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 51-75 of 500

  • 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

  • A Study of XmAb®22841 Monotherapy & in Combination w / Pembrolizumab in Subjects w / Selected Advanced Solid Tumors

    This is a Phase 1, multiple dose, ascending-dose escalation study and expansion study designed to define a maximum tolerated dose and / or recommended dose of XmAb22841 monotherapy and in combination with pembrolizumab; to assess safety, tolerability, pharmacokinetics, immunogenicity, and anti-tumor activity of XmAb22841 monotherapy and in combination with pembrolizumab in subjects with select advanced solid tumors.
    Location: 10 locations

  • Stereotactic Body Radiotherapy in Treating Patients with Oligometastatic Breast Cancer or Metastatic Non-small Cell Lung Cancer

    This phase II trial studies how well stereotactic body radiotherapy (SBRT) works in treating patients with triple negative breast cancer that has spread to limited number of other places in the body (oligometastatic) or non-small cell lung cancer that has spread to other places in the body (metastatic). Stereotactic body radiation therapy uses special equipment to position a patient and deliver radiation to tumors with high precision. This method can kill tumor cells with fewer doses over a shorter period and cause less damage to normal tissue.
    Location: 9 locations

  • Radiation Therapy, Palbociclib, and Hormone Therapy in Treating Breast Cancer Patients with Bone Metastasis

    This phase II trial studies how well radiation therapy given with standard care palbociclib and hormone therapy work in treating patients with breast cancer that has spread from one part of the body to the bone. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Palbociclib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Antihormone therapy, such as fulvestrant, letrozole, anastrozole, exemestane, or tamoxifen, may lessen the amount of estrogen made by the body. Giving radiation therapy, palbociclib, and hormone therapy may work better in treating breast cancer patients with bone metastasis.
    Location: 10 locations

  • A Study of ASP1948, Targeting an Immune Modulatory Receptor, in Subjects With Advanced Solid Tumors

    The purpose of this study is to evaluate the tolerability and safety profile of ASP1948 when administered as a single agent and in combination with nivolumab in participants with locally advanced (unresectable) or metastatic solid tumors; characterize the pharmacokinetic profile of ASP1948 when administered as a single agent and in combination with nivolumab and determine the recommended Phase 2 dose (RP2D) of ASP1948 when administered as a single agent and in combination with nivolumab. This study will also evaluate the antitumor effect of ASP1948 when administered as a single agent and in combination with nivolumab.
    Location: 14 locations

  • DS-8201a Versus T-DM1 for Human Epidermal Growth Factor Receptor 2 (HER2)-Positive, Unresectable and / or Metastatic Breast Cancer Previously Treated With Trastuzumab and Taxane [DESTINY-Breast03]

    This study is designed to compare the anti-tumor activity as well as the safety and efficacy of DS-8201a versus T-DM1 in HER2-positive, unresectable and / or metastatic breast cancer subjects previously treated with trastuzumab and taxane.
    Location: 12 locations

  • Oral Paclitaxel Efficacy Safety and PK in Recurrent and Metastatic Breast Cancer

    The objective of this study is to evaluate the efficacy, safety and pharmacokinetics of DHP107 (Oral Paclitaxel, Korea brand name: Liporaxel®) compared to IV Paclitaxel in patients with Recurrent or Metastatic Breast Cancer.
    Location: 9 locations

  • Safety and Efficacy of SGN-LIV1A Plus Pembrolizumab for Patients With Locally-Advanced or Metastatic Triple-Negative Breast Cancer

    This trial studies SGN-LIV1A with pembrolizumab in patients with triple-negative breast cancer. It will find out what side effects happen when participants get these two drugs. A side effect is anything the drugs do besides treating cancer. Pembrolizumab is a drug that can be used to treat triple-negative breast cancer. The trial will also find out if the drugs work to treat this type of cancer. Participants in this study have metastatic breast cancer. This means the cancer has spread to other parts of the body.
    Location: 9 locations

  • First-in-human Study of ATR Inhibitor BAY1895344 in Patients With Advanced Solid Tumors and Lymphomas

    The ATR(ataxia-telangiectasia and Rad3 related protein) inhibitor BAY1895344 is developed for the treatment of patients with advanced solid tumors and lymphomas. The purpose of the proposed trial is to evaluate the safety and tolerability of BAY1895344, and to identify the maximum tolerated dose of BAY1895344 that could be safely given to cancer patients. Further, the response of the cancer to the treatment will be determined.
    Location: 11 locations

