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Clinical trials for HER2-positive Breast Cancer

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
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    The EU Clinical Trials Register currently displays   44334   clinical trials with a EudraCT protocol, of which   7366   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 ).  
     
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    180 result(s) found for: HER2-positive Breast Cancer. Displaying page 1 of 9.
    1  2  3  4  5  6  7  8  9  Next»
    EudraCT Number: 2010-022902-41 Sponsor Protocol Number: BIG4-11/BO25126/TOC4939g Start Date*: 2011-09-26
    Sponsor Name:F. Hoffmann-La Roche Ltd.
    Full Title: A randomized multicenter, double-blind, placebo-controlled comparison of chemotherapy plus trastuzumab plus placebo versus chemotherapy plus trastuzumab plus pertuzumab as adjuvant therapy in pa...
    Medical condition: Patients with operable HER2-positive primary breast cancer
    Disease: Version SOC Term Classification Code Term Level
    17.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10065430 HER-2 positive breast cancer PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) HU (Completed) CZ (Completed) ES (Ongoing) FR (Completed) IE (Completed) SE (Completed) DK (Completed) SI (Completed) NL (Completed) BE (Completed) SK (Completed) AT (Completed) IT (Completed) BG (Completed)
    Trial results: View results
    EudraCT Number: 2012-002018-37 Sponsor Protocol Number: BO27938 Start Date*: 2013-04-09
    Sponsor Name:F. Hoffmann-La Roche Ltd
    Full Title: A RANDOMIZED, MULTICENTER, OPEN LABEL PHASE III STUDY TO EVALUATE THE EFFICACY AND SAFETY OF TRASTUZUMAB EMTANSINE VERSUS TRASTUZUMAB AS ADJUVANT THERAPY FOR PATIENTS WITH HER2-POSITIVE PRIMARY BRE...
    Medical condition: HER2-positive primary breast cancer.
    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
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10027475 Metastatic breast cancer LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Completed) SE (Prematurely Ended) AT (Prematurely Ended) CZ (Completed) DE (Completed) GB (GB - no longer in EU/EEA) IT (Completed) IE (Prematurely Ended) ES (Ongoing) GR (Completed) FR (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2017-002115-34 Sponsor Protocol Number: ABY-025-MI301 Start Date*: 2018-06-14
    Sponsor Name:Region Uppsala
    Full Title: A multicenter phase II/III-study of 68Ga-ABY-025 PET for non-invasive quantification of HER2-expression in advanced breast cancer
    Medical condition: Breast cancer.
    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: SE (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2011-005328-17 Sponsor Protocol Number: MO28048 Start Date*: 2012-04-26
    Sponsor Name:F. Hoffmann-La Roche Ltd
    Full Title: A phase III prospective, two-cohort non-randomised, multi-centre, multinational, open label study to assess the safety of assisted- and self-administered subcutaneous trastuzumab as therapy in pati...
    Medical condition: HER2-positive primary breast cancer
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10029104 Neoplasms benign, malignant and unspecified (incl cysts and polyps) SOC
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IE (Completed) CZ (Completed) DE (Completed) ES (Completed) FR (Completed) HU (Completed) PT (Completed) GB (Completed) NO (Completed) IT (Completed) GR (Completed) LT (Completed) PL (Completed) SI (Completed) SK (Completed) FI (Completed) BG (Completed) NL (Completed) SE (Completed)
    Trial results: View results
    EudraCT Number: 2016-000435-41 Sponsor Protocol Number: GOIRC-01-2016 Start Date*: 2016-09-23
    Sponsor Name:GRUPPO ONCOLOGICO ITALIANO DI RICERCA CLINICA (GOIRC)
    Full Title: Phase II, Open Label, Randomized, Biomarker Study of Immune-mediated Mechanism of Action of Neoadjuvant Subcutaneous (SC) Trastuzumab in Patients with Operable or Locally Advanced/Inflammatory HER2...
