View clinical trials related to Breast Neoplasms.
Filter by:This study will identify how personal beliefs, values and family experiences affect a person's decision as to whether or not to be tested for changes in a gene called BRCA1 or BRCA2. Changes in these genes are associated with a significantly increased risk of breast and ovarian cancer in women, a slightly higher risk of prostate cancer in men, and a slightly higher risk of colon cancer in both men and women. Families enrolled in the National Cancer Institute's familial cancer research project who also participated in a telephone survey (protocol 78-C-0039) regarding their level of interest in BRCA1/2 testing results may be eligible for this study. All participants will complete a 20- to 30-minute questionnaire assessing knowledge, risk perception and personality traits, and will participate in an education session to review the following: - Information about their individual cancer risk, based on family history - Potential benefits and risks (medical, psychological and social) of BRCA1/2 testing, both for those who test positive and those who test negative - Overview of DNA testing (what is done and how accurate it may or may not be) - Medical management options for those at increased risk for breast and ovarian cancer - Environmental cancer risk factors - Instruction in breast self-examination Participants will then be asked whether or not they want to undergo BRCA1/2 testing Those who want to be tested will be divided into two groups to compare counseling methods (client-centered vs. counselor-driven counseling). A small blood sample (2 to 3 tablespoons) will be drawn for genetic analysis. Test results will be provided in person at a second visit-this may take 6 months or more. A follow-up telephone call 2 weeks after receipt of the test results will address participants' questions and provide support. During a third visit, scheduled 6 months after receipt of the test results, participants will complete questionnaires evaluating mood, attitude, self-esteem, family interactions, cancer screening practices, and other factors. Finally, 1 year after receipt of the test results, participants will be contacted by telephone and asked about their feelings about the test and its outcome. Individuals who choose not to have gene testing will not participate in any in-person sessions after the initial visit. They will be followed with no more than two telephone interviews to assess their feelings and attitudes related to their decision not to be tested. Individuals may reconsider and change their mind at any time regarding their decision-whether to be tested or not. The results of the study will help experts devise the most effective methods of educating and counseling people at high risk for having an altered BRCA1/2 gene.
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.
This is a prospective study evaluating the role of Positron Emission Tomography (PET scan) in breast cancer. The radiopharmaceutical [18F] 2-deoxyglucose will be used as both an imaging modality and to evaluate tumor metabolism in patients with breast cancer. Patients with stage II, stage IIIA or IIIB, or stage IV breast cancer and evaluable disease in the breast and/or at metastatic sites will be studied. Patients will be injected intravenously with [18F]2-deoxyglucose and a PET scan conducted over 90 minutes. Examination of the role of PET scan in assessing the response of breast cancer to chemotherapy, especially in stage II and stage III patients, will be done. Up to three PET scans within one year may be performed. Findings by PET scan will be correlated both with those of concurrent imaging techniques (x-ray, CT scan, MRI, bone scan or mammogram), and with histologic, biochemical, and flow cytometric information on the tumor, and with findings in subsequent surgical specimens. Changes in tumor glucose metabolism with treatment will be assessed by PET imaging studies and by biochemical methods when possible.
This is a pilot feasibility trial of AC (Adriamycin, cyclophosphamide) chemotherapy with G-CSF (filgrastim) followed by infusional Taxol (paclitaxel) as adjuvant treatment for patients with high risk stage II and stage III breast cancer. Cycles will be 14 days in duration. After 3 fourteen day cycles of AC with filgrastim, patients will be treated with 3 fourteen day cycles of 96 hour infusional paclitaxel. The goal of this study will be to assess the toxicity and feasibility of administering dose-intensive AC chemotherapy followed by infusional paclitaxel in 14 day cycles.
This is a pilot, chemoprevention study. Patients receive fenretinide daily for 25 of every 28 days for 4 months and tamoxifen daily for 23 months, beginning the second month of fenretinide. Patients are removed from study for unacceptable toxicity, the development of invasive breast cancer, or for dysfunctional uterine bleeding.
This is a prospective, randomized Phase III trial of FLAC chemotherapy with GM-CSF versus PIXY321 in advanced breast cancer. The primary endpoints of this study will be the duration of thrombocytopenia and the time to recovery of platelets to 50,000/microliters. Other clinical endpoints will include the depth and duration of leukopenia, neutropenia, and anemia, the platelet and RBC transfusion requirements, and the number of documented instances of sepsis and hospitalizations for fever and neutropenia. Laboratory correlates will include the detailed evaluation of the effects on circulating hematopoietic progenitor cells by GM-CSF and PIXY321 and the potential effects these agents have on the bone marrow micro-environment. After 5 cycles of FLAC with GM-CSF versus PIXY321, patients will be treated with 5 cycles of 96 hour infusional taxol. The goal of this part of the study will be to assess the toxicity and feasibility of administering infusional taxol following dose-intensive FLAC chemotherapy.
This is a phase I/II study of interleukin-1, G-CSF and high dose ICE chemotherapy with autologous bone marrow transplant in patients with relapsed breast, testicular and lymphoid cancers. The initial goal of this study was to define the toxicity of interleukin-1 administered for 7 days prior to ICE chemotherapy. A total of 22 patients have been treated with IL-1 and ICE and results showed a more rapid engraftment (4.5 days) with IL-1. A second cohort of 18 patients also received G-CSF and engraftment was further shortened in some subgroups. Overall, the median time to engraftment was 16 days with both IL-1 and G-CSF. Accrual will continue to further define the toxicity and efficacy of this regimen.
This is a phase I study to determine the maximal tolerated dose of IL-3 given alone or sequentially with GM-CSF following FLAC chemotherapy in metastatic breast cancer patients.
Patients with untreated clinical stage II breast cancer are eligible. An excisional biopsy of the primary tumor is acceptable, but without definitive local therapy or prior chemotherapy. Histologic confirmation of invasive carcinoma is required. Patients are prospectively randomized to receive five 21-day cycles of dose-intense (5-fluorouracil, adriamycin, leucovorin, cytoxan, granuloctye-colony stimulating factor [FLAC/G-CSF]) chemotherapy either before (preoperative) or after (postoperative) local therapy. Chemotherapy is given as an outpatient. For patients receiving preoperative chemotherapy, local therapy (modified radical mastectomy, or breast segmentectomy/axillary dissection/breast radiotherapy according to patient preference) is performed 3-4 weeks after last chemotherapy. For patients receiving postoperative chemotherapy, chemotherapy will begin 2-3 weeks after local therapy. Immediate reconstruction for mastectomy is acceptable. Upon completion of local therapy and chemotherapy in either treatment group, all estrogen receptor positive patients receive tamoxifen for 5 years. Follow-up consists of history and physical examination each 3 months for first 3 years, each six months for years 4 and 5, and yearly thereafter. Mammogram, bone scan, chest x-ray and blood work are performed yearly.
To evaluate a dose intensive chemotherapy regimen for the treatment of locally advanced and metastatic breast cancer using granulocyte-macrophage colony-stimulating factor (GM-CSF) to ameliorate chemotherapy-induced toxicity. Combination chemotherapy consists of Flurouricil, Leucovorin, Adriamycin, and Cytoxan (FLAC) which will be given every 21 days for 10 cycles. This protocol will replace the phase I study of this regimen (MB-232/88-C-0207) which found the MTD of this regimen to be at the first dose level. This is a phase II study to determine response rates of this regimen in advanced breast cancer.