Active clinical trials for "Breast Neoplasms"

The purpose of this survey is to examine the effect on quality of life (QOL) improvement and convenience of switching to leuprorelin acetate 3 months depot 11.25 milligram (mg) injection kit (Leuplin SR 11.25 mg injection kit) from a 4-week adjuvant therapy with a luteinizing hormone-releasing hormone analog (LH-RHa) 1 month depot over 48 weeks in premenopausal breast cancer participants in daily medical practice. Influence of condition of estrogen receptor expression on the efficacy and safety of leuprorelin acetate SR 11.25 mg injection kit was also evaluated.

The purpose of this study is to measure the performance characteristics for the collection, fixation and transportation of clinical nipple aspirate fluid (NAF) specimens of the ForeCYTE Breast Aspirator across 3 independent labs and the National Reference Laboratory for Breast Health (NRLBH). The study hypothesis is that each lab will have a specimen acceptability rate of at least 90%. If it is assumed that the true level of acceptability testing is approximately 96%, then the lower bound of a one-sided 95% confidence interval is expected to be at least 90%.

Glubran 2 as a surgical glue maybe effective in reducing seroma formation post axillary dissection in breast cancer patients.

Background: - BRCA1 and BRCA2 gene mutations have been linked to a higher risk of developing breast cancer and other cancers, and may be associated with types of breast cancer that are more difficult to treat and more likely to recur. New cancer treatments are being developed specifically to treat individuals who have these gene mutations. However, more information is needed about the prevalence of these mutations in minority populations, including Hispanic/Latino populations. To study these populations, researchers are interested in collecting genetic material (DNA) and medical history information from Hispanic/Latino women who have been diagnosed with breast cancer. Objectives: - To collect saliva samples and medical and family history information from Hispanic/Latino women with breast cancer. Eligibility: - Hispanic/Latino women at least 18 years of age who have been diagnosed with breast cancer. Design: Participants will complete a questionnaire with information about place of birth, languages spoken by parents and grandparents, and information about their breast cancer diagnosis. Participants will provide a saliva sample (2 to 3 tablespoons) for analysis. No treatment will be provided as part of this protocol....

To access the effectiveness of High-dose Cyclophosphamide Combined Chemotherapy combined with adoptive cellular therapy with dentritic and cytokine-induced killer cells in triple negative metastatic breast cancer patients

Gene expression studies have identified at least four molecularly distinct subtypes of breast cancer including two biologically distinct ER-positive subtypes of breast cancer: luminal A and luminal B (with luminal B tumors having poorer outcomes than luminal A tumors). Although some luminal B tumors can be identified by their expression of HER2, the major biological distinction between luminal A and B is the proliferation signatures, including genes such as CCNB1, MKI67, and MYBL2, which have higher expression in luminal B tumors than in luminal A tumors. The high cost of gene expression profiling has limited its incorporation into general clinical practice. To date, there is no available IHC-based surrogate assay that can distinguish between luminal A and luminal B tumors. We hypothesized that the IHC determination of the Ki67 index as well as ER, PgR, and HER2 status is able to distinguish the luminal B subtype of breast cancers from the luminal A subgroup.

RATIONALE: Diagnostic procedures, such as magnetic resonance imaging (MRI), may help doctors find CNS metastases and plan treatment. PURPOSE: This randomized clinical trial is studying how well MRI finds CNS metastases in women with stage IV breast cancer.

This study is being done to evaluate the impact of moderate-intensity exercise (such as walking) on quality of life, energy level, endurance and mood in women with metastatic breast cancer. Studies have shown that women with early stage breast cancer who exercise during treatment have more energy, less sleep disturbance, less anxiety and depression, and better strength and endurance than women who do not exercise. These studies have also shown that women who exercised during treatment for early stage breast cancer did not develop injuries or increased fatigue from exercising during chemotherapy and radiation treatments. The investigators are conducting this trial to see if women with metastatic breast cancer experience similar benefits from exercise as women with earlier breast cancer. The investigators also wish to determine whether women with advanced disease are able to exercise safely during their treatment under the supervision of an exercise physiologist.

Primary Objectives: To estimate and compare the sensitivity and specificity of computed tomography (CT), plain radiography (XR), and skeletal scintigraphy (SS) with each other for the assessment of response of bone metastasis in patients with breast cancer. To estimate and compare the sensitivity and specificity of M. D. Anderson (MDACC) bone metastasis criteria with that of current criteria (UICC, WHO) in breast cancer patients for the assessment of the behavior of osseous metastasis in breast cancer patients. Secondary Objective: To evaluate the progression free survival (PFS) and overall survival (OS) of each response group (CR, PR, SD, PD) assessed by imaging and response criteria.

Surgery for breast cancer has a major role in enhancing long term survival and cure, but several physiological aspects associated with surgery are implicated as enhancing tumor spread and formation of distant metastases. These include: an increase in pro-angiogenic factors, direct spread of tumor cells, accumulation of grown factors, immune suppression and direct effects of anesthetics and opiate pain relievers on cancer cells. Some of these pro-metastatic mechanism may be blocked by the interventions proposed in this study, namely by administration of beta-adrenergic blockers and COX2 inhibitors around the time of surgery. Studies have shown that surgery increases levels of catecholamines and prostaglandins, which in turn may promote the release of pro-angiogenic factors such as VEGF, and enhance vascularization of micro metastases. Opiates given for pain relief during and after surgery have been reported to enhance tumor cell division and cause immune suppression. The immune system is significantly suppressed during surgery. This suppression has been shown to affect the systemic resistance to infection as well as neoplastic metastatic processes. Several studies have shown that increased levels of catecholamines and prostaglandins add to the immune suppression. Studies in rats found that peri-operative administration of the beta beta-blocker propranolol together with the COX2 inhibitor etodolac significantly reduced the suppression of NK cell activity as well as the risk for distant metastases. A recent retrospective clinical study found that among breast cancer patients treated with a combination of regional anesthesia and a COX inhibitor the recurrence rated were significantly less than among patients undergoing surgery without these two interventions. The purpose of the proposed prospective trial is to examine if peri-operative administration of the combination of a beta-blocker together with a COX2 inhibitor will prevent suppression of cellular immunity, decrease VEGF levels, and decrease cancer recurrence rates. In the proposed study breast cancer patients will be treated with a combination of a beta-blocker and COX2 inhibitor (or placebo) before, during and after surgery. (A control group of healthy women will serve as untreated controls). The variables which will be examined are: number and activity of NK cells, levels of Th1 and Th2 cytokines, serum stress hormones and angiogenic factors, and the ability of leukocytes to produce Th1 and Th2 cytokines as a result of in vitro stimulation. In addition to these immediate parameters, long term follow up will be conducted in order to determine the effect of the intervention on long term cancer recurrence over five years. Statistical analysis will be done using t-tests, ANOVA, and multivariate regressions, with regard to the known risk factors for recurrence such as tumor grade, lymph node involvement etc. Sample size for immunological parameters will be 40 patients in each group and 20 healthy women. Sample size for estimates of cancer recurrence at five years of follow up wiil be 460 women (230 in each group). This sample size provides a power of 80% to detect a 50% reduction in cancer recurrence at an α of 0.05.