    Medical condition: HER2-positive Breast Cancer
    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: Female
    Trial protocol: IT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2014-004432-18 Sponsor Protocol Number: Caremore-Trastuzumab Start Date*: 2015-02-18
    Sponsor Name:Erasmus MC Cancer Institute
    Full Title: Activity of trastuzumab based chemotherapy in metastatic breast patients with HER2-negative primary tumor but HER2 positive circulating tumor cells (CareMore-Trastuzumab)
    Medical condition: Metastastic breast cancer
    Disease:
    Population Age: Adults, Elderly Gender: Female
    Trial protocol: NL (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2019-002741-37 Sponsor Protocol Number: CBYL719G12301 Start Date*: 2020-04-07
    Sponsor Name:Novartis Pharma AG
    Full Title: EPIK-B2: A two part, Phase III, multicenter, randomized (1:1), double-blind, placebo-controlled study to assess the efficacy and safety of alpelisib (BYL719) in combination with trastuzumab and per...
    Medical condition: HER2-positive advanced breast cancer
    Disease: Version SOC Term Classification Code Term Level
    21.1 100000004864 10072737 Advanced breast cancer LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Trial now transitioned) HU (Prematurely Ended) DE (Temporarily Halted) CZ (Completed) BE (Completed) ES (Ongoing) NL (Prematurely Ended) GB (GB - no longer in EU/EEA) AT (Completed) IT (Prematurely Ended) SK (Prematurely Ended) SE (Prematurely Ended) BG (Temporarily Halted) GR (Completed) FI (Completed)
    Trial results: (No results available)
    EudraCT Number: 2011-000509-29 Sponsor Protocol Number: BO25734/TDM4997g Start Date*: 2011-12-02
    Sponsor Name:F. Hoffmann-La Roche Ltd
    Full Title: A Phase III randomized, multicenter, two-arm, open-label trial to evaluate the efficacy of trastuzumab emtansine compared with treatment of physician’s choice in patients with HER2-positive metasta...
    Medical condition: HER2-Positive Metastatic Breast Cancer (MBC)
    Disease: Version SOC Term Classification Code Term Level
    18.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10065430 HER-2 positive breast cancer PT
    18.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10027475 Metastatic breast cancer LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) SE (Completed) DE (Completed) SK (Completed) BE (Completed) CZ (Completed) HU (Completed) NO (Completed) IT (Completed) ES (Completed)
    Trial results: View results
    EudraCT Number: 2009-015628-27 Sponsor Protocol Number: CAUY922A2109 Start Date*: 2010-08-25
    Sponsor Name:Novartis Pharma Services AG
    Full Title: A phase Ib/II, multi-center, open-label study to evaluate the efficacy of AUY922 in combination with Trastuzumab in patients with locally advanced or metastatic HER2-positive breast cancer, that ha...
    Medical condition: locally advanced or metastatic HER2-positive breast cancer, that has progressed after or during at least one Trastuzumab-containing regimen
    Disease: Version SOC Term Classification Code Term Level
    13.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10027475 Metastatic breast cancer LLT
    13.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10055113 Breast cancer metastatic PT
    Population Age: Adults, Elderly Gender: Female
    Trial protocol: SE (Completed) FR (Completed) GB (Completed) DE (Completed) NL (Completed)
    Trial results: View results
    EudraCT Number: 2020-000981-41 Sponsor Protocol Number: TUXEDO-1 Start Date*: 2020-06-26
    Sponsor Name:Med. Univ. Wien, Klinik f. Innere Mdizin I, Onkologie
    Full Title: Phase II Study of Trastuzumab-Deruxtecan (T-DX; DS-8201a) in HER2-positive Breast Cancer Patients with newly diagnosed or progressing Brain Metastases
    Medical condition: HER2-positive Breast Cancer with newly diagnosed or progressing Brain Metastases
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: AT (Completed)
    Trial results: View results
    EudraCT Number: 2021-000398-10 Sponsor Protocol Number: EFC16133 Start Date*: 2022-04-19
    Sponsor Name:Sanofi-aventis recherche & développement
    Full Title: A randomized, multicenter, double-blind, Phase 3 study of amcenestrant (SAR439859) versus tamoxifen for the treatment of patients with hormone receptor-positive, human epidermal growth factor 2-neg...
