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Breast Neoplasms clinical trials

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NCT ID: NCT00495209 Completed - Breast Cancer Clinical Trials

Pre-Surgical Qigong Therapy for Women With Breast Cancer

Start date: July 26, 2006
Phase:
Study type: Observational

The use of complementary and alternative medicine (CAM) in the United States has increased dramatically in the past 10 years. Nowhere is this trend more apparent than when one examines CAM use by patients diagnosed with cancer. As with the general population, patients with cancer typically use CAM-based modalities alongside their conventional cancer treatments. Patients are often seeking a holistic approach to managing and preventing disease. Although most patients will combine alternative approaches with conventional medicine, some patients do in fact decline curative conventional treatments in favor of more non-toxic alternative approaches. One such approach that patients combine with conventional medicine or use in place of conventional medicine is qigong. Qigong is a bioenergy therapy with a long history of therapeutic use for many diseases, including cancer. Preliminary experiments and a review of the literature show that qigong might improve the outcome for cancer patients. However, none of this research has been confirmed in the peer-reviewed Western scientific literature. Although it is unlikely that EQT will result in significant decreases in tumor size, patients are using qigong either as a complementary approach, and sometimes even in place of conventional medicine, it is, therefore, important for us to determine whether there is any merit to this treatment modality. The goal of this pilot trial is to examine one form of medical qigong (external qi therapy (EQT)) to determine feasibility. In an exploratory nature we will also examine any changes in tumor size in women with breast cancer who are awaiting surgery.

NCT ID: NCT00494481 Completed - Clinical trials for Advanced Breast Cancer

E3 Breast Cancer Taxotere Combination

Start date: January 2006
Phase: Phase 2
Study type: Interventional

To assess the efficacy of ZD6474 in combination with docetaxel in the treatment of ABC using the progression event count methodology

NCT ID: NCT00494234 Completed - Breast Neoplasms Clinical Trials

Study to Assess The Efficacy and Safety of a PARP Inhibitor For The Treatment of BRCA-positive Advanced Breast Cancer

ICEBERG 1
Start date: June 15, 2007
Phase: Phase 2
Study type: Interventional

The purpose of the study is to see if the drug KU-0059436 (olaparib) is effective and well tolerated in treating participants with measurable breast cancer gene (BRCA)1- or BRCA2-positive advanced breast cancer and for whom no curative therapeutic option exists.

NCT ID: NCT00493870 Completed - Breast Cancer Clinical Trials

TAC Versus TC for Adjuvant Breast Cancer

Start date: May 29, 2007
Phase: Phase 3
Study type: Interventional

The purpose of this research study is to find out what effects (good and bad) TC or TAC has on early stage HER2- breast cancer.

NCT ID: NCT00493649 Completed - Breast Cancer Clinical Trials

Adj TC + Herceptin Early Stage Breast Cancer

Start date: June 2007
Phase: Phase 2
Study type: Interventional

The purpose of this research study is to find out what effects (good and bad) docetaxel/cyclophosphamide (brand names: Taxotere and Cytoxan, or TC) plus trastuzumab (brand name: Herceptin, or H) has HER2+ breast cancer.

NCT ID: NCT00493636 Completed - Breast Cancer Clinical Trials

1st or 2nd Line MBC (Metastatic Breast Cancer) With Previous Avastin (Bevacizumab) Therapy

Start date: June 2007
Phase: Phase 2
Study type: Interventional

The study is being conducted to compare progression-free survival in patients treated with sorafenib and gemcitabine/capecitabine versus patients treated with placebo and gemcitabine/capecitabine for locally advanced or metastatic breast cancer that has progressed during or following treatment with a bevacizumab-containing regimen.

