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Breast Neoplasms clinical trials

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NCT ID: NCT00285857 Terminated - Breast Cancer Clinical Trials

Phase II Trial - Breast Cancer Chemoprevention by Lovastatin

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

The purpose of the study is to determine whether oral lovastatin, used for 6 months, results in a decrease of abnormal breast duct cytology in women at high inherited breast cancer risk.

NCT ID: NCT00282529 Terminated - Breast Cancer Clinical Trials

Identification of a Screening Tool and Treatment of Lymphedema Secondary to the Management of Breast Cancer Study

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

The proposed research is designed to establish lymphedema incidence rates for a varied population of breast cancer patients. Patients with breast preservation, mastectomy, sentinel lymph node biopsy, axillary dissection and radiation therapy will be included with the goal of determining the impact that each of these treatments has on development of lymphedema. Establishing incidence in these populations is crucial to the remainder of the study. We conduct a two phase study. The first phase will use arm measurements, a symptom survey (The Lymphedema and Breast Questionnaire), a functional survey (Disability of the Arm, Shoulder, and Hand Questionnaire), and operative and pathology information to create a simple screening tool to predict the development of lymphedema. Currently, lymphedema is only diagnosed after arm swelling develops. The goal of the screening tool is to identify those patients at significantly increased risk for development of lymphedema as compared to the general population of breast cancer survivors. Phase 2 of the study will test a lymphedema prevention strategy in a high risk population. The goal of this phase is to reduce the incidence of lymphedema in those patients that have undergone an axillary node dissection with radiation therapy by using a combination of education, a compression sleeve and decongestive exercises. If prevention is successful, the development of a screening tool becomes even more important to identify those patients that should undergo a prevention regimen.

NCT ID: NCT00281528 Terminated - Breast Neoplasms Clinical Trials

Weekly vs. Every 2 Week vs. Every 3 Week Administration of ABI-007 (Abraxane)/Bevacizumab Combination in Metastatic Breast Cancer

Start date: February 1, 2006
Phase: Phase 2
Study type: Interventional

This is a multi-center, open-label, randomized Phase II study in previously untreated patients with metastatic breast cancer to evaluate the antitumor activity and safety of weekly dose-dense ABI-007 (Abraxane) compared to 2-weekly regimen vs the standard 3-weekly infusion. All patients will also receive concurrent bevacizumab.

NCT ID: NCT00276822 Terminated - Breast Cancer Clinical Trials

Improving Communication With Patients With Breast Cancer

Start date: October 2005
Phase: N/A
Study type: Interventional

RATIONALE: An education program based on patients' health communication needs may improve patients' overall healthcare experience and sense of control. PURPOSE: This clinical trial is studying the health communication needs of patients with breast cancer to develop patient education programs.

NCT ID: NCT00272987 Terminated - Neoplasms, Breast Clinical Trials

ErbB2 Over-expressing Metastatic Breast Cancer Study Using Paclitaxel, Trastuzumab, and Lapatinib

Start date: December 13, 2005
Phase: Phase 3
Study type: Interventional

This study was originally designed as a Phase III randomized, double blind, placebo controlled study to assess the safety and tolerability, and efficacy of paclitaxel plus trastuzumab plus lapatinib compared with paclitaxel plus trastuzumab plus placebo in women with ErbB2 overexpressing metastatic breast cancer. The planned study was a two stage design with an initial open-label safety stage to be conducted in approximately 65 subjects followed by a randomized phase conducted in a further 700 subjects. The open-label part of the study sequentially enrolled three cohorts with patients receiving a different dose combination of paclitaxel, trastuzumab and lapatinib. Following poor recruitment rate in the open label stage, the randomized stage of the study was terminated, thus no subjects were enrolled into the randomization stage.

NCT ID: NCT00267553 Terminated - Breast Neoplasms Clinical Trials

Treatment and Survival Continuation Study of Atamestane Plus Toremifene vs Letrozole in Advanced Breast Cancer

Start date: November 2005
Phase: Phase 3
Study type: Interventional

Protocol 777-CLP-32 is the treatment and survival continuation protocol of Biomed 777-CLP-29, and will continue to compare combined hormonal therapy using the experimental aromatase inhibitor (AI) atamestane combined with the FDA-approved anti-estrogen toremifene (Fareston®), to the single agent FDA-approved aromatase inhibitor letrozole (Femara®) for the treatment of advanced breast cancer. The purpose of this study is to determine whether maximal estrogen suppression achieved via the combination of atamestane, plus toremifene (Fareston®), is more effective than letrozole (Femara®) in delaying the growth of breast cancer.

NCT ID: NCT00263198 Terminated - Breast Neoplasms Clinical Trials

PTK and Letrozole in Post-menopausal Women With Advanced Breast Cancer

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

The purpose of this study is to test the safety of PTK787/ZK222584 and Letrozole when given in combination, and to see what effects they have on breast cancer that has metastasized.

NCT ID: NCT00253318 Terminated - Breast Cancer Clinical Trials

RAD001 Plus Docetaxel in Patients With Metastatic Breast Cancer

Start date: November 1, 2005
Phase: Phase 1
Study type: Interventional

Primary: - To assess the safety and tolerability and to find the maximum tolerated dose of the combination administration of RAD001 plus docetaxel when given to patients with metastatic breast cancer who are being considered for standard docetaxel treatment (phase I). - To characterize the pharmacokinetics of RAD001 and docetaxel when co-administered (phase I). Secondary: - To determine the phosphorylation status of the components of the mTOR signaling pathway and the expression of modifiers of apoptosis in the primary breast tumors, in order to determine whether these markers can be used as predictors of sensitivity to the combination of RAD001 and docetaxel - To determine the effect of the combination of RAD001 and docetaxel on the expression and phosphorylation of mTOR's targets in the accessible tumor tissue, in order to identify potential pharmacodynamics markers of response to this drug combination

NCT ID: NCT00251433 Terminated - Neoplasms, Breast Clinical Trials

GW572016 With Docetaxel and Trastuzumab for the Treatment Of Untreated ErbB2 Over-Expressing Metastatic Breast Cancer

Start date: September 26, 2005
Phase: Phase 1
Study type: Interventional

This study was designed to be two-part study (Phase I/Phase II). Part I was designed to find the optimal (best) doses of GW572016, docetaxel, and trastuzumab when given together. Part II was designed to evaluate the tumor response rate (shrinkage or lack of growth) in patients receiving all three drugs compared to patients receiving only docetaxel and trastuzumab.

NCT ID: NCT00251095 Terminated - Breast Neoplasm Clinical Trials

Comparison of Safety and Efficacy of TOCOSOL(R) Paclitaxel Versus Taxol(R) for Treatment of Metastatic Breast Cancer

Start date: September 2005
Phase: Phase 3
Study type: Interventional

The purpose of this study is to compare the objective response rates of patients randomized to receive either TOCOSOL(R) Paclitaxel or Taxol(R) (paclitaxel injection) administered every week to patients with metastatic breast cancer. The study hypothesis is that the objective response rate with TOCOSOL Paclitaxel given every week is non-inferior to that observed with Taxol given every week.