Clinical Trials Using Trastuzumab

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Clinical trials are research studies that involve people. The clinical trials on this list are studying Trastuzumab. All trials on the list are supported by NCI.

NCI’s basic information about clinical trials explains the types and phases of trials and how they are carried out. Clinical trials look at new ways to prevent, detect, or treat disease. You may want to think about taking part in a clinical trial. Talk to your doctor for help in deciding if one is right for you.

Trials 1-25 of 52
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  • Phase 2 Study of Tucatinib vs Placebo in Combination With Capecitabine & Trastuzumab in Patients With Advanced HER2+ Breast Cancer

    The purpose of this study is to assess the effect of tucatinib vs. placebo in combination with capecitabine and trastuzumab on progression-free survival (PFS) per RECIST 1.1 based on independent central review.
    Location: 23 locations

  • 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

    This multicenter, non-randomized, open-label study will evaluate the efficacy and safety of six treatment regimens in participants with advanced solid tumors for whom therapies that will convey clinical benefit are not available and / or are not suitable options per the treating physician's judgment.
    Location: 17 locations

  • Margetuximab Plus Chemotherapy vs Trastuzumab Plus Chemotherapy in the Treatment of HER2+ Metastatic Breast Cancer

    The purpose of this study is to determine whether patients treated with margetuximab plus chemotherapy have longer progression free survival and overall survival than patients treated with trastuzumab plus chemotherapy.
    Location: 14 locations

  • Neratinib with or without Fulvestrant in Metastatic HER2-Negative but HER2 Mutant Breast Cancer

    This phase II trial studies how well neratinib with or without fulvestrant works in treating patients with human epidermal growth factor receptor 2 (HER2)-negative breast cancer that carries HER2 gene mutations and has spread to other parts of the body (metastatic). Neratinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using fulvestrant may fight breast cancer by blocking the use of estrogen by the tumor cells. Giving neratinib with fulvestrant may provide a more effective treatment for patients with this type of breast cancer.
    Location: 13 locations

  • Carboplatin and Paclitaxel With or Without Trastuzumab in Treating Patients With HER2-Positive Stage III-IV or Recurrent Uterine Cancer

    This randomized phase II trial studies how well carboplatin and paclitaxel with or without trastuzumab works in treating patients with human epidermal growth factor receptor 2 (HER2)-positive stage III-IV or recurrent uterine cancer. Drugs used in chemotherapy, such as carboplatin and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as trastuzumab, can block tumor growth in different ways. Some block the ability of tumors to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. It is not yet known whether carboplatin and paclitaxel are more effective when given with or without trastuzumab in treating uterine cancer.
    Location: 15 locations

  • I-SPY 2 TRIAL: Neoadjuvant and Personalized Adaptive Novel Agents to Treat Breast Cancer

    The purpose of this study is to further advance the ability to practice personalized medicine by learning which new drug agents are most effective with which types of breast cancer tumors and by learning more about which early indicators of response (tumor analysis prior to surgery via magnetic resonance imaging (MRI) images along with tissue and blood samples) are predictors of treatment success.
    Location: 14 locations

  • A Safety Study of SGN-LIV1A in Breast Cancer Patients

    This study will examine the safety and tolerability of SGN-LIV1A in patients with metastatic breast cancer. SGN-LIV1A will be given every 3 weeks alone or in combination with trastuzumab.
    Location: 14 locations

  • First-in-Human Dose Escalation Trial in Subjects With Advanced Malignancies

    This is a Phase 1, first-in-human, open-label, non-randomized, dose escalation, trial to explore the safety, tolerability, pharmacokinetic (PK), pharmacodynamic (PD) and clinical activity signals of MSC2363318A.
    Location: 10 locations

  • A Study of Abemaciclib (LY2835219) in Women With HR+, HER2+ Locally Advanced or Metastatic Breast Cancer

    The purpose of this study is to evaluate the effectiveness of abemaciclib plus trastuzumab with or without fulvestrant or chemotherapy in women with hormone receptor positive (HR+), human epidermal growth factor receptor 2 positive (HER2+) locally advanced or metastatic breast cancer after prior exposure to at least two HER2-directed therapies for advanced disease.
    Location: 7 locations

  • Safety and Pharmacokinetics of Atezolizumab Combination Treatments in Participants With HER2-Positive and HER2-Negative Breast Cancer

    This is a Phase Ib, open-label, two-stage study with two active regimens in each stage designed to evaluate the safety and tolerability of combination treatment with atezolizumab, trastuzumab, and pertuzumab (with and without docetaxel) or atezolizumab and trastuzumab emtansine in participants with human epidermal growth factor receptor 2 (HER2) positive metastatic breast cancer (MBC) and locally advanced early breast cancer (EBC), and atezolizumab with doxorubicin and cyclophosphamide in HER2-negative breast cancer.
    Location: 8 locations

  • Pembrolizumab, Trastuzumab, Fluorouracil, and Combination Chemotherapy as First Line Therapy in Treating Patients with HER2-Positive Stage IV Esophagogastric Cancer

