View clinical trials related to Breast Neoplasm.
Filter by:The primary purpose of the study is to examine the safety and effectiveness of combination therapy consisting of daily oral capecitabine and weekly intravenous vinorelbine in stage IV breast cancer subjects. The study is designed to assess the safety and effectiveness of this combination therapy. Safety will be assessed by analyzing the types of toxicity, the severity of toxicity and the need for dose modification or delay due to toxicity. Effectiveness will be assessed by analyzing response rates, time to treatment failure, time to progression and overall survival. Our hypothesis is that the regimen will be more effective than standard historic regimens for this type and stage of cancer.
The purpose of this study is to examine the effect of the combination of everolimus and letrozole compared to placebo and letrozole as pre-surgical therapy in patients with newly diagnosed estrogen receptor positive breast cancer.
The purpose of this study is to investigate a safe dose of TAK-165, once daily (QD), in patients with HER2-tumor expression.
This study will assess the usefulness of a technique called complementary deoxyribonucleic acid (cDNA) microarray-an examination of a wide array of genes to identify disease-associated patterns-for measuring tumor response to chemotherapy in breast cancer patients. The study will look for "markers" that can help select the most effective type of chemotherapy. It will also evaluate the safety and effectiveness of a new drug combination of capecitabine and docetaxel. Patients age 18 years and older with stage II or III breast cancer whose tumor is 2 centimeters or larger may be eligible for this study. Those enrolled will be treated with surgery, standard chemotherapy using doxorubicin (Adriamycin) and cyclophosphamide (Cytoxan), and the capecitabine and docetaxel combination. Patients will have a physical examination, mammogram and magnetic resonance imaging to evaluate their tumor before beginning treatment. They will then have four 21-day treatment cycles of docetaxel and capecitabine, as follows: docetaxel intravenously (through a vein) on day 1 and capecitabine pills (by mouth) twice a day from days 2 through 15. No drugs will be given from days 16 through 21. This regimen will be repeated four times, after which the tumor will be re-evaluated by physical examination, mammogram, and magnetic resonance imaging. Patients will then have surgery to remove the cancer-either lumpectomy with removal of the underarm lymph nodes; mastectomy and removal of the underarm lymph nodes; or modified radical mastectomy. After recovery, they will have four more cycles of chemotherapy, this time with a doxorubicin and cyclophosphamide. Both drugs will be given intravenously on day 1 of four 21-day cycles. Some patients who had a mastectomy (depending on their tumor characteristics and whether tumor cells were found in their lymph nodes) and all those who had a lumpectomy will also have radiation therapy. Patients with hormone receptor-positive tumors will also receive tamoxifen treatment for 5 years. In addition to the above procedures, all patients will have tumor biopsies (removal of a small piece of tumor tissue) before beginning treatment, on day 1 of cycle 1, before cycle 2, and at the time of surgery, and physical examinations, chest X-rays, bone scans, computerized tomography (CT) scans, electrocardiograms, multi-gated acquisition scan-MUGA (nuclear medicine test of cardiac function) or echocardiograms of heart function, mammograms and blood tests at various times during the study. Patients will be followed at National Institutes of Health (NIH) for 3 years after diagnosis with physical examinations, blood tests, X-rays, and computed tomography (CT) scans. Although it is not known whether this treatment will help an individual patient's cancer, possible benefits are tumor shrinkage and decreased risk of disease recurrence. In addition, the information gained about genetic changes after chemotherapy will help determine if additional studies on the use of cDNA microarray to measure tumor response are warranted.
This study will look at genetic changes which occur in the development of male and female breast cancer and other cancer. It will use a new technology called DNA microarray hybridization that looks at a wide array of genes to identify disease-associated patterns in the human genome (complete set of human genes). Numerous studies have linked particular genes to a given disease, but there is very little information on patterns of gene expression (production of proteins from genetic coding) in the entire human genome. Pinpointing genetic abnormalities in disease may help classify different forms of cancer and perhaps lead to new avenues of treatment or prevention. A primary goal of this study will be to create a database of gene expression for human cancers and other disorders that will provide the basis for finding genetic abnormalities in disease. Tumors specimens used in this study will be taken from tissues biopsied from patients with breast, colon cancer, sarcomas or melanoma as part of their routine care. Patients in the study will be among those receiving care at the: Department of Oncology, University Hospital, University of Lund, Sweden (breast cancer); Department of Medicine, University of Michigan, Ann Arbor, Michigan (breast cancer); Surgery Branch, National Cancer Institute, Bethesda, Maryland (melanoma), Johns Hopkins Univ. (colon cancer), Memorial Sloan Kettering (sarcoma). Patients in the study will have a family history taken and will complete a questionnaire. Some patients will be asked to have a blood test. Breast cancer patients will have a mammogram if one has not been done within the last year.
This research study is designed to work in cooperation with another study being conducted by the National Cancer Institute. The National Cancer Institute (NCI) is studying the effects of a drug called raloxifene on premenopausal women believed to have a high risk of developing breast cancer (98-C-0123). In this study, researchers are interested in learning about the effects of raloxifene on the uterus and ovaries of the women participating in the NCI study. To do this researchers plan to conduct ultrasounds on the patients enrolled in the NCI study. In addition researchers plan to take samples of the lining of the uterus in these patients (endometrial biopsy) if found to be necessary. The purpose of this study is to determine the reproductive effects of raloxifene on women who have normal functioning ovaries by taking ultrasounds of the ovaries and lining of the uterus (endometrium).
