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Breast Neoplasms clinical trials

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NCT ID: NCT03794596 Withdrawn - Breast Cancer Clinical Trials

A Proof of Concept, Window Trial of the IMmunological Effects of AveLumab and Aspirin in Triple-Negative Breast Cancer

IMpALA
Start date: September 2019
Phase: Phase 2
Study type: Interventional

This research is being done because the investigators are looking for new and better ways to treat a type of breast cancer called triple negative breast cancer. This type of breast cancer can be more difficult to treat than other types of breast cancer as it does not respond to drugs such as hormonal therapies. One type of treatment that looks promising is immunotherapy using new drugs called immune checkpoint inhibitors. Immune checkpoints help to regulate the immune system and can stop the immune system from attacking cancer cells. Immune checkpoint inhibitors block this 'off-switch' and aim to help the immune system control the cancer. These drugs have been very effective in other cancers such as melanoma and are now being tested in breast cancer. In this study patients will receive an immune checkpoint inhibitor called avelumab. Half the patients on the study will also receive aspirin tablets for approximately 18 days as the investigators wish to compare the effects of avelumab alone versus in combination with aspirin. Patients will attend hospital approximately five times in order to complete all necessary study assessments. The first visit screens patients for suitability, after which a baseline visit will collect the first of two breast tissue biopsies. At the third visit a single dose of Avelumab will be given via an infusion (a drip in the forearm). Patients will then return approximately two weeks later for a second breast tissue biopsy before having a final follow up visit another two weeks later. Blood and urine samples will be taken at various visits throughout the study to help us learn more about the effects these treatments may have on the immune system and on breast cancer cells.

NCT ID: NCT03794388 Completed - Clinical trials for Breast Cancer Patient

Evaluation in the Treatment of Neuropathic Pain Post Breast Surgery

CAPTRANE
Start date: March 19, 2019
Phase: Phase 3
Study type: Interventional

Breast cancer is the most common cancer in women in Europe. Therefore, breast cancer has become a chronic disease and patients need to learn to live with it as well as with the adverse effects related to the disease itself or to the therapies used. As noted in the third "Plan cancer", pain is a major criterion in the quality of life of patients treated for breast cancer. Neuropathic pain was defined in 2011 by the international Association for the Study of Pain (I.A.S.P.) as the direct result of a lesion or disease affecting the somato-sensory system. Surgical treatment is often the first treatment of breast cancer. It can be conservative by performing a partial mastectomy (lumpectomy or quadrantectomy) or non-preservative by total mastectomy. Intercostobrachial neuralgia (NICB) or Post mastectomy painful Syndrome (MPRR) was first described by Wood in 1978 as "chronic pain beginning immediately or early after a mastectomy" Or a lumpectomy affecting the anterior thorax, armpit and/or arm in its upper half. These post-surgical pains are related to a lesion of the nerves in the breast area. In particular, the intercostobrachial nerve can be severed, stretched or crushed during surgery. Post-operative neuropathic pain in patients with breast cancer is underdiagnosed either by general practitioner or in a specialized environment. The diagnosis of neuropathic pain is performed during examination and clinical examination. Several scales allow to detect neuropathic pain but only the DN4 is recognized to be the most specific and sensitive scale. Patients do not always express this pain. They do not always reconcile with the surgery. Either because the pain occurs a long time after the surgery, or they find it normal to get hurt. These diagnostic difficulties cause a delay in setting up a suitable analgesic treatment. However, neuropathic pain responds poorly to common analgesics. Diagnosis, evaluation and early management of neuropathic pain are a priority in order to avoid their chronicization, to improve the quality of life of patients with breast cancer and to enable them to return to work quickly. We therefore assume that the diagnosis of early neuropathic pain at 2 months of surgery associated with initiation of appropriate topical treatment without the systemic effects of conventional oral treatments, would reduce the incidence of Chronic neuropathic pain 6 months after surgery.

