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 76-100 of 562

  • 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

  • A First-in-human Study Using BDC-1001 in Advanced HER2-Expressing Solid Tumors

    A first-in-human study using BDC-1001 in HER2 expressing advanced malignancies
    Location: 8 locations

  • Study of MT-5111 in HER2-positive Solid Tumors

    This will be a Phase 1, first in human, open-label, dose escalation and expansion study of MT-5111 (a recombinant fusion protein) in subjects with HER2-positive solid tumors.
    Location: 8 locations

  • Exercise Intervention with Concurrent First-Line Therapy in Treating Patients with Hormone Receptor Positive Metastatic Breast Cancer

    This phase Ia / Ib trial determines the maximum amount of exercise intervention given at the same time (concurrent) as first-line therapy in treating patients with hormone receptor positive breast cancer that has spread to other places in the body (metastatic). Exercise may help delay the development of resistance to hormone therapy while slowing the growth of tumors. This study will test any good and bad effects of aerobic exercise performed while the patient is receiving the usual first-line treatment for metastatic breast cancer.
    Location: 8 locations

  • 9-ING-41 in Patients With Advanced Cancers

    GSK-3β is a potentially important therapeutic target in human malignancies. The Actuate 1801 Phase 1 / 2 study is designed to evaluate the safety and efficacy of 9-ING-41, a potent GSK-3β inhibitor, as a single agent and in combination with cytotoxic agents, in patients with refractory cancers.
    Location: 9 locations

  • A Study of ZN-c5 in Subjects With Breast Cancer

    This is a Phase 1 / 2, open-label, multicenter, dose-escalation and expansion study to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of ZN-c5 administered orally in subjects with advanced estrogen receptor positive, human epidermal growth factor receptor 2 negative (ER+ / HER2-) breast cancer. ZN-c5 will be evaluated both as monotherapy and in combination with palbociclib (IBRANCE®).
    Location: 8 locations

  • Rucaparib Camsylate and Radiation Therapy in Treating Patients with Triple Negative Breast Cancer or Hormone Receptor Positive Breast Cancer

    This phase I trial studies the side effects and best dose of rucaparib camsylate when given together with radiation therapy in treating patients with triple negative breast cancer or hormone receptor positive breast cancer. Rucaparib camsylate is an inhibitor of PARP, an enzyme that helps repair deoxyribonucleic acid (DNA) when it becomes damaged. Blocking PARP may help keep cancer cells from repairing their damaged DNA, causing them to die. PARP inhibitors are a type of targeted therapy. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Giving rucaparib camsylate and radiation therapy may work better in treating patients with triple negative breast cancer or hormone receptor positive breast cancer.
    Location: 8 locations

  • Carboplatin with or without Pembrolizumab in Treating Patients with Advanced Breast Cancer with Locally Recurrent Chest Wall Disease That Cannot Be Removed by Surgery

    This randomized phase II trial studies how well carboplatin with or without pembrolizumab work in treating patients with breast cancer that has spread to other places in the body (advanced) with chest wall disease that has come back (locally recurrent) and cannot be removed by surgery. Drugs used in chemotherapy, such as carboplatin, work in different ways to stop the growth of cancer 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.
    Location: 9 locations

  • Comparing Two Different Surgical Techniques for Breast Reconstruction

    This phase III trial compares prepectoral breast reconstruction to subpectoral breast reconstruction for patients who are undergoing breast reconstruction. The prepectoral technique involves putting a tissue expander on top of the pectoralis muscle (a large muscle in the upper chest), while the subpectoral technique involves putting a tissue expander under the pectoralis muscle. The tissue expander is a temporary, balloon-like implant used to expand the breast skin and muscle before a permanent implant is placed months later through a different procedure. This study may help researchers find out whether the subpectoral approach is better, the same as, or worse than the prepectoral approach and also learn which approach causes fewer complications after surgery (for example, infection or the need for a second surgery) and which approach causes less pain and use of pain medication after surgery.
    Location: 7 locations

  • Pembrolizumab and Ablative Radiotherapy with or without Olaparib for the Treatment of Metastatic Triple-Negative Breast Cancer

    This phase II trial studies the effect of pembrolizumab, ablative radiotherapy with or without olaparib in treating patients with triple-negative breast cancer that has spread to other places of the body (metastatic). Pembrolizumab is an antibody, like the proteins made by the immune system to protect the body from harm. Pembrolizumab blocks the protein PD 1 (programmed cell death receptor 1) that usually acts as a “brake” on the immune system. Blocking this protein is like releasing the brakes, so that the immune system can target tumor cells and destroy them. Stereotactic ablative radiation therapy uses special equipment to position a patient and deliver radiation to tumors with high precision. This method may kill tumor cells with fewer doses over a shorter period and cause less damage to normal tissue. Olaparib is a type of medication called a PARP inhibitor. PARP is a protein that helps repair damage to deoxyribonucleic acid (DNA), the genetic material that serves as your body’s instruction book. Changes (mutations) in DNA can cause tumor cells to grow quickly and out of control. But PARP inhibitors have been shown to prevent PARP from working, so tumor cells can’t repair themselves, and they stop growing. The combination of radiation with pembrolizumab or radiation with pembrolizumab and olaparib may activate the body’s immune cells to travel to and attack and destroy other sites of triple-negative breast cancer in the body.
    Location: 7 locations

