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Clinical trials for Breast implants

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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  • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
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    The EU Clinical Trials Register currently displays   44335   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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    70 result(s) found for: Breast implants. Displaying page 1 of 4.
    1  2  3  4  Next»
    EudraCT Number: 2012-004878-26 Sponsor Protocol Number: 26842468452 Start Date*: 2013-02-07
    Sponsor Name:Karolinska University Hospital Solna
    Full Title: Antibiotic prophylaxis in patients undergoing primary or secondary breast reconstruction with implants, a randomized parallel two armed prospective clinical trial.
    Medical condition: The incidence of postoperative infections in patients with breast cancer or a history of breast cancer, after elective surgery with primary or secondary first-time breast reconstruction with implan...
    Disease:
    Population Age: Adults, Elderly Gender: Female
    Trial protocol: SE (Prohibited by CA)
    Trial results: (No results available)
    EudraCT Number: 2020-002459-40 Sponsor Protocol Number: BREAST-AB-01 Start Date*: 2020-12-17
    Sponsor Name:Rigshospitalet
    Full Title: Prophylactic treatment of breast implants with a solution of gentamicin, vancomycin and cefazolin antibiotics for women undergoing breast reconstructive surgery: a randomized controlled trial (The ...
    Medical condition: Implant-based breast reconstruction following mastectomy
    Disease:
    Population Age: Adults, Elderly Gender: Female
    Trial protocol: DK (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2019-003093-13 Sponsor Protocol Number: BREAKFAST Start Date*: 2020-01-14
    Sponsor Name:FONDAZIONE IRCCS "ISTITUTO NAZIONALE DEI TUMORI"
    Full Title: Targeting triple negative BREAst cancer metabolism with a combination of chemotherapy and a diet mimicking FASTing plus/minus metformin in the preoperative setting: the BREAKFAST trial
    Medical condition: Targeting triple negative BREAst cancer
    Disease: Version SOC Term Classification Code Term Level
    21.0 100000004864 10025541 Malignant breast neoplasm LLT
    Population Age: Adults, Elderly Gender: Female
    Trial protocol: IT (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2018-000910-39 Sponsor Protocol Number: BRTR1 Start Date*: 2018-12-13
    Sponsor Name:AZIENDA OSPEDALIERO-UNIVERSITARIA UDINE
    Full Title: Efficacy of tranexamic acid in reducing post-operative bleeding in oncologic-reconstructive breast surgery
    Medical condition: Post-operative hematoma
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004872 10064765 Breast hematoma LLT
    20.0 100000004863 10018857 Haematoma postoperative LLT
    Population Age: Adults, Elderly Gender: Female
    Trial protocol: IT (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2018-004165-13 Sponsor Protocol Number: IJB-LBC-NEOCHECKRAY-2018 Start Date*: 2019-06-06
    Sponsor Name:Institut Jules Bordet
    Full Title: Neo-adjuvant chemotherapy combined with SBRT to the primary tumour +/- durvalumab (MEDI4736), +/- oleclumab in luminal B breast cancer: a phase ll randomized trial
    Medical condition: Luminal B 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 Gender: Female
    Trial protocol: BE (Trial now transitioned) FR (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2014-005017-23 Sponsor Protocol Number: FM-14-B02 Start Date*: 2016-01-26
    Sponsor Name:Fondazione Michelangelo - Avanzamento dello studio e cura dei tumori
    Full Title: Neo-Adjuvant study with the PDL1-directed antibody in Triple Negative, Early High-Risk and Locally Advanced Breast Cancer undergoing treatment with nab-paclitaxel and carboplatin
    Medical condition: Women with a diagnosis of invasive unilateral, early high-risk and locally advanced or inflammatory, triple negative (HER2-negative and ER-negative and PgRnegative) breast cancer of high proliferat...
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10006200 Breast cancer stage II PT
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10006196 Breast cancer NOS stage III LLT
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10006195 Breast cancer NOS stage II LLT
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10006201 Breast cancer stage III PT
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10075566 Triple negative breast cancer PT
    21.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10021975 Inflammatory breast cancer stage III LLT
    Population Age: Adults, Elderly Gender: Female
    Trial protocol: DE (Completed) AT (Completed) ES (Completed) IE (Completed) IT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2005-002625-31 Sponsor Protocol Number: 10041 Start Date*: 2006-12-11
    Sponsor Name:European Organisation for Research and Treatment of Cancer
    Full Title: Microarray In Node negative and 1 to 3 positive lymph node Disease may Avoid ChemoTherapy. A prospective, randomised study comparing the 70-gene expression signature with common clinical-pathologi...
