Treatment Clinical Trials for Breast Cancer

Clinical trials are research studies that involve people. The clinical trials on this list are for breast cancer 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 101-125 of 564
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  • Early Stereotactic Body Radiation Therapy or High-Dose Radiotherapy in Treating Patients with Metastatic Breast or Non-small Cell Lung Cancer

    This phase II trial studies how well early stereotactic body radiation therapy (SBRT) or high-dose radiotherapy works in treating patients with breast or non-small cell lung cancer that has spread to other places in the body (metastatic). SBRT or high-dose radiotherapy has been shown to shrink or stabilize breast and non-small cell lung cancer. It is not yet known whether starting SBRT or high-dose radiotherapy when metastatic tumors have just begun to grow will extend life, compared with the usual approach to managing breast or non-small cell lung cancer.
    Location: 7 locations

  • A Study Exploring the Safety and Tolerability of INCB081776 in Participants With Advanced Malignancies

    The purpose of this study is to evaluate the safety and tolerability, pharmacokinetics, pharmacodynamics, and early clinical activity of single-agent INCB081776 (Part 1) and INCB081776 in combination with INCMGA00012 (Part 2).
    Location: 8 locations

  • PRS-343 in HER2-Positive Solid Tumors

    A multi center, open-label, Phase 1 dose escalation study with expansion cohort is designed to determine the MTD, RP2D and dosing schedule of PRS-343 in patients with HER2+ advanced or metastatic solid tumors.
    Location: 7 locations

  • A Study of Autogene Cevumeran (RO7198457) as a Single Agent and in Combination With Atezolizumab in Participants With Locally Advanced or Metastatic Tumors

    This is a Phase 1a / 1b, open-label, multicenter, global, dose-escalation study designed to evaluate the safety, tolerability, immune response, and pharmacokinetics of autogene cevumeran (RO7198457) as a single agent and in combination with atezolizumab (MPDL3280A, an engineered anti-programmed death-ligand 1 [anti-PD-L1] antibody).
    Location: 11 locations

  • PI3Kbeta Inhibitor AZD8186 and Docetaxel in Treating Patients Advanced Solid Tumors with PTEN or PIK3CB Mutations That Are Metastatic or Cannot Be Removed by Surgery

    This phase I trial studies the side effects and best dose of PI3Kbeta inhibitor AZD8186 when given together with docetaxel in treating patients with solid tumors with PTEN or PIK3CB mutations that have spread to other places in the body (metastatic) or cannot be removed by surgery. PI3Kbeta inhibitor AZD8186 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as docetaxel, 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 PI3Kbeta inhibitor AZD8186 and docetaxel may work better in treating patients with solid tumors.
    Location: 8 locations

  • Mesothelin-Specific Genetically Engineered Lymphocytes with or without Cyclophosphamide and Pembrolizumab in Treating Patients with Malignant Pleural Disease

    This phase I / II trial studies the side effects and best dose of mesothelin-specific chimeric antigen receptor-engineered peripheral blood lymphocytes and to see how well it works with or without cyclophosphamide and pembrolizumab in treating patients with a malignant disease found in the thin layer of tissue that covers the lungs and lines the interior wall of the chest cavity (pleura), including malignant pleural mesothelioma, or previously treated non-small cell lung cancer or breast cancer that has spread to the pleura. Placing a gene that has been created in the laboratory into white blood cells (lymphocytes) may help the body build an immune response to kill tumor cells expressing the protein mesothelin. Drugs used in chemotherapy, such as 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. 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. Giving mesothelin-specific chimeric antigen receptor-engineered peripheral blood lymphocytes with or without cyclophosphamide may be a better treatment for malignant pleural disease.
    Location: 7 locations

  • Study of a Shortened Radiation Therapy Schedule in Patients with Breast Cancer, the FAST-R Trial