  • A Study of Tucatinib Plus Trastuzumab Deruxtecan in HER2+ Breast Cancer

    This trial studies how well the drug tucatinib works when given with trastuzumab deruxtecan. It will also look at what side effects happen when these drugs are given together. A side effect is anything a drug does besides treating cancer. Participants in this trial have HER2-positive (HER2+) breast cancer that has either spread to other parts of the body (metastatic) or cannot be removed completely with surgery (unresectable). All participants will get both tucatinib and trastuzumab deruxtecan.
    Location: 10 locations

  • Study of ONCR-177 Alone and in Combination With PD-1 Blockade in Adult Subjects With Advanced and / or Refractory Cutaneous, Subcutaneous or Metastatic Nodal Solid Tumors or With Liver Metastases of Solid Tumors

    ONCR-177-101 is a phase 1, open-label, multi-center, dose escalation and expansion study of ONCR-177, an oncolytic Herpes Simplex Virus for intratumoral injection, alone and in combination with PD-1 blockade in adult subjects with advanced and / or refractory cutaneous, subcutaneous or metastatic nodal solid tumors or with Liver Metastases of Solid Tumors. The purpose of this study is to determine the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D), as well as to evaluate preliminary efficacy.
    Location: 8 locations

  • A Study of Gene Edited Autologous Neoantigen Targeted TCR T Cells With or Without Anti-PD-1 in Patients With Solid Tumors

    This is a first in human, single arm, open label, Phase 1a / 1b study to determine the safety, feasibility, and efficacy of a single dose of NeoTCR-P1 T cells in participants with solid tumors.
    Location: 8 locations

  • Evaluation of IPI-549 Combined With Front-line Treatments in Pts. With Triple-Negative Breast Cancer or Renal Cell Carcinoma (MARIO-3)

    MARIO-3 is a Phase 2 multi-arm combination cohort study designed to evaluate IPI-549, Infinity Pharmaceutical's first-in-class, oral immuno-oncology product candidate targeting immune-suppressive tumor-associated myeloid cells through selective inhibition of phosphoinositide-3-kinase (PI3K)-gamma, in combinations with Tecentriq and Abraxane (nab-paclitaxel) in front-line triple negative breast cancer (TNBC) and in combination with Tecentriq and Avastin (bevacizumab) in front-line renal cell cancer (RCC).
    Location: 7 locations

  • Phase 1 / 2 Study of SAR439859 Single Agent and in Combination With Other Anti-cancer Therapies in Postmenopausal Women With Estrogen Receptor Positive Advanced Breast Cancer

    Primary Objectives: Dose Escalation: Part A (SAR439859 monotherapy); Part C (combination of SAR439859 with palbociclib); Part F (Safety-Run-In - combination of SAR439859 with alpelisib): -To determine the maximum tolerated dose (MTD) and recommended dose (RD) of SAR439859 based on the dose-limiting toxicity observance in monotherapy (Part A) and in combination with palbociclib (Part C), and to confirm the combination RD with alpelisib (Part F). Dose Expansion: Part B (SAR439859 monotherapy): -To assess antitumor activity by Objective Response Rate (ORR) at the SAR439859 recommended dose in monotherapy Dose Expansion: Part D (combination of SAR439859 with palbociclib) and Part G (combination of SAR439859 with alpelisib): -Overall safety profile of SAR439859 in combination with palbociclib or alpelisib Secondary Objectives: - Overall safety profile of SAR439859 as monotherapy (Parts A,B), in combination with palbociclib (Part C) or in combination with alpelisib (Part F) - Pharmacokinetic (PK) profile of SAR439859 as monotherapy (Parts A,B), in combination with palbociclib (Parts C,D), in combination with alpelisib (Parts F,G), and PK of palbociclib (Parts C,D) and alpelisib (Parts F,G) alone and / or with SAR439859 - Antitumor activity of SAR439859 as monotherapy (Part A), in combinations with palbociclib (Part C,D) or alpelisib (F,G), and Clinical Benefit Rate (CBR: CR, PR and SD≥24 weeks) in Parts A,B,C,D,F,G - ORR and CBR in Parts B, D and G per estrogen receptor 1 (ESR1) gene mutational status (mutant and wild type) at baseline and in treatment - Time to 1st response (CR,PR) (Part B,D,G) - Residual ER availability with [(18)F] Fluoroestradiol Positron Emission Tomography (FES PET) scan (Part A) - To assess potential induction / inhibition effect of SAR439859 on CYP3A (Part A,B)
    Location: 7 locations

