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Breast Neoplasms clinical trials

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NCT ID: NCT00317720 Completed - Breast Cancer Clinical Trials

Trastuzumab and RAD001 in Patients With Human Epidermal Growth Receptor 2 (HER-2) Overexpressing Breast Cancer

Start date: April 2006
Phase: Phase 1/Phase 2
Study type: Interventional

Primary Objectives: 1. To identify the optimal dose and pharmacokinetics of RAD001 in combination with trastuzumab in a Phase I trial 2. To determine the efficacy of RAD001 plus trastuzumab in HER-2-overexpressing patients with resistance to trastuzumab-based therapy for metastatic breast cancer in a Phase II trial. 1. Trastuzumab resistance will be defined as the development of progressive disease after trastuzumab-based therapy for metastatic breast cancer. Patients who develop metastases while receiving adjuvant or neoadjuvant trastuzumab will be eligible. 2. Efficacy would be measured by the rate of objective response plus stable disease lasting 6 months (complete response (CR) + partial response (PR) + stable disease SD). Secondary objectives: 1. To determine the pharmacokinetics of RAD001 in combination with trastuzumab. In the phase II portion of the study, pharmacokinetic studies will be optional. 2. To determine the nature and degree of toxicity of RAD001 in combination with trastuzumab in this cohort of patients 3. To determine expression levels of total and phosphorylated mTOR and p70S6K-T389-P as well as relevant downstream signaling components (e.g., S6, 4E-BP1) in pre- and post- treatment tumor samples. 4. To correlate biomarker expression with response to therapy.

NCT ID: NCT00317603 Completed - Breast Cancer Clinical Trials

Vaccination With Autologous Breast Cancer Cells Engineered to Secrete Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF) in Metastatic Breast Cancer Patients

Start date: January 1, 2006
Phase: Phase 1
Study type: Interventional

The purpose of this trial is to test the safety of a vaccine made from a patient's own breast cancer cells, and determine if this vaccine will delay or stop the growth of the cancer. The vaccine is made by genetically modifying a patient's own tumor cells to secrete granulocyte-macrophage colony-stimulating factor (GM-CSF) to activate the immune response.

NCT ID: NCT00316875 Completed - Breast Cancer Clinical Trials

Lapatinib and Doxorubicin Hydrochloride Liposome in Treating Patients With Metastatic Breast Cancer

Start date: May 2006
Phase: Phase 1
Study type: Interventional

RATIONALE: Lapatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as doxorubicin hydrochloride liposome work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving lapatinib together with doxorubicin hydrochloride liposome may kill more tumor cells. PURPOSE: This phase I trial is studying the side effects and best dose of doxorubicin hydrochloride liposome when given together with lapatinib in treating patients with metastatic breast cancer.

NCT ID: NCT00316836 Completed - Breast Cancer Clinical Trials

Breast Density, Hormone Levels, and Anticancer Drug Levels in Women With Invasive Breast Cancer Who Are Receiving Exemestane or Anastrozole

Start date: April 2006
Phase:
Study type: Observational

RATIONALE: Understanding the relationship between breast density, levels of hormones in the blood, and levels of anticancer drugs in the blood may help improve the ability to plan effective treatment for women with invasive breast cancer. PURPOSE: This clinical trial is studying the relationship between breast density and blood levels of hormones and anticancer drugs in women with invasive breast cancer who are receiving exemestane or anastrozole.

NCT ID: NCT00316407 Completed - Clinical trials for Stage IV Breast Cancer

Lapatinib/Carboplatin/Paclitaxel in Previously Treated Ovarian or Breast Cancer Patients

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

The purpose of this study is to determine the effectiveness, safety, tolerability and best dose of Lapatinib (GW572016) in combination with carboplatin and paclitaxel.

NCT ID: NCT00316199 Completed - Clinical trials for Metastatic Breast Cancer

Efficacy Study of Gemcitabine-Paclitaxel to Treat Metastatic Breast Cancer

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

The purpose of this study is to determine the response rate to a gemcitabine-paclitaxel combination administered on a 3-weekly schedule in Chinese patients with unresectable, locally recurrent breast cancer or metastatic breast cancer.

NCT ID: NCT00314977 Completed - Breast Cancer Clinical Trials

Sequential vs Upfront Intensified Neoadjuvant Chemotherapy in Patients With Large Resectable or Locally Advanced Breast Cancer.

INTENS
Start date: February 2006
Phase: Phase 3
Study type: Interventional

2 different treatment schedules may be used for neoadjuvant chemotherapy in breast cancer using adriamycin, cyclophosphamide and taxotere. The most optimal sequence- concurrent or sequential- is however unclear. The aim of the study is to compare the efficacy and tolerability of neoadjuvant chemotherapy with AC followed by T(adriamycin, cyclophosphamide, taxotere) versus TAC ( with upfront T) in patient with large resectable or locally advanced breast cancer.

NCT ID: NCT00314405 Completed - Clinical trials for Infiltrative Breast Cancer

Identification of Sentinel Lymph Nodes With Methylene Blue and Isotope

Start date: April 2006
Phase: N/A
Study type: Interventional

The aim of this study is to evaluate the performance of a double labelling method using isotope and methylene blue dye injection to localize precisely Sentinel Lymph Node (SLN) in a series of 100 patients with infiltrative breast cancer justifying SLN excision. Method and patients: SLN excision will be performed on 100 patients treated for infiltrative breast cancer. After preoperative methylene blue dye injection and lymphoscintigraphy, individual localization of the radioactive and stained nodes will be performed. After the surgery, SLN will be submitted to serial analysis and immunohistochemistry. A comparison of the two methods and an economical evaluation of the complete procedure will be performed.

NCT ID: NCT00313248 Completed - Breast Neoplasm Clinical Trials

Evaluation of a New Agent for Treatment of Advanced Stage Breast Cancer

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

The purpose of this study is to evaluate whether treatment with a new drug called ZK-Epothilone (ZK-Epo) in patients with metastatic breast cancer helps to decrease or stop tumor growth.

NCT ID: NCT00313170 Completed - Clinical trials for Metastatic Breast Cancer

A Clinical Trial to Compare Efficacy and Tolerability of Fulvestrant 250mg, 250mg Plus 250mg Loading Regimen and 500mg

FINDER II
Start date: May 30, 2006
Phase: Phase 2
Study type: Interventional

This study will assess the relationship between fulvestrant dose and efficacy in postmenopausal women with oestrogen receptor positive advanced breast cancer.