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Breast Cancer clinical trials

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NCT ID: NCT02505698 Suspended - Breast Cancer Clinical Trials

A Data Collection Study for the Evaluation of a Novel Infra-red Breast Imaging System for Risk Assessment

Start date: October 2015
Phase: N/A
Study type: Observational

Three-dimensional functional Metabolic Imaging (3D MIRA) is a new infrared imaging technology using the Real Imager 8 (RI8) developed by Real Imaging. This technology generates 3D metabolic maps of the breast and based on sophisticated machine learning technology, provides objective risk assessment for the presence of malignant tumor in the breast. The procedure is non-invasive, comfortable and does not involve ionizing radiation. It is based on acquiring infrared images of the breast. Those images are processed and analyzed by computers to provide the objective risk assessment. The technology is intended to be used as a screening tool for breast cancer and emerges as highly useful in women for whom screening mammography is sub-optimal, such as women with dense breast. 3D MIRA is unaffected by breast density and is therefore ideal for evaluating patients with mammographically dense breasts. Real Imaging is continuously developing the technology including image acquisition hardware and objective analysis of the imaging biomarkers. To further improve and optimize this novel metabolic imaging technology, Real Imaging will introduce an improved imaging device. The purpose of this clinical study is to collect more imaging data in order to establish superiority of the newer device over the previous one. The investigators hypothesize is that the new device will be at least as good as the previous one.

NCT ID: NCT02472353 Suspended - Breast Cancer Clinical Trials

Use of Metformin to Reduce Cardiac Toxicity in Breast Cancer

Start date: July 2014
Phase: Phase 2
Study type: Interventional

The goal of this study is to determine if co-administration of metformin and doxorubicin in breast cancer patients receiving neoadjuvant or adjuvant therapy will reduce the number of patients who develop a significant change in left ventricle ejection fraction (LVEF).

NCT ID: NCT02352025 Suspended - Breast Cancer Clinical Trials

S-equol in Women With Triple Negative Breast Cancer

Start date: April 2015
Phase: Phase 0
Study type: Interventional

The primary objective of this study is to determine if S-equol, an ER-beta agonist, is effective in decreasing the proliferation rate of triple negative breast cancer.

NCT ID: NCT02313116 Suspended - Breast Cancer Clinical Trials

Computed Optical Margin Assessment for Breast Cancer Surgery, Phase I (Part B)

Start date: April 2014
Phase: N/A
Study type: Observational

This intraoperative study is a prospective study analyzing specimens from fifty subjects. Patients scheduled to undergo breast-conserving surgery will be recruited in accordance with the inclusion and exclusion criteria. The study period per subject is the time it takes to assess the ex vivo breast tissue sample using the study device. Image review will be conducted during surgery and compared to the margin status findings in the post-operative pathology report.

NCT ID: NCT02166658 Suspended - Breast Cancer Clinical Trials

A Study of Cabazitaxel for Patients With Breast or Lung Cancer and Recurrent or Progressive Brain Metastases - Cabazitaxel for Brain Metastases (CaBaMet)

CaBaMet
Start date: August 2015
Phase: Phase 2
Study type: Interventional

Patients suffering from histologically or cytologically confirmed stage IV lung or breast cancer with progressive or recurrent brain metastases after prior external beam radiotherapy will receive treatment with cabazitaxel until progression of brain metastases (BM) or unacceptable toxicity.

NCT ID: NCT02062983 Suspended - Breast Cancer Clinical Trials

Early Predictor of Herceptin Cardio Toxicity in Breast Cancer Patients

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

Early identification of patients at risk for cardiotoxicity represent a primary goal for cardiologist and oncologist From all adjuvant trials echocardiography is ideal for evaluating Left Ventricular function though its operator dependent. The use of other technique such as endomyocardial biopsy, is troublesome in clinical practice Cardiac magnetic resonance imaging (MRI) have greater reproducibility in evaluating left ventricular ejection fraction (LVEF). This technique provides morphological, functional, perfusion, and viability information in one assessment. It is expensive and time consuming but id the diagnostic method of choice for patients with technically limited images from ECG and in patients with discordant information that is clinically significant from prior tests

NCT ID: NCT02046057 Suspended - Breast Cancer Clinical Trials

Evaluation of Needle Core Biopsy of Axillary Sentinel Lymph Node in Breast Cancer

ENCASe
Start date: February 2018
Phase: N/A
Study type: Interventional

The purpose of the study is to determine if it is possible to identify and perform a needle biopsy of the sentinel lymph node. The investigators hope to identify breast cancer cells in the lymph nodes under the arm without making an operation necessary. The rationale for this study is that for patients without enlarged lymph nodes under the arm, sentinel lymph node biopsy is the standard way of determining if breast cancer has spread to the lymph nodes under the arm. While the complications from a sentinel lymph node dissection are less than that of a complete axillary lymph node dissection, sentinel lymph node dissection still carries small risks of arm swelling, decreased movement, fluid collections, nerve injury, and pain. Furthermore, the majority of sentinel lymph nodes do not contain cancer. The investigators hope to develop a method to find cancer in the axillary lymph nodes and avoid the complications of an operation.