    This phase II trial studies how well pembrolizumab works when given together with trastuzumab and combination chemotherapy as first line therapy in treating patients with HER2-positive stage IV esophagogastric cancer. Monoclonal antibodies, such as pembrolizumab and trastuzumab, may block tumor growth in different ways by targeting certain cells. Drugs used in combination chemotherapy, such as capecitabine, cisplatin, oxaliplatin, and fluorouracil work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving pembrolizumab with trastuzumab and combination chemotherapy may work better as first line therapy in treating patients with esophagogastric cancer.
    Location: 7 locations

  • Randomized, Open Label, Clinical Study of the Targeted Therapy, Palbociclib, to Treat Metastatic Breast Cancer

    The primary objective of this study is to demonstrate that the combination of palbociclib with anti-HER2 therapy plus endocrine therapy is superior to anti-HER2-based therapy plus endocrine therapy alone in improving the outcomes of subjects with hormone receptor-positive, HER2+ metastatic breast cancer.
    Location: 10 locations

  • Ramucirumab, Trastuzumab, Capecitabine, and Cisplatin in Treating Patients with Stage IV HER2-Positive Gastroesophageal Junction or Gastric Cancer

    This phase II trial studies how well ramucirumab, trastuzumab, capecitabine, and cisplatin work in treating patients with stage IV human epidermal growth factor receptor (HER)2-positive gastroesophageal junction or gastric cancer. Ramucirumab may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as trastuzumab, may interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy, such as capecitabine and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving ramucirumab, trastuzumab, capecitabine, and cisplatin may kill more tumor cells in HER2-positive gastroesophageal junction or gastric cancer.
    Location: 6 locations

  • LJM716, Alpelisib, and Trastuzumab in Treating Patients with Metastatic HER2-Positive Breast Cancer

    This phase I trial studies the side effects and best dose of alpelisib when given together with anti-human epidermal growth factor receptor (HER)3 monoclonal antibody LJM716, and trastuzumab in treating patients with human epidermal growth factor receptor 2 (HER2)-positive breast cancer that has spread to other parts of the body. Alpelisib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as anti-HER3 monoclonal antibody LJM716 and trastuzumab, interfere with the ability of tumor cells to grow and spread. Giving alpelisib with anti-HER3 monoclonal antibody LJM716 and trastuzumab may be a better treatment for breast cancer.
    Location: 6 locations

  • Radiation Therapy and Sequential or Concurrent Combination Chemotherapy in Treating Patients with Estrogen Receptor-Negative Early Stage Breast Cancer

    This randomized phase II trial studies how well radiation therapy and sequential or concurrent combination chemotherapy works in treating patients with estrogen receptor-negative early stage breast cancer. Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Monoclonal antibodies, such as trastuzumab, may interfere with the ability of tumor cells to grow and spread. It is not yet known whether radiation therapy is more effective with sequential or concurrent combination chemotherapy in treating estrogen receptor-negative early stage breast cancer.
    Location: 6 locations

  • A Safety Extension Study of Trastuzumab Emtansine in Participants Previously Treated With Trastuzumab Emtansine Alone or in Combination With Other Anti-Cancer Therapy in One of the Parent Studies

    This is a global, multicenter, open-label safety extension study. Participants receiving single-agent trastuzumab emtansine or trastuzumab emtansine administered in combination with other agents in a Genentech / Roche-sponsored parent study who are active and deriving benefit at the closure of parent study are eligible for continued treatment in this study.
    Location: 6 locations

  • Everolimus, Letrozole, and Trastuzumab in Treating Patients with Hormone Receptor-Positive and HER2-Positive Advanced Metastatic Breast Cancer or Other Solid Tumors

    This phase I trial studies the side effects and best dose of everolimus and trastuzumab when given together with letrozole in treating patients with hormone receptor-positive and human epidermal growth factor (EGF) receptor 2 (HER2)-positive breast cancer or other solid tumors that have spread to other places in the body. Everolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Estrogen can cause the growth of breast cancer cells. Hormone therapy using letrozole may fight breast cancer by blocking the use of estrogen by tumor cells. Monoclonal antibodies, such as trastuzumab, may find tumor cells and help kill them. Giving everolimus, letrozole, and trastuzumab together may be a better treatment for breast cancer and other solid tumors.
    Location: 5 locations

  • Paclitaxel, Trastuzumab, and Pertuzumab before Surgery in Treating Patients with Inflammatory Breast Cancer

    This phase II trial studies how well paclitaxel, trastuzumab, and pertuzumab before surgery work in treating patients with inflammatory breast cancer. Drugs used in chemotherapy, such as paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Monoclonal antibodies, such as trastuzumab and pertuzumab, may interfere with the ability of tumor cells to grow and spread. Pertuzumab may also stop the growth of breast cancer by blocking blood flow to the tumor. Giving paclitaxel, trastuzumab, and pertuzumab may work better in treating breast cancer.
    Location: 6 locations

  • Taselisib and Anti-HER2 Therapy in Treating Patients with Advanced HER2+ Breast Cancer

