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Breast Cancer clinical trials

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NCT ID: NCT03471663 Not yet recruiting - Breast Cancer Clinical Trials

A First-in-Human Study of D-0502 Alone and in Combination With Palbociclib in Women With Advanced or Metastatic ER-Positive and HER2-Negative Breast Cancer

Start date: April 2018
Phase: Phase 1
Study type: Interventional

This is a phase I, open-label study of D-0502 single agent and D-0502 in combination with standard dose of palbociclib to assess the safety and tolerability, identify an MTD, and/or RP2D, evaluate the PK properties and evaluate preliminary anti-tumor activities in women with advanced or metastatic ER-positive, HER2-negative breast cancer.

NCT ID: NCT03471442 Recruiting - Breast Cancer Clinical Trials

Erector Spinae Plane Block Versus Paravertebral Block

Start date: February 20, 2018
Phase: N/A
Study type: Interventional

This study aims to compare the effectiveness of paravertebral block and erector spinae plane block after mastectomy. The primary objective of this randomized controlled trial is to demonstrate equivalent dermatomal spread for ultrasound-guided single-injection Erector Spinae Plane (ESP) block performed at T4-T5 level and ultrasound-guided single-injection (paravertebral) PVB block at the same level. Secondary objectives are Numerical Rating Scale (NRS) pain scores in the first 24 post-operative hours, opioid analgesia use intra-operatively and in the first 24 post-operative hours, block procedural time and patient discomfort during block insertion. The investigators hypothesize that ESP block efficacy is not inferior to PVB with reference to dermatomal sensory spread and analgesic efficacy, while being easier to perform with less associated discomfort during block insertion.

NCT ID: NCT03470402 Recruiting - Breast Cancer Clinical Trials

Decision Support for BRCA Testing in Ethnically Diverse Women

Start date: December 13, 2017
Phase: N/A
Study type: Interventional

The objective of this study is to expand genetic testing for hereditary breast and ovarian cancer syndrome to a broader population of high-risk women by prompting appropriate referrals from the primary care setting with the use of an electronic health record-embedded breast cancer risk navigation (BNAV) tool. To address patient-related barriers to genetic testing, we developed a web-based decision aid, RealRisks, which is designed to improve genetic testing knowledge, accuracy of breast cancer risk perceptions, and self-efficacy to engage in a collaborative dialogue about genetic testing. The study design is a randomized controlled trial of patient educational materials and provider EHR notice alone (control arm) or in combination with RealRisks and BNAV (intervention arm). The researchers hypothesize that combining the patient-centered RealRisks with the provider-centered BNAV will increase appropriate uptake of genetic counseling. The researchers also hypothesize that genetic counseling decisions will be more informed, and result in less decision conflict and improved shared decision making.

NCT ID: NCT03468881 Not yet recruiting - Breast Cancer Clinical Trials

A Communication Skills Package to Prevent Fear of Cancer Recurrence

Start date: May 2018
Phase: N/A
Study type: Observational

This study (FORECAST 2) builds upon the work of the successful pilot study (FORECAST) that found some evidence that breast cancer patients' fears of cancer recurrence (FCR) were sensitive to the communication exchange with therapeutic radiographers during weekly review appointments. The aim of FORECAST 2 is to co-design and pilot a communication training package for therapeutic radiographers to help them manage emotional talk with breast cancer patients who are undergoing treatment, with the intention to minimise patients' development of FCR during this trajectory.

