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1,543 active trials for Breast Cancer

MammaPrint, BluePrint, and Full-genome Data Linked With Clinical Data to Evaluate New Gene EXpression Profiles

The FLEX Registry will be implemented to operate as a large-scale, population based, prospective registry. All patients with stage I to III breast cancer who receive MammaPrint® and BluePrint testing on a primary breast tumor are eligible for entry into the FLEX Registry, which is intended to enable additional study arms at low incremental effort and cost. FLEX Registry will utilize an adaptive design, where additional targeted substudies and arms can be added after the initial study is opened.

Start: April 2017

Micrima MARIA Data Collection for Machine Learning Study

The MARIA® breast imaging system is a CE-marked radiofrequency (RF) medical imaging device. The system employs an electromagnetic imaging technique that exploits the dielectric contrast between normal and cancerous tissues. The use of artificial intelligence will provide additional, novel functionality to the MARIA® system but requires participant data in order to develop and validate the machine learning algorithms that aim to increase the accuracy and overall clinical utility of the device. This study aims to collect data from sites for this purpose.

Start: June 2021

Adaptive Training Exercise Programs for Improving Cardiorespiratory Fitness After Breast Cancer Treatment, The ACTIVATE Trial

This clinical trial studies the feasibility of implementing various adaptive training exercise programs to improve cardiorespiratory fitness in patients after receiving breast cancer treatment. Information from this study may help researchers better understand how to implement adaptive training interventions to improve cardiorespiratory fitness in patients after receiving breast cancer treatment.

Start: June 2021

Partial Breast Proton Therapy for Early Stage Breast Cancer

The purpose of this is to determine the efficacy and toxicity of proton therapy when used to deliver partial breast radiotherapy in patients with early stage breast cancer with low or intermediate risk factors.

Start: May 2011

Neoadjuvant DPX-Survivac Aromatase Inhibition, Radiotherapy or Cyclophosphamide in HR+HER2- Breast Cancer

The study seeks to establish the safety of neoadjuvant aromatase inhibitor with: DPX-Survivac, DPX-Survivac plus radiation, or DPX-Survivac with cyclophosphamide in stage I to III HR+HER2- breast cancer. There will be sequential enrollment into 3 arms with an anticipated N=6 participants per arm for N=18 participants in total. All participants will receive letrozole 2.5 mg daily during the 6 weeks of neoadjuvant therapy. Neoadjuvant therapy occurs weeks 1-6, with standard of care surgery taking place week 7 to 9.

Start: June 2021

DNX-2440 for Resectable Colorectal Liver Metastasis

The purpose of this study is to test an experimental oncolytic adenovirus called DNX-2440 in patients with resectable multifocal (? 2 lesions) liver metastasis, who are scheduled to have curative-intent liver resection surgery. Up to 18 patients will receive two sequential intra-tumoral injections of DNX-2440 into a metastatic liver tumor prior to surgery for liver resection, to evaluate safety and biological endpoints across 3 dose levels (dose escalation). Upon conclusion of the dose-escalation phase, the selected safe and biologically appropriate dose will be administered using the same schema for an additional 12 patients with colorectal cancer liver metastasis (expansion cohort) using established biologic endpoints.

Start: February 2021

Plant Sterol INtervention for Cancer Prevention (PINC)

Several types of human cells convert cholesterol into other molecules, including oxysterols. Oxysterols can promote breast cancer growth and help tumours to spread. Some breast cancer types recruit other cells (host cells) able to produce oxysterols within the local cancer environment. How these other cells help breast tumours metastasize or resist chemotherapy is not well understood, but epidemiological and clinical studies suggest elevated LDL-C is associated with worse survival, poorer response to therapy and an increased propensity for disease relapse in breast cancer patients. In this trial the investigators will test how an LDL-C lowering dietary intervention (using commercially available phytosterol added food products), alters the ability of non-cancer cells (adipocytes, fibroblasts and macrophages) collected from high LDL-C volunteers to change chemotherapy response and metastatic process in breast cancer cells. In this trial, volunteers with high LDL-C levels will be recruited by the University of Leeds, and divided randomly into two arms that cross over. The experimental period (yogurt drink enriched with phytosterols) and placebo period (non-enriched yogurt drink) will each last for 8 weeks, alternated with a 4 weeks of wash-out period. Samples will be collected 4 times (week-0, week-8, week-12, week-20) during the study and will include blood, white blood cells (macrophages), and fat tissue cells. Measurements will include oxysterol, LDL-C and phytosterol concentrations (volunteers' serum/plasma, media from the host cells/breast cancer experimental culture) and how the host cells alter the behaviour of cancer cells in the laboratory.

