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Breast Neoplasms clinical trials

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NCT ID: NCT01483196 Completed - Clinical trials for Stage IIIA Breast Cancer

Vascular and Cognitive Assessments in Patients With Breast Cancer Undergoing Chemotherapy After Surgery

Start date: January 2012
Phase: N/A
Study type: Interventional

This clinical trial studies vascular and cognitive assessments in patients with breast cancer undergoing chemotherapy after surgery. Learning about vascular and cognitive function may help plan treatment and improve the quality of life of breast cancer patients. Transcranial Doppler ultrasound (TCD) may help study the side effects of chemotherapy in breast cancer patients and allow doctors to plan better treatment

NCT ID: NCT01482702 Completed - Breast Cancer Clinical Trials

Impact of Weight Loss Interventions for Overweight Breast Cancer Survivors

VCC0910
Start date: October 2009
Phase: N/A
Study type: Interventional

Obesity is an epidemic and the majority of breast cancer survivors are overweight or obese. The American Cancer Society has called for weight loss treatment to be standard of care for overweight women with breast cancer. During therapy women with breast cancer often gain weight and lose lean muscle mass. Overweight breast cancer survivors are more likely to have their cancer come back. The reason why overweight breast cancer survivors are more likely to re-occur has not been well studied, but changes in how insulin works may contribute. Overweight survivors are also at risk for the other chronic diseases associated with obesity. Fortunately, weight losses of as little as 5-7% of baseline body weight can improve risk of chronic disease. An effective behaviorally-based, lifestyle intervention delivered via the internet has been developed at the University of Vermont. This successful intervention has not been tested among breast cancer survivors. Given that women tend to lose muscle mass during cancer therapy the addition of a resistance training component to the weight loss intervention may be important. Therefore the overall goal of this project is to pilot test a proven distantly- delivered behavioral weight loss intervention among overweight breast cancer survivors and to evaluate whether a resistance program results in improvements in lean body mass, while studying how both interventions change insulin sensitivity. Specifically, this project is a randomized, controlled clinical trial designed to test the effectiveness and acceptability of a 6-month behavioral weight loss intervention with and without resistance training. Participants will be randomized to one of two groups: 1) behavioral weight control treatment via the Internet; or 2) behavioral weight control treatment via the Internet plus a resistance training program. Women eligible to participate include overweight breast cancer survivors who are age 50 or older and 6-36 months past receiving chemotherapy. Assessments will be conducted at baseline and six months and will include measures of body weight, muscle mass, adherence to treatment, and insulin sensitivity.

NCT ID: NCT01482156 Completed - Clinical trials for Metastatic Breast Cancer

Dose Finding Study of RAD001 (Everolimus, Afinitor®) in Combination With BEZ235 in Patients With Advanced Solid Tumors

Start date: January 2012
Phase: Phase 1
Study type: Interventional

Study has two parts: 1. Dose-finding: to determine the maximum tolerated dose (MTD) and to evaluate the safety and tolerability of RAD001 (everolimus , Afinitor®) in combination with BEZ235 in patients with advanced solid tumors. 2. Dose-expansion: to assess safety and tolerability of RAD001 and BEZ235 at the MTD in patients with ER+/HER2- metastatic breast cancer and metastatic renal cell cancer

NCT ID: NCT01480869 Completed - Breast Cancer Clinical Trials

Study of Vitamin D Supplementation Tailored to Vitamin D Deficiency in Breast Cancer Patients

VITACAL
Start date: July 2011
Phase: Phase 3
Study type: Interventional

The purpose of this study is to compare normalization of vitamin D serum level after 6 months of vitamin D supplementation adjusted to baseline vitamin D serum level vs.conventional vitamin D supplementation.

NCT ID: NCT01480674 Completed - Breast Cancer Clinical Trials

An Observational Study of Patients With HER2-Positive Metastatic or Locally Advanced Breast Cancer Treated With Herceptin (Trastuzumab) in 1st Line and Without Progression For 3 Years

Start date: March 2011
Phase: N/A
Study type: Observational

This observational study will characterize retrospectively patients with HER2-positive metastatic or locally advanced breast cancer who had received treatment with Herceptin (trastuzumab) in 1st line and who were without progression for at least three years. Patients will be followed prospectively for one year.