    This early phase I trial is to find out the side effects and possible benefits of providing radiation on a shortened (compressed) schedule of 5 days in a row in preventing cancer from coming back in patients with invasive stage IIA-IIIA breast cancer who have undergone surgery to remove the breast or as much of the breast tissue as possible. (mastectomy). A standard schedule of radiation after mastectomy is 16-25 days. Undergoing a compressed schedule may decrease the amount of time patients must spend in the clinic for radiation treatments and reduce the disruption in patients’ routine activities (such as employment or childcare) that can occur with a long course of treatment. This trial may help the researchers learn whether the compressed 5-day schedule is better than, the same as, or worse than the standard 16-25 day schedule.
    Location: 6 locations

  • A Phase 2 Study of T-DXd in Patients With Selected HER2 Expressing Tumors

    This is an open-label, multi-center, multi-cohort, Phase 2 study to evaluate the efficacy and safety of trastuzumab deruxtecan (T-DXd) for the treatment of selected HER2-expressing tumors. This study will enroll 7 tumor-specific cohorts: urothelial bladder cancer, biliary tract cancer, cervical cancer, endometrial cancer, ovarian cancer, pancreatic cancer, and rare tumors. Study hypothesis: Trastuzumab deruxtecan will show meaningful clinical activity and a favorable risk benefit profile in selected HER2-expressing solid tumors.
    Location: 6 locations

  • Study of AMG 650 in Adult Participants With Advanced Solid Tumors

    To evaluate the safety and tolerability of AMG 650 in adult participants and to determine the maximum tolerated dose (MTD) and / or recommended phase 2 dose (RP2D).
    Location: 6 locations

  • GB1275 Monotherapy and in Combination With an Anti-PD1 Antibody in Patients With Specified Advanced Solid Tumors or in Combination With Standard of Care in Patients With Metastatic Pancreatic Adenocarcinoma

    This first-in-human (FIH ) study is an open-label, multicenter study that consists of a Phase 1 Dose Escalation phase of GB1275 monotherapy or in combination with Anti-PD-1 Antibody or in combination with Standard of Care in Patients with Metastatic Pancreatic Adenocarcinoma followed by a Phase 2 Basket Expansion phase in Patients with Specified Metastatic Solid Tumors
    Location: 7 locations

  • Phase 2 Study of Amcenestrant (SAR439859) Versus Physician's Choice in Locally Advanced or Metastatic ER-positive Breast Cancer

    Primary Objective: To determine whether amcenestrant per os improves progression free survival (PFS) when compared with a endocrine monotherapy of the choice of the physician, in participants with metastatic or locally advanced breast cancer Secondary Objectives: - To compare the overall survival in the 2 treatment arms - To assess the objective response rate in the 2 treatment arms - To evaluate the disease control rate in the 2 treatment arms - To evaluate the clinical benefit rate in the 2 treatment arms - To evaluate the duration of response in the 2 treatment arms - To evaluate the PFS according to the estrogen receptor 1 gene (ESR1) mutation status in the 2 treatment arms - To evaluate the pharmacokinetics of amcenestrant as single agent - To evaluate health related quality of life in the 2 treatment arms - To compare the overall safety profile in the 2 treatment arms
    Location: 6 locations

  • Study of ORIC-101 in Combination With Anticancer Therapy

    The purpose of this study is to establish the recommended Phase 2 dose (RP2D), safety, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary antitumor activity of ORIC-101 in combination with nab-paclitaxel or other anticancer therapies when administered to patients with advanced or metastatic solid tumors.
    Location: 6 locations