  • PROCLAIM-CX-2009: A Trial to Find Safe and Active Doses of an Investigational Drug CX-2009 for Patients With Selected Solid Tumors

    The purpose of this first-in-human study of CX-2009 is to characterize the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and antitumor activity of CX-2009 in adult subjects with metastatic or locally advanced unresectable solid tumors. PROCLAIM: PRObody CLinical Assessment In Man CX-2009 clinical trial 001 PROBODY is a trademark of CytomX Therapeutics, Inc
    Location: 11 locations

  • Evaluation of Lasofoxifene Versus Fulvestrant in Advanced or Metastatic ER+ / HER2− Breast Cancer With an ESR1 Mutation

    This is an open label, randomized, multicenter study evaluating the activity of lasofoxifene relative to fulvestrant for the treatment of pre- and postmenopausal women with locally advanced or metastatic ER+ / HER2− breast cancer with an acquired ESR1 mutation and who have disease progression on an aromatase inhibitor (AI) in combination with a cyclin dependent kinase (CDK) 4 / 6 inhibitor. The primary objective is to evaluate the progression free survival (PFS) of 5 mg lasofoxifene relative to fulvestrant for the treatment of pre- and postmenopausal women with locally advanced or metastatic estrogen receptor positive (ER+) / human epidermal growth factor 2 negative (HER2−) breast cancer with an estrogen receptor 1 (ESR1) mutation. The secondary objectives are to evaluate: 1. Clinical benefit rate (CBR) and Objective Response Rate (ORR) 2. Duration of response 3. Time to response 4. Overall Survival (OS) 5. Pharmacokinetics of lasofoxifene 6. Quality of life (QoL): Quality of Life (QoL): vaginal assessment scale (VAS) and vulvar assessment scale (VuAS) questionnaires 7. Safety of lasofoxifene 8. Response to various ESR1 mutation (Y537S, Y537C, D538G, E380Q, S463P, V534E, P535H, L536H, L536P, L536R, L536Q, or Y537N).
    Location: 8 locations

  • A Trial to Evaluate Efficacy and Safety of Ribociclib With Endocrine Therapy as Adjuvant Treatment in Patients With HR+ / HER2- Early Breast Cancer

    A phase III multi-center, randomized, open-label trial to evaluate efficacy and safety of ribociclib with endocrine therapy as adjuvant treatment in patients with HR+ / HER2- Early Breast Cancer
    Location: 15 locations

  • Javelin Parp Medley: Avelumab Plus Talazoparib In Locally Advanced Or Metastatic Solid Tumors

    Avelumab in combination with talazoparib will be investigated in patients with locally advanced (primary or recurrent) or metastatic solid tumors, including non-small cell lung cancer (NSCLC), triple negative breast cancer (TNBC), hormone receptor positive (HR+) breast cancer, recurrent platinum sensitive ovarian cancer, urothelial cancer (UC), and castration resistant prostate cancer (CRPC).
    Location: 9 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

  • Hypofractionated Radiation Therapy in Treating Patients with Stage II-III Breast Cancer Undergoing Total Nodal Irradiation

    This phase II trial studies how well hypofractionated radiation therapy works in treating patients with stage II-III breast cancer undergoing total nodal irradiation. Hypofractionated radiation therapy delivers higher doses of radiation therapy over a shorter period of time and may kill more tumor cells and have fewer side effects.
    Location: 8 locations

  • Eliminating Surgery after Systemic Therapy in Treating Patients with HER2 Positive or Triple Negative Breast Cancer

    This clinical trial studies eliminating surgery and how well radiation therapy after systemic therapy works in treating patients with HER2 positive or triple negative breast cancer when image-guided biopsy shows no residual cancer. Patients then receive standard breast radiotherapy.
    Location: 10 locations

  • Ruxolitinib Phosphate and Chemotherapy before Surgery in Treating Patients with Triple Negative Inflammatory Breast Cancer

    This phase II trial studies how well ruxolitinib phosphate and chemotherapy before surgery work in treating patients with triple negative inflammatory breast cancer. Ruxolitinib phosphate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. 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 ruxolitinib phosphate, paclitaxel, and chemotherapy before surgery may kill more tumor cells.
    Location: 8 locations

  • Conjugated Estrogens / Bazedoxifene in Treating Patients with Ductal Carcinoma in Situ Undergoing Surgery

