Clinical Trials Using Neratinib

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Clinical trials are research studies that involve people. The clinical trials on this list are studying Neratinib. 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 1-10 of 10
  • 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

  • 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

  • An Open-label, Phase 2 Study of Neratinib in Patients With Solid Tumors With Somatic Human Epidermal Growth Factor Receptor (EGFR, HER2, HER3) Mutations or EGFR Gene Amplification

    This is an open-label, multicenter, multinational, Phase 2 study exploring the efficacy and safety of neratinib therapy in patients with solid tumors with activating HER2, HER3 or EGFR mutations or with EGFR gene amplification.
    Location: 9 locations

  • A Study Looking the Incidence and Severity of Diarrhea in Patients With Early-Stage HER2+ Breast Cancer Treated With Neratinib and Loperamide

    An Open-Label Study to Characterize the Incidence and Severity of Diarrhea in Patients with Early-Stage HER2+ Breast Cancer Treated with Neratinib and Intensive Loperamide Prophylaxis
    Location: 7 locations

  • Abemaciclib, DNA-PK / TOR Kinase Inhibitor CC-115, or Neratinib in Treating Patients with Brain Tumors after Biomarker Screening

    This randomized phase II trial studies how well abemaciclib, DNA-PK / TOR Kinase Inhibitor CC-115, or neratinib works in treating patients with brain tumors after biomarker screening. Drugs such as abemaciclib, DNA-PK / TOR Kinase Inhibitor CC-115, or neratinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Screening tumor samples for biomarkers may help doctors to determine if certain treatments work better on patients with certain biomarkers. Giving abemaciclib, DNA-PK / TOR kinase inhibitor CC-115, or neratinib may work better in treating patients with brain tumors.
    Location: 7 locations

  • Neratinib in Treating Older Patients with Stage IV HER2-Positive Breast Cancer

    This phase II trial studies the side effects of and how well neratinib works in treating older patients with stage IV HER2-positive breast cancer. Neratinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
    Location: 6 locations

  • Trastuzumab, Neratinib, Loperamide Hydrochloride, and Crofelemer in Reducing Severity of Diarrhea in Patients with Stage II-IIIC Breast Cancer

    This phase II trial studies the side effects and how well trastuzumab, neratinib, loperamide hydrochloride, and crofelemer work in reducing severity of diarrhea in patients with stage II-IIIC breast cancer. Monoclonal antibodies, such as trastuzumab, may interfere with the ability of tumor cells to grow and spread. Neratinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Loperamide hydrochloride and crofelemer may reduce the severity of diarrhea. Giving rastuzumab, neratinib, loperamide hydrochloride, and crofelemer may work better in treating patients with stage II-IIIC breast cancer.
    Location: UCSF Medical Center-Mount Zion, San Francisco, California

  • Neratinib in Treating Pediatric Patients with Recurrent or Refractory Solid Tumors or Hematologic Malignancies

    This phase I / II trial studies the side effects and best dose of neratinib and to see how well it works in treating pediatric patients with solid tumors, lymphoma, or leukemia that has come back or has not responded to previous treatment. Neratinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.
    Location: Memorial Sloan-Kettering Cancer Center, New York, New York

  • A Dose-Escalation Study Evaluating the Combination of Trastuzumab Emtansine (T-DM1) With Neratinib in Women With Metastatic HER2-Positive Breast Cancer

    This study is being done for the following reasons: - The study has two parts. The purpose of the first part (Phase I) of the study is to find out the highest dose of neratinib that can be given safely with T-DM1. - The purpose of the second part of the study (Phase II) is to find out whether the dose of neratinib with T-DM1 determined in Phase I will keep breast cancer from getting worse for a period of time. - In order to learn more about study therapy levels in blood and discover genetic and protein changes associated with cancer, the study includes special research tests using samples from blood and from breast tumor. Blood samples will be collected before study treatment, once during treatment, and after study treatment stops. - In the optional part of this study, three biopsies will be performed to obtain fresh tumor samples from an area where your cancer has spread.
    Location: University of Pittsburgh Cancer Institute (UPCI), Pittsburgh, Pennsylvania

  • Neratinib and Paclitaxel with or without Pertuzumab and Trastuzumab before Combination Chemotherapy in Treating Patients with Metastatic or Locally Advanced Breast Cancer

    This phase I / II trial studies the side effect and best dose of neratinib and to see how well it works with paclitaxel and with or without pertuzumab and trastuzumab before combination chemotherapy in treating patients with breast cancer that has spread to other places in the body. Neratinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as pertuzumab and trastuzumab, may interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy, such as paclitaxel, doxorubicin hydrochloride, and cyclophosphamide, 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 neratinib, pertuzumab, trastuzumab, paclitaxel and combination chemotherapy may work better in treating patients with breast cancer.
    Location: M D Anderson Cancer Center, Houston, Texas