NCT ID: NCT03792529 Recruiting - Breast Cancer Clinical Trials

Prognosis and Targeted Therapy Related Molecular Screening Program for Patients of Breast Cancer in China

Start date: July 20, 2017
Phase:
Study type: Observational

The anticipated objectives of this study are: 1) to understand the pathogenesis and molecular typing of breast cancer patients in China (mainly HER2 overexpression, triple negative and hormone receptor-positive patients) by detecting DNA and RNA in tumor tissue (fresh tissue or paraffin section), and to compare the similarities and differences between the western population and Chinese population; 2) plasma samples of patients with HER2 overexpression , hormone receptor-positive and triple negative (ER, PR, HER2 expression negative) were sequenced for ctDNA and ctRNA, to find out whether there are genes or gene sets related to therapeutic effect; 3) to study the specific changes of liquid molecular detection results according to the previous research results, and establish mathematical models to predict and monitor the effects of targeted therapy and endocrine therapy; 4) to compare liquid biopsy and imaging and clinical features in monitoring clinical therapeutic effect, and to elaborate the advantages and disadvantages of liquid biopsy and conventional imaging; 5) to provide molecular detection basis for follow-up clinical research and screening for targets of new drugs.

NCT ID: NCT03791853 Recruiting - Breast Neoplasms Clinical Trials

Light-CT in the Diagnosis of Breast Tumor and Lymph Node

Start date: April 1, 2018
Phase:
Study type: Observational

Intraoperative pathological diagnosis such as frozen section and imprint cytology is not routinely recommended in clinical practice because of time and accuracy concerns. Full-field optical coherence tomography (FF-OCT) is a new optical imaging technique that could generate sectioning tomogram from fresh tissue and provide close-to-pathology depiction of the morphological structure and pathological changes in minutes without conventional tissue preparation, slicing, and staining, and dynamic cell imaging (DCI) added the viability information of cells/tissue, which could be more important in cancer diagnosis. This study was to evaluate the feasibility and diagnostic value of FF-OCT and DCI in breast lesions and lymph node specimens during breast cancer surgery. We evaluated normal breast tissue, benign breast lesions, breast cancer and axillary lymph node specimens resected from patients undergoing breast surgery.

NCT ID: NCT03791840 Completed - Breast Neoplasms Clinical Trials

The Value of High-resolution Ultrasound in the Detection of Lymph Node Metastasis: a Proposal of NI-RADS

NI-RADS
Start date: December 1, 2017
Phase:
Study type: Observational

The status of axillary lymph node (ALN) is an important reference indicator for breast cancer surgery and systemic treatment, which is also an important prognostic indicator for breast cancer. Therefore, it is extremely important for surgeons to accurately determine whether axillary lymph nodes have metastasis and the number of metastatic lymph nodes. The value of ultrasound diagnosing the status of axillary lymph nodes was controversial in recent publications. Therefore, there is a high need to prove the accuracy and precision of ultrasound for axillary lymph node metastasis in breast cancer patients. The aim of this study is to assess the usefulness of ultrasound in the diagnosis of axillary lymph node status in breast cancer patients by gathering in vivo and vitro ultrasonographic parameters to build a clinical useful categorization system

NCT ID: NCT03791736 Terminated - Breast Cancer Clinical Trials

Evaluation of Impact of Sandostatin® Injection Before Axillary Clearance on Lymphocele Formation

SANDOSTATINE
Start date: July 6, 2016
Phase: N/A
Study type: Interventional

The lymphocele is the main early postoperative complication of axillary clearance for breast cancer patients with rates up to 85%. The usual treatment consists of external drainage. However, this method increases the duration of hospitalization. As a result, some practitioners have abandoned drainage, allowing for ambulatory surgery. If this solution makes it possible to reduce the duration of the hospitalizations, it involves iterative punctures of the axillary hollow in case of lymphocele These punctures may be responsible for pain, hematoma or infection of the operative site. To date, no method has proved superior in terms of decreasing the incidence of lymphocele postoperatively axillary clearance. Octreotide (Sandostatin®) is a peptide, one of whose effects is to reduce the inflammation responsible for lymphoceles. The aim of the study is to inject Sandostatin® before surgery, with the aim of reducing the incidence of seroma by 50% after axillary clearance

