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 526-550 of 552

  • Cryoablation, Atezolizumab, and Nab-paclitaxel for the Treatment of Locally Advanced or Metastatic Triple Negative Breast Cancer

    This early phase I trial studies the side effects and feasibility of cryoablation, atezolizumab, and nab-paclitaxel in treating patients with triple negative breast cancer that has spread to nearby tissue or lymph nodes (locally advanced) or has spread to other places in the body (metastatic). Cryosurgery, also known as cryoablation or cryotherapy, kills tumor cells by freezing them. Immunotherapy with monoclonal antibodies, such as atezolizumab, 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 nab-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 cryoablation, atezolizumab and nab-paclitaxel may improve response to the disease.
    Location: Mayo Clinic in Florida, Jacksonville, Florida

  • Topical Afimoxifene in Treating Patients with Breast Cancer Who Have Undergone Radiation Therapy on One Breast

    This phase II trial studies how well topical afimoxifene works in treating patients with breast cancer who have undergone radiation therapy on one breast. Topical afimoxifene is a quick-drying medicated gel that may block the growth of breast cancer cells when applied to the breast skin. The purpose of this research is to determine what effect, if any, differences in skin type between women have on the delivery of topical afimoxifene to the breast tissue, and whether radiation affects the delivery of topical afimoxifene to breast tissue.
    Location: Northwestern University, Chicago, Illinois

  • Abexinostat, Palbociclib, and Fulvestrant for the Treatment of Breast or Gynecologic Cancer

    This phase I trial investigates the side effects and best dose of abexinostat and palbociclib when given together with fulvestrant in treating patients with breast or gynecologic cancer. Abexinostat may prevent tumor cells from growing and multiplying and may kill tumor cells. Palbociclib may prevent or slow the growth of tumor cells when used with other anti-hormonal therapy. Estrogen can cause the growth of breast and gynecologic tumor cells. Fulvestrant may help fight breast or gynecologic cancer by blocking the use of estrogen by the tumor cells. Giving abexinostat, palbociclib, and fulvestrant may work better in treating patients with breast or gynecologic cancer.
    Location: 2 locations

  • Abemaciclib and Niraparib before Surgery for the Treatment of Hormone Receptor Positive HER2 Negative Breast Cancer

    This phase I trial tests the side effects and best dose of abemaciclib and niraparib in treating patients with breast cancer that is positive for estrogen or progesterone receptors (hormone receptor positive [HR+]) and HER2 negative. Abemaciclib may stop the growth of tumor cells by blocking certain proteins called cyclin-dependent kinases, which are needed for cell growth. PARPs are proteins that help repair DNA mutations. PARP inhibitors, such as niraparib, can keep PARP from working so tumor cells can't repair themselves and grow. Giving abemaciclib and niraparib together before surgery may make the tumor smaller.
    Location: OHSU Knight Cancer Institute, Portland, Oregon

  • A Breast Cancer Vaccine (SV-BR-1-GM) in Combination with Pembrolizumab for the Treatment of Persistent, Recurrent, or Metastatic Breast Cancer

    This phase I / II trial studies the side effects of a breast cancer vaccine (SV-BR-1-GM) and how well it works in combination with pembrolizumab for the treatment of breast cancer that is persistent, has come back (recurrent), or has spread to other places in the body (metastatic). Breast cancer vaccine SV-BR-1-GM is a human breast cancer cell line that has been genetically engineered to produce a substance called “GM-CSF” (granulocyte-macrophage colony stimulating factor) which occurs naturally in the body. GM-CSF is normally produced by white blood cells and helps the body develop immunity to disease-causing germs. 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. Anti-cancer drugs such as cyclophosphamide may help boost the immune response. Interferon alpha 2b may help stimulate the immune system to fight cancer. This trial may help doctors see whether SV-BR-1-GM injections help boost the immune system and / or help control or help shrink breast cancer along with the other drugs that also boost the immune system.
    Location: Thomas Jefferson University Hospital, Philadelphia, Pennsylvania

  • Lorcaserin in Treating Chemotherapy-Induced Peripheral Neuropathy in Patients with Stage I-IV Gastrointestinal or Breast Cancer

