Clinical Trials Using Neratinib

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 1-15 of 15
  • 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: 25 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

  • 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: 12 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

  • Capecitabine and Neratinib in Treating Patients with HER2 Positive Stage IV Breast Cancer

    This phase Ib / II trial studies the side effects and best dose of capecitabine when given together with neratinib and to see how well it works in treating patients with HER2 positive stage IV breast cancer. 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. Neratinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving capecitabine and neratinib may work better than capecitabine alone in treating patients with 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

  • Neratinib with or without Fulvestrant in Treating Patients with HER2 and Estrogen Receptor Positive Locally Advanced or Metastatic Breast Cancer That Cannot Be Removed by Surgery

    This randomized phase II trial studies how well neratinib with or without fulvestrant works in treating patients with HER2 and estrogen receptor positive breast cancer that has spread to other places in the body or cannot be removed by surgery. Neratinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and may stop breast cancer cells from growing abnormally by inhibiting (or blocking) members of a family of proteins that include HER2. Drugs used in chemotherapy, such as fulvestrant, 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. It is not yet known whether giving neratinib with or without fulvestrant will work better in treating patients with breast cancer.
    Location: 8 locations

  • 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: 7 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 Loperamide
    Location: 8 locations

  • 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: 2 locations

  • Neratinib and Divalproex Sodium in Treating Patients with Advanced Solid Tumors or RAS-Mutated Cancers

    This phase I / II trial studies the best dose of neratinib and divalproex sodium in treating patients with solid tumors that have spread to other places in the body (advanced) or advanced cancers that have a genetic mutation in the RAS gene. Neratinib and divalproex sodium may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
    Location: Virginia Commonwealth University / Massey Cancer Center, Richmond, Virginia

  • 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. Immunotherapy with pertuzumab and trastuzumab, may induce changes in body’s immune system and 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

  • 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 trastuzumab, 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 and Everolimus, Palbociclib, or Trametinib in Treating Participants with Refractory and Advanced or Metastatic Solid Tumors with EGFR Mutation / Amplification, HER2 Mutation / Amplification, or HER3 / 4 Mutation or KRAS Mutation

    This phase I trial studies the side effects and best dose of neratinib in combination with everolimus, palbociclib, or trametinib in participants with solid tumors with EGFR mutation / amplification, HER2 mutation / amplification, HER3 / 4 mutation, or KRAS mutation that do not respond to treatment and have spread to other parts of the body. Neratinib, palbociclib, and trametinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as everolimus, 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 with everolimus, palbociclib, or trametinib may work better than neratinib alone in treating participants with solid tumors.
    Location: M D Anderson Cancer Center, Houston, Texas

  • Study of Neratinib +Trastuzumab or Neratinib + Cetuximab in Patients With KRAS / NRAS / BRAF / PIK3CA Wild-Type Metastatic Colorectal Cancer by HER2 Status

    This is a phase II trial to examine the efficacy of neratinib plus trastuzumab or neratinib plus cetuximab in patients with "quadruple wild-type" (all RAS / NRAS / BRAF / PIK3CA wild-type), metastatic colorectal cancer based on HER2 status (amplified, non-amplified [wild-type] or mutated). Patients must have confirmed quadruple wild-type (WT) genotype, via NSABP MPR-1 or from colonic biopsy or a metastatic biopsy taken prior to treatment, and known HER2 status.
    Location: University of Pittsburgh Cancer Institute (UPCI), Pittsburgh, Pennsylvania