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Metastatic Breast Cancer clinical trials

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NCT ID: NCT01416558 Terminated - Clinical trials for Metastatic Breast Cancer

Nab-paclitaxel in Metastatic Breast Cancer Patients Failing Solvent Based Taxane (Tiffany)

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

Nab-paclitaxel has demonstrated to be an active agent in breast cancer and probably a less toxic alternative to solvent based taxanes. It is indicated in metastatic breast cancer after failure of anthracyclines. However, most patients receive anthracyclines as well as taxanes as part of their (neo-)adjuvant therapy. There is currently no standard treatment for patients with an early relapse (<12 months) after a taxane containing (neo-)adjuvant therapy. Nab-paclitaxel, a novel nano-particle encapsulated paclitaxel is expected to have only limited cross-resistant to solvent-based taxanes and might therefore be indicated in this setting.

NCT ID: NCT01416389 Completed - Clinical trials for Metastatic Breast Cancer

A Study of LY2523355 in Participants With Breast Cancer

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

The purpose of the study is to evaluate the anti-tumor activity of LY2523355 relative to ixabepilone for the treatment of metastatic or locally recurrent breast cancer using change in tumor size as a continuous measure of response.

NCT ID: NCT01414933 Completed - Clinical trials for Metastatic Breast Cancer

High Throughput Technologies to Drive Breast Cancer Patients to Specific Phase I/II Trials of Targeted Agents

SAFIR-01
Start date: May 2011
Phase: N/A
Study type: Observational

High sensitivity to targeted agents has been observed in patients whose tumor cells present a genetic/genomic deregulation of the target (Kit mutation, ERBB2 amplification, EGFR mutations) together with addiction to the given target. More recently, activation of "alternative pathways" (Kras mutation, PI3K mutations) have been reported as a common resistance mechanism to single agent tyrosine kinase inhibitors (trastuzumab, cetuximab). From these data has emerged the hypothesis that identification of the deregulated pathway through new molecular tools could allow to propose a more tailored targeted regimen. Based on these concepts, numbers of phase I/II trials enrich their populations in patients presenting specific molecular alterations. High throughput technologies (array CGH, sequencing, gene expression array) identify deregulated genes. In addition, these technologies determine whether such genomic alterations are single (expected efficacy of single agent) or multiple (rationale for combination). In a pilot study that included 135 patients, we recently performed a combination of array CGH and hot spot mutation array in order to drive patients into phase I/II clinical trials. This study led to the conclusions that high throughput technologies i. are feasible (80%) and robust, ii. identify "targetable" genomic alterations in around 40% of samples. In the present study, the investigators will perform high throughput technologies to drive 400 metastatic breast cancer patients into specific phase I/II trials.

NCT ID: NCT01401959 Completed - Clinical trials for Metastatic Breast Cancer

Trial of Eribulin in Patients Who Do Not Achieve Pathologic Complete Response (pCR) Following Neoadjuvant Chemotherapy

Start date: September 23, 2011
Phase: Phase 2
Study type: Interventional

The investigators propose to evaluate eribulin as adjuvant therapy in breast cancer patients who have residual invasive disease in breast or lymph node tissue following standard neoadjuvant chemotherapy and surgery regimen. Three cohorts of patients will be evaluated separately based on tumor type: triple-negative, hormone-receptor-positive/HER2-negative, and HER2-positive breast cancers.

NCT ID: NCT01401062 Completed - Clinical trials for Metastatic Breast Cancer

Fresolimumab and Radiotherapy in Metastatic Breast Cancer

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

The purpose of this study is to test safety of combining fresolimumab and local radiotherapy and to see if the combination can achieve tumor regression.

NCT ID: NCT01392586 Terminated - Clinical trials for Metastatic Breast Cancer

Systemic Therapy With or Without Upfront Surgery in Metastatic Breast Cancer

SUBMIT
Start date: February 2012
Phase: Phase 3
Study type: Interventional

SUBMIT is a clinical trial that intends to answer the question whether up front breast surgery in patients with primary distant metastatic breast cancer will result in an improvement of the 2-year survival compared to the survival achieved with systemic therapy and delayed local treatment or systemic therapy alone. Randomization will take place immediately after the diagnosis of primary distant metastatic breast cancer. Patients either randomize for up front surgery of the breast tumor (UFS) followed by systemic therapy or for systemic therapy (ST) potentially followed by delayed local treatment of the breast tumor. The primary endpoint of this trial is the 2-years survival. Quality of life is one of the most important secondary endpoints.

NCT ID: NCT01387373 Completed - Clinical trials for Metastatic Breast Cancer

Intra-hepatic Chemotherapy in Patient With Non-resectable Liver Metastases From Breast Cancer

Start date: April 2010
Phase: Phase 2
Study type: Interventional

This is a phase II trial evaluating intra-hepatic chemotherapy with oxaliplatin every second week in combination with systemic capecitabine and in patients with a HER2-positive tumour in combination with trastuzumab (Herceptin®) in patient with non-resectable liver metastases from breast cancer. Only patients without extrahepatic disease are included.

NCT ID: NCT01387295 Completed - Clinical trials for Metastatic Breast Cancer

Intra-hepatic Chemotherapy in Patients With Liver Metastases From Breast Cancer and Limited Extrahepatic Disease

Start date: April 2010
Phase: Phase 2
Study type: Interventional

This is a phase II trial evaluating intra-hepatic chemotherapy with oxaliplatin every second week in combination with systemic capecitabine and in patients with a HER2-positive tumour in combination with trastuzumab (Herceptin®) in patient with non-resectable liver metastases from breast cancer. Only patients with limited extrahepatic disease are included.

NCT ID: NCT01380808 Completed - Clinical trials for Metastatic Breast Cancer

Capecitabine and Pseudomonas Aeruginosa Combination in Metastatic Breast Cancer (MBC)

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

The progression free survival could be prolonged adding pseudomonas aeruginosa to monotherapy capecitabine.

NCT ID: NCT01377324 Completed - Clinical trials for Metastatic Breast Cancer

Molecular Imaging of Fulvestrant Effects on Availability of ER Binding Sites

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

The dose of fulvestrant to optimally downregulate estrogen receptors (ER) is currently subject of debate. Effects of fulvestrant on the ERs may be evaluable by molecular imaging using positron emission tomography with the ER-specific FES tracer. In this pilot study we will evaluate the effects of the new dose of fulvestrant (500mg i.m.)on the availability of ER binding sites in 15 metastatic breast cancer patients.