Treatment Clinical Trials for Breast Neoplasm

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 488

  • Dinaciclib and Pembrolizumab in Treating Participants with Metastatic or Locally Advanced Breast Cancer That is Unresectable

    This phase Ib trial studies the best dose and side effects of dinaciclib when given together with pembrolizumab in treating participants with breast cancer that has spread to other places in the body or to nearby tissues and lymph nodes and cannot be removed by surgery. Dinaciclib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as pembrolizumab, may interfere with the ability of tumor cells to grow and spread. Giving dinaciclib and pembrolizumab may work better in treating participants with breast cancer.
    Location: UCSF Medical Center-Mount Zion, San Francisco, California

  • Vaccine Therapy and Basiliximab in Treating Patients With Stage IV Breast Cancer

    This phase I trial studies the side effects and best way to give vaccine therapy and basiliximab in treating patients with stage IV breast cancer. Vaccines made from peptides or gene-modified viruses may help the body build an effective immune response to kill tumor cells. Monoclonal antibodies, such as basiliximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Giving vaccine therapy together with basiliximab may be an effective treatment for breast cancer.
    Location: University of Pennsylvania / Abramson Cancer Center, Philadelphia, Pennsylvania

  • Veliparib and Radiation Therapy before Surgery in Treating Patients with Stage IIB-IV Breast Cancer with Incomplete Response to Chemotherapy

    This phase I trial studies the side effects and best dose of veliparib when given together with radiation therapy before surgery in treating patients with stage IIB-IV breast cancer with incomplete response to chemotherapy. Veliparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Radiation therapy uses high energy x-rays to kill tumor cells. Giving veliparib together with radiation therapy before surgery may kill more tumor cells.
    Location: Indiana University / Melvin and Bren Simon Cancer Center, Indianapolis, Indiana

  • Phase III Study of BKM120 / Placebo With Fulvestrant in Postmenopausal Patients With Hormone Receptor Positive HER2-negative Locally Advanced or Metastatic Breast Cancer Refractory to Aromatase Inhibitor

    The purpose of this study is to determine wether the addition of daily BKM120 to fulvestrant is effective and safe in treating patients with hormone receptor-positive, HER2-negative locally advanced or metastatic breast cancer refractory to aromatase inhibitor.
    Location: Translational Research In Oncology (TRIO), Los Angeles, California

  • Eribulin Mesylate and Cyclophosphamide in Treating Patients with Solid Tumors

    This phase Ib / II trial studies the side effects and best dose of eribulin mesylate when giving together with cyclophosphamide and how well they work in treating patients with solid tumor. Drugs used in chemotherapy, such as eribulin mesylate 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.
    Location: UCSF Medical Center-Mount Zion, San Francisco, California

  • Bevacizumab and Temsirolimus Alone or in Combination with Valproic Acid or Cetuximab in Treating Patients with Advanced or Metastatic Malignancy or Other Benign Disease

    This phase I trial studies the side effects and best dose of bevacizumab and temsirolimus alone or in combination with valproic acid or cetuximab in treating patients with a malignancy that has spread to other places in the body or other disease that is not cancerous. Monoclonal antibodies, such as bevacizumab and cetuximab, may interfere with the ability of tumor cells to grow and spread. Temsirolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as valproic acid, 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 bevacizumab and temsirolimus work better when given alone or with valproic acid or cetuximab in treating patients with a malignancy or other disease that is not cancerous.
    Location: M D Anderson Cancer Center, Houston, Texas

  • Veliparib and Combination Chemotherapy in Treating Patients with Metastatic Pancreatic Cancer

    This phase I / II trial studies the side effects and best dose of veliparib when given together with combination chemotherapy and to see how well it works in treating patients with pancreatic cancer that has spread to other places in the body. Veliparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as fluorouracil, oxaliplatin, and leucovorin calcium, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving veliparib and combination chemotherapy may kill more tumor cells.
    Location: MedStar Georgetown University Hospital, Washington, District of Columbia

  • Combined Vaccine Therapy in Treating Patients with Metastatic Solid Tumors

    This phase I trial studies the side effects and best dose of a combined vaccine therapy and to see how well it works in treating patients with solid tumors that have spread to other parts of the body (metastatic). The cancer vaccine is made up of two proteins (that look like the tumor cells) mixed up with a special compound that may help train and boost the immune system to recognize and fight the tumor cells.
    Location: Ohio State University Comprehensive Cancer Center, Columbus, Ohio