    Medical condition: Breast cancer
    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: FR (Completed) HU (Prematurely Ended) EE (Prematurely Ended) BE (Prematurely Ended) PT (Prematurely Ended) DK (Prematurely Ended) IT (Prematurely Ended) ES (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2008-005713-22 Sponsor Protocol Number: TDM4370g/BO21977 Start Date*: 2009-03-18
    Sponsor Name:F. Hoffmann-La Roche Ltd
    Full Title: Estudio de Fase III multicéntrico, randomizado, abierto, de la eficacia y seguridad de Trastuzumab-MCC-DM1 frente a Capecitabina + Lapatinib en pacientes con cáncer de mama localmente avanzado o me...
    Medical condition: Tratamiento de pacientes con cáncer de mama HER-2 positivo localmente avanzado o metastásico que hayan recibido un taxano y trastuzumab tras progresión de la enfermedad.
    Disease: Version SOC Term Classification Code Term Level
    9.1 10027475 Metastatic breast cancer LLT
    9.1 10065430 HER-2 positive breast cancer LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Completed) DE (Completed) SE (Completed) PT (Completed) DK (Completed) FR (Completed) SI (Completed) GB (Completed) BG (Completed) FI (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2013-004770-10 Sponsor Protocol Number: IBCSG_45-13/BIG_4-13 Start Date*: 2014-09-23
    Sponsor Name:International Breast Cancer Study Group (IBCSG)
    Full Title: A phase Ib/II trial evaluating the efficacy of MK-3475 and trastuzumab in patients with trastuzumab-resistant, HER2-positive metastatic breast cancers
    Medical condition: Patients with HER2-positive, PD-L1 expressing, unresectable locoregional or metastatic breast carcinoma which has progressed on prior trastuzumab-based therapy. A parallel cohort of 15 patients wi...
    Disease: Version SOC Term Classification Code Term Level
    18.1 100000004864 10027475 Metastatic breast cancer LLT
    Population Age: Adults, Elderly Gender: Female
    Trial protocol: BE (Completed) IT (Completed) AT (Completed)
    Trial results: View results
    EudraCT Number: 2012-002556-17 Sponsor Protocol Number: SAKK22/10/UC-0140/1207 Start Date*: 2013-02-04
    Sponsor Name:UNICANCER
    Full Title: A randomized phase II trial of pertuzumab in combination with trastuzumab with or without chemotherapy, both followed by T-DM1 in case of progression, in patients with HER2-positive metastatic brea...
    Medical condition: HER2-positive metastatic breast cancer
    Disease: Version SOC Term Classification Code Term Level
    14.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10006187 Breast cancer PT
    Population Age: Gender: Female
    Trial protocol: FR (Completed) DE (Completed) NL (Completed)
    Trial results: View results
    EudraCT Number: 2012-003442-32 Sponsor Protocol Number: ML28589 Start Date*: 2013-01-08
    Sponsor Name:ROCHE SAS
    Full Title: AN OPEN-LABEL, RANDOMIZED, MULTICENTER PHASE III STUDY IN PATIENTS WITH HER2-POSITIVE METASTATIC BREAST CANCER RESPONDING TO FIRST LINE TREATMENT WITH INTRAVENOUS TRASTUZUMAB FOR AT LEAST 3 YEARS A...
    Medical condition: HER2-positive metastatic breast cancer
    Disease: Version SOC Term Classification Code Term Level
    14.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10055113 Breast cancer metastatic PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Completed)
    Trial results: View results
    EudraCT Number: 2016-004986-18 Sponsor Protocol Number: DS8201-A-U201 Start Date*: 2017-11-08
    Sponsor Name:Daiichi Sankyo Inc.