  • Mesothelin-Targeted T-Cells after Cyclophosphamide in Treating Patients with Metastatic, Mesothelin-Expressing, HER2 Negative Breast Cancer

    This phase I trial studies the side effects and best dose of mesothelin-targeted T-cells when given after cyclophosphamide in treating patients with mesothelin-expressing, human epidermal growth factor receptor 2 (HER2) negative breast cancer that has spread to other parts of the body (metastatic). Placing genes that have been created in the laboratory into T-cells may help them recognize and kill the breast cancer cells by targeting mesothelin protein. 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. Giving mesothelin-targeted T-cells after cyclophosphamide may work better at treating patients with metastatic, mesothelin-expressing, HER2 negative breast cancer.
    Location: 7 locations

  • Pembrolizumab, Endocrine Therapy, and Palbociclib in Treating Postmenopausal Patients with Newly Diagnosed Metastatic Stage IV Estrogen Receptor Positive Breast Cancer

    This phase II trial studies how well pembrolizumab works when given together with endocrine therapy and palbociclib in treating postmenopausal patients with newly diagnosed stage IV estrogen receptor positive breast cancer that has spread to other parts of 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. Estrogen can cause the growth of breast cancer cells. Antihormone therapy, such as letrozole and fulvestrant, may lessen the amount of estrogen made by the body. Palbociclib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving pembrolizumab, palbociclib, and letrozole or fulvestrant may be an effective treatment for patients with stage IV estrogen receptor positive breast cancer.
    Location: 7 locations

  • A Study Of Avelumab In Combination With Other Cancer Immunotherapies In Advanced Malignancies (JAVELIN Medley)

    This is a Phase 1b / 2 dose-optimization study to evaluate safety, pharmacokinetics, pharmacodynamics, and preliminary antitumor activity of avelumab (MSB0010718C) in combination with other cancer immunotherapies in patients with locally advanced or metastatic solid tumors. The primary purpose is to assess the safety and early signs of efficacy of various avelumab combinations with other cancer immunotherapies, optimizing dosing regimens as appropriate, in a limited series of indications.
    Location: 7 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: 7 locations

  • A Study of AL101 Monotherapy in Patients With Notch Activated Triple Negative Breast Cancer

    The current study is designed to evaluate the efficacy and safety of AL101 monotherapy in subjects with Notch-activated recurrent or metastatic TNBC; Notch activation will be determined by a Next Generation Sequencing (NGS) test.
    Location: 7 locations

  • Study of the Body’s Response to Exercise and a Plant-Based Diet in Overweight Postmenopausal Women with Hormone Receptor Positive 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 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 breast cancer.
    Location: 7 locations

  • Immediate Lymphatic Reconstruction after Axillary Lymph Node Dissection for the Decrease in Incidence of Lymphedema in Patients with Breast Cancer

    This phase III trial compares immediate lymphatic reconstruction after axillary lymph node dissection to axillary lymph node dissection alone in decreasing the incidence of lymphedema in patients with breast cancer. Lymph nodes are found throughout the body, and they contain lymph, a milky fluid that is made up of white blood cells (cells that help fight infections). When lymph nodes in the armpit (axillary lymph nodes) are removed during breast cancer surgery, some of the lymph vessels can leak and become blocked. This may prevent lymph from leaving the area. Lymphedema occurs when lymph collects in the arm (including the hand), causing it to swell. Performing immediate surgery to reconstruct lymphatic drainage of the arm (immediate lymphatic reconstruction) after axillary lymph node dissection may reduce the chance of developing lymphedema and improve quality of life compared to axillary lymph node dissection alone.
    Location: 7 locations

  • Study of DF1001 in Patients With Advanced Solid Tumors

    DF1001-001 is a study of a new molecule that targets natural killer (NK) cells and T-cell activation signals to specific receptors on cancer cells. The study will occur in two phases. The first phase will be a dose escalation phase, enrolling patients with various types of solid tumors that express human epidermal growth factor receptor 2 (HER2). Two combination therapy cohorts will be opened for enrollment, DF1001 + nivolumab and DF1001 + Nab paclitaxel. The second phase will include a dose expansion using the best dose selected from the first phase of the study. Multiple cohorts will be opened with eligible patients having either selected solid tumors, or solid tumors expressing high levels of HER2.
    Location: 10 locations

  • Capivasertib+Paclitaxel as First Line Treatment for Patients With Locally Advanced or Metastatic TNBC

    Phase III Study of Capivasertib + Paclitaxel versus Placebo + Paclitaxel as First line Treatment for Patients with Locally Advanced or Metastatic Triple-negative Breast Cancer (TNBC)
    Location: 7 locations

  • Aerobic Training in Supporting Patients with Solid Tumors before Surgery, PRESTO 1 study

    This early phase I trial studies the safest level of aerobic training and to see how well it works in supporting patients with solid tumors who are undergoing surgery. Aerobic exercise may improve the outcomes of their cancers.
    Location: 7 locations