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 64
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  • Targeted Therapy Directed by Genetic Testing in Treating Patients with Advanced Refractory Solid Tumors, Lymphomas, or Multiple Myeloma (The MATCH Screening Trial)

    This phase II MATCH trial studies how well treatment that is directed by genetic testing works in patients with solid tumors or lymphomas that have progressed following at least one line of standard treatment or for which no agreed upon treatment approach exists. Genetic tests look at the unique genetic material (genes) of patients' tumor cells. Patients with genetic abnormalities (such as mutations, amplifications, or translocations) may benefit more from treatment which targets their tumor's particular genetic abnormality. Identifying these genetic abnormalities first may help doctors plan better treatment for patients with solid tumors, lymphomas, or multiple myeloma.
    Location: 1196 locations

  • 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 (advanced / metastatic) and cannot be removed by surgery. Trastuzumab is a form of “targeted therapy” because it works by attaching itself to specific molecules (receptors) on the surface of cancer cells, known as HER2 receptors. When trastuzumab attaches to HER2 receptors, the signals that tell the cells to grow are blocked and the cancer cell may be marked for destruction by the body’s immune system. Immunotherapy with monoclonal antibodies, such as pertuzumab and cetuximab, 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 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: 735 locations

  • Testing the Drug Atezolizumab or Placebo with Usual Therapy in First-Line HER2-Positive Metastatic Breast Cancer

    This randomized phase III trial studies how well paclitaxel, trastuzumab, and pertuzumab with or without atezolizumab works in treating patients with breast cancer that has spread to other parts of the body (metastatic). 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. Trastuzumab is a form of “targeted therapy” because it works by attaching itself to specific molecules (receptors) on the surface of cancer cells, known as HER2 receptors. When trastuzumab attaches to HER2 receptors, the signals that tell the cells to grow are blocked and the cancer cell may be marked for destruction by the body’s immune system. Monoclonal antibodies, such as pertuzumab, may interfere with the ability of cancer cells to grow and spread. Immunotherapy with monoclonal antibodies, such as atezolizumab, may induce changes in body’s immune system and may interfere with the ability of tumor cells to grow and spread. It is not yet known whether giving paclitaxel, trastuzumab, and pertuzumab with or without atezolizumab may kill more tumor cells.
    Location: 489 locations

  • Testing the Ability to Decrease Chemotherapy in Patients with HER2-Positive Breast Cancer Who Have No Remaining Cancer at Surgery after Limited Pre-operative Chemotherapy and HER2-Targeted Therapy

    This trial studies how well paclitaxel, trastuzumab, and pertuzumab work in eliminating further chemotherapy after surgery in patients with HER2-positive stage II-IIIa breast cancer who have no cancer remaining at surgery (either in the breast or underarm lymph nodes) after pre-operative chemotherapy and HER2-targeted therapy. 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. Trastuzumab is a form of “targeted therapy” because it works by attaching itself to specific molecules (receptors) on the surface of tumor cells, known as HER2 receptors. When trastuzumab attaches to HER2 receptors, the signals that tell the cells to grow are blocked and the tumor cell may be marked for destruction by the body’s immune system. Pertuzumab is a monoclonal antibody that may interfere with the ability of tumor cells to grow and spread. Giving paclitaxel, trastuzumab, and pertuzumab may enable fewer chemotherapy drugs to be given without compromising patient outcomes compared to the usual treatment.
    Location: 449 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: 30 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 (metastatic). Trastuzumab is a form of targeted therapy because it attaches itself to specific molecules (receptors) on the surface of cancer cells, known as HER2 receptors. When trastuzumab attaches to HER2 receptors, the signals that tell the cells to grow are blocked and the cancer cell may be marked for destruction by the body's immune system. Immunotherapy with monoclonal antibodies, such as avelumab, may induce changes in the body's immune system and 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. Utolimumab is a monoclonal antibody that may interfere with the ability of tumor cells to grow and spread. Giving trastuzumab, vinorelbine tartrate, and avelumab with or without utomilumab may work better in treating patients with breast cancer.
    Location: 26 locations

  • Neratinib HER Mutation Basket Study

    This is an open-label, multicenter, multinational, Phase 2 basket study exploring the efficacy and safety of neratinib as monotherapy or in combination with other therapies in participants with HER (EGFR, HER2) mutation-positive solid tumors.
    Location: 26 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 alone or in combination with trastuzumab.
    Location: 16 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: 18 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: 13 locations

  • Tucatinib Plus Trastuzumab in Patients With HER2+ Colorectal Cancer

    This trial studies how well the drug tucatinib works when given with trastuzumab and when given by itself. The participants in this trial have HER2-positive (HER2+) metastatic colorectal cancer (mCRC). 'Metastatic' means that the cancer has spread to other parts of the body. In the first part of this study, participants enrolled into Cohort A and received both tucatinib and trastuzumab. In the second part of this study, participants are randomly assigned to either Cohort B or Cohort C. Participants in Cohort B will receive tucatinib and trastuzumab. Participants in Cohort C will receive tucatinib. Participants in Cohort C who do not respond to therapy may have an option to receive tucatinib plus trastuzumab.
    Location: 14 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). ********************************************************************************************* ********************************************************************************* Results will be made available at the end of study, but you can review individual cohort results at www.tapur.org / news as they become available. These individual cohort results are published in abstract, poster, and / or manuscript format and links to all are available on the study website. Indexing of available results on PubMed is ongoing. ********************************************************************************************* *********************************************************************************
    Location: 10 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: 10 locations

