Clinical Trials Using Trastuzumab

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 57
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  • S1613, Trastuzumab and Pertuzumab or Cetuximab and Irinotecan Hydrochloride in Treating Patients with Locally Advanced or Metastatic HER2 / Neu Amplified Colorectal Cancer That Cannot Be Removed by Surgery

    This randomized phase II trial studies how well trastuzumab and pertuzumab work compared to cetuximab and irinotecan hydrochloride in treating patients with HER2 / neu amplified colorectal cancer that has spread from where it started to other places in the body and cannot be removed by surgery. Monoclonal antibodies, such as trastuzumab and pertuzumab, may interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy, such as cetuximab and irinotecan hydrochloride, 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 trastuzumab and pertuzumab may work better compared to cetuximab and irinotecan hydrochloride in treating patients with colorectal cancer.
    Location: 650 locations

  • A Study of Tucatinib vs. Placebo in Combination With Capecitabine & Trastuzumab in Patients With Advanced HER2+ Breast Cancer

    This study is being done to see if tucatinib works better than placebo to help patients who have a specific type of breast cancer called HER2 positive breast carcinoma. The breast cancer in this study is either metastatic (spread into other parts of the body) or cannot be removed completely with surgery. All patients in the study will get capecitabine and trastuzumab, two drugs that are often used to treat this cancer. Patients in this study will be randomly assigned to get either tucatinib or placebo (a pill with no medicine). This is a blinded study, so neither patients nor their doctors will know whether a patient gets tucatinib or placebo. Each treatment cycle lasts 21 days. Patients will swallow tucatinib pills or placebo pills two times every day. They will swallow capecitabine pills two times a day during the first two weeks of each cycle. Patients will get trastuzumab injections from the study site staff on the first day of every cycle.
    Location: 30 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: 25 locations

  • Neratinib HER Mutation Basket Study (SUMMIT)

    This is an open-label, non-randomized, multicenter, multinational, Phase 2 study exploring the efficacy and safety of neratinib as monotherapy or in combination with other therapies in patients with ERBB mutation-positive or EGFR gene-amplified solid tumors.
    Location: 23 locations

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

    This study will examine the safety and tolerability of SGN-LIV1A (ladiratuzumab vedotin) in patients with metastatic breast cancer. SGN-LIV1A will be given every 3 weeks alone or in combination with trastuzumab.
    Location: 19 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: 20 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: 15 locations

  • Trastuzumab, Vinorelbine Tartrate, and Avelumab with or without Utomilumab in Treating Patients with HER2-Positive Metastatic Breast Cancer

    This phase II trial studies the how well trastuzumab, vinorelbine tartrate, and avelumab with or without utomilumab work in treating patients with HER2-positive breast cancer that has spread to other parts of the body. Monoclonal antibodies, such as trastuzumab, avelumab, and utomilumab, may interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy, such as vinorelbine tartrate, 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 trastuzumab, vinorelbine tartrate, and avelumab with or without utomilumab may work better in treating patients with breast cancer.
    Location: 13 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: 12 locations

  • Tucatinib (ONT-380) and Trastuzumab in Treating Patients with HER2+ Metastatic Colorectal Cancer

    This phase II trial studies how well the HER2 inhibitor tucatinib (ONT-380, ARRY-380) works in combination with trastuzumab in treating patients with HER2-positive (HER2+) metastatic colorectal cancer (CRC). Tucatinib may stop the growth of tumor cells by blocking HER2, a receptor needed for cell growth in patients with HER2+ tumors. Monoclonal antibodies, such as trastuzumab, may interfere with the ability of HER2+ tumor cells to grow and spread. Giving tucatinib and trastuzumab in combination may work better in treating patients with HER2+ metastatic CRC.
    Location: 9 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: 8 locations

  • Carboplatin with or without Pembrolizumab in Treating Patients with Advanced Breast Cancer with Locally Recurrent Chest Wall Disease That Cannot Be Removed by Surgery

    This randomized phase II trial studies how well carboplatin with or without pembrolizumab work in treating patients with breast cancer that has spread to other places in the body with chest wall disease that has come back and cannot be removed by surgery. Monoclonal antibodies, such as carboplatin and pembrolizumab, may interfere with the ability of tumor cells to grow and spread.
    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: 8 locations