  • Investigation of Novel Surgical Imaging for Tumor Excision

    This is a multi-center, two-arm randomized, blinded pivotal study to demonstrate the safety and efficacy of the LUM Imaging System (LUM015 imaging agent in conjunction with the LUM Imaging Device and decision software), in identifying residual cancer in the lumpectomy bed of female breast cancer patients undergoing breast surgery in order to assist surgeons in reducing the rates of positive margins. All enrolled subjects will be injected with LUM015 prior to surgery. Surgeons are blinded to whether a participant will be randomized into the device arm until after the standard of care lumpectomy is complete. Participants will then be randomized to receiving the device. Therapeutic (Lumicell guided) shaves will be removed based on the guidance of the LUM Imaging System. Patients will be followed until their first standard of care post-operative follow-up visit.
    Location: 6 locations

  • PF-06952229 Treatment in Adult Patients With Advanced Solid Tumors

    A Phase 1 dose escalation and expansion study evaluating safety, tolerability and pharmacokinetics of PF-06952229 in adult patients with advanced solid tumors.
    Location: 6 locations

  • A Safety, Pharmacokinetic, Pharmacodynamic and Anti-Tumor Study of PF-06873600 as a Single Agent and in Combination With Endocrine Therapy

    Open-label, multi-center, non-randomized, multiple dose, safety, tolerability, pharmacokinetic, and pharmacodynamics and clinical activity study of PF-06873600 administered as a single agent and then in combination with endocrine therapy. The study contains two parts, a Part 1 single agent dose escalation and combination endocrine therapy dose finding component and a Part 2 dose expansion in combination with endocrine therapy.
    Location: 7 locations

  • CAB-ROR2-ADC Safety and Efficacy Study in Patients With Solid Tumors

    The objective of this study is to assess safety and efficacy of CAB-ROR2-ADC in solid tumors
    Location: 7 locations

  • A Study of Multiple Immunotherapy-Based Treatment Combinations in Hormone Receptor (HR)-Positive Human Epidermal Growth Factor Receptor 2 (HER2)-Negative Breast Cancer

    This study is designed to evaluate the efficacy, safety, and pharmacokinetics of several immunotherapy-based combination treatments in participants with inoperable locally advanced or metastatic HR-positive, HER2-negative breast cancer who have progressed during or following treatment with a cyclin-dependent kinase (CDK) 4 / 6 inhibitor in the first- or second-line setting, such as palbociclib, ribociclib, or abemaciclib. The study will be performed in two stages. During Stage 1, participants will be randomized to fulvestrant (control) or an atezolizumab-containing doublet or triplet combination. Those who experience disease progression, loss of clinical benefit, or unacceptable toxicity may be eligible to receive a new triplet combination treatment in Stage 2 until loss of clinical benefit or unacceptable toxicity. New treatment arms may be added and / or existing treatment arms may be closed during the course of the study on the basis of ongoing clinical efficacy and safety as well as the current treatments available.
    Location: 6 locations

  • A Phase 1 / 2 Safety Study of Intratumorally Dosed INT230-6

    This study evaluates the intratumoral administration of escalating doses of a novel, experimental drug, INT230-6. The study is being conducted in patients with several types of refractory cancers including those at the surface of the skin (breast, squamous cell, head and neck) and tumors within the body such (pancreatic, colon, liver, lung, etc.). Sponsor also plans to test INT230-6 in combination with anti-PD-1 and anti-CTLA-4 antibodies.
    Location: 6 locations

  • Trial of ZW25 (Zanidatamab) in Patients With Advanced HER2-expressing Cancers

    This is a first-in-human, 3-part study to investigate the safety, tolerability, and effectiveness of ZW25 (zanidatamab) by itself and combined with selected chemotherapy agents in patients with locally advanced (unresectable) and / or metastatic human epidermal growth factor receptor 2 (HER2)-expressing cancers. This study will also the evaluate the way the body absorbs, distributes, and eliminates ZW25 (pharmacokinetics or PK).
    Location: 6 locations

  • Carboplatin and Gemcitabine Hydrochloride with or without Pembrolizumab in Treating Patients with Metastatic Triple-Negative Breast Cancer

