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Breast Neoplasms clinical trials

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NCT ID: NCT01521676 Recruiting - Breast Cancer Clinical Trials

Predictive Clinical and Biological Parameters in Breast Cancer

BC-BIO
Start date: December 2010
Phase: N/A
Study type: Interventional

Research of predictive clinical and biological factors in breast cancer : genomic, proteomic, mutation

NCT ID: NCT01521000 Recruiting - Breast Cancer Clinical Trials

The Use of Bioimpedance to Determine Pre-Clinical Lymphedema in the Post-Operative Breast Cancer Patient

L-Dex
Start date: July 2010
Phase: N/A
Study type: Interventional

Primary Objective: To determine whether early intervention (with garment sleeve and gauntlet) in patients with pre-clinical lymphedema can halt the progression of lymphedema. Secondary Objectives:To evaluate whether bioimpedance is an accurate, reliable method to measure pre-clinical and clinical lymphedema. Tertiary Objective: To determine whether bioimpedance analysis is better than the gold standard of volume displacement to measure lymphedema. The successful completion of this study will address whether bioimpedance analysis is a reliable, accurate method to measure pre-clinical and clinical lymphedema. In addition, we intend to evaluate whether bioimpedance analysis is better than the gold standard of volume displacement for measuring lymphedema. And most importantly, we will evaluate whether a short trial of compression garments in women identified to have pre-clinical lymphedema can actually halt the progression of disease. Bryn Mawr Hospital would propose to publish the research and findings of this study, which may have future bearing on the post-operative therapeutic management of subjects with pre-clinical lymphedema following axillary surgery. Study Design:Randomized, Pilot Study

NCT ID: NCT01520103 Completed - Clinical trials for Her2-negative Metastatic Breast Cancer

Study to Compare Vinorelbine In Combination With the mTOR Inhibitor Everolimus vs. Vinorelbin Monotherapy for Second-line Treatment in Advanced Breast Cancer

VicTORia
Start date: January 2012
Phase: Phase 2
Study type: Interventional

The purpose of this study is Examination of the superiority of a combination of vinorelbine with the mTOR Inhibitor Everolimus vs. vinorelbine monotherapy for second-line treatment in advanced breast cancer.

NCT ID: NCT01519700 Completed - Breast Cancer Clinical Trials

Phase III Study Comparing the Efficacy and Safety of EP2006 and Filgrastim

PIONEER
Start date: December 2011
Phase: Phase 3
Study type: Interventional

The study will assess the efficacy of EP2006 compared to Filgrastim with respect to the mean duration of severe neutropenia during treatment with myelosuppressive chemotherapy in breast cancer patients.

NCT ID: NCT01516736 Completed - Breast Cancer Clinical Trials

Phase III Study Comparing the Efficacy and Safety of LA-EP2006 and Peg-Filgrastim

PROTECT2
Start date: March 2012
Phase: Phase 3
Study type: Interventional

The study will assess the efficacy of LA-EP2006 compared to Peg-Filgrastim with respect to the mean duration of severe neutropenia during treatment with myelosuppressive chemotherapy in breast cancer patients.

NCT ID: NCT01516307 Completed - Clinical trials for Metastatic Breast Cancer

Trial of Active Immunotherapy With Globo H-KLH (OPT-822) in Metastatic Breast Cancer Subjects

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

The purpose of this study is to compare active immunotherapy (OPT-822/OPT-821) with PBS in combination with low dose cyclophosphamide, in post-treated metastatic breast cancer subjects with stable disease or response to treatment.

NCT ID: NCT01516190 Active, not recruiting - Breast Cancer Clinical Trials

The Preoperative Health & Body Study

PreHab
Start date: August 2011
Phase: N/A
Study type: Interventional

This study is designed to look at the changes that occur in women who take part in exercise and Mind-Body programs between breast cancer diagnosis and breast surgery. The investigators will look at changes in stress, anxiety, mood and quality of life, to see if these types of short programs can make women feel better during this time. The investigators are also interested in looking at whether a short exercise or Mind-Body program leads to any changes in markers in breast cancer cells, such as their growth and death rates, or in blood hormones such as insulin, which have been linked to breast cancer development. Since the investigators do not know if these blood or tumor tests have any relationship to cancer recurrence, the investigators do not plan to share the results of these tests with you or your physician.

NCT ID: NCT01515800 Completed - Breast Cancer Clinical Trials

S1105: Text-Messaging Intervention to Reduce Early Discontinuation of AI Therapy in Women With Early-Stage Breast Cancer

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

RATIONALE: Measuring how text-message affects treatment compliance in women with breast cancer may help doctors plan the best treatment. PURPOSE: This randomized trial studies how well text-message works in reducing early discontinuation of aromatase inhibitor therapy in patients with early-stage breast cancer who underwent breast surgery.

NCT ID: NCT01514565 Recruiting - Breast Cancer Clinical Trials

Tumor Suppressor Status as a Predictor of Chemotherapy Response in Triple Negative Breast Cancer

Start date: December 2011
Phase: N/A
Study type: Observational

This is a prospective observational study aimed to validate biomarkers that predict response.

NCT ID: NCT01513408 Active, not recruiting - Breast Cancer Clinical Trials

Relevance of T Lymphocytes Tumor Infiltrates CD8 and Foxp3 as Immune Prognostic Biomarker in Breast Cancer Treated by Neo Adjuvant Chemotherapy

PRIMUNEO
Start date: May 2012
Phase: N/A
Study type: Interventional

Neoadjuvant chemotherapy is standard therapy for the management of localised breast cancer, and makes it possible to evaluate tumour response. Achieving pathological complete response (pCR) after chemotherapy is the most important prognostic factor for these patients. However, patients with pCR can suffer relapse. In parallel, long-term prognosis of patients who do not achieve pCR is poorly documented, and no specific prognostic factors have been clearly identified.Preclinical and clinical studies argue for an immunogenic role of some chemotherapy regimens, such as anthracyclines, taxanes or trastuzumab. By facilitating recruitment of CD8 T-lymphocytes in the tumour bed, these agents could favourably influence antitumour immune response, partially contributing to efficacy. Conversely, tumours can promote accumulation of regulatory T-lymphocytes expressing Foxp3, thus evading anti-tumour immune response, and increased numbers of regulatory T-cells are associated with less favourable prognosis in breast cancer patients. We have previously shown that a high number of CD8 T-cells associated with low Foxp3 infiltration, as quantified by immunohistochemistry on surgical specimens, is associated with better response and better survival in breast cancer patients, independently of whether pCR was achieved, the type of chemotherapy used, and the type of breast cancer. Therefore, we propose to validate in a prospective study this immunological prognostic marker in a large cohort of patients treated with neoadjuvant chemotherapy.