Treatment Clinical Trials for Breast Neoplasm

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Clinical trials are research studies that involve people. The clinical trials on this list are for breast neoplasm treatment. 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 426-450 of 459

  • Phase Ib / II Study of MCS110 in Combination With PDR001 in Patients With Advanced Malignancies

    The purpose of this study of MCS110 with PDR001 is to characterize the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and antitumor activity of the combination of MCS110 with PDR001 in adult patients with solid tumors.
    Location: 5 locations

  • Randomized Phase 2 Study of Atezolizumab and Entinostat in Patients With aTN Breast Cancer With Phase 1b Lead In

    The purpose of this study is to determine the safety and tolerability of entinostat used in combination with atezolizumab in patients with Advanced Triple Negative Breast Cancer (aTNBC). Additionally the purpose of the study is to assess how effective entinostat and atezolizumab are in combination in patients with aTNBC.
    Location: 3 locations

  • A Double-blind Study of Paclitaxel in Combination With Reparixin or Placebo for Metastatic Triple-Negative Breast Cancer

    Reparixin oral tablets are being tested as a CSC targeting agent in patients with metastatic non- human epidermal growth factor receptor (HER2)-amplified BC. An open label Phase 1b clinical study (REP0111) is ongoing (enrollment completed) in five US sites, under IND # 112502, to test safety, tolerability, pharmacokinetics and detect early signs of antitumor activity of increasing doses of reparixin oral tablets in combination with a fixed dose of weekly paclitaxel. The study has demonstrated safety and tolerability of the combination across the three dose levels explored and recorded objective responses in the published range for single agent weekly paclitaxel in the target population. The highest dose level explored (i.e., 1200 mg t.i.d.) was identified as the recommended phase 2 dose. Durable responses have been recorded in patients with TNBC. The current phase 2 study thus aims to evaluate the Progression Free Survival of patients with metastatic TNBC [newly diagnosed metastatic or relapsed following (neo)adjuvant chemotherapy] receiving reparixin in combination with paclitaxel versus paclitaxel alone.
    Location: 3 locations

  • A PD Study of Oral eFT508 in Subjects With Advanced TNBC and HCC

    This study will evaluate the pharmacodynamic (PD), safety, antitumor activity, and PK of eFT508 in female subjects who have pathologically documented, radiographically measurable, metastatic or locally advanced and unresectable TNBC and have received prior cancer therapy regimen for metastatic disease, and in male and female subjects who have histologically or cytologically confirmed advanced HCC not amenable to surgical resection and have failed systemic therapy.
    Location: City of Hope Comprehensive Cancer Center, Duarte, California

  • Paclitaxel, Trastuzumab, and Pertuzumab with or without Pembrolizumab in Treating Patients with Metastatic Breast Cancer

    This randomized phase III trial studies how well paclitaxel, trastuzumab, and pertuzumab with or without pembrolizumab works in treating patients with breast cancer that has spread to other parts of the body. 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, pertuzumab, and pembrolizumab, may interfere with the ability of tumor cells to grow and spread. Giving paclitaxel, trastuzumab, and pertuzumab with pembrolizumab may kill more tumor cells.
    Location: NRG Oncology, Philadelphia, Pennsylvania

  • Ribociclib and Aromatase Inhibitor in Treating Older Participants with Hormone Receptor Positive Metastatic Breast Cancer

    This phase IIA trial studies the side effects of ribociclib and aromatase inhibitor and how well they work in treating participants with hormone receptor positive breast cancer that has spread to other places in the body. Ribociclib and aromatase inhibitors may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
    Location: 4 locations

  • Radiofrequency Tagged Surgery in Treating Patients with Breast Cancer

    This pilot clinical trial studies how well radiofrequency tagged surgery works in treating patients with breast cancer. Tagging radiofrequency markers to lymph nodes in the area of the armpit (axilla) to which cancer has spread may help doctors more accurately identify lymph nodes for removal.
    Location: UCLA / Jonsson Comprehensive Cancer Center, Los Angeles, California

  • A Study of TAS0728 in Patients With Solid Tumors With HER2 or HER3 Abnormalities

    This is a First-in-Human (FIH), 2-part, Phase 1 / 2, open-label, multicenter study design to evaluate the safety, tolerability, PK, pharmacodynamics, PGx, and efficacy of TAS0728. This study consists of Phase 1 and Phase 2a components in subjects with advanced solid tumors with HER2 or HER3 overexpression, amplification, or mutation who have progressed despite standard therapy or for which no standard therapy exists, particularly urothelial cancer, biliary tract cancer, metastatic breast cancer, non-small cell lung cancer and colorectal cancer.
    Location: Emory University Hospital / Winship Cancer Institute, Atlanta, Georgia