This study will evaluate the effectiveness of combination chemotherapy with paclitaxel (Taxol) and cyclophosphamide (Cytoxan), followed by high-dose melphalan and etoposide for treating inflammatory breast cancer. Patients also receive infusions of their own previously collected progenitor cells (primitive cells that can make new cells to replace ones destroyed by chemotherapy). Patients 18 years of age or older with stage IIIB inflammatory breast cancer that has not metastasized (spread beyond the breast) may be eligible for this study. Candidates are screened with a medical history and physical examination, blood and urine tests, and chest x-ray. They have computed tomography (CT) of the head, chest, abdomen and pelvis as well as a bone scan to determine the extent of disease, and a nuclear medicine scan called MUGA to examine the heart's pumping ability. They may receive a rehabilitation medicine evaluation. Participants undergo the following tests and procedures: - Central venous line placement: Patients have a central venous line (plastic tube) placed into a major vein in the chest before beginning treatment. The line remains in the body throughout treatment and is used to give chemotherapy and other medications and to withdraw blood samples. The line is usually placed under local anesthesia in the radiology department or the operating room. - Chemotherapy: Patients receive two or more cycles of paclitaxel and cyclophosphamide. Paclitaxel is given intravenously (I.V., through a vein) for 72 hours using a portable pump. Cyclophosphamide is given daily for 3 days I.V. over 1 hour. The cycles may be 28 days apart. A drug called Mesna is given with this treatment to protect the bladder from irritation from cyclophosphamide. Patients who have not previously been treated with doxorubicin (Adriamycin) may receive a maximum of four cycles of doxorubicin and cyclophosphamide by vein on a single day during each cycle, with cycles 21 days apart. When all the paclitaxel/cyclophosphamide cycles are completed, patients receive melphalan and etoposide, both drugs I.V. over 1 to 8 hours for three consecutive days. - G-CSF treatment: After each paclitaxel/cyclophosphamide cycle and after the melphalan/etoposide treatment, patients are given a drug called G-CSF. G-CSF, injected under the skin, stimulates production of infection-fighting white blood cells. - Apheresis: This is a procedure to collect progenitor cells for later reinfusion. For this procedure, blood is collected through a catheter (plastic tube) placed in an arm vein. The blood is circulated through a cell-separating machine, where the white cells, including the progenitor cells, are extracted, and the red cells are returned to the patient through another catheter in the other arm. Apheresis is done after each of two cycles of paclitaxel/cyclophosphamide. - Progenitor cell transplant: Progenitor cells are reinfused after melphalan/etoposide treatment. - Glucose infusion: A salt solution with chemically modified glucose is infused I.V. over a period of from 12 to 48 hours, with subsequent donation of blood cells for blood and immune system studies. Patients have a maximum of two glucose infusions, separated by at least 3 months. - Tumor biopsy: Some patients have a biopsy of their tumor (removal of a small piece of tumor tissue for microscopic study) before starting chemotherapy. - Blood tests: Blood is drawn frequently to monitor safety and treatment response, and for research purposes. - Dental consultation: Some patients may have a dental consultation before the progenitor cell transplant.
This is a dosage escalation study to estimate the maximum tolerated dose of 9-cis-retinoic acid given in combination with tamoxifen. Groups of 3 to 6 patients receive oral 9-cis-retinoic acid daily for 4 weeks, after which daily oral tamoxifen is added to the regimen. Patients continue treatment for up to 28 weeks, with tamoxifen continued after the study if medically appropriate.
Women who are at high risk for breast cancer, either because of linkage to high risk breast and ovarian cancer families, or because of a carcinoma in the opposite breast, will be studied. Women will have a physical examination and mammography to ensure that no breast abnormalities are present. Eligible women will undergo biopsy of the breast to obtain normal breast tissue. Short-term cell cultures will be established from this tissue and early passages of the short-term cell lines will be stored. A bank of high risk normal mammary epithelial cells will be established. To further characterize the mammary epithelial cells in this population of women, cell cultures will subsequently be analyzed for their growth and metabolic properties, sensitivity to chemopreventive agents, steroid receptor characteristics, oncogene expression and regulation, and genetic changes.
The ability of chemotherapy to cure cancer, including breast cancer, has been limited by drug resistant residual tumor cells remaining after chemotherapy that generally result in relapse. Additional therapeutic strategies to eradicate these residual tumor cells are needed. The augmentation of specific anti-tumor immune responses, such as those mediated by T-cells, might represent such an additional strategy for the control or elimination of residual tumor cells. This approach might be especially effective if T-cell mediated responses were enhanced during both the period of T-cell repopulation that follows acute T-cell depletion and in the setting of minimal residual tumor burden present after dose intensive chemotherapy. Such chemotherapy is known to result in severe T-cell depletion. This pilot study has been designed to examine the feasibility of combining dose intensive chemotherapy with interventions aimed at the reconstitution of T-cell immunity. Metastatic or adjuvant breast cancer patients who have received dose intensive chemotherapy will subsequently receive a combination of autologous chemotherapy-naive T-cells, a patient-specific tumor antigen vaccine, and recombinant human interleukin-2. These interventions will be assessed for their ability to modulate T-cell number, T-cell function, and T-cell specificity during the period of T-cell repopulation. Such modulation may result in the effective reconstitution of generalized T-cell immunity with the generation of vaccine-specific anti-tumor T-cell responses.