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Breast Cancer clinical trials

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NCT ID: NCT01901991 Completed - Breast Cancer Clinical Trials

Localization of Nonpalpable Breast Lesions

Start date: January 2014
Phase: N/A
Study type: Interventional

Each year the Danish mammography-screening programme identifies a large number of patients with small non-palpable breast cancers or precancerous lesions. The majority of these patients are suitable for breast conserving surgery (BCS). The object of BCS is to remove the suspicious lesion completely without removing excess healthy breast tissue. To obtain this accurate lesion localization is essential. Until today the standard procedure in Denmark has been wire guided localization (WGL). Although the method has been utilized for a number of years it has several disadvantages. Often inaccurate lesion localization leads to incomplete lesion removal (positive margin) and subsequently reoperation. It can postpone the additional systemic treatment, offered after the operation. Other disadvantages are poor cosmetic outcome and inconvenient planning for the patient and the departments involved. The wire needs to be placed on the day of the operation, which decreases the flexibility of the procedure. The purpose of this study is to test a new method named radioactive seed localization (RSL). The method uses a small titanium seed containing radioactive iodine. It will be placed in the centre of the lesion, and during the operation, the surgeon can locate it with a handheld gamma probe. The seed can be placed a few days in advance, which means a more flexible course of treatment. The method seems promising with regards to reoperation rates, but it needs further testing. Hypothesis: RSL is a more accurate method, for localization of nonpalpable breast lesions, than WGL. Using RSL obtains, to a great extent, adequate negative margins, resulting in a reduced number of re-operations. The study will be performed as a randomised clinical trial, where the two methods will be compared to each other. The trial will be performed at the department of breast surgery at Rigshospitalet and include patients with nonpalpable breast lesions. Besides reoperation rates, duration of the surgical procedure and the amount of removed breast tissue will be compared.

NCT ID: NCT01901146 Completed - Breast Cancer Clinical Trials

Efficacy and Safety Study of ABP 980 Compared With Trastuzumab in Women With HER2-positive Early Breast Cancer

Lilac
Start date: April 29, 2013
Phase: Phase 3
Study type: Interventional

The purpose of this research study is to compare the effectiveness and safety of ABP 980 against trastuzumab in women with human epidermal growth factor receptor 2 (HER2)-positive early breast cancer.

NCT ID: NCT01900418 Completed - Breast Cancer Clinical Trials

Physical Activity to Reduce Joint Pain During Aromatase Inhibitor Therapy

Start date: August 2013
Phase: N/A
Study type: Interventional

For post-menopausal women diagnosed with hormone-receptor positive breast cancer tumors, aromatase inhibitors (AIs) are the standard adjuvant hormone treatment to prolong disease-free survival and time-to-recurrence. Unfortunately, joint pain/stiffness/achiness (arthralgia) is a common side-effect of AIs. This "proof-of-concept" study explores how an evidence-based physical activity (PA) program- the Arthritis Foundation's Walk with Ease (WWE) program- can be adapted for breast cancer survivors on AI therapy to: 1) Help them maintain or achieve recommended levels of PA, 2) reduce their joint pain/stiffness/achiness, and 3) thereby enable them to remain on AI therapy as prescribed.

NCT ID: NCT01899079 Completed - Breast Cancer Clinical Trials

A Prospective Observational Study of Clinical Outcomes for the NanoString® Technologies Prosigna Gene Signature Assay

Start date: June 2013
Phase: N/A
Study type: Observational

The primary objective of this study is to assess the extent to which the Prosigna™ Breast Cancer Prognostic Gene Signature Assay affects the medical oncologist's treatment recommendations regarding adjuvant chemotherapy and actual treatments received for patients with early-stage breast cancer.