NCT ID: NCT00493350 Completed - Breast Cancer Clinical Trials

Prospective Validation Trial of Circulating Tumor Cells (CTCs) in Women With Metastatic Breast Cancer

Start date: October 2005
Phase: Phase 4
Study type: Observational

Primary Objectives: 1. To validate the prognostic significance of circulating tumor cells (CTCs) in patients with newly diagnosed metastatic breast cancer (MBC). 2. To prospectively determine if assessment of CTCs can be used to stratify patients with MBC into two prognostic groups independent of existing methods i.e. hormone-receptor status, site of metastasis (e.g. visceral vs. non visceral) and treatment administered (e.g. chemotherapy vs. hormonal therapy). 3. To incorporate this information into the current TNM staging system by sub-classifying stage IV disease into two prognostic groups, Stage IVA and Stage IVB. Secondary Objective: 1. To perform global gene profiling on selected specimens and correlate the profiles with clinical outcomes.

NCT ID: NCT00490646 Completed - Clinical trials for Metastatic Breast Cancer

A Phase II Combination of Trastuzumab and Ixabepilone Versus Trastuzumab and Docetaxel in Patients With Advanced and/or Metastatic Breast Cancer

Start date: February 2008
Phase: Phase 2
Study type: Interventional

The purpose of this randomized, Phase 2 open-label study was to assess the response rate of participants with Human Epidermal Growth Factor Receptor 2 (Her2+) locally advanced and/or metastatic breast cancer (not previously treated with chemotherapy or trastuzumab) to treatment with ixabepilone plus trastuzumab and/or docetaxel plus trastuzumab.

NCT ID: NCT00490503 Completed - Breast Cancer Clinical Trials

Non-Invasive Magnetic Resonance Imaging (MRI) and Magnetic Resonance Spectroscopy Techniques (MRS) for Assessing Neoadjuvant Chemotherapy in Locally Advanced Breast Cancer

Start date: October 25, 2006
Phase:
Study type: Observational

The goal of this clinical research study is to learn if magnetic resonance imaging (MRI) with magnetic resonance spectroscopy (MRS) can show the effects of pre-surgical chemotherapy in breast cancer patients who are eligible to receive preoperative chemotherapy.

NCT ID: NCT00490139 Completed - Neoplasms, Breast Clinical Trials

ALTTO (Adjuvant Lapatinib And/Or Trastuzumab Treatment Optimisation) Study; BIG 2-06/N063D

ALTTO
Start date: May 16, 2007
Phase: Phase 3
Study type: Interventional

This is a randomised, open label multi-centre phase III study comparing the activity of lapatinib alone versus trastuzumab alone versus trastuzumab followed by lapatinib versus lapatinib concomitantly with trastuzumab in the adjuvant treatment of patients with ErbB2 overexpressing and/or amplified breast cancer. Patients will be enrolled according to one of two design schemas, with Design 2 having two chemotherapy options (Design 2 and 2B), and will be randomised to one of four treatment regimens within each design schema. The primary objective of this study is to compare disease-free survival (DFS) in patients with HER2 overexpressing and/or amplified breast cancer randomised to trastuzumab for one year versus lapatinib for one year versus trastuzumab (12 or 18 weeks, according to assigned design) followed by a six-week treatment-free interval followed by lapatinib (28 or 34 weeks, according to assigned design) versus trastuzumab in combination with lapatinib for one year (52 weeks). Secondary objectives include treatment comparisons with respect to overall survival, time to recurrence, time to distant recurrence, safety and tolerability, incidence of brain metastasis, and analyses conducted separately for cohorts of patients defined by presence or absence of cMyc oncogene amplification, expression level of PTEN and presence or absence of the p95HER2 receptor. On August 18, 2011, the ALTTO Independent Data Monitoring Committee (IDMC) met to review the first planned interim analysis. The IDMC reported that the comparison of lapatinib alone versus trastuzumab alone crossed the futility boundary, indicating that the lapatinib alone arm was unlikely to meet the pre-specified criteria to demonstrate non-inferiority to trastuzumab alone with respect to disease-free survival (DFS). The IDMC also stated that the other three arms (trastuzumab alone, sequential trastuzumab/lapatinib arm and the combination arm) should continue as planned with no changes.