    This phase I trial studies how well lorcaserin works in treating chemotherapy-induced peripheral neuropathy in patients with stage I-IV gastrointestinal or breast cancer. Chemotherapy-induced peripheral neuropathy is a nerve problem that causes pain, numbness, tingling, swelling, or muscle weakness in different parts of the body. This condition can occur in patients who have received taxane chemotherapy drugs, or the chemotherapy drug oxaliplatin. Lorcaserin may improve chemotherapy-induced peripheral neuropathy by reducing pain, preventing or relieving joint symptoms, and improving balance.
    Location: Ohio State University Comprehensive Cancer Center, Columbus, Ohio

  • Pembrolizumab and Tamoxifen with or without Vorinostat for the Treatment of Estrogen Receptor Positive Breast Cancer

    This phase II trial studies how well pembrolizumab and tamoxifen with or without vorinostat work for the treatment of estrogen receptor positive breast cancer. 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 is a type of hormone made by the body that helps develop and maintain female sex characteristics and the growth of long bones. Estrogen may contribute to the growth of breast cancer cells. Tamoxifen blocks the effects of the hormone estrogen in breast tissue, which may help keep breast cancer cells from growing. Vorinostat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. This trial is being done to find a drug combination to better control estrogen receptor positive breast cancer and reduce the number of pills taken to treat this type of cancer.
    Location: University of California San Francisco, San Francisco, California

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

    This phase II 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

  • Standard of Care Therapy with or without Stereotactic Radiosurgery and / or Surgery in Treating Patients with Limited Metastatic Breast Cancer

    This randomized phase II / III trial studies how well standard of care therapy with stereotactic radiosurgery and / or surgery works and compares it to standard of care therapy alone in treating patients with breast cancer that has spread to one or two locations in the body (limited metastatic) that are previously untreated. Standard of care therapy comprising chemotherapy, hormonal therapy, biological therapy, and others may help stop the spread of tumor cells. Radiation therapy and / or surgery is usually only given with standard of care therapy to relieve pain; however, in patients with limited metastatic breast cancer, stereotactic radiosurgery, also known as stereotactic body radiation therapy, may be able to send x-rays directly to the tumor and cause less damage to normal tissue and surgery may be able to effectively remove the metastatic tumor cells. It is not yet known whether standard of care therapy is more effective with stereotactic radiosurgery and / or surgery in treating limited metastatic breast cancer.
    Location: 108 locations

  • Immunotherapy Using Tumor Infiltrating Lymphocytes for Patients With Metastatic Cancer

    Background: The NCI Surgery Branch has developed an experimental therapy that involves taking white blood cells from patients' tumors, growing them in the laboratory in large numbers, and then giving the cells back to the patient. These cells are called Tumor Infiltrating Lymphocytes, or TIL and we have given this type of treatment to over 200 patients with melanoma. Researchers want to know if TIL shrink s tumors in people with digestive tract, urothelial, breast, or ovarian / endometrial cancers. In this study, we are selecting a specific subset of white blood cells from the tumor that we think are the most effective in fighting tumors and will use only these cells in making the tumor fighting cells. Objective: The purpose of this study is to see if these specifically selected tumor fighting cells can cause digestive tract, urothelial, breast, or ovarian / endometrial tumors to shrink and to see if this treatment is safe. Eligibility: - Adults age 18-70 with upper or lower gastrointestinal, hepatobiliary, genitourinary, breast, ovarian / endometrial cancer, or glioblastoma refractory to standard chemotherapy. Design: Work up stage: Patients will be seen as an outpatient at the NIH clinical Center and undergo a history and physical examination, scans, x-rays, lab tests, and other tests as needed. Surgery: If the patients meet all of the requirements for the study they will undergo surgery to remove a tumor that can be used to grow the TIL product. Leukapheresis: Patients may undergo leukapheresis to obtain additional white blood cells. {Leukapheresis is a common procedure, which removes only the white blood cells from the patient.} Treatment: Once their cells have grown, the patients will be admitted to the hospital for the conditioning chemotherapy, the TIL cells and aldesleukin. They will stay in the hospital for about 4 weeks for the treatment. Follow up: Patients will return to the clinic for a physical exam, review of side effects, lab tests, and scans about every 1-3 months for the first year, and then every 6 months to 1 year as long as their tumors are shrinking. Follow up visits will take up to 2 days.
    Location: 2 locations

