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Breast Cancer clinical trials

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NCT ID: NCT01617668 Completed - Breast Cancer Clinical Trials

A Randomized, Phase 2, Neoadjuvant Study of Weekly Paclitaxel With LCL161 in Patients With Triple Negative Breast Cancer

Start date: August 2012
Phase: Phase 2
Study type: Interventional

To assess whether adding LCL161 to weekly paclitaxel enhances the efficacy of paclitaxel in women with triple negative breast cancer whose tumors are positive for a defined pattern of gene expression

NCT ID: NCT01615068 Completed - Breast Cancer Clinical Trials

An Observational Study in Patients With HER2 Positive Metastatic Breast Cancer (SystHERs Registry)

Start date: June 5, 2012
Phase:
Study type: Observational

This multi-center, prospective observational study will evaluate the treatment patterns, and the safety in patients with HER2-positive (HER2+) metastatic breast cancer (MBC). Eligible patients will have an initial metastatic breast cancer diagnosis that has not been previously treated with systemic therapy; patients may be enrolled up to 6 months after the diagnosis. Data will be collected for up to 8 years.

NCT ID: NCT01613430 Completed - Breast Cancer Clinical Trials

Evaluating Coaches of Older Adults for Cancer Care and Health Behaviors

COACH
Start date: June 2012
Phase: N/A
Study type: Interventional

The overall goal of the COACH study is to conduct a comparative effectiveness trial to assess the effectiveness of trained, participant-designated health coaches versus traditional health education efforts on cancer screening among African American older adults. We hypothesize that members of older adults' extended families can be trained to be effective coaches who support them through the cancer control spectrum, i.e., prevention, screening, diagnosis and treatment. This research objective is guided by the theoretical model of the PRECEDE-PROCEED conceptual framework that has been widely adopted in health promotion. The target jurisdictions for this study are Baltimore City (BC) and Prince George's County (PGC), Maryland. The study is anchored in community-based participatory research (CBPR) principles, involving community members in all its phases. The CBPR component is guided by Community Advisory Groups (CAGs) representing key stakeholders in the two jurisdictions. The CAGs are essential in determining the questions included in data collection instruments, mechanisms of recruitment, interpretation of findings, and dissemination of results within the target communities.

NCT ID: NCT01612871 Completed - Breast Cancer Clinical Trials

Circulating miRNAs as Biomarkers of Hormone Sensitivity in Breast Cancer

MIRHO
Start date: June 27, 2012
Phase: Phase 4
Study type: Interventional

This is a biomedical and prospective study of interventional type. The trial will include 29 patients over a period of 15 months + 24 months of follow up maximum. The study will be conduct in womens with metastatic invasive breast cancer or locally advanced breast cancer and for which treatment with tamoxifen or anti aromatase (first line hormone therapy for metastatic breast cancer) is indicated. The main objective of this pilot study is to evaluate the feasibility to detect in the circulating blood of patients, before treatment (T0), the presence of the fifteen tissular microRNAs described in preclinical studies as possibly involved in hormone resistance/sensitivity. In parallel of the detection of these specific miRNAs, we will conduct a larger scale analysis of circulating miRNAs in these patients before (T = 0) and after one month of treatment (T28).

NCT ID: NCT01612650 Completed - Breast Cancer Clinical Trials

Assessment of Substitution of Focused Cliches and Ultrasound for Tomosynthesis

TOMOSEIN
Start date: February 24, 2012
Phase: N/A
Study type: Interventional

This study aims to assess if using tomosynthesis for breast cancer surveillance will allow a significant decrease of ultrasound cliches (and radiation exposure)

NCT ID: NCT01612338 Completed - Breast Cancer Clinical Trials

Interventions to Increase Screening by Breast Cancer Survivors and Their High Risk Female Relatives

Start date: July 2012
Phase: N/A
Study type: Interventional

The University of Michigan (UM) Schools of Nursing, Public Health, and Medicine, the Michigan Department of Community Health (MDCH) and the Michigan Cancer Consortium (MCC) are conducting a multidisciplinary academic/practice three-year project to increase appropriate breast cancer screening for young breast cancer survivors and their cancer-free, female relatives at greatest risk for breast cancer. The aims of this project are to: 1) identify and survey 3000 breast cancer survivors reported to the Michigan Cancer Surveillance Program who were diagnosed between the ages of 20-45 years regarding their breast cancer screening utilization; 2) identify and survey the survivors' female relatives regarding their breast cancer screening utilization; and 3) implement two versions (targeted vs. enhanced tailored) of an evidence-based intervention recommended by the Guide to Community Preventive Services to increase breast cancer screening. A follow-up survey will assess the effectiveness of each intervention on a) breast cancer screening utilization; b) perceived barriers and facilitators to screening; c) self-efficacy in utilizing screening services; d) family support related to screening; e) knowledge of the genetics of breast cancer and personal risk factors; and f) satisfaction with the intervention.

NCT ID: NCT01611051 Completed - Breast Cancer Clinical Trials

A Study Comparing Pegylated rhG-CSF and rhG-CSF as Support to Breast Cancer Patients Receiving Chemotherapy

Start date: March 2012
Phase: Phase 3
Study type: Interventional

Neutropenia is one of the most frequent adverse effects of chemotherapy, and the main factor to limit the dosage and the continuation of chemotherapy. A newly pegylated rhG-CSF was independently developed by JIANGSU HENGRUI Medicine Co., Ltd, China. Phase 1a, 1b and phase 2 trials have shown that pegylated rhG-CSF has decreased renal clearance, increased plasma half-life, and prolonged efficacy in compare with rhG-CSF. The purpose of this study is to determine the safety and effectiveness of pegylated rhG-CSF in preventing neutropenia following chemotherapy in patients with breast cancer.

NCT ID: NCT01611038 Completed - Breast Cancer Clinical Trials

Methylselenocysteine Effects on Circadian Rhythm

Start date: October 2011
Phase: N/A
Study type: Interventional

The primary objective of this study is to determine if vitamin supplementation with a naturally occurring dietary amino acid called organic selenium (i.e., methylselenocysteine) can restore disruption of circadian rhythm in shift workers.

NCT ID: NCT01610284 Completed - Breast Cancer Clinical Trials

Phase III Study of BKM120/Placebo With Fulvestrant in Postmenopausal Patients With Hormone Receptor Positive HER2-negative Locally Advanced or Metastatic Breast Cancer Refractory to Aromatase Inhibitor

BELLE-2
Start date: August 7, 2012
Phase: Phase 3
Study type: Interventional

This study was a multi-center, randomized, double-blind, placebo controlled Phase III study to determine the efficacy and safety of treatment with buparlisib plus fulvestrant versus fulvestrant plus placebo in postmenopausal women with hormone Receptor-positive (HR-positive), human epidermal growth factor receptor 2-negative (HER2-negative), locally advanced or metastatic breast cancer (MBC) whose disease has progressed on or after aromatase inhibitor (AI) treatment.

NCT ID: NCT01606072 Completed - Breast Cancer Clinical Trials

Perioperative Use of Desmopressin (DDAVP) in Breast Cancer

Start date: November 2011
Phase: Phase 2
Study type: Interventional

The propose for this study is to evaluate the safety and tolerability of desmopressin when administered perioperatively to patients with breast cancer undergoing surgery as first treatment, and select the optimum dose for the clinical development of the product.