    This phase Ib trial studies the side effects and best dose of taselisib when given with anti-human epidermal growth factor receptor 2 (HER2) therapies in treating patients with HER2 positive (HER2+) breast cancer that has spread to other places in the body and usually cannot be cured or controlled with treatment. Taselisib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as trastuzumab emtansine, pertuzumab, and trastuzumab, may block tumor growth in different ways by targeting certain cells. Drugs used in chemotherapy, such as paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Estrogen can cause the growth of breast cancer cells. Antihormone therapy, such as fulvestrant, may lessen the amount of estrogen made by the body. It is not yet known whether taselisib works better when given together with trastuzumab emtansine, pertuzumab, and trastuzumab, or with pertuzumab, trastuzumab, paclitaxel, and fulvestrant in treating patients with breast cancer.
    Location: 5 locations

  • Genetic Analysis-Guided Irinotecan Hydrochloride Dosing of mFOLFIRINOX in Treating Patients with Locally Advanced Gastroesophageal or Stomach Cancer

    This pilot phase I trial studies genetic analysis-guided irinotecan hydrochloride dosing of modified fluorouracil, irinotecan hydrochloride, leucovorin calcium, oxaliplatin (mFOLFIRINOX) with or without trastuzumab in treating patients with gastroesophageal or stomach cancer that has spread from where it started to nearby tissue or lymph nodes. Drugs used in chemotherapy, such as fluorouracil, irinotecan hydrochloride, leucovorin calcium, and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Leucovorin calcium may also help fluorouracil work better. Trastuzumab binds to human epidermal growth factor 2 (HER2) on the surface of HER2-positive cancer cells, and may kill tumor cells. Genetic analysis may help doctors determine what dose of irinotecan hydrochloride patients can tolerate.
    Location: 4 locations

  • Ruxolitinib Phosphate and Trastuzumab in Treating Patients with Metastatic HER2-Positive Breast Cancer

    This phase I / II trial studies the side effects and best dose of ruxolitinib phosphate when given together with trastuzumab and to see how well they work in treating patients with breast cancer that has spread to other parts of the body and is positive for human epidermal growth factor receptor 2 (HER2), a protein that may be present on the surface of cancer cells. Ruxolitinib phosphate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Trastuzumab is a type of drug called a monoclonal antibody and may block tumor growth by targeting tumor cells with HER2 on their surface and causing them to die. Giving ruxolitinib phosphate together with trastuzumab may be a better treatment for breast cancer.
    Location: 4 locations

  • Paclitaxel and Cyclophosphamide with or without Trastuzumab before Surgery in Treating Patients with Previously Untreated Breast Cancer

    This phase II trial studies the side effects and how well giving paclitaxel and cyclophosphamide with or without trastuzumab before surgery works in treating patients with previously untreated breast cancer. Drugs used in chemotherapy, such as paclitaxel and cyclophosphamide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as trastuzumab, may block tumor growth in different ways by targeting certain cells. Giving combination chemotherapy with or without trastuzumab before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.
    Location: 4 locations

  • Palbociclib in Treating Patients with Metastatic HER-2 Positive Breast Cancer with Brain Metastasis

    The purpose of this study is to evaluate if the study drug palbociclib has anti-tumor activity against the breast cancer that has spread to the brain and also to determine the overall radiographic response rate in the central nervous system (CNS). Palbociclib is an anti-cancer medication that has been shown to stop cancer cells from growing. It has been approved in hormone positive breast cancer, along with other hormone therapies and has been found to be effective. The preclinical studies suggest that the drug may also have activity in other types of breast cancer, such as human epidermal growth factor receptor 2 (HER2) positive breast cancer. The purpose of this study is to see if the study drug is effective in patients with brain metastasis, who have HER2-positive breast cancer.
    Location: 3 locations

  • TAPUR: Testing the Use of Food and Drug Administration (FDA) Approved Drugs That Target a Specific Abnormality in a Tumor Gene in People With Advanced Stage Cancer

    The purpose of the study is to learn from the real world practice of prescribing targeted therapies to patients with advanced cancer whose tumor harbors a genomic variant known to be a drug target or to predict sensitivity to a drug. NOTE: Due to character limits, the arms section does NOT include all TAPUR Study relevant biomarkers. For additional information, contact TAPUR@asco.org, or if a patient, your nearest participating TAPUR site (see participating centers).
    Location: 4 locations

  • Ribociclib with Trastuzumab or Trastuzumab Emtansine in Treating Patients with Locally Advanced or Metastatic HER2-Positive Breast Cancer

    This phase Ib / II trial studies the side effects and best dose of ribociclib with trastuzumab or trastuzumab emtansine and to see how well they work in treating patients with breast cancer that has spread from where it started to nearby tissue or lymph nodes or other places in the body and is human epidermal growth factor receptor 2 (HER2)-positive. Ribociclib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as trastuzumab, block tumor growth in different ways by targeting certain cells. Immunotoxins, such as trastuzumab emtansine, are antibodies linked to a toxic substance and may help find tumor cells and kill them without harming normal cells. Giving ribociclib with trastuzumab emtansine or trastuzumab may work better in treating patients with breast cancer.
    Location: 3 locations


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