Start: February 2020

Modified Pectoral Nerve Block Versus Serratus Plane Block

In PECSII or modified PECSI block, local anesthetic (LA) is injected between pectoralis major muscle (PMm) and pectoralis minor muscle (Pmm) to block lateral and medial pectoral nerves and between pectoralis minor muscle (Pmm) and serratus anterior muscle in the anterior axillary line to block the intercostal nerves II-VI (Blanco et al., 2012). In Serratus anterior plane block (SAPB) local anesthetic (LA) is injected above the serratus muscle (between latissmus dorsi muscle and serratus muscle) or below the serratus muscle (between serratus muscle and 4th rib) in the mid-axillary line to block the intercostal nerves II-VI and spares the pectoral nerves (Blanco et al., 2013).

Start: May 2021

Screening Magnetic Resonance Imaging of the Brain in Patients With Breast Cancer

This research study is studying the usefulness of magnetic resonance imaging (MRI) to screen for brain metastases (spread of the breast cancer to the brain).

Start: July 2019

Follow-up of Sequential Chemotherapy and Stimulation for Fertility Preservation in Young Patients With Breast Cancer

Interventional research with low risks and constraints, prospective and monocentric on the assessment of long-term fertility in patients who underwent an adjuvant sequential chemotherapy with or without a controled ovarian hyperstimulation. This study follows a previous one called NCT 01614704.

Start: March 2018

Improving Care After Inherited Cancer Testing

The IMPACT Study seeks to refine and evaluate the effectiveness of interventions on improving guideline-adherent cancer risk management (CRM) and family communication (FC) of genetic test results. These interventions will be delivered to individuals with a documented pathogenic/likely pathogenic variant or variant of uncertain significance (VUS) in an inherited cancer gene.

Start: August 2021

Water-based Versus Land-based Exercise for Breast Cancer Survivors

Physical activity and exercise have demonstrated to be an integral part of the cancer-continuum care. Despite strong evidence suggesting that both endurance and strength training should be encourage in cancer patients, there is still controversy regarding exercise dosage, frequency, volume and optimal environment of delivery. In this randomised controlled trial we aim to compare water-based versus land-based exercise in breast cancer survivors to decrease cancer-related fatigue (CRF), improve Health-Related Quality of Life (HRQoL), exercise tolerance, muscle strength and physical activity levels.

