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 526-550 of 556

  • X-ray Psoralen Activated Cancer Therapy in Head and Neck, Breast, Sarcoma and Melanoma

    In this Phase I trial for subjects with advanced head & neck cancer, breast cancer, soft tissue sarcoma or melanoma all subjects will receive open label X-PACT treatment as a intra-tumoral injection. The primary objective will be to establish the safety of X-PACT when dosed with 5 intra-tumoral injections of the combination product (the phosphor device and methoxsalen sterile solution and subsequently exposing the tumor to X-ray energy) over a period of 6 weeks (on day D1, D3 and D5 of Week 1, on D1 of Week 2, and a booster on D1 of Week 6). After the week 8 tumor assessment subjects demonstrating stable disease, partial response or unconfirmed progression assessed by iRecist, will be eligible to receive two additional booster treatments 4-6 weeks apart. Treatment will be considered safe provided ≤ 2 out of 12 patients experience a dose-limiting toxicity (DLT) during the 6 weeks after the first intra-tumoral injection.
    Location: UNC Lineberger Comprehensive Cancer Center, Chapel Hill, North Carolina

  • Concurrent WOKVAC Vaccination, Chemotherapy, and HER2-Targeted Monoclonal Antibody Therapy before Surgery for the Treatment of Patients with Breast Cancer

    This phase II trial studies the immunologic response and side effects of using the WOKVAC vaccine in combination with chemotherapy and HER2-targeted monoclonal antibody therapy before surgery in treating patients with breast cancer. Vaccines like WOKVAC are made from tumor-associated antigens which may help the body build an effective immune response to kill tumor cells. Chemotherapy drugs, such as 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. Trastuzumab and pertuzumab are forms of targeted therapy because they work by attaching themselves to specific molecules (receptors) on the surface of tumor cells, known as HER2 receptors. When trastuzumab and pertuzumab attach to HER2 receptors, the signals that tell the cells to grow are blocked and the tumor cell may be marked for destruction by the body's immune system. Giving the WOKVAC vaccine at the same time (concurrently) with paclitaxel, trastuzumab, and pertuzumab before surgery may kill more tumor cells.
    Location: Fred Hutch / University of Washington Cancer Consortium, Seattle, Washington

  • Testing the Addition of an Anti-cancer Drug, BAY 1895344, to the Usual Chemotherapy Treatment (Cisplatin, or Cisplatin and Gemcitabine) for Advanced Solid Tumors with Emphasis on Urothelial Cancer

    This phase I trial investigates the best dose and side effects of BAY 1895344 when given together with chemotherapy in treating patients with solid tumors or urothelial cancer that has spread to other places in the body (advanced). BAY 1895344 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Chemotherapy drugs, such as cisplatin and gemcitabine, 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. The purpose of this trial is to test the safety of a drug called BAY 1895344 in combination with the usual chemotherapy treatment (cisplatin, or cisplatin and gemcitabine) for the treatment of advanced solid tumors, including urothelial cancer.
    Location: Location information is not yet available.

  • Radio-immunotherapy (CDX-301, Radiotherapy, CDX-1140) for the Treatment of Unresectable or Metastatic Breast Cancer Patients

    This phase I trial evaluates the side effects of radio-immunotherapy (CDX-301, radiotherapy, CDX-1140) in treating patients with breast cancer that cannot be removed by surgery (unresectable) or has spread to other places in the body (metastatic). CDX-301 may induce cross-presenting dendritic cells, master regulators in the immune system. CDX-1140 and poly-ICLC may activate cross-presenting dendritic cells, and generate tumor-specific T lymphocytes, a type of immune cells, that can search out and attack cancers. Radiation therapy uses high energy to kill tumor cells and shrink tumors. Giving immune modulators and radiation therapy may stimulate the immune system and stimulate tumor cell death.
    Location: Roswell Park Cancer Institute, Buffalo, New York

  • Diabetes Prevention Program (METFIT) in Reducing Insulin Resistance in Stage I-III Breast Cancer Survivors