  • Neratinib, Capecitabine, and Trastuzumab Emtansine in Treating Patients with HER2-Positive Breast Cancer That Has Spread to the Brain

    This phase II trial studies how well neratinib, capecitabine, and trastuzumab emtansine work in treating patients with human epidermal growth factor receptor 2 (HER2)-positive breast cancer that has spread to the brain. Neratinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as capecitabine, 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. Trastuzumab emtansine (T-DM1) is a monoclonal antibody, called trastuzumab, linked to a chemotherapy drug called DM1. Trastuzumab attaches to HER2 positive cancer cells in a targeted way and delivers DM1 to kill them. Giving neratinib, capecitabine, and trastuzumab emtansine together may be an effective treatment for breast cancer.
    Location: 10 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: 10 locations

  • A Study of Tucatinib vs. Placebo in Combination With Ado-trastuzumab Emtansine (T-DM1) for Patients With Advanced or Metastatic HER2+ Breast Cancer

    This study is being done to see if tucatinib with ado-trastuzumab emtansine (T-DM1) works better than T-DM1 alone 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. 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. All patients in the study will get T-DM1, a drug that is often used to treat this cancer. Each treatment cycle lasts 21 days. Patients will swallow tucatinib pills or placebo pills two times every day. Patients will get T-DM1 injections from the study site staff on the first day of every cycle.
    Location: 14 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. Trastuzumab is a form of “targeted therapy” because it works by attaching itself to specific molecules (receptors) on the surface of cancer cells, known as HER2 receptors. When trastuzumab attaches to HER2 receptors, the signals that tell the cells to grow are blocked and the cancer cell may be marked for destruction by the body’s immune system. It is not yet known whether radiation therapy is more effective with sequential or concurrent combination chemotherapy in treating early stage breast cancer.
    Location: 8 locations

  • Combination Margetuximab, INCMGA00012, MGD013, and Chemotherapy Phase 2 / 3 Trial in HER2+ Gastric / GEJ Cancer (MAHOGANY)

    This is a Phase 2 / 3, randomized, open-label study for the treatment of patients with HER2-positive Gastric cancer (GC) or Gastroesophageal Junction (GEJ) cancer to determine the efficacy of margetuximab combined with INCMGA00012 (also known as MGA012) (Cohort A) and margetuximab combined with INCMGA00012 or MGD013 and chemotherapy compared to trastuzumab combined with chemotherapy (Cohort B).
    Location: 9 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 (advanced) with chest wall disease that has come back (locally recurrent) and cannot be removed by surgery. Drugs used in chemotherapy, such as carboplatin, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and 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. Immunotherapy with monoclonal antibodies, such as pembrolizumab 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 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

  • Open-Label, Dose-Escalation Study of Pemigatinib in Subjects With Advanced Malignancies - (FIGHT-101)

    The purpose of this study will be to evaluate the safety, tolerability, and pharmacological activity of pemigatinib in subjects with advanced malignancies. This study will have three parts, dose escalation (Part 1), dose expansion (Part 2) and combination therapy (Part 3).
    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, 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. Trastuzumab and pertuzumab are monoclonal antibodies that may interfere with the ability of tumor cells to grow and spread. Evaluating the response to paclitaxel, trastuzumab, and pertuzumab before surgery may help patients and doctors determine treatment options after surgery.
    Location: 6 locations

  • Chemotherapy with or without Metformin Hydrochloride in Treating Patients with HER2 Positive Breast Cancer That Can Be Removed by Surgery

    This randomized phase II trial studies how well chemotherapy with or without metformin hydrochloride work in treating patients with HER2 positive breast cancer that can be removed by surgery. Drugs used in chemotherapy, such as docetaxel, carboplatin, trastuzumab, pertuzumab, and pegfilgrastim, 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. Metformin hydrochloride may prevent or lower risk of breast cancer and decrease cancer cells, lower risk of cancer spreading. It is not yet known whether giving metformin hydrochloride with chemotherapy will work better in treating patients with breast cancer.
    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: 6 locations

  • Study of Neoadjuvant Chemotherapy Plus Trastuzumab and Pertuzumab in HER2-Negative Breast Cancer Patients With Abnormal HER2 Signaling

    This is a prospective, single arm, open label, multicenter interventional study designed to evaluate the efficacy of neoadjuvant chemotherapy with anti-HER2 antibodies in patients with HER2-negative invasive breast cancer who have abnormal HER2 signaling activity determined by the Celcuity CELx HER2 Signaling Function (HSF) testing.
    Location: 5 locations


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