  • Non-Viral TCR Gene Therapy

    Background: A person s white blood cells can be modified in a lab to recognize certain changes in their tumor. Many of these cells are collected from the person, modified, then given back to the person. This may help treat some cancers. Objective: To learn if a person s white blood cells modified with T-cell receptors can cause solid tumors to shrink. Eligibility: People ages 18-70 who have cancer of the gastrointestinal tract, genitourinary tract, ovary, breast, or lung that has spread, or who have glioblastoma. Design: Participants will be screened and have their cells prepared for treatment in another protocol. Participants will be hospitalized one week before treatment. They will stay approximately 3 - 4 weeks after treatment. Participants will get the modified white blood cells and chemotherapy through an IV catheter, which is a small plastic tube inserted in a vein. Participants will take drugs by mouth to prevent infection. They will receive filgrastim as a shot or injection under the skin. Participants will have tests before, during, and after treatment: Heart, blood, and urine tests Chest X-ray Physical exam Scans: They will lie in a machine that takes pictures of the body. Possible apheresis: The participant s blood is removed through a needle in an arm. The blood goes through a machine that removes the white blood cells. The rest of the blood is returned through a needle in the other arm. Participants will have visits about 6 and 12 weeks after treatment. If they are responding to treatment, they will then have visits every 3-6 months for 3 years. Then they will join another study and be followed about 12 more years.
    Location: National Institutes of Health Clinical Center, Bethesda, Maryland

  • Nicotinamide Riboside in Reducing Paclitaxel or Nab-paclitaxel Induced Peripheral Neuropathy in Patients with Stage IV Breast Cancer or Platinum-resistant Recurrent Ovarian, Peritoneal, Endometrial, or Fallopian Tube Cancer

    This phase II trial studies how well nicotinamide riboside works in reducing paclitaxel or nab-paclitaxel induced peripheral neuropathy in patients with stage IV breast cancer or ovarian, peritoneal, endometrial, or fallopian tube cancer that remains despite platinum therapy (platinum resistant) or has come back (recurrent). Patients being treated with paclitaxel or nab-paclitaxel for breast, ovarian, peritoneal, endometrial, or fallopian tube cancer may experience symptoms of peripheral neuropathy including numbness or tingling, pricking sensations, or muscle weakness in the hands or feet or other areas of your body. Nicotinamide riboside, a nutritional supplement and type of vitamin B3, may prevent the progression of peripheral neuropathy in patients with breast, ovarian, peritoneal, endometrial or fallopian tube cancer being treated with paclitaxel or nab-paclitaxel.
    Location: 2 locations

  • Administering Peripheral Blood Lymphocytes Transduced With a CD70-Binding Chimeric Antigen Receptor to People With CD70 Expressing Cancers

    Background: In a new cancer therapy, researchers take a person s blood, select a certain white blood cell to grow in the lab, and then change the genes of these cells using a virus. The cells are then given back to the person. This is called gene transfer. For this study, researchers will modify the person s white blood cells with anti-CD70. Objectives: To see if a gene transfer with anti-CD70 cells can safely shrink tumors and to be certain the treatment is safe. Eligibility: Adults age 18 and older diagnosed with cancer that has the CD70-expressing cancer. Design: Participants will be screened with medical history, physical exam, scans, and other tests. They may by admitted to the hospital. Leukapheresis will be performed. For this, blood is removed through a needle in the arm. A machine separates the white blood cells. The rest of the blood is returned through a needle in the other arm. Eligible participants will have an intravenous catheter placed in their upper chest. Over several days, they will get chemotherapy drugs and the anti-CD70 cells. They will recover in the hospital. Participants will take an antibiotic for 6 months after treatment. They will repeat leukapheresis. Participants will visit the clinic every 1-3 months for the first year after treatment, every 6 months for the second year, and then as determined by their physician. Follow-up visits will take 1-2 days. At each visit, participants will have lab tests, imaging studies, and a physical exam. Throughout the study, blood will be taken and participants will have many tests to determine the size and extent of their tumor and the treatment s impact.
    Location: National Institutes of Health Clinical Center, Bethesda, Maryland

