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Breast Cancer clinical trials

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NCT ID: NCT01561287 Completed - Breast Cancer Clinical Trials

A Comparison of Dermal Autograft to AlloDerm in Breast Reconstruction

Start date: July 2011
Phase: Phase 4
Study type: Interventional

Breast Cancer affects about 1 out of 8 American women. Twenty percent of breast cancer patients undergo some form of breast reconstruction. Several types of reconstructive procedures are available for appropriate patients. A reconstructive sequence consisting of a tissue expander followed by permanent implant placement is a popular choice for many women. In the past several years, acellular dermal matrices (allografts) have been used at the time of tissue expander placement to extend submuscular coverage. Reported benefits include the ability to initially fill the expander to a greater extent, improved control of the inframammary crease, and possible decrease in capsular contracture rate. Potential disadvantages of dermal allografts include foreign body reaction, incomplete tissue integration, or increased infection rates. The latter is especially worrisome, as infection in the setting of a tissue expander often necessitates the removal of the implant and interruption of the reconstructive sequence. There have been a few scattered reports of the use of dermal autografts in implant-based breast reconstruction, but they have not been widely used. Dermal autografts carry the potential benefit of improved tissue integration and lowered complication rates. However, to date there have been no studies which compare acellular dermal allograft matrices to dermal autograft for use in breast reconstruction. The objectives of this study are to compare dermal allograft to dermal autograft with respect to cost, tissue integration, patient satisfaction with scar, and complication profile in patients undergoing mastectomy followed by tissue expander/implant reconstruction.

NCT ID: NCT01559194 Completed - Breast Cancer Clinical Trials

Low Fat Versus Protein Sparing Diet for Weight Loss & Impact on Biomarkers Associated With Breast Cancer Risk

LEAF
Start date: May 2005
Phase: Phase 3
Study type: Interventional

The primary specific aim of this study was to determine if overweight and obese premenopausal women can lose weight and if long term weight loss impacts biomarkers associated with breast cancer risk.

NCT ID: NCT01556243 Completed - Breast Cancer Clinical Trials

Breast-Conserving Surgery and Radiation Therapy in Patients With Multiple Ipsilateral Breast Cancer

Start date: July 2012
Phase: Phase 2
Study type: Interventional

RATIONALE: Breast-conserving surgery is a less invasive type of surgery for breast cancer and may have fewer side effects and improve recovery. Radiation therapy uses high-energy x rays to kill tumor cells. Giving radiation therapy after surgery may kill any tumor cells that remain after surgery. PURPOSE: This phase II trial studies how well breast-conserving surgery and radiation therapy work in treating patients with multiple ipsilateral breast cancer

NCT ID: NCT01555645 Completed - Breast Cancer Clinical Trials

Stress Management in Breast Cancer Patients

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

The purpose of this study within Caring sciences is to identify women with breast cancer who have stress symptoms and to offer these women appropriate care to reduce stress and increase well-being. This will be achieved by 1. Studying the prevalence of stress related symptoms in female patients with breast cancer 2. Testing the use of two short screening instruments to identify women at risk for developing long-standing stress symptoms 3. Studying the level and intensity of stress management interventions required to achieve increased well-being, using a stepped-care approach. 4. Studying the effects of interventions based on cognitive behavior therapy, delivered individually or in a group format. The hypothesis is that half of the individuals assigned to a low intensity intervention will be significantly improved after treatment. For individuals who continue to have symptoms after low intensity treatment it is hypothesized that continued treatment in a group setting with high intensity interventions will be more cost-effective. In addition the assumption is that reduction of stress symptoms in women with breast cancer will lead to a reduction in socio-economic costs.