NCT ID: NCT03791008 Completed - Breast Cancer Clinical Trials

Assessment of Feasibility and Acceptability of Personalized Breast Cancer Screening

DECIDO
Start date: January 30, 2019
Phase: N/A
Study type: Interventional

The overall objective is to assess the acceptability and feasibility of offering personalized breast cancer (BC) screening. The specific objectives are: 1) To design an information system; 2) To evaluate the barriers and facilitators of the coordination of health care services and the screening program; 3) To develop a proof of concept of personalized screening; and 4) To evaluate cost-effectiveness. Methodology: 1. Prototype information system with basal and longitudinal variables relevant to a personalized screening system; 2. Qualitative study with focus groups and survey. The attitude and acceptability on a sample of 210 health professionals will be assessed; 3. Prospective observational study, for proof of concept. Participants will be professionals working in Primary Care, Population Breast Screening Program, or Hospital Breast Unit. It will include 385 women, aged 40-50 from the city of Lleida. Various indicators of acceptability and feasibility will be assessed in women and health professionals; 4. Probabilistic analytical models will be used to evaluate cost-effectiveness. The present protocol addresses the specific objective number 3, the proof of concept of personalised screening. Expected results: The investigators expect to provide valuable and necessary information for the design of personalized screening.

NCT ID: NCT03790813 Not yet recruiting - Breast Cancer Clinical Trials

Informative Tools to Optimize Neoadjuvant Therapy in ER Positive, HER2 Negative Breast Cancers

ER
Start date: January 7, 2019
Phase: N/A
Study type: Interventional

This study evaluates the addition of Ki-67, Oncotype DX and MRI in the treatment of early stage breast cancer with neoadjuvant treatment. All enrolled patients will have Ki-67 and Oncotype AND/OR an MRI before and after surgery.

NCT ID: NCT03789877 Completed - Cancer Survivor Clinical Trials

A Home-Based Walking Program and rTMS in Helping Breast Cancer Survivors Get More Physical Activity

Start date: January 16, 2019
Phase: N/A
Study type: Interventional

This trial studies how well a home-based walking program, with or without repetitive transcranial magnetic stimulation, works in helping breast cancer survivors get more physical activity. Physical activity has been shown to improve health outcomes and quality of life among breast cancer survivors and can help lessen certain side effects of treatment such as fatigue, depression, and treatment-related weight gain. Repetitive transcranial magnetic stimulation is a procedure that uses electromagnets to stimulate brain activity. Using rTMS with a home-based walking program may help breast cancer survivors get more physical activity.

NCT ID: NCT03789851 Recruiting - Breast Cancer Clinical Trials

Minimally Invasive Biopsy Predicting Breast pCR After NAC for Breast Cancer

MIBPBPCR
Start date: June 1, 2017
Phase: N/A
Study type: Interventional

Neoadjuvant chemotherapy (NAC) is widely used as an efficient breast cancer treatment. Ideally, a pathological complete remission (pCR) can be achieved. With improvements in molecular typing guided NAC and targeted therapies, there has been dramatic improvement in pCR rates, especially among triple-negative and human epidermal growth factor receptor 2 positive breast cancers. Rates of pCR in these groups of patients can reach 60% or higher. NAC has significantly promoted the loco-regional de-escalating treatment of breast cancer, and the need for breast surgery in NAC cases with pCR has been questioned, especially in patients undergoing breast-conserving surgery with whole breast radiotherapy. The main impediments for potential elimination of breast surgery have been the fact that conventional and functional breast imaging techniques are incapable of accurate prediction of residual disease. However, imaging-guided minimally invasive biopsy (MIB) techniques might have the potential to overcome this impediment. The investigators design and begin a prospective one-armed clinical study to explore the accuracy of MIB in predicting breast pCR after NAC.