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Breast Neoplasms clinical trials

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NCT ID: NCT01035268 Terminated - Breast Cancer Clinical Trials

Adipose Tissue Transfer for Moderate Breast Cancer Conservative Treatment Sequella

GRATSEC
Start date: February 8, 2010
Phase: Phase 3
Study type: Interventional

This is a phase III randomized multi-center study of equivalence comparing the radiological follow-up for patients benefiting from the correction of the esthetical relapse of the preservative treatment by fatty transfer compared with a simple supervision. It is planned that 440 patients participate in this study which plans to compare 2 groups of patients: a group of patients which will benefit from the surgical treatment by transfer of fatty tissue and a group of patients under simple supervision. follow-up consultations are planned in 10 in 45 days post-surgery then at 3 months, 6 months, 12 months and 5 years to look for the expected unwanted effects in relation with the surgery but also to estimate the impact of the fatty transfer on the rate of local and\or from a distance relapse. During these consultations, the surgeon and the patient will also estimate the cosmetic result of the surgery thanks to a questionnaire of cosmetic evaluation and to standardized photos.

NCT ID: NCT01022138 Terminated - Breast Cancer Clinical Trials

Laboratory-Treated T Cells After Second-Line Chemotherapy in Treating Patients With HER2/Neu-Negative Metastatic Breast Cancer

Start date: March 8, 2010
Phase: Phase 2
Study type: Interventional

RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Treating a patient's T cells in the laboratory may help the T cells kill more tumor cells when they are put back in the body. Giving laboratory-treated T cells after chemotherapy may be an effective treatment for breast cancer. PURPOSE: This phase II trial is studying how well giving laboratory-treated T cells after second-line chemotherapy works in treating patients with HER2/neu-negative metastatic breast cancer.

NCT ID: NCT01019512 Terminated - Breast Cancer Clinical Trials

Flexitouch Lymphedema System in Treating Stage II Lymphedema in Patients With Breast Cancer

Start date: July 2009
Phase: N/A
Study type: Interventional

RATIONALE: The Flexitouch lymphedema system may lessen lymphedema caused by treatment for breast cancer. It is not yet known whether the Flexitouch lymphedema system is more effective than complex decongestive therapy in treating lymphedema. PURPOSE: This randomized clinical trial is studying the Flexitouch lymphedema system in treating stage II lymphedema in patients with breast cancer.

NCT ID: NCT01012440 Terminated - Breast Cancer Clinical Trials

Role of Positron Emission Mammography (PEM) Flex Solo II Positron Emission Tomography (PET) Scanner in Evaluating Neoadjuvant Chemotherapy Response in Patients With Breast Cancer

Start date: November 2009
Phase: N/A
Study type: Interventional

The purpose of this study is: 1. To evaluate the hypothesis: Can PEM Flex Solo II PET scanner ascertain response to neoadjuvant chemotherapy in patients with breast cancer? 2. To compare the results from the PEM Flex Solo II PET scanner to the standard of care bilateral breast MRI.

NCT ID: NCT01010854 Terminated - Breast Cancer Clinical Trials

Valproic Acid in Combination With FEC100 for Primary Therapy in Patients With Breast Cancer

VPA-FEC100
Start date: December 10, 2008
Phase: Phase 2
Study type: Interventional

The drugs FEC 100 (5-fluorouracil, epirubicin, and cyclophosphamide) are one of the approved options to treat Locally Advanced or Primary Metastatic Breast Cancer. In this study, the investigators will add another drug called Valproic Acid (VPA) to see whether this makes the treatment better. The addition of Valproic Acid to chemotherapy has been studied in about 65 subjects with cancer and was found to be safe and tolerable. Valproic Acid is approved by the Food and Drug Administration (FDA) for the treatment of seizures, mood swings, and migraine headaches. It is not currently approved for cancer, which is why the investigators are conducting this study. The results of a Phase I study of Valproic Acid and FEC100 in subjects with cancer that has spread has led the investigators to believe that this combination is better than just the standard treatment alone. The investigators are now testing the combination in a study with subjects who have either a large tumor, many lymph nodes involved or patients whose tumor has spread. In addition to the treatment, a main goal of the study is to find out which subjects will benefit from this combination. In the Phase I trial the investigators noticed that while this combination appears to make the chemotherapy more effective, it did not appear to cause more side effects induced by the chemotherapy.

