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Breast Neoplasms clinical trials

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NCT ID: NCT02934815 Recruiting - Breast Cancer Clinical Trials

Relational and Emotional Mechanisms of a Supportive-expressive Group Intervention in Breast Cancer

BC-SEGT
Start date: January 2015
Phase: N/A
Study type: Interventional

To test the feasibility of supportive-expressive group intervention (SEGT) for women with primary breast cancer and to provide a preliminary test of its efficacy.

NCT ID: NCT02934360 Recruiting - Breast Neoplasms Clinical Trials

TR(ACE) Assay Clinical Specimen Study

Start date: September 2016
Phase: N/A
Study type: Observational

The TR(ACE) Assay is a quantitative in vitro diagnostic test run on the TR(ACE) Instrument intended for the measurement of high molecular weight human DNA from plasma as an aid to monitoring disease progression or response to therapy or recurrent or residual disease.

NCT ID: NCT02934126 Completed - Breast Cancer Clinical Trials

The Development of a Personalized Decision Aid: Perspectives of Patients and Health Care Professionals on Shared Decision Making and Informational Needs on Radiotherapy for Breast Cancer

M16SDM
Start date: September 2016
Phase: N/A
Study type: Observational

Background: The Dutch guideline on breast cancer treatment shows several grey areas, where no clear recommendation is given on the radiotherapy options, but where the advice is to discuss the treatment of choice with the patient. Currently, patients are exposed to different information given by the professionals' personal styles of informing patients. The challenge for all oncological professionals is to give clear, structured, and neutral information on the pros and cons of the treatment option(s) in the context of the natural course of the disease to the patient; to elicit patients' needs and preferences. How and which information should be shared in a decision aid is up for investigation, as well as how this should best be implemented. Research goals: Qualitative assessment of patients' and health care professionals' informational needs and perspectives on breast cancer radiotherapy and shard decision making. Methods: Semi-structured interviews will be held with both breast cancer patients and health care professionals. To reach as heterogeneous groups as possible patients of different ages, with different education levels and who underwent different treatments or chose not to get radiotherapy at all will be selected . Data will be collected til saturation is reached. Interviews will be transcribed verbatim and analysed using thematic analysis. Results: Results of the qualitative study are expected at the beginning of 2017. Hypothesis: Investigating the patients' and health care professionals' perspectives on shared decision making and informational needs on radiotherapeutic options will help the development of a personalized decision aid eligible for broad implementation.

NCT ID: NCT02931864 Completed - Quality of Life Clinical Trials

Effects of an e-Home Based Symptom Management and Mindfulness Training Programme on QoL in Breast Cancer Survivors

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

Breast cancer is the most common cancer in women in Singapore. Breast cancer survivors usually experience side effects/symptoms after surgery and/or adjuvant chemotherapy and/or radiotherapy such as fatigue, lymphedema, problems with sleeping, peripheral neuropathy, and anxiety/depression. Currently, there is no study to include both symptom management and mindfulness training components for breast cancer survivors. And given breast cancer survivors have infrequent clinical follow-up, we aim to develop an e-Home based symptom management and mindfulness training programme for breast cancer survivors and to determine its effects on quality of life, symptom distress, psychosocial adjustment, psychological morbidity, and unplanned outpatient attendance or hospitalisation in breast cancer survivors. We employ a randomised clinical trial with four study arms (with 47 subjects in each arm) together with a process evaluation; group 1 (usual care), group 2 (experimental group: five weekly sessions of online symptom management + mindfulness training programme and usual care), group 3 (comparison group 1: five weekly sessions of online symptom management programme and usual care), and group 4 (comparison group 2: five weekly sessions of online mindfulness training programme and usual care). Subjects will complete questionnaires measures of 6-item Social Support Questionnaire, Breast Cancer Survivor Self-Efficacy Scale, the Quality of Life-Cancer Survivor Scale, Memorial Symptom Assessment Scale, Psychosocial Adjustment to Illness Scale, short version of the Fear of Recurrence Scale, Hospital and anxiety Depression Scale and Five Facet Mindfulness Questionnaire at baseline (printed questionnaires), at 8 weeks from baseline, at 12 weeks from baseline and at 24 weeks from baseline by an online system or printed questionnaires. Individualised semi-structured interview (15-25 mins) for experimental and comparison groups will be conducted at 24 weeks from baseline to understand the subjects' experiences of the study programme. Data will be analysed using SPSS version 24. Baseline demographic and clinical information of subjects in the experimental, comparison and control groups will be summarised using descriptive statistics, and will be compared using chi square tests and ANOVA/ANCOVA tests. Intention-to-treat approach will be used. Repeated measures analysis of variance will be used to examine the differences on outcome measures among the experimental, comparison and control groups across study time points. In addition, differences in changes in outcome measures among experimental, comparison groups and usual care groups will be tested using multilevel modelling techniques. A p-value smaller than 5% will be considered as statistically significant. Content analysis will be conducted to analyse the interviews data.

