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Breast Neoplasms clinical trials

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NCT ID: NCT00201773 Completed - Breast Cancer Clinical Trials

Exemestane With Celecoxib as Neoadjuvant Treatment in Postmenopausal Women With Stage II, III, and IV Breast Cancer

Start date: July 2003
Phase: Phase 2
Study type: Interventional

To test whether the addition of the COX-2 inhibitor, celecoxib, will decrease the gene expression of CYP19 in breast cancers collected from postmenopausal women that receive neoadjuvant exemestane.

NCT ID: NCT00201760 Completed - Breast Cancer Clinical Trials

Gemcitabine/ Trastuzumab and Gemcitabine/ Cisplatin/ Trastuzumab in Patients With Metastatic Breast Cancer

Start date: February 25, 2005
Phase: Phase 2
Study type: Interventional

This study determines the proportion of metastatic breast cancer patients progression free after 6 months when treated with gemcitabine/ cisplatin/ trastuzumab or gemcitabine/ trastuzumab.

NCT ID: NCT00201708 Completed - Breast Cancer Clinical Trials

Dose-Dense Docetaxel Before or After Doxorubicin/Cyclophosphamide in Axillary Node-Positive Breast Cancer

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

This study will determine if docetaxel will be administered before or after doxorubicin/cyclophosphamides in an adjuvant chemotherapy regimen to be evaluated in a subsequent phase III trial.

NCT ID: NCT00201435 Completed - Breast Neoplasm Clinical Trials

Weekly Taxol Plus Xeloda® vs Taxotere q3wk Plus Xeloda® in the Treatment of Metastatic BC

Start date: March 2005
Phase: Phase 2/Phase 3
Study type: Interventional

We want to compare Taxol given weekly with Taxotere given every 3 week both in comination with Xeloda. We are going to compare time to treatment failure and quality of life.

NCT ID: NCT00200174 Completed - Breast Cancer Clinical Trials

Combined Estrogen Blockade of the Breast With Exemestane and Raloxifene in Postmenopausal Women With a History of Breast Cancer Who Have No Clinical Evidence of Disease

Start date: July 1999
Phase: N/A
Study type: Interventional

The purpose of this research study is to learn about the effects of two drugs when they are given together. The names of the drugs are raloxifene and exemestane. Raloxifene is a drug that is related to estrogen. In the liver and bone, it acts like estrogen. In the breast and uterus it acts like an anti-estrogen. It has been used in postmenopausal women to prevent a disease called osteoporosis. This is a disease that decreases bone strength over many years and may finally lead to bone fractures. In a group of women who were taking the drug, it also seemed to decrease the chances of breast cancer and possibly endometrial cancer (cancer of the uterus). Therefore, we want to study it further to see if it prevents breast cancer. We also want to find out if it may be even better in preventing breast cancer if it is given with another drug. The other drug in this trial is exemestane. Exemestane is a type of drug that works to decrease estrogen levels in postmenopausal women. This type of drug is used in women for the treatment of breast cancer. Before we can decide if the two drugs combined are better for preventing breast cancer, we must first test these drugs together to make sure that they are safe. This safety testing is the purpose of this trial.

NCT ID: NCT00199212 Completed - Clinical trials for Carcinoma Breast Stage IV

PS-341 in Combination With Herceptin in Advanced Breast Cancer That Overexpresses HER-2

Start date: October 2003
Phase: Phase 1
Study type: Interventional

The main objective of this study is to determine the feasibility of the combination of the proteasome inhibitor bortezomib (PS-341, Velcade) with trastuzumab (Herceptin) and to determine the best dose of bortezomib to combine with two trastuzumab schedules, weekly and 3-weekly.

NCT ID: NCT00198250 Completed - Breast Cancer Clinical Trials

Venlafaxine for Hot Flashes After Breast Cancer

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

The purpose of this study is to evaluate Venlafaxine as a treatment option for hot flashes in breast cancer survivors. The goals of this study are to assess the effectiveness and toxicity of venlafaxine hydrochloride and identify the psychological, behavioral, and physical outcomes associated with relief of hot flashes in women following treatment for breast cancer.

NCT ID: NCT00198237 Completed - Breast Cancer Clinical Trials

Genomic & Proteomic Analysis of Docetaxel & Capecitabine as Primary Chemo for Stage II-III Breast Cancer

Start date: March 2003
Phase: Phase 2
Study type: Interventional

The primary objective of this study is to determine the efficacy & toxicity of combined docetaxel & capecitabine as primary chemo for subjects w/ stage II-III breast cancer.

