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Breast Neoplasms clinical trials

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NCT ID: NCT00916578 Completed - Breast Cancer Clinical Trials

Xeloda (Capecitabine) and External Beam Radiation

Start date: June 5, 2009
Phase: Phase 2
Study type: Interventional

The goal of this clinical research study is to find out if Xeloda® (capecitabine) and radiation therapy can help to control breast cancer that did not respond well to chemotherapy. The safety of this study treatment will also be studied.

NCT ID: NCT00916162 Completed - Breast Cancer Clinical Trials

Drug Withdrawal in Women With Progressive Breast Cancer While on Aromatase Inhibitor Therapy

Start date: August 2006
Phase: N/A
Study type: Observational

The purpose of this research study is to study the effects of stopping aromatase inhibitory (AI) therapy on breast cancer progression. Aromatase inhibitors are a class of drugs used to treat breast cancer in postmenopausal women. They work by decreasing the level of estrogen, which is believed to stimulate the growth of tumor tissue. Breast cancer that progresses despite therapy with an AI is thought to have been resistant to AI therapy. There is scientific evidence to suggest that resistant breast cancer cells learn to grow at the very low levels of estrogen present on AI therapy and that increasing estrogen levels even slightly by stopping AI therapy with inhibit the breast cancer cells. An improvement or stabilization of breast cancer has been observed after stopping therapy with tamoxifen, a different anti-estrogen therapy, and has been reported in the literature after stopping AI therapy. This research study will be the first study to formally test the rate of disease improvement (response) or stabilization after stopping AI therapy.

NCT ID: NCT00915603 Completed - Clinical trials for Metastatic Breast Cancer

Trial of Paclitaxel/Bevacizumab +/- Everolimus for Patients With HER2-Negative Metastatic Breast Cancer

Start date: July 2009
Phase: Phase 2
Study type: Interventional

This randomized, double blind, placebo controlled trial will evaluate the impact of adding everolimus to the combination of weekly paclitaxel plus bevacizumab in the first-line treatment of women with HER2-negative metastatic breast cancer. Patients will be randomized (1:1) to receive either paclitaxel/bevacizumab/everolimus (Treatment Arm 1) or paclitaxel/ bevacizumab/placebo (Treatment Arm 2). Patients will be evaluated for response to treatment every 8 weeks; responding and/or stable patients will continue treatment, with re-evaluations every 8 weeks, until tumor progression or intolerable toxicity occurs. Outcomes will be assessed for each treatment arm separately. This trial is not intended to compare treatment arms primarily. Any such analyses are exploratory and will be conducted without adjustment for multiple hypothesis testing.

NCT ID: NCT00915018 Completed - Breast Cancer Clinical Trials

Study Evaluating Neratinib Plus Paclitaxel VS Trastuzumab Plus Paclitaxel In ErbB-2 Positive Advanced Breast Cancer

NEFERTT
Start date: August 21, 2009
Phase: Phase 2
Study type: Interventional

This study is investigating the effects of an experimental drug (neratinib) in combination with paclitaxel versus trastuzumab in combination with paclitaxel for the treatment of women who have not received previous treatment for erbB-2-positive locally recurrent or metastatic breast cancer. The study will compare the effectiveness of each regimen in shrinking tumors and extending the lives of women with erbB-2 (HER2) positive breast cancer. The study will also compare the safety of the two regimens and as well as the quality of life of subjects receiving either regimen.

NCT ID: NCT00912340 Completed - Breast Cancer Clinical Trials

Phase II Trial of EVEROLIMUS ± Trastuzumab in Hormone-Refractory Metastatic Breast Cancer

Start date: May 2009
Phase: Phase 2
Study type: Interventional

This phase II trial studies how well everolimus with or without trastuzumab works in treating patients with breast cancer that has not responded to hormone therapy and has spread from where it started to other places in the body. Everolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as trastuzumab, may interfere with the ability of tumor cells to grow and spread. Giving everolimus and adding trastuzumab at the time of disease progression may be an effective treatment for breast cancer.