    Full Title: A Phase 2, Multicenter, Open-Label Study of DS-8201a, an Anti-HER2-Antibody Drug Conjugate (ADC) for HER2-Positive, Unresectable and/or Metastatic Breast Cancer Subjects Who are Resistant or Refrac...
    Medical condition: Unresectable/metastatic breast cancer with HER2 positive expression
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000020826 10027475 Metastatic breast cancer LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Ongoing) BE (Completed) GB (GB - no longer in EU/EEA) FR (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2007-004805-80 Sponsor Protocol Number: 1200.11 Start Date*: 2007-10-31
    Sponsor Name: [...]
    1.
    2. Boehringer Ingelheim Limited
    Full Title: Phase II trial of BIBW 2992 in patients with HER2-positive metastatic breast cancer after failure of trastuzumab therapy
    Medical condition: The medical condition under investigation is HER-2 positive metastatic breast cancer. Patients will have progressed on, or be intolerant of, treatment with trastuzumab (Herceptin).
    Disease: Version SOC Term Classification Code Term Level
    9.1 10055113 Breast cancer metastatic PT
    9.1 10065430 HER-2 positive breast cancer LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2021-000603-21 Sponsor Protocol Number: D967RC00001 Start Date*: 2021-11-12
    Sponsor Name:ASTRAZENECA AB
    Full Title: A Phase 3 Open-label Trial of Neoadjuvant Trastuzumab Deruxtecan (TDXd) Monotherapy or T-DXd followed by THP Compared to ddAC-THP in Participants with High-risk HER2-positive Early-stage Breast Can...
    Medical condition: Early stage HER2-positive breast cancer (T stage >= T3, lymph node positive, or inflammatory)
    Disease: Version SOC Term Classification Code Term Level
    21.0 100000004864 10025541 Malignant breast neoplasm LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Trial now transitioned) ES (Ongoing) PL (Trial now transitioned) BG (Completed) DE (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2007-002016-26 Sponsor Protocol Number: FBCSG-01-2007 Start Date*: 2007-08-08
    Sponsor Name:Finnish Breast Cancer Group
    Full Title: A randomized phase III study comparing trastuzumab plus docetaxel (HT) followed by 5-FU, epirubicin, and cyclophosphamide (FEC) to the same regimen followed by single-agent trastuzumab as adjuvant ...
    Medical condition: Invasive early breast cancer that has been removed by surgery.
    Disease: Version SOC Term Classification Code Term Level
    9.1 10006187 Breast cancer LLT
    Population Age: Adults Gender: Female
    Trial protocol: FI (Completed) SE (Completed) GB (GB - no longer in EU/EEA) IS (Completed)
    Trial results: (No results available)
    EudraCT Number: 2007-005182-35 Sponsor Protocol Number: BO20906 Start Date*: 2008-06-20
    Sponsor Name:F. Hoffmann-La Roche Ltd.
    Full Title: A Multicenter Phase III Randomized Trial of Adjuvant Therapy for Patients with HER2-Positive Node-Positive or High Risk Node-Negative Breast Cancer Comparing Chemotherapy Plus Trastuzumab with Chem...
    Medical condition: Resected node-positive or high risk node-negative, invasive HER2-positive breast cancer.
    Disease: Version SOC Term Classification Code Term Level
    9.1 10006291 Breast neoplasms malignant and unspecified (incl nipple) HLGT
    Population Age: Adults, Elderly Gender: Female
    Trial protocol: DE (Prematurely Ended) FR (Completed) GB (Prematurely Ended) IE (Prematurely Ended) LV (Prematurely Ended) ES (Completed) BE (Prematurely Ended) AT (Completed) SK (Completed) CZ (Completed) HU (Prematurely Ended) PT (Prematurely Ended) EE (Prematurely Ended) SE (Prematurely Ended) SI (Prematurely Ended) IT (Prematurely Ended) BG (Prematurely Ended) GR (Prematurely Ended)
    Trial results: View results
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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