    This trial studies how well a diabetes prevention program (METFIT) works in reducing insulin resistance in stage I-III breast cancer survivors. METFIT program, a diet and lifestyle intervention, utilizes intermittent fasting to reduce insulin resistance in insulin resistant breast cancer survivors. Intermittent fasting has been shown to have benefits for patients undergoing cancer therapy by improving symptoms such as fatigue in breast cancer patients. Intermittent fasting has also shown potential for decreasing the risk of breast cancer coming back (recurrence). This trial is being done to determine if METFIT program can be successfully and effectively implemented to reduce insulin resistant in breast cancer survivors.
    Location: City of Hope Comprehensive Cancer Center, Duarte, California

  • Dendritic Cell Vaccines against Her2 / Her3, Cytokine Modulation Regimen, and Pembrolizumab for the Treatment of Brain Metastasis from Triple Negative Breast Cancer or HER2+ Breast Cancer

    This phase IIa trial studies how well dendritic cell vaccines against Her2 / Her3, cytokine modulation (CKM) regimen, and pembrolizumab work for the treatment of triple negative breast cancer or HER2+ breast cancer that has spread to the brain (brain metastasis). Dendritic cell vaccines work by boosting the immune system (a system in the body that protect against infection) to recognize and destroy the cancer cells. CKM regimen, consisting of rintatolimod, interferon alpha-2b and celecoxib, attempt to direct the immune cells to the cancer cells and maximize the effectiveness of pembrolizumab. Pembrolizumab is an “immune checkpoint inhibitor” which is designed to either “unleash” or “enhance” the cancer immune responses that already exist by either blocking inhibitory molecules” or by activating stimulatory molecules. Giving dendritic cell vaccines, CKM regimen, and pembrolizumab may shrink the cancer.
    Location: Roswell Park Cancer Institute, Buffalo, New York

  • 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

  • Functional Precision Oncology for HER2 Negative or Non-amplified Metastatic or Recurrent, Unresectable Breast Cancer, FORESEE study

    This clinical trial investigates if precision oncology may help guide treatment for patients with HER2 negative or non-amplified breast cancer that has spread to other places in the body (metastatic) or has come back (recurrent) and cannot be removed by surgery (unresectable). Precision oncology uses genetic information from a person’s tumor to help guide the choice of treatment. By looking at the genetic makeup of the cancer, researchers hope to give the right drug to achieve the best response from the treatment (targeted treatment). However, looking at the DNA of the cancer alone does not capture the complex biology of breast cancer and many factors may affect the growth of a cancer. Organoids are generated from a patient's breast cancer biopsy sample, and are small, live versions of a patient's cancer. Organoids retain many of the characteristics of the cancer where they came from, including its genetic composition, which makes it easier to evaluate how effective various drugs may be in treating breast cancer. Gathering biopsy samples and exposing them to multiple cancer drugs to see how well they do or do not work may help doctors in choosing a specific treatment plan that is best suited for patients with breast cancer.
    Location: Huntsman Cancer Institute / University of Utah, Salt Lake City, Utah

  • 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: UCSF Medical Center-Mount Zion, 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

  • 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

  • PRS-343 in Combination With Atezolizumab in HER2-Positive Solid Tumors

    A Phase 1b, open-label, dose escalation study of PRS-343 in combination with atezolizumab in patients with HER2-positive advanced or metastatic solid tumors.
    Location: 2 locations

  • 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

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

    Background: In gene transfer therapy, cells are taken from a person s tumor to isolate mutations. White blood cells are then taken from the person's body, changed with a type of virus to attack the tumor cells, and returned to the person. Objective: To see if gene transfer therapy shrinks tumors. Eligibility: People with certain metastatic cancer for which standard treatments have not worked Design: Participants will complete screening and stages 1-3 under another protocol. Screening includes: Undergoing a biopsy or surgery at the NIH to obtain pieces of tumor in order to grow tumor cells Medical history Physical exam Scans Blood, urine, heart, and lung tests The study has 7 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. An IV catheter will be placed in the chest. 2. Care at home over 6-12 weeks. 3. Stopping therapy for 4-6 weeks while their cells are changed in a lab. 4. Hospital stay for 1 week to get chemotherapy by IV. 5. Receiving changed cells by catheter. Then getting a drug over 1-5 days to help the cells live longer. 6. Recover in the hospital for 1 2 weeks. Participants will get drugs and have blood and urine tests. 7. 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

  • 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

  • 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