NCT ID: NCT00912275 Completed - Clinical trials for Metastatic Breast Cancer

Lapatinib in Combination With Oral Vinorelbine for Metastatic Breast Cancer

Start date: November 24, 2008
Phase: Phase 1/Phase 2
Study type: Interventional

Phase I part: to determine the recommended dose, and observe the preliminary response and safety profile of the combination of oral lapatinib with vinorelbine in patients with ErbB2 positive metastatic breast cancer. Phase II part: to determine the progression free survival, response rate, and to evaluate the safety profile of the combination of oral lapatinib with vinorelbine in patients with ErbB2 positive metastatic breast cancer. Phase I part has been completed. Phase II part is underway.

NCT ID: NCT00911911 Completed - Breast Cancer Clinical Trials

Proteomic Signature in Breast Cancer: Correlation With Tumor Response to Neo-adjuvant Chemotherapy

SPAM
Start date: January 2007
Phase: N/A
Study type: Interventional

The scope of the trial is to identify proteomic signatures correlated with tumor response to neo-adjuvant chemotherapy.

NCT ID: NCT00911716 Completed - Breast Cancer Clinical Trials

TC Avastin. ICORG 08-10, V6

Start date: October 2008
Phase: N/A
Study type: Interventional

RATIONALE: Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Drugs used in chemotherapy, such as docetaxel and cyclophosphamide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) together with bevacizumab may kill more tumor cells. PURPOSE: This clinical trial is studying the side effects of giving bevacizumab together with docetaxel and cyclophosphamide and to see how well it works in treating patients with early-stage high-risk breast cancer. This is a single arm, non randomised pilot study investigating the safety of the combination of Docetaxel + Cyclophosphamide+ Bevacizumab in the adjuvant treatment of patients with early stage, HER 2 negative, high risk breast cancer.

NCT ID: NCT00909441 Completed - Breast Cancer Clinical Trials

Sentinel Node Biopsy Following NeoAdjuvant Chemotherapy in Biopsy Proven Node Positive Breast Cancer

SN-FNAC
Start date: February 2009
Phase: N/A
Study type: Interventional

Title of Study: Sentinel node biopsy following neoadjuvant chemotherapy in biopsy proven node positive breast cancer. Objectives of the study: Primary objective 1. Evaluate the accuracy of sentinel node biopsy in breast cancer patients presenting with positive nodal disease, proven by ultrasound guided fine needle aspiration, following neoadjuvant chemotherapy. Secondary objectives 1. Evaluate the technical success of sentinel node biopsy following neoadjuvant chemotherapy. 2. Evaluate the accuracy of clinical examination and ultrasound examination of the axilla in identifying the presence of residual disease in the axilla following neoadjuvant chemotherapy in biopsy proven node positive breast cancer patients. Number of patients: N = 300 Population: Patients with unresected breast cancer that are eligible for neoadjuvant chemotherapy that present with biopsy proven positive axillary nodes. Study duration: From February 2009 to February 2012 - 3 years

NCT ID: NCT00908791 Completed - Breast Cancer Clinical Trials

Proof of Principle Trial to Determine if Nutritional Supplement Conjugated Linoleic Acid (CLA) Can Modulate the Lipogenic Pathway in Breast Cancer Tissue

Start date: June 2009
Phase: Early Phase 1
Study type: Interventional

Conjugated Linoleic Acid (CLA) is obtained in the human diet by consumption of foods containing ruminant fat. Milk and dairy products have shown the highest amounts of CLA. Clarinol (CLA), is considered a natural supplement and is not regulated by the Food and Drug Administration (FDA). CLA is known to inhibit proliferation of human breast cancer cells and tumors in rodent breast cancer models and reduced Spot 14 (THRSP, S14) and Fatty Acid Synthase (FASN) gene expression in breast cancer cells and tht the two major CLA isomers used in nutritional supplements (C9, t11 and t10, c12) were equipotent in reducing breast cancer cell growth. This study looks at the hypothesis that S14 expression is decreased by CLA and will characterize the major pharmacodynamic (PD) effects of CLA in newly diagnosed Breast cancer patients on Tumor tissue lipogenic pathway. FASN, S14 and Lipoprotein Lipase (LPL), Ki67 and apoptotic index expression will be assessed by quantitative immunohistochemistry (IHC) in initial breast cancer biopsies and compared to that in resected breast tumor tissue after the study subject has been taking CLA for ten to twenty-eight days. Tissue from adjacent breast adipocytes will also be analyzed to determine whether adipose tissue effects can serve as a surrogate marker for those in tumor tissue. A sample of the original biopsy will be compared to the tumor resection sample to determine the levels of CLA in the breast cancer cells.