  • A Dose Escalation and Confirmation Study of PT-112 in Advanced Solid Tumors in Combination With Avelumab

    This is a Phase 1b / 2a, open-label, multi-center, non-randomized, dose-escalation study of PT-112 in combination with the anti-PD-L1 antibody, avelumab, in selected advanced solid tumors. The study is to be conducted in two parts: the Dose Escalation Phase of PT-112 within the combination and the Dose Confirmation Phase. The Dose Escalation Phase will determine the Maximum Tolerated Dose (MTD) and recommended Phase 2 dose (RP2D) of PT-112 in the combination as avelumab will be administered at a flat dose of 800 mg. The trial will evaluate the PK (pharmacokinetic) effects of PT-112 and the safety and tolerability of the combination as well as preliminary clinical effects. The Dose Confirmation Phase will consist of two additional cohorts in patients with non-small cell lung cancer or urothelial carcinoma who will be treated at or below the MTD of PT-112 in the combination.
    Location: University of Colorado Hospital, Aurora, Colorado

  • Phase I Trial of Endoxifen Gel versus Placebo in Women Undergoing Breast Surgery

    This randomized phase I trial studies the side effects and best dose of Z-endoxifen hydrochloride in treating participants who are undergoing breast surgery. Z-endoxifen hydrochloride may treat or reduce the risk of breast cancer.
    Location: 3 locations

  • Endocrine Therapy in Treating Patients with HER2 Negative, Low Risk Breast Cancer

    This pilot phase IV trial studies how well endocrine therapy works in treating patients with HER2 negative, low risk breast cancer. Estrogen can cause the growth of breast cancer cells. Endocrine therapies such as aromatase inhibitors and selective estrogen receptor modulators may lessen the amount of estrogen made by the body.
    Location: Fred Hutch / University of Washington Cancer Consortium, Seattle, Washington

  • Dose-escalation Study of BAY1129980

    The purpose of this study is to evaluate: - The side effects of BAY1129980 when given every 21 days different dose levels. - Determine the dose level of BAY1129980 that should be tested in future clinical research studies. - Measure how much BAY1129980 is in the blood at specific times after administration. - If treatment with BAY1129980 shows any effect on reducing the tumor growth. - If there are specific biomarkers that might be able to explain why some patients respond to treatment and others do not. - If treatment with BAY1129980 causes an immune response from the body against the drug (immunogenicity).
    Location: 8 locations

  • Safety and Efficacy Study of MLN0128 in Combination With Exemestane or Fulvestrant in Postmenopausal Women With ER / PR+ Metastatic Breast Cancer

    This is a phase 1b / 2 study of the safety and efficacy of MLN0128 in combination with exemestane or fulvestrant therapy in women with estrogen receptor positive / human epidermal growth factor receptor 2 negative (ER+ / HER2-) advanced or metastatic breast cancer that has progressed on treatment with everolimus in combination with exemestane or fulvestrant.
    Location: 4 locations

  • Anti-M-CSF Monoclonal Antibody MCS110, Dose-Dense Doxorubicin Hydrochloride, Cyclophosphamide, and Paclitaxel in Treating Patients with Estrogen Receptor Positive and HER2 Negative Stage II-III Breast Cancer

    This phase I trial studies the side effects and best dose of anti-M-CSF monoclonal antibody MCS110 when giving together with dose-dense doxorubicin hydrochloride, cyclophosphamide, and paclitaxel in treating patients with estrogen receptor positive and HER2 negative stage II-III breast cancer. Monoclonal antibodies, such as anti-M-CSF monoclonal antibody MCS110, may interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy, such as doxorubicin hydrochloride, cyclophosphamide, and 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. Giving anti-M-CSF monoclonal antibody MCS110, doxorubicin hydrochloride, cyclophosphamide, and paclitaxel may work better in treating patients with breast cancer.
    Location: Siteman Cancer Center at Washington University, Saint Louis, Missouri

  • DNA Vaccine with or without Durvalumab in Treating Patients with Triple Negative Breast Cancer

    This randomized phase I trial studies the side effects of deoxyribonucleic acid (DNA) vaccine with or without durvalumab in treating patients with triple negative breast cancer. Vaccines made from DNA may help the body build an effective immune response to kill tumor cells that express breast cancer. Monoclonal antibodies, such as durvalumab, may interfere with the ability of tumor cells to grow and spread. Giving DNA vaccine with durvalumab may work better in treating patients with triple negative breast cancer.
    Location: Siteman Cancer Center at Washington University, Saint Louis, Missouri

  • Imipramine Hydrochloride before Surgery in Treating Patients with Triple Negative Breast Cancer

