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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: 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: NCT03183206 Recruiting - Breast Cancer Clinical Trials

Safety and Efficiency of γδ T Cell Against Breast Cancer

Start date: June 15, 2017
Phase: Phase 1/Phase 2
Study type: Interventional

In this study, effects of γδT cells on human Breast Cancer in combination with tumor reducing surgery, for example, cryosurgery going to be investigated.

NCT ID: NCT03178383 Recruiting - Breast Cancer Clinical Trials

Integration of Cancer Health Activities Into African American Churches

Start date: July 1, 2016
Phase: N/A
Study type: Interventional

This population-based application responds to the American Cancer Society Research Scholar Grant, Priority Program in Cancer Control. Recent years have seen a growing research interest in learning how to get known-effective health education strategies to reach more people who could benefit from them. An important part of this growing movement is a focus on sustained impact, or continued program benefit after the funding period is over. It is believed that the best way to achieive this sustained impact is through integrating the program into the host community at multiple levels. This innovative strategy has not been systematically tested in community-based settings, where the most vulnerable people can be reached. Since churches have a historical and ever-growing role in health promotion particularly among African Americans, they are an ideal place to reach this group for cancer education. The proposed project will compare two ways to apply a known-effective cancer educational strategy through African American churches: 1) a standard method vs. 2) a new method in which the churches integrate the strategy into their organizational structure and practice at multiple levels. It will be determined whether this "integrated approach" results in more effective and sustained cancer education and screening activities at both the church and individual levels over time. The educational strategy is one that has been used successfully in previous work: Project HEAL (Health through Early Awareness and Learning). Project HEAL is a series of three cancer early detection workshops (breast, prostate, colorectal) delivered through trained and certified lay peer community health advisors in African American churches. 14 churches will be randomly chosen to conduct either the standard Project HEAL program or an integrated Project HEAL strategy where the churches build the program into their organization in multiple ways (e.g., allocating volunteer or paid staff, space, or funds; policy change; ministry development). The project will be conducted in three phases: 1) refining the integrated approach with community and stakeholder feedback; 2) pilot testing the integrated approach in 2 churches; and 3) conducting the study to comparatively evaluate the standard vs. the integrated approaches in 14 churches. A scientifically rigorous evaluation plan will be used to look at outcomes at both the individual and the church level. This project will make important contributions to research in evidence-based medicine and sustainability. In a climate of limited resources, identifying sustainable and effective ways to increase cancer awareness and screening in African American men and women is more important than ever.

NCT ID: NCT03173469 Recruiting - Breast Cancer Clinical Trials

Preoperative Breast Magnetic Resonance Imaging for Patients Undergoing Mammoplasty

Start date: June 15, 2017
Phase: N/A
Study type: Observational

all female with operable breast cancer seeking health care at general surgery department Assiut university hospitals,and decision of therapeutic mammoplasty was taken depending on clinical examination, findings on mammography and sonography, will undergo MRI breast, and see if MRI finding will change decision of the surgery.

NCT ID: NCT03168074 Recruiting - Breast Cancer Clinical Trials

Phase II Study of Single Agent Lenvatinib

Start date: March 28, 2017
Phase: Phase 2
Study type: Interventional

The Investigators hypothesize that single agent lenvatinib has biological activity in estrogen receptor positive breast cancer, and that the effects are more pronounced in patients with positive RET expression in the tumor.

NCT ID: NCT03164863 Recruiting - Breast Cancer Clinical Trials

Onco4D(TM) Biodynamic Chemotherapy Selection for Breast Cancer Patients

Start date: March 6, 2017
Phase: N/A
Study type: Observational

Millions of cancer patients every year receive chemotherapy with only a 20-60% probability of pathological response, while most experience adverse side effects that lower quality of life without prolonging it. Reliable identification of ineffective therapies can eliminate needless human suffering while increasing overall probability of positive response to treatment. Chemotherapy resistance profiling entails testing whether a patient exhibits strong resistance to a therapy prior to its final selection by the oncologist. However, there are no effective methods for quickly assessing patient chemotherapy resistance. Patient Derived Xenograft (PDX) models have replaced older Chemotherapy Sensitivity and Resistance Assays (CSRAs) to some degree, but both technologies suffer from long testing times, high cost, and/or low accuracy. Motility Contrast Tomography (MCT) has recently emerged as a technology that measures the biodynamic response of intact tumor biopsies to applied therapeutics by using Doppler detection of infrared light scattered from intracellular motions inside living tissue. Several small scale animal, xenograft, and human studies have shown this phenotypic profiling technique to be highly accurate in prediction of response and resistance to chemotherapy. This project will be the first human trial of biodynamic phenotyping to predict chemotherapy response among breast cancer patients. Specifically, the study cohort will include patients selected for neoadjuvant chemotherapy treatment, because this setting offers the opportunity for near-term outcome measurement at the time of post-chemo surgery. Pre-therapy fresh tumor specimens will be imaged using MCT, and the resulting bio-dynamic signatures will be compared to confirmed pathological response at the time of surgery. Observation of a high predictive value will provide the basis for expanded clinical trials and prompt commercialization of a biodynamic chemotherapy selection assay for breast and other cancer patients.

NCT ID: NCT03162289 Recruiting - Breast Cancer Clinical Trials

Intermittent Fasting Accompanying Chemotherapy in Gynecological Cancers

FIT2
Start date: May 10, 2017
Phase: N/A
Study type: Interventional

The aim of this trial is an evaluation of the effectiveness of intermittent fasting as a supplementary therapy in patients with breast cancer and ovarian cancer in respect to quality of life, reduction of side effects and possible reduction in tumor progression.

NCT ID: NCT03161600 Recruiting - Breast Cancer Clinical Trials

Improving Surgical/Medical Oncology Collaboration for Breast Cancer Treatment Planning: Pilot Testing the Impact of Continuing Education and Patient Care Planning

Start date: May 18, 2017
Phase: N/A
Study type: Interventional

This study will explore provider's screening and management practices for eligibility for neoadjuvant therapy from baseline to following the project intervention (use of a novel existing technology, the Carevive Care Planning System at the point of care plus provider continuing medical education.

NCT ID: NCT03159585 Recruiting - Breast Cancer Clinical Trials

To Evaluate the Efficacy of NY-ESO-1-specific T Cell Receptor (TCR) Affinity Enhancing Specific T Cell in Solid Tumors

Start date: June 1, 2017
Phase: Phase 1
Study type: Interventional

The main purpose of this trial is to investigate the safety and tolerability of TAEST16001(TCR Affinity Enhancing Specific T cell Therapy)in the multi-line treatment failed advanced solid tumors including bone and soft tissue sarcoma, melanoma, liver cancer, esophageal cancer, breast cancer, thyroid and ovarian cancer. The patients must meet the two criteria: human leukocyte antigens (HLA)-A*0201+ and NY-ESO-1 positive cells≥25% by immunohistochemisty.