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Breast Cancer clinical trials

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NCT ID: NCT03190967 Not yet recruiting - Breast Cancer Clinical Trials

T-DM1 Alone Versus T-DM1 and Metronomic Temozolomide in Secondary Prevention of HER2-Positive Breast Cancer Brain Metastases Following Stereotactic Radiosurgery

Start date: June 23, 2017
Phase: Phase 1/Phase 2
Study type: Interventional

Background: Sometimes breast cancer spreads (metastasizes) to the brain. Researchers want to study new treatments for brain metastases. The drug Temozolomide is approved to treat brain tumors. Researchers want to see if combining it with the drug T-DMI prevents the formation of new metastases in the brain. Objective: To study if Temozolomide with T-DM1 lowers the chance of having new metastases in the brain. Eligibility: Adults at least 18 years old with a HER2-positive breast cancer that has spread to the brain and was recently treated with stereotactic radiation or surgery. Design: Participants will be screened with - Medical history - Physical exam - Heart tests - A scan (CT) that makes a picture of the body using a small amount of radiation - A scan (MRI) that uses a magnetic field to make an image of the brain - Blood tests. - Pregnancy test. The study will be done in 3-week cycles. All participants will get T-DM1 on Day 1 of every cycle through a small plastic tube inserted in an arm vein. Some participants will also take Temozolomide capsules by mouth every day. Participants will keep a medication diary. During the study, participants will also: - Repeat most of the screening tests. - Answer questions about their general well-being and functioning. Participants will have lumbar puncture at least 2 times. A needle is inserted into the spinal canal low in the back and cerebrospinal fluid is collected. This will be done with local anesthesia and with the help of images. Participants will be asked to provide tumor samples when available. Participants will have a follow-up visit about 1 month after stopping the study drug. They will be contacted by telephone or email every 3 months after that.

NCT ID: NCT03190720 Not yet recruiting - Breast Cancer Clinical Trials

Development of Exercise Promotion Program Using a Mobile Community

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

This study aims to investigate the effect of a mobile community based on a smart phone application to enhance physical activities of breast cancer survivors.

NCT ID: NCT03190083 Not yet recruiting - Breast Cancer Clinical Trials

Efficacy of Digital Breast Tomosynthesis + Standard 2- Dimensional Mammography in Breast Cancer

Start date: August 2017
Phase: N/A
Study type: Interventional

The purpose of this study is to determine if a 3-dimensional mammogram (DBT) may provide additional information to evaluate the extent of disease and additional findings that would aid in staging a new breast cancer patient. This would impact surgical planning and improve patient outcomes.

NCT ID: NCT03186937 Not yet recruiting - Breast Cancer Clinical Trials

A Window of Opportunity Study of Methionine Deprivation in Triple Negative Breast Cancer

Start date: June 30, 2017
Phase: Phase 2
Study type: Interventional

Given preliminary data demonstrating that methionine deprivation enhances cell surface expression of TRAIL receptor-2, the objective of this clinical trial is to confirm that methionine restriction enhances its expression in triple negative breast cancer and to establish the feasibility and acceptability of this dietary intervention in humans. This study will also examine the effect of methionine restriction on cancer stem cells and metabolic health.

NCT ID: NCT03180086 Not yet recruiting - Breast Cancer Clinical Trials

Breast Cancer Risk Assessment in Women Aged 40-49

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

In a randomized controlled trial, the investigators will test the effect of a novel strategy for breast cancer risk assessment and risk-based management of women in their 40s seen in primary care. The investigators anticipate that this approach will lead to more optimal use of mammography screening and breast cancer prevention interventions in women in their 40s and as a result will improve care of these women.