    Medical condition: Lymph-node negative early breast cancer and breast cancer with 1 to 3 positive nodes
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10057654 Breast cancer female PT
    Population Age: Adults Gender: Female
    Trial protocol: BE (Completed) ES (Completed) SI (Completed) DE (Completed) GB (Completed) IT (Completed) PT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2008-008276-14 Sponsor Protocol Number: BO22495 Start Date*: 2009-04-27
    Sponsor Name:F. Hoffmann-la Roche Ltd
    Full Title: A Phase Ib/II, open-label study of the safety, tolerability, and efficacy of trastuzumab-MCC-DM1 in combination with pertuzumab administered intravenously to patients with HER2-positive locally adv...
    Medical condition: Treatment in patients with HER2-overexpressing locally advanced or metastatic breast cancer
    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: FR (Completed) DE (Completed) BE (Completed)
    Trial results: View results
    EudraCT Number: 2005-005186-10 Sponsor Protocol Number: EGF105485 Start Date*: 2006-09-12
    Sponsor Name:GlaxoSmithKline Research & Development Limited
    Full Title: A Randomized, Double-blind, Multicenter, Placebo-controlled Study of Adjuvant Lapatinib in Women with Early-Stage ErbB2 Overexpressing Breast Cancer
    Medical condition: Women with early-stage ErbB2-overexpressing breast cancer. Eligible women must have had an initial diagnosis of histologically or cytologically confirmed invasive breast cancer (Stage I through St...
    Disease: Version SOC Term Classification Code Term Level
    14.1 100000004864 10065430 HER-2 positive breast cancer LLT
    Population Age: Adults, Elderly Gender: Female
    Trial protocol: DE (Completed) CZ (Completed) HU (Completed) LT (Completed) ES (Completed) BE (Completed) DK (Completed) LV (Completed) GR (Completed) SK (Completed) GB (Completed) IT (Completed)
    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: 2021-002176-39 Sponsor Protocol Number: V3002401 Start Date*: 2022-02-07
    Sponsor Name:Veru Inc.
    Full Title: ARTEST - A Randomized Phase 3 Study to Evaluate the Efficacy and Safety of Enobosarm Monotherapy Versus Active Control for the Treatment of AR+/ER+/HER2- Metastatic Breast Cancer in Patients with A...
    Medical condition: (AR+)/estrogen receptor positive(ER+)/human epidermal growth factor receptor 2 negative (HER2-) metastatic breast cancer
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004864 10027475 Metastatic breast cancer LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2008-002819-40 Sponsor Protocol Number: TDM4450g Start Date*: 2009-03-02
    Sponsor Name:F. Hoffmann-La Roche Ltd
    Full Title: A randomized, multicenter, Phase II study of the efficacy and safety of trastuzumab-MCC-DM1 vs. trastuzumab (Herceptin®) and docetaxel (Taxotere®) in patients with metastatic HER2-positive breast c...
    Medical condition: HER2-positive metastatic breast cancer
    Disease: Version SOC Term Classification Code Term Level
    9.1 10027475 Metastatic breast cancer LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) ES (Completed) AT (Completed) BE (Completed) HU (Completed) GB (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2020-005735-79 Sponsor Protocol Number: UC-BCG-2011 Start Date*: 2021-09-02
    Sponsor Name:UNICANCER
    Full Title: Treatment with Tucatinib in addition to Pertuzumab and Trastuzumab in patients with HER2-positive metastatic breast cancer after local therapy of isolated brain progression
    Medical condition: HER2-positive metastatic breast cancer with isolated brain progression (defined as new or progressive brain metastases with stable or responding systemic disease) after complete local treatment.
    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
    20.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10055113 Breast cancer metastatic PT
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10006128 Brain metastases LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2011-001965-42 Sponsor Protocol Number: MYL-Her3001 Start Date*: 2013-03-01
    Sponsor Name:MYLAN GmbH
    Full Title: A MULTICENTER, DOUBLE-BLIND, RANDOMIZED, PARALLEL-GROUP, PHASE III STUDY OF THE EFFICACY AND SAFETY OF HERCULES PLUS TAXANE VERSUS HERCEPTIN® PLUS TAXANE AS FIRST LINE THERAPY IN PATIENTS WITH HER2...