NCT ID: NCT01898533 Completed - Breast Cancer Clinical Trials

Feasibility of Blood Oxygenation Level-Dependent Contrast (BOLD) Breast MRI Induced by Breath- Holding

BOLD
Start date: September 2013
Phase:
Study type: Observational

In this study, investigators intend to measure changes in BOLD contrast in the breast induced by breath-holding for subjects receiving radiation therapy to the breast. This study will provide the preliminary data and experience needed to successfully apply BOLD to quantify changes in oxygenation and blood flow of breast and tumor for a larger cohort of breast radiotherapy patients. The current study has the following objectives: 1. To determine the feasibility of BOLD contrast MRI of the breast, induced by breath-hold. 2. To measure the change in BOLD contrast of the breast and / or chest wall tissue for females undergoing radiotherapy

NCT ID: NCT01896778 Completed - Melanoma Clinical Trials

Body Warming in Improving Blood Flow and Oxygen Delivery to Tumors in Patients With Cancer

Start date: October 4, 2013
Phase: N/A
Study type: Interventional

This randomized pilot clinical trial studies body warming in improving blood flow and oxygen delivery to tumors in patients with cancer. Heating tumor cells to several degrees above normal body temperature may kill tumor cells.

NCT ID: NCT01896050 Completed - Breast Cancer Clinical Trials

Loss of Grip Strength, BMI, and Adjuvant Endocrine Therapy Breast Cancer

LOGRIBMET
Start date: September 2009
Phase: N/A
Study type: Observational

Early stage hormone receptor positive breast cancer is typically treated with adjuvant endocrine therapy in order to decrease risk of breast cancer recurrence and to improve overall survival from the disease. Typical agents used for treatment include tamoxifen and the aromatase inhibitors. In postmenopausal women, aromatase inhibitor therapy is increasingly common because it is associated with fewer long-term serious toxicities compared to tamoxifen. However, aromatase inhibitors cause arthralgias in 40-50% of patients, which can influence adherence to therapy and can lead to treatment discontinuation in a minority of cases. The mechanism underlying development of this toxicity remains unclear, and predictors of who will develop these symptoms remain undefined. Initial reports suggest that grip strength decreases during aromatase inhibitor therapy, and that body-mass index may influence development of this symptom. Therefore, this longitudinal study has been developed to determine change in grip strength over time in women treated with aromatase inhibitors and tamoxifen, as well as to identify potential associations between change in grip strength and BMI. Patient self-reported symptoms will also be collected. A total of 115 women with early stage breast cancer who are initiating therapy with either an aromatase inhibitor or tamoxifen will be enrolled.

NCT ID: NCT01895491 Completed - Breast Cancer Clinical Trials

Safety Study of VM206RY in Subjects With Expression of HER2 in Breast Cancer

VM206RY
Start date: March 2011
Phase: Phase 1
Study type: Interventional

The main objective of this study is to evaluate the safety of VM206RY in subjects with expression of HER2 in breast cancer.

NCT ID: NCT01894711 Completed - Breast Cancer Clinical Trials

Real World Efficiency of Trastuzumab in Early Breast Cancer

Start date: May 2010
Phase: N/A
Study type: Observational

AIM To determine the value of trastuzumab in the early breast cancer setting in the Netherlands. RESEARCH QUESTIONS / OBJECTIVES 1. Is adjuvant trastuzumab in daily practice effectively used, that is, how and to whom is it given? 2. Is the introduction of trastuzumab in early breast cancer cost-effective for the Netherlands? To address the research questions (objectives), the following outcome measures will be determined: CLINICAL OUTCOME MEASURES 1. Actual trastuzumab administration as opposed to planned trastuzumab administration 2. Selection criteria for chemotherapy and trastuzumab in daily practice 3. Immediate and longterm toxicities due to adjuvant treatment, specifically cardiac 4. Disease-free, breast cancer specific, and overall survival in relation to trastuzumab ECONOMIC OUTCOME MEASURES 5. Volumes and costs of diagnostic tests and therapies including those for (distant) relapse 6. Cost-effectiveness of trastuzumab in clinical trials versus in real world

NCT ID: NCT01892540 Completed - Breast Cancer Clinical Trials

PET/CT or PET/MRI in Measuring Tumors in Patients Undergoing Clinical Imaging or With Newly Diagnosed Breast Cancer

Start date: May 2013
Phase: N/A
Study type: Interventional

This clinical trial studies positron emission tomography (PET)/computed tomography (CT) or PET/magnetic resonance imaging (MRI) in measuring tumors in patients undergoing clinical imaging or with newly diagnosed breast cancer. New diagnostic procedures, such as PET/CT or PET/MRI, may be more effective than MRI alone in measuring tumors in patients undergoing clinical imaging or with newly diagnosed breast cancer.