NCT ID: NCT03465813 Recruiting - Breast Cancer Clinical Trials

Reducing Distress and Depressive-symptoms in Rural Women

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

Of the 3.1 million U.S. breast cancer survivors, approximately 30% experience significant cancer-related distress ranging from sub-threshold to diagnosable adjustment disorders, depression-symptoms and major depression up to 20 years after diagnosis. Rural cancer survivors report poorer mental health than urban survivors. Lack of access to care, support and stigma associated with cancer and mental health, challenge rural women's ability to prevent cancer-related distress and its deleterious outcomes. These barriers may be overcome by a new Internet-based, psychoeducational program designed for newly diagnosed women; CaringGuidance™- After Breast Cancer Diagnosis. This self-guided program provides information, cognitive-behavioral and supportive coping strategies in a text/audio/visual format accessed via Internet/mobile devices to increase understanding, and provide supportive tools to prevent/manage distress and depressive-symptoms. The aims of this pilot study are to determine preliminary efficacy of the CaringGuidance™ program on distress and depressive-symptoms monthly and over 3 months, for rural women newly diagnosed with breast cancer, and trial measures and methods, prior to a fully powered RCT. Sixty rural women, will be randomized to 3 months of self-guided CaringGuidance™ program access with usual care or usual care alone. Both groups complete monthly standard psychosocial measures, daily activity/symptom logs and receive a monthly call. Program engagement/dose will be measured by the CaringGuidance™ internal data system. Descriptive and inferential statistics will characterize the sample and determine differences between groups at monthly intervals and overall. Variability of outcome variables will also be assessed to determine usefulness.

NCT ID: NCT03465202 Not yet recruiting - Breast Cancer Clinical Trials

Association of Capecitabine Pharmacokinetics and Toxicity With Aging

Start date: May 2016
Phase: Phase 4
Study type: Interventional

This is a multi-centre prospective non-interventional study designed to evaluate the effects of patient age on the pharmacokinetics of capecitabine and its metabolites 5'DFCR, 5'DFUR, and 5-FU. In addition, the study will assess the correlation between the pharmacokinetic parameters calculated and cytidine deaminase, biomarkers of aging, clinical frailty, treatment outcome, and toxicity. To be enrolled, patients must have breast or colorectal cancer and be eligible to receive capecitabine monotherapy in accordance with its approved clinical usage in the UK. Treatment will be administered according to NICE guidelines as well as the clinical judgement of the prescribing physician. One hundred patients (50 breast cancer patients, 50 colorectal cancer patients) who are about to start treatment with capecitabine monotherapy will be recruited to the study and undergo study procedures within the first week of treatment.

NCT ID: NCT03464942 Not yet recruiting - Breast Cancer Clinical Trials

Stereotactic Radiation and Immunotherapy in Patients With Advanced Triple Negative Breast Cancer

Start date: April 2018
Phase: Phase 2
Study type: Interventional

This is a multi-centre, open label, phase 2, randomised controlled trial of patients with advanced triple negative breast cancer (TNBC) who have received no more than one line of chemotherapy (not including neoadjuvant or adjuvant therapy) who will be randomised to be treated with SABR 20Gy in 1# followed by atezolizumab or SABR 24Gy in 3# followed by atezolizumab.

NCT ID: NCT03462251 Recruiting - Breast Cancer Clinical Trials

Ribociclib and Aromatase Inhibitor or Paclitaxel and Bevacizumab for Metastatic Breast Cancer in First Line

Start date: March 2018
Phase: Phase 3
Study type: Interventional

This study is designed to evaluate the efficacy and safety of first-line treatment ribociclib in combination with aromatase inhibitor (AI) or paclitaxel with / without bevacizumab in patients with HR-positive, HER2-negative advanced breast cancer with visceral metastasis. Half of the patients will receive a combination of ribociclib and AI while the other half will receive paclitaxel +/- bevacizumab.

NCT ID: NCT03461224 Completed - Breast Cancer Clinical Trials

Modulated Accelerated RAdiotherapy in Early Breast Cancer

Start date: January 10, 2001
Phase: N/A
Study type: Observational

This trial was a retrospective study on postoperative accelerated hypofractionated IMRT (MARA-1) in patients with early stage breast carcinoma, to compare late toxicity after this treatment and standard fractionated RT delivered with 3D-CRT.

NCT ID: NCT03457506 Recruiting - Breast Cancer Clinical Trials

Intra-individual Comparison of Conventional and Digital PET/CT Scanners

Start date: January 8, 2018
Phase: N/A
Study type: Interventional

In this study, the investigators will analyze the impact of digital PET/CT on the final diagnostic conclusion of the scan in patients with lung cancer, breast cancer, esophageal cancer and a group of mescellaneous cancers.