NCT ID: NCT01480583 Completed - Breast Cancer Clinical Trials

GRN1005 Alone or in Combination With Trastuzumab in Breast Cancer Patients With Brain Metastases

GRABM-B
Start date: October 2011
Phase: Phase 2
Study type: Interventional

The purpose of this study is to assess the efficacy, safety, and tolerability of GRN1005 in patients with brain metastases from breast cancer. For patients with HER2 positive metastatic breast cancer, GRN1005 will be assessed in combination with Trastuzumab (Herceptin®) as per standard-of-care practice. In addition, this study will evaluate the ability of 18F-FLT to determine if the amount of change in the uptake in the brain metastases from breast cancer after GRN1005 treatment, correlates with intra-cranial response (for patients enrolled at NCI).

NCT ID: NCT01479946 Withdrawn - Breast Cancer Clinical Trials

Electrochemotherapy For The Treatment Of Breast Cancer That Has Spread to the Skin

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

Electroporation combined with chemotherapy (ECT) has been shown to be an effective treatment for breast cancer that has spread to skin. In routine clinical practise, ECT is offered to patients when all other treatment options have been exhausted. This study tests the hypothesis that early treatment with ECT may result in improved local control of skin metastases, improved quality of life and reduced health care costs. Patients are randomised to either ECT given as early as possible in the course of the disease or delaying ECT for at least 6 months.

NCT ID: NCT01479348 Terminated - Breast Neoplasms Clinical Trials

Imaging Study for FdCyd and THU Cancer Treatment

Start date: November 1, 2011
Phase: Early Phase 1
Study type: Interventional

Background: - The drugs FdCyd (also called 5-fluoro-2'-deoxycytidine) and THU (also called tetrahydrouridine) are being used in a cancer treatment study. Not a lot is known about how FdCyd works in the body. Researchers want to look at a modified form of FdCyd using imaging studies to see how the drug reacts with the cancer. This study is not a treatment study. It is open only to people who are already on the FdCyd and THU cancer treatment study. Objectives: - To study how FdCyd affects advanced cancer cells. Eligibility: - Participants in National Cancer Institute study 09-C-0214. Design: - Participants will have two imaging studies, one before starting FdCyd and THU treatment and one after starting treatment. - Participants will have the modified FdCyd, known as F-18 FdCyd, with a dose of THU. The doses will be followed by two imaging study scans and frequent blood samples. - This procedure will be repeated at a later date, during the FdCyd and THU treatment period. - Treatment will not be provided as part of this study. This is an imaging study protocol only....

NCT ID: NCT01479244 Completed - Clinical trials for Breast Cancer With Low to Intermediate HER2 Expression

Efficacy and Safety Study of NeuVax™ (Nelipepimut-S or E75) Vaccine to Prevent Breast Cancer Recurrence

PRESENT
Start date: November 2011
Phase: Phase 3
Study type: Interventional

Purpose of this trial: 1. To assess the efficacy and safety of NeuVax™ administered with adjuvant Leukine® (sargramostim, GM-CSF). 2. To evaluate and compare the disease free survival (DFS) in the vaccinated and control subjects.

NCT ID: NCT01479179 Withdrawn - Breast Cancer Clinical Trials

Trastuzumab in Combination With AMG 479 in HER-2 Overexpressing MBC Progressing on Trastuzumab

Start date: November 2012
Phase: Phase 1/Phase 2
Study type: Interventional

The goal of Phase 1 of this clinical research study is to test the safety and tolerability of AMG 479 when given with trastuzumab. The goal of Phase 2 of this clinical research study is to learn if the combination of AMG 479 and trastuzumab can help to control breast cancer. AMG 479 is designed to block tumor cells from growing and spreading. Trastuzumab is designed to prevent or slow down the growth of cancer cells by blocking proteins inside the cancer cell.