Start: September 2020

Pain Monitoring After Breast Biopsy: Benefit of E-health

Each year, approximately 1500 breast biopsies (1000 microbiopsies and 500 macrobiopsies) are performed in the radiologic department of the Montpellier Cancer Institute (ICM). This exam, which is relatively easy for the radiologist, can however lead to major anxiety for patients. Indeed, previous studies show that about 50% of women undergoing a breast biopsy have significant anxiety affects. Anxiety associated with the risks of biopsy, potential breast cancer diagnosis and/or lack of routine sedation procedures increase patient concerns. Distress prior to biopsy is associated with greater pain and discomfort during the procedure. The psychological distress that persists after the biopsy is related to a worse psychological management of side effects of the biopsy breast (e.g., sensitivity, skin irritation). Limiting apprehension, worry and anxiety induced by the uncertainty linked to the biopsy results and the biopsy-related pain should be an integral part of the medical care through the patient follow-up during, after and until the diagnosis is announced. In light of these challenges, new alternative methods are emerging to enhance patient knowledge, develop procedural skills, improve confidence and mitigate procedural anxiety. However, to our knowledge, few methods have been developed during this period of 'waiting-time'. Currently, only care instructions and a consultation to announce the results (about 10 days after the procedure) are proposed to patients at the end of biopsy. Patients are also encouraged to call if they suspect complications such as infection or bleeding. In this context, the investigators propose to integrate a pain management after biopsy via e-health system through the patient's medical care. Radiologist/patient communication could have an impact on patients' anxiety and health-related issues, given the challenging nature of discussions around need for breast biopsy and potential implications of the results. Indeed, paying attention and focusing on symptoms as patients experience them improves their empowerment and their adjustment to the disease. Web-based systems that can provide electronic-Patient reported Outcomes (e-PRO) have been shown to prompt clinicians to intensify symptom management, to improve symptom control and to enhance patient-clinician communication patient satisfaction, as well as well-being. In addition, it is known that improved communication between patients and medical staff to less anxiety after a biopsy and that anxiety is related to pain. Taken as a whole, these elements encourage the integration of e-health and e-PRO for the management of pain and anxiety in patients undergoing a biopsy. The benefits of e-PRO are still being discussed in terms of quality of life (Qol) and psychological distress. The investigator propose to integrate two types of e-health intervention: 1/e-PRO collected by connected objects (smartphone or tablet) as they were used in previous studies, and 2/ e-PRO collected by a phone consultation, which values human communication between the medical staff and the patient. In case of significant pain, the collection of e-PRO by any of these e-health interventions will generate an alert and a reactive and responsive care. In fine, the purpose of this research is to improve the medical organization and care of post-biopsy patients by proposing an innovative connected patient technology, regardless of their remoteness from the hospital. Social inequalities will be reduced by lending a tablet to patients who do not have such a device with a 4G key.

Start: February 2021

A First-in-Human, Phase 1 Study of JAB-3312 in Adult Patients With Advanced Solid Tumors

This is a Phase 1, first-in-human, open-label dose-escalation study to determine the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) and assess the DLT of JAB-3312. It is anticipated that approximately 24 subjects will be enrolled in the dose-escalation phase of the study. JAB-3312 will be administered orally once daily (QD) in 21-day treatment cycles.

Start: September 2019

Memory Perception Assessment in Central/Non-central Nervous System Cancers

Prospective memory (PM) is the ability to implement intended actions in the future. It allows maintaining and retrieving future plans, goals, and activities (i.e., remember to remember). PM is associated with most everyday memory problems . PM is crucial to correctly respond to all the social, occupational and working demands of everyday life, to perform many deferred health-related actions and is involved in therapeutic adherence . Indeed, PM errors are an important part of the aging memory complaints. The prevalence of self-reported PM failures is also significant among young adults, compared with self-reported retrospective memory (RM) failures .Yet, PM errors are major sources of frustration and embarrassment . In oncology, recently investigated the self-reported memory complaints in a 80 case-healthy-control study breast patients . Subjective memory complaints were assessed using the Prospective and Retrospective Memory Questionnaire . Results from the Paquet et al. study show that all participants (i.e., both patients and matched-controls) reported more PM than RM failures in daily-life (p<.001). Breast cancer patients reported more RM and PM failures than controls. However, this group effect was no longer statistically significant when controlling for depression and fatigue. These findings are consistent with the view that memory complaints are closely associated with depression and cancer-related fatigue, and more generally with psychopathological variables .As underlined by Paquet et al. subjective memory complaints should be investigated because they refer to some aspects of the cancer experience that could potentially be linked to quality of life. Thus, it is important to explore psychopathological basis such as depression, anxiety and fatigue while investigating self-reported memory failures in cancer patients. Despites the importance of PM, there have been, to our knowledge, only few studies evaluating PM complaints or PM functioning in patients diagnosed with an intracerebral tumor (such as Diffuse Low-Grade Glioma- DLGG- or glioblastome- GB) or extra-cerebral tumor (such as breast cancer - BC). Therefore, the investigators thought it would be useful, as a first step, to conduct a study to explore and to manage the PM and RM subjective complaints in cancer patients compared to another chronic disease, such as HIV. In fine, these data will help to identify a new target for psychological management focused on either psychopathological or neuropsychological rehabilitation

Start: May 2019

Evaluation of the Efficacy of a Physical Therapy-yoga-patient Educational Program for Breast Cancer Patients With Pain Due to Hormonal Therapy Treatment.

