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Breast Neoplasms clinical trials

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NCT ID: NCT00216073 Terminated - Clinical trials for Metastatic Breast Cancer

Capecitabine, Oxaliplatin and Trastuzumab in Treating Patients With HER2 Positive Metastatic Breast Cancer

Start date: March 2004
Phase: Phase 2
Study type: Interventional

In vitro data suggest synergy between oxaliplatin and 5-FU. The combination of oxaliplatin with 5-fluorouracil produced objective response rates ranging from 27-34% in two studies of patients with prior chemotherapy. Capecitabine was designed as an orally administered, tumor selective fluoropyrimidine, preferentially converted to 5-FU at the tumor site by the higher levels of pyrimidine nucleoside phosphorylase (PyNPase) in tumor tissues compared to normal tissues. The end result is higher concentrations of 5-fluorouracil in tumor relative to surrounding normal tissue. Trastuzumab is synergistic in vitro with multiple chemotherapeutic agents including the platinum compounds. Studies have shown the efficacy of trastuzumab combined with chemotherapy in patients with HER2 overexpressing metastatic breast cancer. This trial will investigate the activity of capecitabine and oxaliplatin administered with trastuzumab (CAPOX-T) in patients with HER2 overexpressing in patients with advanced disease.

NCT ID: NCT00216047 Terminated - Breast Cancer Clinical Trials

PTK787 + Trastuzumab for HER2 Overexpressing Metastatic Breast Cancer

Start date: January 2005
Phase: Phase 1/Phase 2
Study type: Interventional

HER2 gene amplification increases VEGF production in breast cancers; combined inhibition of HER2 and VEGF enhances response in xenograft models. The upregulation of VEGF in HER2-overexpressing breast cancers may contribute to the aggressive phenotype observed in HER2-positive breast cancer. New therapeutics targeting VEGF and/or its receptors may enhance the efficacy of trastuzumab monotherapy. This trial will investigate the safety and efficacy of combined HER2 and VEGF inhibition.

NCT ID: NCT00216021 Completed - Clinical trials for Metastatic Breast Cancer

Capecitabine and Oxaliplatin in Treating Patients With Metastatic Breast Cancer

Start date: March 2004
Phase: Phase 2
Study type: Interventional

In vitro data suggest synergy between oxaliplatin and 5-FU. The combination of oxaliplatin with 5-fluorouracil produced objective response rates ranging from 27-34% in two studies of patients with prior chemotherapy. Capecitabine was designed as an orally administered, tumor selective fluoropyrimidine, preferentially converted to 5-FU at the tumor site by the higher levels of pyrimidine nucleoside phosphorylase (PyNPase) in tumor tissues compared to normal tissues. The end result is higher concentrations of 5-fluorouracil in tumor relative to surrounding normal tissue. This trial will investigate the activity of this novel capecitabine/oxaliplatin (CAPOX) combination in patients with advanced disease. In addition, an exploratory analysis will correlate response with thymidine synthase and thymidine phosphorylase expression in primary tumor samples.

NCT ID: NCT00214864 Completed - Clinical trials for Metastatic Breast Cancer

A Study of Weekly Taxotere and Xeloda in Metastatic Breast Cancer

Start date: December 2002
Phase: Phase 2
Study type: Interventional

The purpose of this study is to attempt to find better tolerated doses and schedules of this highly effective combination chemotherapy regimen.

NCT ID: NCT00214149 Terminated - Breast Cancer Clinical Trials

Multi-catheter High Dose Rate (HDR) Breast Brachytherapy

Start date: October 2004
Phase: Phase 2
Study type: Interventional

Breast conservation therapy (BCT) is now widely accepted as a treatment option for most women with Stage I and II invasive breast cancer and most patients with ductal carcinoma in situ (DCIS). Despite superior cosmetic outcome, BCT is more complex and requires a protracted treatment regimen comprised of 6 weeks of daily external beam radiation therapy to the whole breast. The purpose of this study is to determine if an acceptable outcome can be achieved with radiation delivered only to the region of the tumor bed. If this is true, partial breast irradiation may lend itself to much shorter treatment times (one week) and the toxicities to adjacent normal structures (heart, lung, chest wall) will be greatly reduced.

NCT ID: NCT00213980 Completed - Breast Cancer Clinical Trials

Bone Mineral Density Effects of Zoledronate in Postmenopausal Women With Breast Cancer

Start date: January 2000
Phase: Phase 2
Study type: Interventional

This is a two arm, double-blind randomized study looking at the effect of zoledronate, a bisphosphonate, on the bone mineral density (BMD) of postmenopausal women with breast cancer.

NCT ID: NCT00212121 Active, not recruiting - Breast Cancer Clinical Trials

Radiation Dose Intensity Study in Breast Cancer in Young Women

Start date: July 2004
Phase: Phase 3
Study type: Interventional

hypothesis: 10 Gy additional boost to the tumor bed will yield an increase in local control at 10 years from 88% to 93%, with still acceptable cosmesis.

NCT ID: NCT00212095 Completed - Clinical trials for Metastatic Breast Cancer

Docetaxel Combined With Ketoconazole in Treatment of Breast Cancer

Start date: June 2005
Phase: Phase 2
Study type: Interventional

Patients with locally advanced or metastatic breast cancer and with measurable primary breast tumor will be treated with 70mg docetaxel combined with ketoconazole. Serial tumor biopsies and plasma samples will be taken for gene expression and proteomics studies to identify biomarkers that may predict for treatment response.

NCT ID: NCT00212082 Completed - Clinical trials for Metastatic Breast Cancer

Gene Expression Profiles in Predicting Chemotherapy Response in Breast Cancer

Start date: April 2002
Phase: Phase 2
Study type: Interventional

We hypothesize that changes in tumor gene expression profiles vary in response to different sequences and types of chemotherapy, and that gene expression changes will correlate with tumor response. We are also looking to correlate drug pharmacokinetics and treatment toxicity with genotype of drug metabolizing enzymes and tranporters.Patients with metastatic breast cancer and who have measurable primary breast tumor will be randomized to one of two alternating sequences of adriamycin and docetaxel. Serial tumor biopsies and plasma samples will be obtained for gene expression and proteomic studies to identify biomarkers that will predict for chemotherapy response.

NCT ID: NCT00212069 Completed - Clinical trials for Metastatic Breast Cancer

Serum Proteomics to Predict Gemcitabine Sensitivity in Breast Cancer

Start date: March 2004
Phase: Phase 2
Study type: Interventional

Tumors are heterogeneous with varying response to chemotherapeutic agents. We hypothesize that tumors that are sensitive to a particular chemotherapeutic agent have a distinctive tumor protein profile compared to those that are resistant. We further hypothesize that since tumor is continuously perfused by serum, serum protein profile can be used as a surrogate marker of tumor protein profile. The primary objective of this study is to identify a serum protein profile that predicts gemcitabine/carboplatin sensitivity or resistance in breast cancer patients with prior exposure to anthracyclines and taxanes. Secondary objectives are to establish the serum protein profile of breast cancer patients who have had prior exposure to anthracyclines and taxanes, and to study the pharmacogenetics of gemcitabine toxicity by correlating germline genotype of transporters and drug metabolizing enzymes with plasma and intracellular gemcitabine pharmacokinetics.