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Breast Neoplasms clinical trials

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NCT ID: NCT03193008 Active, not recruiting - Breast Cancer Clinical Trials

Current Value of Axillary Ultrasound in the Staging of Breast Cancer. Is BSGC Still Necessary?

Start date: April 1, 2017
Phase: N/A
Study type: Observational

AUS/FNAC allows the identification of tumors without axillary tumor involvement, or with low axillary tumor burden, many of which do not benefit from SLNB, in the staging of early breast cancer. Objective: To calculate the negative predictive value of AUS/FNAC in those patients with breast cancer who meet ACOSOG Z0011 criteria.

NCT ID: NCT03192293 Recruiting - Breast Cancer Clinical Trials

Metformin and Simvastatin in Addition to Fulvestrant

Start date: January 20, 2017
Phase: Phase 2
Study type: Interventional

This is a prospective single arm open-label Phase 2 study utilising the combination of Fulvestrant, Metformin and Simvastatin in post-menopausal ER-positive metastatic breast cancer, with the primary endpoint being Clinical Benefit Rate (defined as complete response, partial response or stable disease, equal to or more than 24 weeks). The hypothesis is that the addition of Metformin and Simvastatin to Fulvestrant will improve the Clinical Benefit Rate from 40% (historical data from control arm of PALOMA-3 study) to 60%. A total of 28 patients will be enrolled over a period of 24 months. Eligible patients will receive 500 mg Fulvestrant by intramuscular injection on days 1 and 15 of cycle one and then on day one of each subsequent cycle (28 days). Patients will be given 850mg oral Metformin twice-a-day (based on xenograft models which showed that Metformin had anti-tumor effects at a minimum dose of 1500mg per day), and 20mg oral Simvastatin every night (drawing reference from the investigators' group's window-of-opportunity study), daily throughout the cycle. As part of the in-build safety and tolerability design, all patients will have a lead-in period of 7 days where they receive 850mg oral Metformin twice-a-day and 20mg oral Simvastatin every night. Special adverse events of interest include lactic acidosis, diarrhea, bloatedness, transaminitis and rhabdomyolysis. If no dose-limiting toxic effects (DLT) occur, Fulvestrant will be commenced, and considered the start of cycle 1. If DLT occurs in any of the patients, the combination of Metformin and Simvastatin will be modified for the affected patient as per protocol, with further monitoring for another 7 days. This combination will be deemed safe for that patient if no DLT occurs, following which cycle 1 can officially commence. At the time of study entry, blood samples will be drawn to establish baseline physiological parameters including fasting insulin, glucose, lipids and Homeostasis Model Assessment 2 (HOMA2). In patients who have accessible tumor sites and are willing to provide tissue for translational research, pre- and post-treatment (at end of 8 weeks) biopsies will be taken for correlative biomarker studies. Patients will be evaluated on an 8-weekly basis for toxicities and efficacy assessments during the first 6 months of treatment, followed by 12-weekly thereafter until disease progression, unacceptable toxicities, or patient withdrawal.

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: NCT03188393 Suspended - Clinical trials for Stage IIIA Breast Cancer

Assessing the Accuracy of Tumor Biopsies After Chemotherapy to Determine if Patients Can Avoid Breast Surgery

Start date: April 13, 2017
Phase: Phase 2
Study type: Interventional

This phase II trial studies how well biopsy of breast after chemotherapy works in predicting pathologic response in patients with stage II-IIIA breast cancer undergoing breast conserving surgery. Tumor tissue collected from biopsy before surgery may help to check if chemotherapy destroyed the breast cancer cells and may be compared to the tumor removed during surgery to check if they are the same.

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: NCT03186599 Recruiting - Breast Cancer Clinical Trials

Analysis of Initial Adherence and Its Impact on Long-term Adherence to Hormonal Therapy for Breast Cancer

Start date: June 8, 2017
Phase: N/A
Study type: Interventional

A trial will be conducted on 200 breast cancer patients with adjuvant hormonal therapy. The study included 6 months baseline measurement, and 12 months intervention. Patients will be assigned to high adherence or low adherence group. Then, through randomization, low adherence patients will be assigned to the intervention or control group. Study Coordinator delivers the intervention using the WALKON mobile application. Control participants receive usual care with continuous monitoring using Medication Event Monitoring System (MEMS) device.

NCT ID: NCT03185871 Not yet recruiting - Breast Carcinoma Clinical Trials

Celecoxib Window of Opportunity Trial to Assess Tumor and Stroma Responses

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

The overall purpose of this study is to assess whether celecoxib can reduce the change in collagen alignment and inflammatory response in the tumor tissue of primary breast cancer patients with invasive breast carcinoma after 2 weeks of oral intake.

NCT ID: NCT03185169 Recruiting - Clinical trials for Urinary Tract Infections

GSM (Genitourinary Syndrome Of Menopause) Management In Breast Cancer Survivors

Start date: November 18, 2016
Phase: Early Phase 1
Study type: Interventional

The impact of treatment for GSM on the quality of life will be examined for postmenopausal women (defined as last menstrual period > 1 year ago or 6 months ago with FSH >40) who have been diagnosed with breast cancer.