    This pilot phase I / II trial studies the side effects and best dose of imipramine hydrochloride before surgery and to see how well it works in treating patients with triple negative breast cancer. Imipramine hydrochloride is a tricyclic antidepressant that may be effective in decreasing the proliferation (multiplying) rate of triple negative breast cancer.
    Location: Cancer Therapy and Research Center at The UT Health Science Center at San Antonio, San Antonio, Texas

  • Stellate Ganglion Blockade with Bupivacaine Hydrochloride in Reducing Hot Flashes in Hispanic Patients with Breast Cancer

    This randomized pilot clinical trial studies how well a stellate ganglion blockade with bupivacaine hydrochloride works in reducing hot flashes in Hispanic patients with breast cancer. A stellate ganglion blockade using bupivacaine hydrochloride (a local anesthetic used to block signals at nerve endings) may help to reduce the number and severity of hot flashes in Hispanic patients with breast cancer.
    Location: Northwestern University, Chicago, Illinois

  • Paclitaxel and Carboplatin before Surgery in Treating Nigerian Women with Stage IIA-IIIC Breast Cancer

    This phase II trial studies how well paclitaxel works with carboplatin before surgery in treating Nigerian women with stage IIA-IIIC breast cancer before surgery. Drugs used in chemotherapy, such as paclitaxel 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.
    Location: University of Chicago Comprehensive Cancer Center, Chicago, Illinois

  • A Study of LY2835219 (Abemaciclib) in Combination With Therapies for Breast Cancer That Has Spread

    The main purpose of this study is to evaluate the safety of a study drug known as LY2835219 in combination with different therapies (letrozole, anastrozole, tamoxifen, exemestane, exemestane plus everolimus, trastuzumab, or LY3023414 plus fulvestrant) for breast cancer that has spread to other parts of the body.
    Location: 3 locations

  • Alisertib with or without Fulvestrant in Treating Patients with Locally Advanced or Metastatic, Endocrine-Resistant Breast Cancer

    This phase II trial studies how well alisertib with or without fulvestrant works in treating patients with endocrine-resistant breast cancer that has spread to other places in the body. Alisertib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Hormone therapy using fulvestrant may fight breast cancer by blocking the use of estrogen by the tumor cells or reducing the amount of estrogen made by the body. Giving alisertib with or without fulvestrant may work better in treating patients with breast cancer.
    Location: Mayo Clinic, Rochester, Minnesota

  • Durvalumab and Combination Chemotherapy in Treating Patients with Stage I-III Triple Negative Breast Cancer

    This phase I / II trial studies the side effects and best dose of durvalumab when given together with paclitaxel albumin-stabilized nanoparticle formulation, doxorubicin hydrochloride, and cyclophosphamide and to see how well they work in treating patients with stage I-III breast cancer that does not have estrogen receptors, progesterone receptors, or large amounts of human epidermal growth factor receptor (HER)2 / neu protein. Monoclonal antibodies, such as durvalumab, may interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy, such as paclitaxel albumin-stabilized nanoparticle formulation, 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 durvalumab together with paclitaxel albumin-stabilized nanoparticle formulation, doxorubicin hydrochloride, and cyclophosphamide may kill more tumor cells.
    Location: Yale University, New Haven, Connecticut

  • Viral Therapy In Treating Patients with Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck Cancer or Metastatic Breast Cancer

    This phase I trial studies the side effects and the best dose of viral therapy in treating patients with squamous cell carcinoma of the head and neck that has returned (come back) after a period of improvement or has spread to other parts of the body or breast cancer that has spread to other parts of the body. A virus called encoding thyroidal sodium iodide symporter, which has been changed in a certain way, may be able to kill tumor cells without damaging normal cells.
    Location: Mayo Clinic, Rochester, Minnesota

  • 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

  • Trastuzumab, Pertuzumab, Tocilizumab in Treating Participants with Metastatic or Unresectable HER2 Positive Breast Cancer

    This phase I trial studies the best dose and side effects of trastuzumab, pertuzumab and tocilizumab in treating participants with HER2 positive breast cancer that has spread to other places in the body or cannot be removed by surgery. Monoclonal antibodies such as trastuzumab, pertuzumab and tocilizumab, may interfere with the ability of tumor cells to grow and spread
    Location: University of Michigan Comprehensive Cancer Center, Ann Arbor, Michigan

  • Pembrolizumab and Binimetinib in Treating Patients with Locally Advanced or Metastatic Triple Negative Breast Cancer

    This phase I / II trial studies the best dose of pembrolizumab and binimetinib and how well it works when giving together with pembrolizumab in treating patients with triple negative breast cancer that has spread to other parts of the body. Monoclonal antibodies, such as pembrolizumab, may block tumor growth in different ways by targeting certain cells. Binimetinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving pembrolizumab and binimetinib may work better in treating patients with triple negative breast cancer.
    Location: Mayo Clinic in Florida, Jacksonville, Florida