NCT ID: NCT02931552 Completed - Breast Neoplasms Clinical Trials

Nuevo Amanecer II: Translating a Stress Management Program for Latinas

Start date: September 2016
Phase: N/A
Study type: Interventional

The primary aim is to assess the effectiveness of the Nuevo Amanecer-II (NA-II) cognitive-behavioral stress management program through a 6-month RCT with 150 Spanish-speaking Latinas with breast cancer in three rural settings in terms of improving quality of life (QoL) and reducing distress, compared to a usual care control group (that is offered the program at the end of the 6 months). The investigators will also test the effects of the program on biomarkers of stress (hair and saliva cortisol) and aging (telomere length from saliva). Trained Latinas, called Compañeras (Companions), who have had breast cancer deliver the stress management program in-person to Spanish-speaking Latinas with breast cancer.

NCT ID: NCT02929576 Withdrawn - Breast Cancer Clinical Trials

Efficacy and Safety Study of Enzalutamide in Combination With Paclitaxel Chemotherapy or as Monotherapy Versus Placebo With Paclitaxel in Patients With Advanced, Diagnostic-Positive, Triple-Negative Breast Cancer

ENDEAR
Start date: September 2016
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate and compare the clinical benefit and safety of treatment with enzalutamide in combination with paclitaxel chemotherapy or as monotherapy versus placebo with paclitaxel in patients with locally advanced or metastatic, diagnostic-positive, triple-negative breast cancer (TNBC).

NCT ID: NCT02927912 Recruiting - Clinical trials for Stage IB Breast Cancer

Intraoperative Electron Beam Radiotherapy Boost in Treating Patients With Stage I-II Breast Cancer Undergoing Surgery With Reconstruction

Start date: October 16, 2017
Phase: Phase 2
Study type: Interventional

This phase II trial studies the side effects of intraoperative electron beam radiotherapy boost and to see how well it works in treating patients with stage I-II breast cancer undergoing surgery with reconstruction. Giving a single dose of electron beam radiation to the tumor cavity during the breast surgery before reconstruction may be a better way to kill tumor cells and shrink tumors.

NCT ID: NCT02927249 Terminated - Clinical trials for Node Positive HER2 Negative Breast Cancer

Aspirin in Preventing Recurrence of Cancer in Patients With HER2 Negative Stage II-III Breast Cancer After Chemotherapy, Surgery, and/or Radiation Therapy

Start date: December 8, 2016
Phase: Phase 3
Study type: Interventional

This randomized phase III trial studies how well aspirin works in preventing the cancer from coming back (recurrence) in patients with human epidermal growth factor receptor 2 (HER2) negative breast cancer after chemotherapy, surgery, and/or radiation therapy. Aspirin is a drug that reduces pain, fever, inflammation, and blood clotting. It is also being studied in cancer prevention. Giving aspirin may reduce the rate of cancer recurrence in patients with breast cancer.

NCT ID: NCT02926729 Recruiting - Breast Cancer Clinical Trials

Real-Time Assessment Of Breast Cancer Lumpectomy Specimen Margins With Nonlinear Microscopy

Start date: July 17, 2019
Phase: N/A
Study type: Interventional

This research is studying a new investigative imaging instrument called a nonlinear microscope (NLM). A nonlinear microscope can produce images similar to an ordinary pathologist's microscope, but without first processing tissue to make slides. This study will determine if a NLM can be used to evaluate tissue during lumpectomy surgery for breast cancer in order to reduce the probability that standard pathologic examination of the specimen after the end of the operation will find close or positive margins, thus possibly requiring the patient to have additional breast surgery.

NCT ID: NCT02926690 Recruiting - Clinical trials for Relapsed/Refractory Locally Advanced or Metastatic Breast Cancer and Triple Negative Breast Cancer

Safety Study of MELK Inhibitor to Treat Patients With Advanced Breast Cancer and Triple Negative Breast Cancer

Start date: May 29, 2017
Phase: Phase 1
Study type: Interventional

The purpose of this study is to determine the maximum tolerated dose (MTD) of OTS167 administered via oral capsule (PO) to patients with relapsed/refractory locally advanced or metastatic breast cancer.