  • Administration of Autologous T-Cells Genetically Engineered to Express T-Cell Receptors Reactive Against Neoantigens in People With Metastatic Cancer

    Background: A person s tumor is studied for mutations. When cells are found that can attack the mutation in a person s tumor, the genes from those cells are studied to find the parts that make the attack possible. White blood cells are then taken from the person s body, and the gene transfer occurs in a laboratory. A type of virus is used to transfer the genes that make those white blood cells able to attack the mutation in the tumor. The gene transfer therapy is the return of those white blood cells back to the person. Objective: To see if gene transfer therapy of white blood cells can shrink tumors. Eligibility: People with certain metastatic cancer for which standard treatments have not worked. Design: Participants may complete screening under another protocol. Screening includes: - Getting tumor cells from a previous procedure - Medical history - Physical exam - Scans - Blood, urine, heart, and lung tests The study has 8 stages: 1. Screening tests repeated over 1-2 weeks. Participants will have leukapheresis: Blood is removed by a needle in one arm. A machine removes white blood cells. The rest of the blood is returned by a needle in the other arm. 2. Care at home over approximately 12 weeks. 3. Stopping therapy for 4-6 weeks while their cells are changed in a lab. 4. Hospital stay approximately 3-4 weeks for treatment. An IV catheter will be placed in the chest to administer drugs. 5. Patients on Arm 2 of the study will receive the first dose of pembrolizumab while in the hospital. Three additional doses will be given after the cell infusion 3 weeks apart. 6. Receiving changed cells by catheter. Then getting a drug over 1-5 days to help the cells live longer. 7. Recover in the hospital for 1-2 weeks. Participants will get drugs and have blood and urine tests. 8. Participants will take an antibiotic and maybe an antiviral for at least 6 months after treatment. They will have repeat screening tests at visits every few months for the first year, every 6 months for the second year, then as determined. ...
    Location: National Institutes of Health Clinical Center, Bethesda, Maryland

  • ASTX727 and Talazoparib for the Treatment of Triple Negative or Hormone Resistant / HER2-Negative Metastatic Breast Cancer

    This phase I trial studies the side effects and best dose of ASTX727 and talazoparib in treating patients with triple negative or hormone resistant / HER2-negative breast cancer that has spread to other places in the body (metastatic). ASTX727 is a combination of two chemotherapy drugs, cedazuridine and decitabine, and may increase the immune system's response to cancer and talazoparib. Talazoparib is an anticancer drug called a PARP (poly ADP ribose polymerase) inhibitor and is in development for the treatment of a variety of cancers. The combination of ASTX727 and talazoparib may help boost the immune system to stop or reverse the growth of tumors.
    Location: 2 locations

  • MRI-Guided Accelerated Partial Breast Irradiation in Treating Patients with Early Breast Cancer

    This phase II trial studies how well magnetic resonance imaging (MRI)-guided accelerated partial breast irradiation works in treating patients with breast cancer that is early in its growth and may not have spread to other parts of the body. Accelerated partial breast irradiation is a localized form of radiation delivered after surgery to the part of the breast where the tumor was removed only, which may spare the remaining healthy breast tissue. MRI is an imaging technique used to form pictures of the area of treatment to allow for the treatment to focus more on the tumor site. This study may help researchers determine if giving MRI-guided accelerated partial breast irradiation after surgery reduces the side effects that can occur to surrounding healthy tissue.
    Location: University of Wisconsin Hospital and Clinics, Madison, Wisconsin

  • ONC201 with or without Methionine-Restricted Diet in Treating Patients with Metastatic or Unresectable Triple Negative Breast Cancer