  • Radiation Therapy in Treating Patients with Stage 0-II Breast Cancer

    This phase II trial studies the side effects and how well radiation therapy works in treating patients with stage 0-II breast cancer. Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue.
    Location: M D Anderson Cancer Center, Houston, Texas

  • Cyclophosphamide and Vaccine Therapy With or Without Trastuzumab in Treating Patients With Stage IV Breast Cancer

    This randomized clinical trial studies cyclophosphamide and vaccine therapy with or without trastuzumab in treating patients with stage IV breast cancer. Drugs used in chemotherapy, such as cyclophosphamide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Vaccines made from gene-modified tumor cells may help the body build an effective immune response to kill tumor cells. Monoclonal antibodies, such as trastuzumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. It is not yet known whether cyclophosphamide and vaccine therapy is more effective when given together with or without trastuzumab in treating patients with breast cancer.
    Location: Johns Hopkins University / Sidney Kimmel Cancer Center, Baltimore, Maryland

  • Accelerated Whole Breast Radiotherapy in Treating Patients with Breast Cancer Who Have Undergone Surgery

    This phase II trial studies how well accelerate whole breast radiotherapy works in treating patients with breast cancer who have undergone surgery. Radiation therapy uses high energy x-rays to kill tumor cells. This may be an effective treatment for breast cancer.
    Location: Rutgers Cancer Institute of New Jersey, New Brunswick, New Jersey

  • GEN1029 (HexaBody®-DR5 / DR5) Safety Trial in Patients With Malignant Solid Tumors

    The purpose of the trial is to evaluate the safety of GEN1029 (HexaBody®-DR5 / DR5) in a mixed population of patients with specified solid tumors
    Location: M D Anderson Cancer Center, Houston, Texas

  • Direct Tumor Microinjection and FDG-PET in Testing Drug Sensitivity in Patients with Relapsed or Refractory Non-Hodgkin Lymphoma, Hodgkin Lymphoma, or Stage IV Breast Cancer

    This pilot phase I trial studies the side effects of direct tumor microinjection and fludeoxyglucose F-18 positron emission tomography (FDG-PET) in testing drug sensitivity in patients with non-Hodgkin lymphoma, Hodgkin lymphoma, or stage IV breast cancer that has returned after a period of improvement or does not respond to treatment. Injecting tiny amounts of anti-cancer drugs directly into tumors on the skin or in lymph nodes and diagnostic procedures, such as FDG-PET, may help to show which drugs work better in treating patients with non-Hodgkin lymphoma, Hodgkin lymphoma, or breast cancer.
    Location: Mayo Clinic, Rochester, Minnesota

  • A Study of Poziotinib in Combination With T-DM1 in HER2-Positive Breast Cancer

    This is a Phase 1b, open-label, multicenter study to determine the Maximum Tolerated Dose (MTD) or Maximum Administered Dose (MAD) of poziotinib when administered with standard dosing of T-DM1 (3.6 mg / kg IV on Day 1 of each 21-day cycle) in women with advanced or metastatic HER2+ breast cancer. The poziotinib dose identified in Part 1 of the study will be used in combination with standard dose of T-DM1 in Part 2 of the study to confirm the poziotinib dose and evaluate the preliminary efficacy of the combination therapy.
    Location: UCSF Medical Center-Mount Zion, San Francisco, California

  • A Study of CDX-1140 in Patients With Advanced Solid Tumors

    This is a study to determine the maximum tolerated dose (MTD) for CDX-1140 and to further evaluate its tolerability and efficacy in expansion cohorts once the MTD is determined.
    Location: Icahn School of Medicine at Mount Sinai, New York, New York

  • Rollover Study of SV-BR-1-GM in Combination With Ipilimumab or Pembrolizumab

    This is an open-label rollover study of Study WRI-GEV-007, which evaluates SV-BR-1-GM in metastatic or locally recurrent breast cancer patients. Patients who demonstrate progressive disease on Study WRI-GEV-007 will be eligible to enroll in this study, which will evaluate SV-BR-1-GM in combination with pembrolizumab (Keytruda) if their tumors express PD-L1 or PD-L2, or in combination with ipilimumab (Yervoy) if their tumors do not express PD-L1 or PD-L2. Treatment cycles will be every 3 weeks with evaluations for tumor progression or response every 8-12 weeks.
    Location: Thomas Jefferson University Hospital, Philadelphia, Pennsylvania