NCT ID: NCT01990352 Suspended - Breast Cancer Clinical Trials

Correlate BRCA1 Protein Expression With Response to DNA Damaging Chemotherapy

Start date: November 5, 2013
Phase: Phase 2
Study type: Interventional

Primary Objective: To evaluate if low BRCA1 protein expression has a preferential effect on response when metastatic breast cancer patients are treated with DNA damaging chemotherapy agent, compared to historical controls Secondary Objective: To evaluate if low BRCA1 protein expression has a preferential effect on tumor progression when metastatic breast cancer patients are treated with DNA damaging chemotherapy agent, compared to historical controls

NCT ID: NCT01942980 Suspended - Breast Cancer Clinical Trials

Evaluation of the Efficacy of Hippocampal Avoidance on the Cognitive Toxicity of Whole-Brain Radiation Therapy After Surgical Resection of Single Brain Metastasis of Breast Cancer

Start date: March 2013
Phase: Phase 3
Study type: Interventional

The incidence of brain metastases (BM) in metastatic breast cancer is increasing, due to the improvement in the control of systemic disease, and due to an improved detection through imagery. The treatment management of single BM remains controversial. Indeed, even though it is widely accepted that local treatment increases the median survival time in patients having a good prognostic status, the adding of "adjuvant" whole-brain radiation therapy (WBRT) is currently subject to controversy, due to its potential toxicity. Yet, two randomized trials have demonstrated a clear increase in intra-cerebral recurrence and in death from neurologic origin in case of absence of "adjuvant" WBRT, without change in overall survival (but overall survival was not a primary endpoint in any of these studies). The data from literature on cognitive toxicity (CT) of WBRT on BM are scarce and sometimes controversial. CT of WBRT affects the subcortical frontal functions. It is postulated that the alteration of hippocampal neurogenesis (mainly due to inflammation process), situated in the subgranular zone of the dentate gyrus, has an essential role in the development of these brain dysfunctions. It has been shown that the incidence of BM in the hippocampal region (hippocampus + 5mm expansion) is low, in the range of 8,6%. New irradiation techniques, in particular intensity-modulated radiotherapy associated with rotational radiotherapy, allow to modulate the dose on an intra-cerebral structure, all the while distributing an adapted dose to the remaining brain. This prospective, randomized study, will compare, through a battery of neuropsychological tests, the cognitive impact of WBRT of 40 Gy in 20 fractions with or without hippocampal avoidance by intensity modulated radiotherapy, in patients presenting with a single operated brain metastasis of breast cancer. If the hippocampal avoidance leads to a significant improvement in cognitive function, this radiotherapy scheme could become the standard postoperative treatment to be proposed to patients presenting the best prognostic factors. This would allow to prevent long-term cognitive deficit, while preserving WBRT benefit on intra-cerebral control. Justification of evaluation criteria : Principal criteria : Evaluation criteria to assess cognitive toxicity have been selected on the basis of the recommendations from C. Meyers and P. Brown, who propose an adapted test battery to evaluate memory, verbal function, visual and motor coordination, and executive function. The selected tests have been validated, also in French. They comprise HVLT-R (Hopkins Verbal Learning Test Revised), COWAT (Controlled Oral Word Association Test), Grooved Pegboard test, TMT A and B (Trailmaking tests A and B), and MMSE. The calculation of patient numbers was based on the HVLT-R test, as memory is thought to be the most frequently affected domain. The tests will be performed before treatment ("baseline" cognitive function), at 4 months and at 12 months. In case of a missing answer to the evaluation tests, the reason(s) for not answering will be noted. Secondary criteria : Quality of life : QLQ-C30, QLQ-BN20, ADL, IADL Intra-cerebral Progression-free survival (PFS) Overall survival.

NCT ID: NCT01589861 Suspended - Breast Cancer Clinical Trials

Safety and Efficacy of BKM120 and Lapatinib in HER2+/PI3K-activated, Trastuzumab-resistant Advanced Breast Cancer

PIKHER2
Start date: December 2011
Phase: Phase 1/Phase 2
Study type: Interventional

This study is based upon the following points: 1. Resistance to trastuzumab, either primary or secondary, is a clinically relevant issue. 2. PI3K/AKT activation, due to loss of expression/function of PTEN and/or activating mutations of PIK3CA, is a mechanism of resistance with clinical relevance in breast cancer. Such activation can be detected by: - IHC evaluation of PTEN protein expression - genotyping of PIK3CA exon 9 and 20 - IHC evaluation of phospho-AKT expression 3. BKM120 is an effective PI3K inhibitor. BKM120 and anti-HER2 therapy may have a synergistic antitumor activity in preclinical model of HER2+ breast cancer. 4. Lapatinib is an effective anti-HER2 therapy in trastuzumab-resistant disease. 5. For the evaluation of novel targeted therapies, selecting a patient population enriched for activation of the target to be modulated should allow to maximize the differences in clinical outcome that are expected in the experimental arm, and thus to minimize the patient number to include. 6. We propose to test in a phase I/II study the combination of lapatinib and BKM120 in trastuzumab-resistant HER2+ MBC patients, enriched for activation of PI3K/AKT as detected by loss of expression of PTEN (IHC), and/or mutation of PIK3CA and/or overexpression of phospho-AKT (IHC). Only for phase II patients, mutational status will be an inclusion criteria. For phase I patients molecular status will be a retrospective exploratory analysis.