    The main purpose of this study is to determine if taking the study drug, conjugated estrogens / bazedoxifene (Duavee) causes any changes in the proliferation markers within the breast tissue of the study subjects. The study drug is approved by the US Food and Drug Administration in healthy postmenopausal women to treat certain symptoms of menopause such as hot flashes. Since it is not approved in women with ductal carcinoma in situ (DCIS), its use in this study is experimental. This study will also look at whether taking the study drug causes any significant or undesirable side effects in women with DCIS. The researchers hope that this study will help them determine if taking the study drug is safe in women taking DCIS and if it can possibly reduce the risk of developing breast cancer in women with DCIS.
    Location: 11 locations

  • 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

    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 or other prophylactic measures.
    Location: 8 locations

  • Cisplatin, Romidepsin and Nivolumab in Treating Patients with Locally Recurrent or Metastatic Triple Negative Breast Cancer

    This phase I / II trial studies the side effects and best dose of romidepsin when given together with cisplatin and nivolumab, to see how well they work in treating patients with triple negative breast cancer that has come back at or near the same place as the original (primary) tumor, usually after a period of time during which the cancer could not be detected or spread to other parts of the body. Romidepsin may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as cisplatin, 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. Romidepsin may also help cisplatin work better. Monoclonal antibodies, such as nivolumab, may interfere with the ability of tumor cells to grow and spread. Giving romidepsin together with cisplatin and nivolumab may be a better treatment for tripe negative breast cancer.
    Location: 8 locations

  • Radiation Therapy and Sequential or Concurrent Combination Chemotherapy in Treating Patients with Early Stage Breast Cancer

    This randomized phase II trial studies how well radiation therapy and sequential or concurrent combination chemotherapy works in treating patients with early stage breast cancer. Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy 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 is a form of “targeted therapy” because it works by attaching itself to specific molecules (receptors) on the surface of cancer cells, known as HER2 receptors. When trastuzumab attaches to HER2 receptors, the signals that tell the cells to grow are blocked and the cancer cell may be marked for destruction by the body’s immune system. It is not yet known whether radiation therapy is more effective with sequential or concurrent combination chemotherapy in treating early stage breast cancer.
    Location: 8 locations

  • A Study of LGK974 in Patients With Malignancies Dependent on Wnt Ligands

    This primary purpose of this study is to find the recommended dose of LGK974 as a single agent and in combination with PDR001 that can be safely given to adult patients with selected solid malignancies for whom no effective standard treatment is available.
    Location: 8 locations

  • Study of the Body’s Response to Exercise and a Plant-Based Diet in Overweight Postmenopausal Women with Hormone Receptor Positive, HER2 Negative Stage I-III Breast Cancer

    This phase II trial studies the effects of exercise and a plant-based diet on breast aromatase levels in patients with hormone receptor positive, HER2 negative stage I-III breast cancer. Aromatase is an enzyme that impacts the amount of estrogen in the body. High aromatase levels can increase estrogen levels and cause tumor growth. A plant-based diet consists of fruits, vegetables, whole grains, legumes, nuts and seeds, herbs, and spices and does not include any animal products, such as red meat, poultry, fish, eggs, and dairy products. Exercise combined with a plant-based diet may help slow the growth of cancer by decreasing aromatase levels, promoting other positive changes in the body, and causing weight loss. The purpose of this study is to find out what effects, if any, exercise and a plant-based diet may have on aromatase levels in postmenopausal women who are overweight and being treated with an aromatase inhibitor for their hormone positive, HER2 negative breast cancer.
    Location: 7 locations

  • Study of 3-Day Partial Breast Radiation Therapy for the Treatment of Stage I Breast Cancer

    This phase II trial studies the side effects of a short-course (3-day) schedule of partial breast radiation therapy in treating patients with stage I breast cancer. Partial breast irradiation prevents cancer from growing back after a lumpectomy procedure while limiting radiation exposure to only those areas of the breast where radiation is needed, which may cause fewer and less severe side effects. The 3-day study treatment schedule is shorter than the usual 10-day schedule but it delivers the same total dose of radiation, and it may provide the same benefits of the usual schedule.
    Location: 7 locations

  • Phase 2 Study of SAR439859 Versus Physician's Choice in Locally Advanced or Metastatic ER-positive Breast Cancer (AMEERA-3)

    Primary Objective: To determine whether SAR439859 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 Objective: - 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 SAR439859 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: 7 locations