    This phase II trial studies how well ONC201 with or without methionine-restricted (MR) diet works in treating patients with triple negative breast cancer that has spread to other places in the body or cannot be removed by surgery. ONC201 activates a process that leads to the death of a cell. ONC201 is able to target tumor cells to get rid of them, but does not affect normal cells. Patients on the MR diet eat only methionine-restricted food. The addition of an intermittent MR diet may enhance the activity of ONC201. Giving ONC201 and an MR diet may work better in treating patients with breast cancer.
    Location: University of Wisconsin Hospital and Clinics, Madison, Wisconsin

  • HER2-Pulsed DC1 Booster Vaccines in Treating Patients with HER2 Positive Breast Cancer Who Have Received HER2-Pulsed DC1 Vaccine

    This phase II trial studies how well HER2-pulsed DC1 booster vaccines work in treating patients with HER2 positive breast cancer who have received a HER2-pulsed DC1 vaccine. HER2-pulsed DC1 booster vaccines could improve response to breast cancer therapy and be an important step in preventing breast cancer from returning.
    Location: Moffitt Cancer Center, Tampa, Florida

  • Vaccine Therapy in Preventing Recurrence in Patients with Her-2 Positive Stage I-III Breast Cancer

    This phase II trial studies the side effects and how well vaccine therapy works in preventing recurrence (return of breast cancer) in patients with HER-2 positive stage I-III breast cancer. Vaccines work by boosting the immune system (a system in our bodies that protects us against infection) to recognize and destroy the cancer causing cell proteins.
    Location: 8 locations

  • 18F-FBnTP Positron Emission Mammography in Detecting Breast Cancer in Patients with Intraductal Breast Cancer

    This phase I trial studies how well 18F-FBnTP positron emission mammography works in detecting breast cancer in patients with intraductal breast cancer. 18F-FBnTP positron emission mammography may detect may detect breast lesions with better sensitivity and better specificity.
    Location: Johns Hopkins University / Sidney Kimmel Cancer Center, Baltimore, Maryland

  • Ipatasertib and Atezolizumab for the Prevention of Triple Negative Breast Cancer Recurrence

    This phase II trial investigates how well ipatasertib and atezolizumab work in preventing triple negative breast cancer from coming back (recurrence). Atezolizumab is a protein that affects the immune system by blocking the PD-L1 pathway. The PD-L1 pathway controls the body’s natural immune response, but for some types of cancer the immune system does not work as it should and is prevented from attacking tumors. Atezolizumab works by blocking the PD-L1 pathway, which may help the immune system identify and catch tumor cells. Ipatasertib is a drug that inhibits (stops) an enzyme called Akt in cancer cells. It is thought that inhibiting Akt may make cancer cells more sensitive to treatment, especially in combination with a drug that activates the immune system, like atezolizumab. Giving ipatasertib and atezolizumab may work as a treatment for residual cancer in the breast or lymph nodes.
    Location: 2 locations

  • 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 in Rochester, Rochester, Minnesota

  • Trastuzumab, Vinorelbine Tartrate, and Avelumab with or without Utomilumab in Treating Patients with HER2-Positive Metastatic Breast Cancer

    This phase II trial studies the how well trastuzumab, vinorelbine tartrate, and avelumab with or without utomilumab work in treating patients with HER2-positive breast cancer that has spread to other parts of the body (metastatic). Trastuzumab is a form of targeted therapy because it attaches 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. Immunotherapy with monoclonal antibodies, such as avelumab, may induce changes in the body's immune system and may interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy, such as vinorelbine tartrate, 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. Utolimumab is a monoclonal antibody that may interfere with the ability of tumor cells to grow and spread. Giving trastuzumab, vinorelbine tartrate, and avelumab with or without utomilumab may work better in treating patients with breast cancer.
    Location: 26 locations

  • Carboplatin and Paclitaxel followed by Doxorubicin and Cyclophosphamide in Treating Patients with Triple Negative Breast Cancer

    This phase II trial studies how well carboplatin and paclitaxel followed by doxorubicin and cyclophosphamide work in treating patients with triple negative breast cancer. Drugs used in chemotherapy, such as carboplatin, paclitaxel, doxorubicin, 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: 2 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 nearby tissue or lymph nodes (locally advanced) or that has spread to other places in the body (metastatic). 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: 9 locations