As much as 50% of patients treated with hormonotherapy (HT) for breast cancer (BC) suffer from osteoarticular pain during treatment. Secondary effects have become a real issue because of their consequences on the patients' quality of life, but also on treatment efficacy and survival when they induce dose reduction or premature withdrawal of treatment. Additional medicines (acupuncture, hypnosis, yoga) have become more and more popular these last years. 48 to 80% of patients with BC eventually choose them. A review comparing efficacy of various therapies to decrease osteoarticular pain concludes to a highest efficacy of anti-inflammatory treatments, paracetamol and yoga. It thus appears innovative to complete this care with a patient educational project (PEP) in postural yoga instructed by a trained physical therapist, which will enable patients to practice yoga postures at home by themselves. The investigators conducted a pilot study "SKYPE" with 24 algic patients treated with HT after BC, whose results are very promising. The investigators now propose in the continuity of the pilot study a multicenter randomized controlled study comparing the efficacy of SKYPE care on pain reduction, an educative care combining physical therapy and yoga, to a control group in patients treated with HT for a BC with osteoarticular and/or musculoskeletal pain. Furthermore, in order to examine whether yoga interventions may influence inflammation through their effects on the level of a wide range of pro- and anti-inflammatory cytokines (30), the investigators will Change in circulating cytokines' level between baseline level (T0) and post-treatment level (T2) in both groups will be analyzed and if so correlation will be established.

Start: February 2021

Infrared Imaging for Breast Cancer Modeling

The primary objective of this study is to obtain infrared (IR) images and video and three-dimensional (3-D) scans of patients referred for biopsy based on the results of their diagnostic breast exam(s). This research study is investigating infrared imaging (also referred to as infrared thermography, or digital infrared thermal imaging (DITI)) of breast cancer. The infrared images collected in this study will be used to construct a computational biothermal engineering model of the cancerous breast. Patients will undergo standard breast cancer screening procedures as part of routine care at Parkland Comprehensive Breast Center. For any patients who are referred for biopsy based on the results of their breast cancer screening procedures, this research study will take infrared images of the patient. Patients will undergo infrared imaging prior to biopsy but will not delay biopsy or treatment; infrared images & video may be recorded at biopsy visit. The biopsy will confirm/diagnose whether the patient has a benign or malignant condition.

Start: June 2019

Breast Radiotherapy Audio Visual Enhancement for Sparing the Heart

This study investigates the Breathe Well device to test whether it is superior to the existing treatment standard of the Varian Realtime Position Management (RPM) system in assisting patients with deep inspiration breath hold.

Start: September 2018

A Study of GDC-9545 Alone or in Combination With Palbociclib and/or Luteinizing Hormone-Releasing Hormone (LHRH) Agonist in Locally Advanced or Metastatic Estrogen Receptor-Positive Breast Cancer

This study will evaluate the safety, pharmacokinetic (PK), pharmacodynamic (PD) activity, and preliminary anti-tumor activity of GDC-9545 as a single agent and in combination with palbociclib and/or luteinizing hormone-releasing hormone (LHRH) agonist in participants with advanced or metastatic estrogen receptor (ER)-positive (human epidermal growth factor receptor 2 [HER2]-negative) breast cancer.

Start: November 2017

A Study of LY3484356 in Women With Breast Cancer Before Having Surgery

The purpose for this study is to see if the study drug, LY3484356, is safe and to determine what effects it has on breast cancer in participants with Estrogen Receptor Positive (ER+), HER2 Negative (HER2-) early stage (stage I-III) breast cancer, when given prior to surgery. Participation in this study could last up to 2.5 months.

Start: April 2021