NCT ID: NCT01009983 Terminated - Breast Cancer Clinical Trials

Paclitaxel, Carboplatin, and Panitumumab in Treating Patients With Metastatic Breast Cancer

Start date: March 2010
Phase: Phase 2
Study type: Interventional

RATIONALE: Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as panitumumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Other find tumor cells and help kill them or carry tumor-killing substances to them. Giving panitumumab together with paclitaxel and carboplatin may be a better way to block tumor growth. PURPOSE: This phase II trial is studying the side effects and how well paclitaxel and carboplatin together with panitumumab works in treating patients with metastatic triple negative breast cancer.

NCT ID: NCT01007890 Terminated - Breast Cancer Clinical Trials

Prediction of Response to Neoadjuvant Chemotherapy in Women With Operable Breast Cancer

PT-304
Start date: November 2009
Phase: Phase 3
Study type: Observational

The objective of this study is to develop a biomarker to predict pathological complete response in women treated with neoadjuvant chemotherapy for breast cancer. Such a biomarker would assist physicians in selecting the most effective chemotherapy for the individual patient.

NCT ID: NCT01007695 Terminated - Cancer Clinical Trials

Molecular Signature of Valproic Acid in Breast Cancer With Functional Imaging Assessment - a Pilot

VAST
Start date: May 2010
Phase: Phase 1
Study type: Interventional

The investigators' hypothesis is that valproic acid given before surgery for newly diagnosed breast cancer will increase breast tumor histone acetylation at tolerable doses and that the increase in breast tumor histone acetylation will correlate with valproic acid blood levels and changes in peripheral blood white blood cell histone acetylation. Published in vitro studies have shown sensitivity of breast cancer cells to histone deacetylase inhibitors (Fortunati et al., 2008; Fuino et al., 2003; Hodges-Gallagher et al., 2007; Olsen et al., 2004). The investigators' gene array data predict sensitivity to valproic acid in over half of breast cancers [Bild, unpublished]. The investigators hypothesize that in women with newly diagnosed breast cancers valproic acid will have an unacceptable toxicity rate less than 15% at doses that increase tumor histone acetylation and that valproic acid will decrease the Ki-67 in at least half of breast tumors by over 20%. The investigators also hypothesize that their genomically-derived signature for sensitivity to valproic acid (GDSS-VPA) can be used to predict which tumors will have a decrease proliferation as measured by Ki-67 by at least 20%. The investigators hypothesize that valproic acid levels and histone acetylation levels in peripheral leukocytes will correlate with a decrease in the Ki-67 proliferation index by 20%. The investigators hypothesize that DCE-MRI imaging studies will provide an accurate and quantitative means of assessing tumor response to valproic acid. Finally, the investigators hypothesize that response to valproic acid will not be affected by intrinsic breast cancer subtype.

NCT ID: NCT01006785 Terminated - Breast Cancer Clinical Trials

Efficacy and Safety of DLBS1425 in Subjects With Advanced/Metastatic Breast Cancer

Start date: August 2009
Phase: Phase 2
Study type: Interventional

The purposes of this study are : - to investigate the safety and clinical efficacy of sole therapy with DLBS1425 in suppressing disease-(tumour) progression in subjects with advanced/metastatic breast cancer; and - to determine the minimal effective and safe dose of DLBS1425 in the therapy of advanced/metastatic breast cancer

NCT ID: NCT00998738 Terminated - Pain Clinical Trials

Calcium and Magnesium in Preventing Peripheral Neuropathy Caused by Ixabepilone in Patients With Breast Cancer

Start date: November 2009
Phase: Phase 3
Study type: Interventional

This randomized phase III trial studies calcium and magnesium to see how well they work in preventing peripheral neuropathy caused by ixabepilone in patients with breast cancer. Giving calcium together with magnesium may stop or delay the development of peripheral neuropathy in patients with cancer who are receiving treatment with ixabepilone. It is not yet known whether calcium and magnesium are effective in preventing peripheral neuropathy caused by ixabepilone.