  • Radiation Therapy and Sequential or Concurrent Combination Chemotherapy in Treating Patients with 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 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 early stage breast cancer.
    Location: 7 locations

  • Response to Paclitaxel, Trastuzumab, and Pertuzumab before Surgery in Determining Treatment after Surgery in Patients with Stage II-III HER2-Positive Breast Cancer

    This phase I trial studies whether the response to paclitaxel, trastuzumab, and pertuzumab before surgery helps to determine treatment after surgery in patients with stage II-III HER2-positive breast cancer. Drugs used in chemotherapy, such as paclitaxel, trastuzumab, and pertuzumab, 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. Evaluating the response to paclitaxel, trastuzumab, and pertuzumab before surgery may help patients and doctors determine treatment options after surgery.
    Location: 6 locations

  • A Study of ALX148 in Patients With Advanced Solid Tumors and Lymphoma

    A phase 1, dose escalation study of ALX148 in patients with advanced solid tumors and lymphoma
    Location: 5 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

  • 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. Immunotherapy with monoclonal antibodies, such as trastuzumab emtansine, pertuzumab, and trastuzumab, may help the body’s immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. 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

  • 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

  • Pembrolizumab / Placebo Plus Trastuzumab Plus Chemotherapy in Human Epidermal Growth Factor Receptor 2 Positive (HER2+) Advanced Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma (MK-3475-811 / KEYNOTE-811)

    The study will compare the efficacy and safety of pembrolizumab plus trastuzumab in combination with standard of care (SOC) chemotherapy versus trastuzumab in combination with SOC chemotherapy in participants with HER2-positive gastric cancer. The primary hypotheses of the study are that pembrolizumab plus trastuzumab in combination with chemotherapy is superior to trastuzumab plus chemotherapy in terms of 1) progression free survival (PFS) per Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1) as assessed by blinded independent central review (BICR), and 2) overall survival (OS).
    Location: 5 locations

  • DS-8201a in Pre-treated HER2 Breast Cancer That Cannot be Surgically Removed or Has Spread [DESTINY-Breast02]

    This study will compare DS 8201a to standard treatment. Participants must have HER2 breast cancer that has been treated before. Their cancer: - cannot be removed by an operation - has spread to other parts of the body
    Location: 5 locations

  • Trastuzumab, Pertuzumab, and Combination Chemotherapy in Treating Patients with Locally Advanced, Resectable, or Inflammatory Her2 Positive Breast Cancer

    This phase II trial studies how well trastuzumab, pertuzumab, and combination chemotherapy work in treating patients with Her2 positive breast cancer that has spread from where it started to nearby tissue or lymph nodes, can be removed by surgery, or is inflammatory. Immunotherapy with monoclonal antibodies, such as trastuzumab and pertuzumab, may help the body’s immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy, such as doxorubicin, cyclophosphamide, paclitaxel, docetaxel, and carboplatin, 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 trastuzumab, pertuzumab, and combination chemotherapy may work better in treating patients with breast cancer.
    Location: 3 locations

  • Anastrozole, Palbociclib, Trastuzumab and Pertuzumab in Treating Participants with HR-Positive, HER2-Positive Metastatic Breast Cancer

    This phase I / II trial studies the side effects and best dose of anastrozole, palbociclib, trastuzumab and pertuzumab and how well they work in treating participants with hormone receptor-(HR) positive, HER2-positive breast cancer that has spread to other locations in the body. Anastrozole and palbociclib are enzyme inhibitors that may stop the growth of tumor cells by blocking some of the enzymes needed cell growth. Monoclonal antibodies, such as trastuzumab and pertuzumab may interfere with the ability of tumor cells to grow and spread. Giving anastrozole, palbociclib, trastuzumab and pertuzumab may work better in treating participants with HR+, HER2+ metastatic breast cancer.
    Location: 6 locations

  • SYD985 vs. Physician's Choice in Participants With HER2-positive Locally Advanced or Metastatic Breast Cancer

    The purpose of this study is to demonstrate that SYD985 [(vic-)trastuzumab duocarmazine] is superior to physician's choice in prolonging progression free survival.
    Location: 3 locations


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