Active clinical trials for "Breast Neoplasms"

Optimal management of patients with locally advanced breast cancer remains a complex therapeutic problem. Newly diagnosed breast cancers in the United States with a higher incidence in medically underserved areas. The optimal intensity and duration of neoadjuvant chemotherapy still remains controversial due to the difficulty of evaluating response to therapy. The goal would be to prevent over and under treatment of patients with neoadjuvant chemotherapy.

Recent research provides evidence that disrupted circadian rhythms, including hormonal patterns and sleep, are associated with increased risk of breast cancer incidence and faster progression to mortality. We have observed that a loss of normal diurnal cortisol rhythm associated with more awakenings during the night predicts early mortality with metastatic breast cancer. Other recent studies have shown that nighttime shift work is associated with higher breast cancer incidence, and in a murine model disrupting circadian cortisol cycles produced a doubling of implanted tumor growth. There is also recent evidence that abnormal clock genes are associated with cancer. However, it is not clear whether sleep disruption per se affects breast cancer progression, or whether such an effect is mediated by hormonal and immune dysregulation of this prevalent and hormone-mediated cancer. We propose to study sleep disruption as a prognostic factor in the progression of metastatic breast cancer. We will also examine sleep patterns in association with disrupted circadian rhythms of cortisol, ACTH, and melatonin as well as measures of immune function known to be salient to breast cancer progression. These are natural killer cell cytoxicity and specific cytokine, IL-6. We plan to recruit 105 women 45 years through 75 years with metastatic or recurrent breast cancer and 20 age and SES-matched controls for a two-week at home sleep study with Actiwatch and two nights of in-home EEG monitoring, followed by 28 hours of continuous blood sampling and one night of EEG sleep monitoring in our lab at Stanford. This will provide a full examination of circadian hormones associated with sleep patterns. We will relate these assessments to the subsequent course of breast cancer progression. Results of this study will provide specific evidence regarding how improved sleep management may affect the course of breast cancer. Aim 1: To study 24-hr diurnal rhythms of HPA axis hormones and melatonin in women with metastatic or recurrent breast cancer. Hypothesis 1: Women with metastatic or recurrent breast cancer will have reduced amplitude and disrupted phase of 24-hr diurnal rhythms of cortisol, ACTH, and melatonin. Aim 2: To describe sleep disruption in women with metastatic breast cancer and examine psychosocial, endocrine, and immune factors that may be associated with sleep disruption. Hypothesis 2: Women with metastatic or recurrent breast cancer will have a higher incidence of both at home and laboratory-examined sleep disruption than control women without breast cancer. Hypothesis 3: Poorer sleep quality will be associated with more pain, more emotional suppression in response to stressors, less emotional support, greater depression and anxiety, and greater perceived and traumatic stress. Hypothesis 4: Poorer sleep quality and quantity of sleep and daytime sleepiness and fatigue will be associated with abnormal circadian neuroendocrine (i.e., cortisol, ACTH, and melatonin) and immune patterns (i.e., suppressed day and night time NK activity and loss of NK rhythms; increased day time IL-6 levels and /or loss of IL-6 rhythm). Aim 3: To study the relationship between sleep disruption and survival time among metastatic and recurrent breast cancer patients. Hypothesis 5: Poorer sleep quality and quantity of sleep will predict shorter survival. Hypothesis 6: Reduced diurnal amplitude and an abnormal phase of cortisol will predict shorter survival. Explanatory Aim 4: To investigate whether sleep disruption mediates the relation of psychosocial factors to health outcomes.

The purpose of the research is to examine the usefulness of using patient navigators in improving coordination of care between the Breast Examination Center in Harlem (BECH) and the Ralph Lauren Center for Cancer Care and Prevention (RLCCCP) for patients with a suspicious breast finding. This study will collect information to improve the role of the Patient Navigator, nonmedical staff that helps coordinate patient care. The study will also collect information to be used to help remove barriers that happen when several different institutions provide care.

Women with breast cancer and other gynecologic cancers often suffer significant distress and disability from their disease. A practice of meditation-based stress reduction and cognitive-affective-behavioral learning may help women with these conditions decrease their suffering and improve their quality of life.

The purpose of this study evaluate which factors play a role in lymphedema development among women who have had axillary surgery for breast cancer. Potential risk factors for women who have developed lymphedema will be compared to risk factors among women who have not developed lymphedema after breast cancer surgery.

Both capecitabine and oxaliplatin have single agent activity in breast cancer. The combination has improved activity in other solid tumors. This study seeks to assess the activity of the combination in breast cancer.

The purpose of this study to see what happens to breast density in healthy postmenopausal women after treatment with letrozole in one year, compared with treatment with placebo for one year. Other goals of the study include determining if there is a connection between estrogen level and breast density for women in the study and collecting information about the quality of life of those taking part in the study.

Although after treatment for breast cancer such as chemotherapy or hormonal therapy, urogenital atrophy is common, the patients are seldomly treated for several reasons. Management of this problem is important for improving quality of life. "Clino-san" is a kind of vaginal lubricant with pH 5 which is similar pH of premenopausal vaginal discharge. After randomization of patients, they are treated with Clino-san or placebo 3 times/week for 12 weeks. We check the vaginal symptoms, vag dryness severity score, and ultrasonography at baseline, 4, 8, and 12 weeks of treatment.

RATIONALE: Certain psychological and social factors may increase the risk of developing chronic pain after surgery. Evaluating these factors over time in patients who have undergone surgery for breast cancer may help doctors plan treatment and improve patients' quality of life. PURPOSE: This clinical trial is studying the psychological and social factors that may increase the risk of developing chronic pain after surgery in women with breast cancer .

Lifestyle behaviors among women with a family history of breast cancer are likely to be influenced by a number of factors, including both objective risk factors and subjective risk, or perceived risk. The aims of this mixed method study are twofold and will be explored through both quantitative (i.e. secondary survey data) and qualitative data (i.e. personal in-depth interviews) derived from the Sister Study, a large epidemiologic study being conducted through the National Institute of Environmental Health Sciences, which is addressing risk factors for breast cancer in sisters of women who have had breast cancer. The quantitative aims include an exploration of lifestyle behaviors and behavioral differences between White and African American women, as well as well as an exploration of the relationships between lifestyle behaviors (i.e. varying levels of objective risk based on Gail model risk scores, medical risk-reducing factors (i.e. use of Tamoxifen or Raloxifene and/or prophylactic surgery), as well as additional factors that may be contributors to perceived risk. This aim will be addressed using data that have already been collected as part of the baseline activities for the Sister Study. The primary qualitative aim is to gain a better understanding about perceived risk and the relationship between perceived risk and lifestyle behaviors in both White and African American women with a family history of breast cancer. This aim requires the collection of new data through in-person interviews with between 28 and 40 women, depending on how many interviews are required to achieve "data saturation." The mixed method approach will be based on a "complementarity" model, which emphasizes the use of two different methods to address different aspects of the research problem. Results from both methods will become integrated into the discussion of the findings and it is expected that this approach will enrich the study and allow for elaboration of the quantitative results. The secondary data analysis will be derived from approximately 10,000 women, initially enrolled in the Sister Study, who are between the ages of 35 and 74 and have had at least one sister affected by breast cancer. Women for the qualitative interviews will be recruited from a cohort of Sister Study participants residing within North Carolina and will include equal numbers of both White and African American women. It is expected that 28 women will be needed for qualitative data saturati...