NCT ID: NCT00197522 Completed - Breast Neoplasms Clinical Trials

Administration of Autologous Dendritic Cells (DCs) Infected With an Adenovirus Expressing Her-2

Start date: October 2004
Phase: Phase 1
Study type: Interventional

We, the researchers at Hamilton Health Sciences, have developed a novel approach to cancer therapy using transfected dendritic cells (DCs) to generate enhanced immunity to defined tumor antigens. Dendritic cells are highly specialized antigen presenting cells found in the bone marrow, lymph nodes, skin and thymus. Infection of DCs with Adenovirus (Ad) vectors incorporating genes for defined tumor antigens enables intracellular expression and major histocompatability complex (MHC)-restricted presentation of tumor peptides by transfected DCs. Given the potent immunostimulatory properties of DCs and ability to use gene transfer to "load" DCs with tumor antigen, we hypothesize that administration of transduced autologous DCs may have potential therapeutic benefit as a cancer vaccine. We have examined Ad-tumor antigen DC based vaccination in murine models of breast cancer and melanoma. In both models, injection(s) of Ad-transduced DCs results in highly potent immune activation and antigen-specific anti-tumor responses. In these models, high levels of antigen-specific, cytotoxic effector lymphocytes that recognize and kill cancer cells directly correlates with a therapeutic response (tumor regression and/or complete protection of animals subsequently re-challenged with tumor cells). Animals demonstrating specific in vitro immunity are protected against subsequent injection of cancer cells. Moreover, we have observed complete resolution and significant long-term survival in animals with established metastatic disease with no demonstrable toxicity. As opposed to vaccination protocols with tumor peptides or purified epitopes that are MHC-I restricted (i.e. HLA-A2), we have found that injection of DCs transduced with a vector expressing the entire tumor antigen results in peptide presentation from both MHC-I and MHC-II complexes. The subsequent immune response is comprised of both CD4+ and CD8+ T cell populations. Thus, Ad-based gene transfer of tumor antigens appears to be an efficient approach: (1) enabling sustained endogenous peptide processing, and (2) facilitating DC-specific presentation to the host immune system. We have shown that using a replication deficient adenovirus vector expressing Her-2/neu DNA under the control of a human mouse mammary tumor virus (MMTV) promoter that we can transfect bone marrow derived DCs (AdHer2/DC). These cells are then used to immunize recipient mice against tumour challenge with Her2 transgenic tumour cells. The protection is antigen specific (anti Her2). On the basis of these pre-clinical studies we will initiate a pilot trial of the AdHer2/DC vaccine in Her -2/neu overexpressing patients with metastatic breast cancer. Long-term goals and implications of possible results: The goals of this initial pilot phase I study are to evaluate the safety and dosing schedule of the vaccine therapy. The vaccine will be tested in subsequent phase II and III studies to determine efficacy in comparison to standard therapies. The long-term goals are to eventually test this therapy in the adjuvant breast cancer setting in Her-2/neu overexpressing patients.

NCT ID: NCT00196872 Completed - Breast Cancer Clinical Trials

A Study to Compare ETC vs. EC-TX and Ibandronate vs. Observation in Patients With Node-positive Primary Breast Cancer (GAIN)

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

In the recent AGO-study, a dose-dense and dose-intensified sequence of Epirubicin - Paclitaxel - Cyclophosphamide has shown superior efficacy compared to a conventionally dosed sequence of Epirubicin / Cyclophosphamid and Paclitaxel and was therefore chosen as standard treatment in this study. The experimental arm of EC-TX combines several strategies: the combination of EC will be administered every 2 weeks as a dose-dense regimen, the combination of TX can also be considered as dose-dense due to the weekly application of paclitaxel. Furthermore there is clinical evidence, that a combination of capecitabine and Paclitaxel provide synergistic effects with improved tumour response. A randomized phase III study could demonstrate a survival benefit of a combination of capecitabine with Docetaxel in patients with metastatic breast cancer. This synergistic effect is probably based on the preclinical observed taxane-mediated up-regulation of thymidine phosphorylase in the tumour cell, which give drive to an increased transformation of capecitabine to its active form 5-Fluorouracil. Apart from this synergy, the EC-TX regimen includes now 4 highly active compounds for the treatment of breast cancer. The total doses of Epirubicin and Paclitaxel are identical in both arms. The dosage of Cyclophosphamide is lower in the experimental arm, which is preferred due to the induction of leukaemia at higher doses of Cyclophosphamide. The duration of both arms with 18 and 20 weeks is nearly similar. The 2 by 2 factorial design of the trial provides the additional possibility to explore the efficacy of a bisphosphonate as another strategy to further improve the prognosis of node positive breast cancer.