  • MCLA-128 With Trastuzumab / Chemotherapy in HER2+ and With Endocrine Therapy in ER+ and Low HER2 Breast Cancer

    A Phase 2, open-label, multicenter international study will be performed to evaluate the efficacy of MCLA-128-based combinations. Three combination treatments will be evaluated, two in Cohort 1 and one in Cohort 2. MCLA-128 is given in combinations in two metastatic breast cancer (MBC) populations, HER2-positive / amplified (Cohort 1) and Estrogen Receptor-positive / low HER2 expression (Cohort2). Two combinations treatments will be evaluated in Cohort 1, the doublet and triplet. Initially MCLA-128 is given in combination with trastuzumab in the doublet. After the safety of the doublet has been assessed in 4-6 patients, MCLA-128 is given in combination with trastuzumab and vinorelbine in the triplet, in parallel to the efficacy expansion of the doublet. The doublet and triplet combinations are both evaluated in two steps with an initial safety run-in followed by a cohort efficacy expansion. In total up to 40 patients evaluable for efficacy are included in both the doublet and triplet. In Cohort 2 MCLA-128 is administered in combination with the same previous endocrine therapy on which progressive disease is radiologically documented. A total of up to 40 patients evaluable for efficacy are included in the Cohort 2.
    Location: Northwestern University, Chicago, Illinois

  • Gedatolisib and Antibody-drug Conjugate PF-06647020 in Treating Patients with Metastatic Triple Negative Breast Cancer

    This phase I trial studies the side effects of gedatolisib and antibody-drug conjugate PF-06647020 and how well they work in treating patients with triple negative breast cancer that has spread to other places in the body. Gedatolisib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibody, such as antibody-drug conjugate PF-06647020, may interfere with the ability of tumor cells to grow and spread. Given gedatolisib and antibody-drug conjugate PF-06647020 may work better in treating patients with triple negative breast cancer.
    Location: Indiana University / Melvin and Bren Simon Cancer Center, Indianapolis, Indiana

  • This Study in Patients With Different Types of Cancer (Solid Tumours) Aims to Find a Safe Dose of Xentuzumab in Combination With Abemaciclib With or Without Hormonal Therapies. The Study Also Tests How Effective These Medicines Are in Patients With Lung and Breast Cancer.

    For each dose finding cohorts (A, B, C and D): The primary objective of each dose finding cohort is to determine the maximum tolerated dose (MTD) / recommended phase II dose (RP2D) of xentuzumab in combination with abemaciclib with or without hormonal therapy (letrozole, anastrozole, fulvestrant). Dose limiting toxicities (DLT) will be assessed during the first treatment cycle to assess the MTD / RP2D. In case that no MTD is reached a RP2D dose will be determined taking into account safety data and other available information. This will be agreed with the Steering Committee. For each expansion cohorts (E and F): The objectives of the expansion cohorts are to assess the anti-tumour activity of xentuzumab in combination with abemaciclib in patients with non-small cell lung cancer (cohort E). Tentatively a cohort F may be opened to assess the anti-tumour activity of the triplet combination xentuzumab / abemaciclib and fulvestrant in a single-arm expansion group of patients with locally advanced / metastatic hormone receptor positive (HR+) breast cancer who have progressed following prior aromatase inhibitor therapy and prior CDK4 / 6 inhibitor treatment. Cohort F will only be opened if indicated by emerging data from ongoing clinical trials.
    Location: See Clinical Trials.gov

  • Phase I / II Study of U3-1402 in Subjects With Human Epidermal Growth Factor Receptor 3 (HER3) Positive Metastatic Breast Cancer

    This is an open-label, three-part, non-randomized, multiple-dose study to evaluate safety, tolerability, and efficacy of U3-1402 in patients with HER3-positive metastatic breast cancer. HER3 is a unique member of the human epidermal growth factor receptor, which defines a certain type of cancer. The number of patients and treatment cycles are not fixed in this study. Subjects who continue to derive clinical benefit from the study treatment in the absence of withdrawal of consent, progressive disease (PD), or unacceptable toxicity may continue the study treatment until the end of the trial.
    Location: Cancer Therapy and Research Center at The UT Health Science Center at San Antonio, San Antonio, Texas

  • Trial of SPI-2012 Versus Pegfilgrastim in the Management of Chemotherapy Induced Neutropenia in Early- Stage BReast Cancer Patients Receiving Docetaxel and Cyclophosphamide (RECOVER)