NCT ID: NCT01554943 Completed - Breast Cancer Clinical Trials

Late Cardiac Evaluation of the Three Arm Belgian Trial Involving Node-positive Early Breast Cancer Patients

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

Late Cardiac Evaluation of the Three Arm Belgian Trial A phase III randomized trial involving node-positive early breast cancer patients with a long median follow-up (~ 15 years) OBJECTIFS Primary: • To compare the incidence of late cardiac events between anthracycline and non-anthracycline chemotherapy given to node-positive breast cancer patients in the Belgian three arm randomized clinical trial Secondary: - To compare the late incidence of cardiac events between higher and lower dose anthracycline treated node-positive breast cancer patients; - To compare anthracyclines (higher and lower doses) and non-anthracycline chemotherapy for: - left ventricular diastolic function assessed by Echo - exercise capacity assessed by 6-minute walk test (6MWT) - cardiac morphology (myocardial inflammation or injury, fibrosis, LVEF) assessed by MRI - serum cardiac biomarkers (BNP and TNT) - patient-reported cardiac symptoms - patient-reported cardiac symptoms assessed by QOL questionnaires are associated with subclinical findings on LVEF assessment - cognitive function, functional autonomy, and psychological distress

NCT ID: NCT01554371 Completed - Neuropathy Clinical Trials

Eribulin in Combination With Cyclophosphamide in Patients With Solid Tumor Malignancies

Start date: March 27, 2012
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to test the safety of eribulin (Halaven™) and cyclophosphamide (Cytoxan®) given together at different doses. This study will look at what effects, good and/or bad, that these drugs have on solid tumors. Eribulin is a drug that has been approved by the FDA for breast cancer that has spread to other parts of the body. Cyclophosphamide has been approved for different types of cancers (including breast cancer). However, the combination of eribulin and cyclophosphamide is considered experimental; that means this combination has not been approved by the FDA. The funding for this study is provided by Eisai Inc., the maker of eribulin.

NCT ID: NCT01553903 Completed - Breast Cancer Clinical Trials

Feasibility Study for the Determination of Oxysterols in Patients With Breast Cancer Receiving Hormonal Therapy With Tamoxifen or Not

OXYTAM
Start date: December 2011
Phase: Phase 4
Study type: Interventional

This is a biomedical study of interventional type which includes 29 patients on 9 months: 8 months recruiting and 1 month follow up. Patients with hormone dependent breast cancer metastatic or non-metastatic, for which an indication of hormonal therapy treatment (with tamoxifen or anti-aromatase) is retained, will be enrolled in this study. The main objective of this study is to evaluate the feasibility for the determination of Oxysterols (CT, CE, OCDO) in this patient population, before and after the initiation of treatment (ie, at D0 before and D28 after beginning of treatment).

NCT ID: NCT01553097 Completed - Breast Cancer Clinical Trials

Examining a Common Complaint of Women Who Receive Chemotherapy for Breast Cancer- Cognitive Difficulty

Start date: March 2012
Phase: N/A
Study type: Observational

This longitudinal project will investigate a common complaint of women who receive chemotherapy for breast cancer- cognitive difficulty. The relationships of fatigue, stress, and depression to cognitive difficulties will be examined. The findings should lead to interventions to decrease the effects of these problematic side effects.

NCT ID: NCT01552655 Completed - Clinical trials for Breast Cancer Recurrent

Breast Cancer Recurrence - the Accuracy of Dual-time PET/CT

BREAC-AUT
Start date: December 2011
Phase: N/A
Study type: Interventional

The purpose of this study is to elucidate the value of dual-time-point PET/CT in the recurrence of breast cancer and to determine whether the method is better than the modalities used in the standard work up. 150 patients with suspected breast cancer recurrence will be included. All patients will undergo dual-time-point PET/CT, CT of thorax and upper abdomen and bone scintigraphy. After completion of the examinations the early and the late PET/CT scan will be compared with each other, the diagnostic CT-scan and the bone scintigraphy. A verification of suspicious findings will be done by biopsy, if the area is accessible. If a biopsy cannot be obtained, the presence of recurrence will be verified with additional imaging follow-up to ensure the highest possible confidence. Sensitivity, specificity, accuracy, negative and positive predictive value (NPV/PPV) will be calculated for each modality (incl. early and late PET/CT).

NCT ID: NCT01548677 Completed - Breast Cancer Clinical Trials

Efficacy Study of Herceptin to Treat HER2-negative CTC Breast Cancer

TREAT-CTC
Start date: April 2013
Phase: Phase 2
Study type: Interventional

This is a randomized phase II trial for patients with HER2 negative primary Breast Cancer (BC) who after completing (neo) adjuvant chemotherapy and surgery have detectable circulating tumour cells (CTC) in peripheral blood. Eligible patients will be randomised in 1:1 ratio to either the trastuzumab arm or the observation arm.