    Medical condition: Human Epidermal Growth Factor Receptor 2 positive (HER2+) metastatic breast cancer (MBC)
    Disease: Version SOC Term Classification Code Term Level
    17.0 100000004864 10027475 Metastatic breast cancer LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Prematurely Ended) HU (Completed) BG (Completed) CZ (Completed) SK (Completed) LV (Completed) ES (Prematurely Ended) GR (Completed) AT (Completed)
    Trial results: View results
    EudraCT Number: 2018-002553-30 Sponsor Protocol Number: EORTC-1745-ETF-BCG Start Date*: 2018-11-28
    Sponsor Name:European Organisation for research and treatment of Cancer
    Full Title: A Phase II study of Adjuvant PALbociclib as an Alternative to CHemotherapy in Elderly patientS with high-risk ER+/HER2- early breast cance (APPALACHES)
    Medical condition: Localized ER+ breast cancer
    Disease: Version SOC Term Classification Code Term Level
    20.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10070575 Estrogen receptor positive breast cancer LLT
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10070577 Oestrogen receptor positive breast cancer PT
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10006290 Breast and nipple neoplasms malignant HLT
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10006291 Breast neoplasms malignant and unspecified (incl nipple) HLGT
    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: Elderly Gender: Male, Female
    Trial protocol: FR (Trial now transitioned) BE (Trial now transitioned) GB (GB - no longer in EU/EEA) PL (Trial now transitioned) SE (Completed) ES (Ongoing) DE (Trial now transitioned) PT (Trial now transitioned) IT (Trial now transitioned)
    Trial results: View results
    EudraCT Number: 2008-002713-40 Sponsor Protocol Number: MRZ60201-GL-3002 Start Date*: 2008-11-06
    Sponsor Name:Merz Pharmaceuticals GmbH
    Full Title: A prospective, multicenter, randomized, rater- and subject-blind, parallel group trial to investigate the non-inferiority of NT 201, free of complexing proteins, in comparison with Clostridium botu...
    Medical condition: Treatment of glabellar frown lines
    Disease: Version SOC Term Classification Code Term Level
    10.1 10052609 LLT
    Population Age: Adults Gender: Female
    Trial protocol: DE (Completed) AT (Completed) GB (Completed)
    Trial results: View results
    EudraCT Number: 2017-000981-31 Sponsor Protocol Number: FM-17-B01 Start Date*: 2019-03-11
    Sponsor Name:Michelangelo Foundation
    Full Title: Atezolizumab, Pertuzumab and Trastuzumab with chemotherapy as neoadjuvant treatment of HER2 positive early high-risk and locally advanced breast cancer.
    Medical condition: Women with a diagnosis of non-metastatic high-risk invasive unilateral, HER2-positive 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: Female
    Trial protocol: DE (Trial now transitioned) AT (Trial now transitioned) BE (Trial now transitioned) IT (Trial now transitioned) RO (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2010-021067-32 Sponsor Protocol Number: BO25430(TDM4529g) Start Date*: 2011-04-29
    Sponsor Name:F. Hoffmann-La Roche Ltd
    Full Title: An open-label, multicenter extension study of trastuzumab emtansine administered as a single agent or in combination with other anti-cancer therapies in patients previously enrolled in a Genentech ...
    Medical condition: Metastatic Cancer
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10007050 Cancer LLT
    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: DE (Completed) GB (Completed) AT (Completed) BE (Trial now transitioned) HU (Completed) ES (Completed) IT (Completed) FR (Trial now transitioned) PT (Trial now transitioned) PL (Trial now transitioned) SE (Completed) SI (Completed) BG (Completed) CZ (Completed) DK (Completed) HR (Completed)
    Trial results: View results
    EudraCT Number: 2006-004529-27 Sponsor Protocol Number: 1216.18 Start Date*: 2007-07-09
    Sponsor Name:SCS Boehringer Ingelheim Comm.V
    Full Title: Multicenter parallel phase II trial of BI 2536 administered as one hour i.v. infusion every 3 weeks in defined cohorts of patients with various solid tumours. A new drug screening program of the EO...
    Medical condition: patients with five different tumour entities will be included in the present trial: 1. squamous cell carinoma of the head and neck 2. breast cancer 3. ovarian cancer 4. soft tissue sarcoma 5. meanoma
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Completed) DE (Prematurely Ended) FR (Completed) GB (Prematurely Ended) NL (Completed)
    Trial results: View results
    EudraCT Number: 2013-003166-14 Sponsor Protocol Number: RGB-02-101 Start Date*: 2013-11-20
    Sponsor Name:Gedeon Richter Plc.
    Full Title: Multiple, fixed-dose, comparative efficacy and safety evaluation of RGB-02 and Neulasta® in patients undergoing chemotherapy treatment known to induce neutropenia.
    Medical condition: Neutropenia and febrile neutropenia in patients being treated with cytotoxic chemotherapy for malignancy.
    Disease: Version SOC Term Classification Code Term Level
    16.0 10005329 - Blood and lymphatic system disorders 10029354 Neutropenia PT
    16.0 10005329 - Blood and lymphatic system disorders 10016288 Febrile neutropenia PT
    Population Age: Elderly Gender: Female
    Trial protocol: CZ (Completed) HU (Completed) BG (Completed) HR (Completed)
    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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