    The purpose of this study is to compare the efficacy of SPI-2012 with pegfilgrastim in patients with early-stage breast cancer receiving docetaxel and cyclophosphamide (TC) to prevent and reduce Neutropenia that is associated with cancer chemotherapy.
    Location: See Clinical Trials.gov

  • Short-term Preoperative Treatment With Enzalutamide, Alone or in Combination With Exemestane in Primary Breast Cancer

    This study is being carried out to see if the antiandrogen enzalutamide has antitumour effects in early breast cancer. Enzalutamide blocks the action of androgens on the androgen receptor (AR) and may slow down or stop breast cancers growing. Enzalutamide is approved for the treatment of prostate cancer. The trial will be offered to patients who have just been diagnosed with early breast cancer and who are planned to have surgery in the next few weeks. The treatment will bridge the time between the diagnosis and surgery and will be given for 2- 4 weeks. To assess the effect of the treatment, small samples of breast cancer tissue will be analysed before the start and after treatment. The pre-treatment assessment will be done on archived tissue but patients might require an additional biopsy, if sufficient stored tumour tissue is not available. The end of treatment samples will be taken during surgery, unless the patient will receive medical treatment first instead of surgery which might mean additional biopsies of the breast cancer have to be taken. The trial has two cohorts. The cohort of patients with oestrogen receptor (ER) positive breast cancer will test if adding enzalutamide to exemestane is better at slowing the growth of breast cancer than exemestane alone. This cohort will recruit 141 evaluable post-menopausal patients with a tumour size of at least 1 cm. The aromatase inhibitor exemestane is approved for the treatment of ER positive breast cancer. Blocking aromatase decreases oestrogens but can increase androgens. Enzalutamide is therefore added to block the action of androgens on the AR. In the second cohort of patients with triple negative breast cancer (TNBC), enzalutamide will be given alone to see if it can slow the growth tumours with androgen receptors. As only approximately 30% of TNBCs express the AR, a pre screening step will be included to test the tumour AR expression, before patients are approached for the ARB trial. The TNBC cohort will comprise 55 patients.
    Location: See Clinical Trials.gov

  • Breast Cancer Margin Delineation Using Polarization Subtraction Imaging Technology

    This study will evaluate LumaScan, an innovative polarization microscope for real time, intraoperative imaging and evaluation of the surface of excised tissue excised during Breast Conservation Surgery (BCS) for non invasive and invasive breast cancer. The investigators hypothesis is that LumaScan will be comparable for cancer detection to conventional histopathologic evaluation of the same areas of breast tissue. The real time, intraoperative images provided by LumaScan will help improve BCS and lessen the need for BCS re-excision surgeries which can lead to higher cost, poor cosmetic outcomes, reduced survival rates, and loss of confidence in the tissue conservation surgery procedure.
    Location: See Clinical Trials.gov

  • Oral VT-464 in Patients With Castration-Resistant Prostate Cancer Previously Treated With Enzalutamide, Androgen Receptor Positive Triple-Negative Breast Cancer Patients, and Men With ER Positive Breast Cancer

    The goal of this clinical study is to determine the safety and efficacy of VT-464, a lyase-selective inhibitor of CYP17, in patients with castration-resistant prostate cancer (CRPC) who have been previously treated with Enzalutamide, Androgen Receptor Positive Triple-Negative Breast Cancer Patients, and Men with ER positive Breast Cancer.
    Location: See Clinical Trials.gov

  • Phase 1-2 Study of Onapristone in Patients With Progesterone Receptor Expressing Cancers

    This is a multi-center, open-label, randomized, parallel group two-stage phase 1 study with a phase 2 expansion component in pts with recurrent or metastatic APRpos uterine endometrioid adenocarcinoma. Stage 1: Six dose cohorts, 5 using the extended release tablet (ER) formulation (10 mg BID, 20 mg BID, 30 mg BID, 40 mg BID, 50 mg BID) and 1 using the immediate-release (IR) tablet formulation 100 mg QD will be randomized in parallel. After enrollment of 36 patients in Stage 1, a dose of 50 mg BID was determined to be the RP2D. Stage 2: An additional 10 patients with recurrent or metastatic APRpos uterine endometrioid adenocarcinoma (Stage 2a) will be enrolled at the RP2D. Based on the response in Stage 2a, the cohort will be further expanded by up to 19 more patients to a total of 29 patients to confirm the efficacy and safety profile of onapristone in this selected patient population (Stage 2b).
    Location: See Clinical Trials.gov