    This randomized phase II trial studies the side effects of carboplatin and gemcitabine hydrochloride with or without pembrolizumab and to see how well they work in treating patients with triple-negative breast cancer that has spread to the other places in the body (metastatic). 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. Drugs used in chemotherapy, such as carboplatin and gemcitabine 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 pembrolizumab together with carboplatin and gemcitabine hydrochloride may work better in treating patients with triple-negative breast cancer that has spread to the other places in the body.
    Location: 6 locations

  • Palbociclib and Fulvestrant in Treating Patients with Hormone Receptor-Positive, HER2-Negative Metastatic or Locally Advanced Breast Cancer

    This phase II trial studies how well palbociclib and fulvestrant work in treating patients with hormone receptor positive, human epidermal growth factor receptor 2 (HER2)-negative breast cancer that has spread to other places in the body (metastatic) or that has only spread to nearby tissue or lymph nodes (locally advanced). Palbociclib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Hormone therapy such as fulvestrant may block the use of estrogen and progesterone by tumor cells. Giving palbociclib with fulvestrant may work better in treating patients with hormone receptor positive, HER2-negative breast cancer.
    Location: 6 locations

  • Testing the Addition of Pembrolizumab to Sacituzumab Govitecan for the Treatment of PD-L1 Negative Locally Advanced Unresectable or Metastatic Triple Negative Breast Cancer, Saci-IO TNBC Study

    This phase II trial investigates how well the addition of pembrolizumab to sacituzumab govitecan works in treating patients with PD-L1 negative triple negative breast cancer that has spread from its original site of growth to nearby tissues or lymph nodes and is not amenable to surgical resection (locally advanced unresectable) or to other places in the body (metastatic). Sacituzumab govitecan is composed of a chemotherapy drug, called irinotecan, which is attached to an antibody. Antibodies are proteins normally made by the immune system that bind to substances that don't belong in the body to prevent harm. Sacituzumab govitecan binds to the cancer cells and kills them. Pembrolizumab is an immunotherapy, called an anti-PD-1 or a checkpoint inhibitor, and is an antibody (a type of human protein) designed to allow the body’s own immune system to seek out and destroy tumors. This trial is being done to evaluate the effectiveness of sacituzumab govitecan alone or in combination with pembrolizumab, in delaying the worsening of triple negative breast cancers that are PD-L1 negative.
    Location: 6 locations

  • A Study of Multiple Immune and Disease Treatment Combinations in Participants With ER+HER2- Breast Cancer That Has Spread

    The hypothesis of the CA048-001 Phase 1 clinical trial is targeting multiple mechanisms involved in generating and maintaining antitumor immune response will lead to a tolerable and robust anti-tumor response. This study utilizes an innovative clinical trial design to determine the safety, tolerability, pharmacodynamic activity and efficacy of targeting multiple, distinct combination regimens that modulate several immune and non-immune mechanisms by escalating the number of therapies administered.
    Location: 6 locations

  • A Phase 1 / 2 Trial of ARV-471 Alone and in Combination With Palbociclib (IBRANCE®) in Patients With ER+ / HER2- Locally Advanced or Metastatic Breast Cancer

    This is a Phase 1 / 2 dose escalation and cohort expansion study and will assess the safety and tolerability of ARV-471 alone and in combination with palbociclib (IBRANCE®) in patients with estrogen receptor positive / human epidermal growth factor receptor 2 negative (ER+ / HER2-) locally advanced or metastatic breast cancer, who have received prior hormonal therapy and chemotherapy in the locally advanced / metastatic setting.
    Location: 7 locations

  • A Study of SGN-CD228A in Advanced Solid Tumors

    This trial will study SGN-CD228A to find out whether it is an effective treatment for different kinds of cancer. It will also look at what side effects (unwanted effects) may occur. The study will have two parts. Part 1 of the study will find out how much SGN-CD228A should be given for treatment and how often. Part 2 of the study will use the dose found in Part 1 and look at how safe and effective the treatment is.
    Location: 6 locations


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