NCT ID: NCT03176888 Not yet recruiting - Breast Cancer Clinical Trials

Health Benefits of HIT for Breast Cancer Patients

Start date: September 2017
Phase: N/A
Study type: Interventional

Treatment of cancer patients should not only involve removing the cancer, but should also focus on maintaining good health and well-being and quality of life. This can be done by offering patients suitable rehabilitation programmes. Previous research has shown that such programmes need to involve exercise alongside other components, such as psychological support. To date most studies have looked at the positive effects of moderate-intensity exercise such as brisk walking, but this type of exercise is time-consuming and often not done by many patients. Shorter-duration exercise routines consisting of repeated short sprints have been found to improve general health just as well, but one of the most time-efficient routines (termed 'reduced-exertion high-intensity interval training', or 'REHIT') has not been studied in cancer patients. REHIT involves 3 exercise sessions per week, each only 10 minutes long. This makes it an ideal routine to combine with other components of a cancer rehabilitation programme. The present study will determine whether REHIT can improve important markers of health and well-being in newly diagnosed breast cancer patients. To achieve this the investigators will recruit up to 30 patients and divide them into a group who will do REHIT before and for up to 6 weeks after their cancer surgery, and a control group who will receive standard care. Markers of health and well-being will be measured at the start of the study, ~1 week after surgery, and ~7 weeks after surgery. Any changes will be compared between the exercise group and the control group. If beneficial effects are found with the REHIT intervention then this could be more widely implemented as part of cancer treatment. This study is funded by Nuffield Health and will be performed in Oxford, UK.

NCT ID: NCT03175341 Not yet recruiting - Breast Cancer Clinical Trials

Intravenous Ascorbic Acid Supplementation in Neoadjuvant Chemotherapy for Breast Cancer

Start date: June 5, 2017
Phase: Phase 1/Phase 2
Study type: Interventional

Forty years ago clinical studies conducted by Ewan Cameron and Linus Pauling suggested that intravenous (IV) and oral ascorbic acid (AA) may diminish symptoms and could improve survival in terminal cancer patients. Previous phase I and II clinical trials have found that high dose (1.5g/kg ) iv AA is well tolerated in cancer patients. This is a phase I/II, randomized study of parenteral administration of Ascorbic Acid (AA) as a supplement to the conventional neo-adjuvant chemotherapy in women with breast cancer.

NCT ID: NCT03170648 Not yet recruiting - Breast Cancer Clinical Trials

Ear Acupuncture During Chemotherapy Infusion for Breast Cancer, a Feasibility Study

Start date: June 19, 2017
Phase: N/A
Study type: Interventional

This research study is evaluating ear acupuncture as a possible treatment to reduce symptoms related to receiving chemotherapy.

NCT ID: NCT03168048 Not yet recruiting - Breast Cancer Clinical Trials

Oncologic Therapy Support Via Means of a Dedicated Mobile App

OPTIMISE-1
Start date: July 2017
Phase: N/A
Study type: Interventional

The present single-center prospective exploratory study, conducted at Heidelberg University Hospital, assesses the feasibility of introducing a concept for additional patient care based on a mobile application for patients undergoing radiotherapy. Patients presenting themselves for the irradiation of thoracic or pelvic tumors will be surveyed regarding general performance, treatment-related Quality of Life (QoL) and symptoms and their need to personally consult a physician on a treatment-daily basis by means of a mobile application. The primary endpoint of feasibility will be reached when 80% of the patients have successfully answered 80% of their respective questions scheduled for each treatment day. Furthermore, treatment-related patient satisfaction and diagnosis-related QoL is assessed by PSQ-18 and EORTC questionnaires at the end of radiotherapy and at the first follow-up.

NCT ID: NCT03165149 Not yet recruiting - Breast Cancer Clinical Trials

Effect of a Topical Ketamine on Acute and Chronic Pain, Dose Finding

Start date: May 2017
Phase: Phase 2/Phase 3
Study type: Interventional

The aim of this study is to investigate the effect of addition of different doses of Ketamine locally in acute and chronic post-mastectomy pain after breast cancer surgery and on the probability of developing chronic post-mastectomy pain.