prematurely Ended) BE (Completed) GB (Completed) FR (Completed)
    Trial results: View results
    EudraCT Number: 2008-004492-21 Sponsor Protocol Number: CIOCC012008 Start Date*: 2008-10-07
    Sponsor Name:Fundación Hospital de Madrid
    Full Title: Estudio biológico del efecto de GW572016 (Lapatinib) en la apoptosis celular en el Carcinoma Ductal in Situ en pacientes con cáncer de mama HER2 positivo
    Medical condition: Cancer de mama
    Disease:
    Population Age: Adults, Elderly Gender: Female
    Trial protocol: ES (Completed)
    Trial results: (No results available)
    EudraCT Number: 2011-002132-10 Sponsor Protocol Number: MO27775 Start Date*: 2012-03-08
    Sponsor Name:F. Hoffmann-La Roche Ltd.
    Full Title: A randomized, two-arm, open-label, multicenter Phase II trial assessing the efficacy and safety of pertuzumab given in combination with trastuzumab plus an aromatase inhibitor in first line patien...
    Medical condition: HER2- and hormone receptor-positive advanced (metastatic or locally advanced) breast cancer
    Disease: Version SOC Term Classification Code Term Level
    14.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10065430 HER-2 positive breast cancer LLT
    Population Age: Adults, Elderly Gender: Female
    Trial protocol: FR (Completed) ES (Completed) GB (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2012-003064-47 Sponsor Protocol Number: CUDC-101-104 Start Date*: 2012-12-11
    Sponsor Name:Curis, Inc.
    Full Title: A Phase 1 open-label study to investigate the pharmacodynamics, metabolomics and pharmacokinetics of CUDC-101 in subjects with HER2 positive invasive breast cancer.
    Medical condition: HER2 positive breast cancer
    Disease: Version SOC Term Classification Code Term Level
    14.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10065430 HER-2 positive breast cancer LLT
    Population Age: Adults, Elderly Gender: Female
    Trial protocol: GB (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2018-001552-36 Sponsor Protocol Number: 18SEIN08 Start Date*: 2020-09-09
    Sponsor Name:INSTITUT CLAUDIUS REGAUD
    Full Title: The use of FES-PET imaging as a tool to detect a possible reversion of Estrogen Receptor (ER)-α status in patients with metastatic breast cancer HER2 + and ERα neg treated with trastuzumab + pertuz...
    Medical condition: Metastatic breast cancer HER2 + and ERα neg.
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004864 10027475 Metastatic breast cancer LLT
    Population Age: Adults Gender: Female
    Trial protocol: FR (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2008-005466-30 Sponsor Protocol Number: CCR3104 Start Date*: 2010-03-03
    Sponsor Name:University of Manchester [...]
    1. University of Manchester
    2. Institute of Cancer Research
    3. University of South Manchester NHS Foundation Trust
    Full Title: Effect of Perioperative AntiHER2 Therapy on Early Breast Cancer Study - Biological Phase
    Medical condition: HER-2 positive primary breast cancer
    Disease: Version SOC Term Classification Code Term Level
    16.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10065430 HER-2 positive breast cancer PT
    Population Age: Adults, Elderly Gender: Female
    Trial protocol: GB (GB - no longer in EU/EEA)
    Trial results: View results
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