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Breast Neoplasms clinical trials

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NCT ID: NCT03855423 Recruiting - Clinical trials for Breast Cancer Female

Maximum Tolerated Dose, Safety and Pharmacologic Study of TRF in Women With Breast Cancer

Matriac
Start date: February 18, 2019
Phase: N/A
Study type: Interventional

Phase Ib: Maximum Tolerated Dose, Safety and Pharmacologic Study of TRF in Women with Breast Cancer is aimed to determine the highest, safest and tolerable dose of Tocotrienol-rich Fraction (maximal tolerated dose: MTD) that can be used in women with breast cancer.

NCT ID: NCT03855358 Recruiting - Clinical trials for Triple Negative Breast Cancer (TNBC)

A Study of TQB2450 Injection and Anlotinib Hydrochloride Capsules to Treat Triple Negative Breast Cancer (TNBC)

Start date: May 9, 2019
Phase: Phase 1
Study type: Interventional

The purpose of this study is to evaluate the efficacy and safety of PD-L1 inhibitorin in combination with Anlotinib treatment for patients with triple receptor negative breast cancer treated after failure of standard therapy (including Anthracyclines and/or Taxanes).

NCT ID: NCT03854903 Active, not recruiting - Clinical trials for Metastatic Breast Cancer

WI231696: Bosutinib, Palbocicilib and Fulvestrant for HR+HER2- Advanced Breast Cancer Refractory to a CDK4/6 Inhibitor

Start date: April 1, 2019
Phase: Phase 1
Study type: Interventional

This is an open-label, single-arm, phase I trial. It is designed with a conservative dose escalation plan to ensure patient's safety and with a strong translational component to inform if target inhibition is achieved. With concerns regarding safety, based on extensive available pharmacokinetic data and clinical efficacy experience, bosutinib will be given 5-days in a row followed by 2 days rest in a weekly basis, instead of daily. The protocol will enroll patients per 3+3 escalation design. The Dose Limiting Toxicity (DLT) observation period is 28 days. At the end of DLT observation period of each cohort of 3 patients, decision will be made regarding further escalation or de-escalation according to this plan. Once the MTD of the combination is reached, the safety data will be analyzed. There will be no dose reductions during DLT observation period. Dose reduction within patients (individually) is allowed after the 4-week DLT observation period. Treatment in this phase I trial will be administered until there is disease progression or unacceptable toxicity.

NCT ID: NCT03854617 Not yet recruiting - Clinical trials for Human Epidermal Growth Factor 2 Negative Carcinoma of Breast

A Study to Evaluate the Efficacy and Safety of Oral Navelbine in Female Patients With HER2-Negative Metastatic Breast Cancer

Start date: February 20, 2019
Phase: Phase 2
Study type: Interventional

This is a randomized, open-label, parallel, multi-center study, aims to evaluate the efficacy and safety of metronomic chemotherapy with oral Navelbine versus intermittent oral Navelbine in female patients with HER2 negative Metastasis Breast Cancer.

NCT ID: NCT03853707 Completed - Clinical trials for Anatomic Stage IV Breast Cancer AJCC v8

Ipatasertib in Combination With Carboplatin, Carboplatin/Paclitaxel, or Capecitabine/Atezolizumab in Treating Patients With Metastatic Triple Negative Breast Cancer

Start date: March 4, 2019
Phase: Phase 1/Phase 2
Study type: Interventional

This phase I trial studies best dose of ipatasertib and how well it works with carboplatin with or without paclitaxel in treating patients with triple negative breast cancer that has spread to other places in the body (metastatic). Ipatasertib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as carboplatin, paclitaxel, and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. It is not yet known whether giving ipatasertib in combination with carboplatin, carboplatin/paclitaxel, or capecitabine/atezolizumab will work better in treating patients with triple negative breast cancer.

NCT ID: NCT03851497 Completed - Breast Cancer Clinical Trials

Application of Deep-learning and Ultrasound Elastography in Opportunistic Screening of Breast Cancer

Start date: January 1, 2019
Phase:
Study type: Observational

As the most common cancer expected to occur all over the world, breast cancer still faces with the unsatisfied diagnostic accuracy in US imaging. S-detect is a sophisticated CAD system for breast US imaging based on deep learning algorithms. E-breast is a software installed in US machines which automatically reveals tumor elastographic features. This multi-center study intends to further validate the diagnostic efficiency of S-detect and E-breast in opportunistic breast cancer screening populations in China. Our hypothesis is that S-detect and E-breast can increase the diagnostic accuracy and specificity as compared to routinely US examinations by doctors.

NCT ID: NCT03850873 Not yet recruiting - Clinical trials for Advanced Breast Cancer

A Phase I Study of TQB3616 on Tolerance and Pharmacokinetics

Start date: March 1, 2019
Phase: Phase 1
Study type: Interventional

TQB3616 may work in cancer by stopping cancer cells from multiplying.TQB3616 is in a new class of drugs called CDK inhibitors.This research study is the first time that TQB3616 will be given to people.TQB3616 is taken by mouth daily.

NCT ID: NCT03850171 Terminated - Lymphoma Clinical Trials

Cancer Adverse Effects PReventIon With Care & Exercise: the CAPRICE Study

Start date: May 1, 2019
Phase: N/A
Study type: Interventional

Breast cancer is the most common cancer among women worldwide. Similarly, Hodgkin and non- Hodgkin lymphomas make up two of the most prevalent cancers in men and women. Even though remarkable improvements in cancer-free survival have been achieved in the last decades, the development of cardiac toxicity, associated with anthracycline-based chemotherapy (Anth-bC) counteracts the improvements in survival in these patient groups. One of the first clinical manifestation of Anth-bC cardiotoxicity is diastolic dysfunction, with further symptoms being left ventricular dysfunction and heart failure as well as a decline in exercise tolerance. Besides the direct cardiotoxic effects of anticancer treatment, many drugs also have adverse effects on the vascular endothelium. The concept of 'Exercise is Medicine' has become well established in exercise-oncology research. Exercise therapy is now considered a safe and well-tolerated adjunct therapy inducing beneficial effects on body composition, aerobic fitness and muscular strength, pain and fatigue, quality of life (QoL), depressive symptoms, and all cause survival. However, there is insufficient data on the superiority of performing exercise training therapy before and during chemotherapy with regard to cardiotoxic and cardiovascular side effects. Further, there is no data on patient preference for and barriers toward different timings of exercise training therapy. Therefore, the aim of the study is to compare left ventricular (LV) function measured by LV global longitudinal strain (GLS) in breast cancer and lymphoma patients undergoing Anth-bC randomised to completing an exercise-based rehabilitation programme during chemotherapy to those randomised to complete the programme after chemotherapy. Further, blood samples will be drawn to analyse biomarkers of myocardial injury (brain natriuretic peptide and high-sensitive cardiac troponin). Additional measurements include aortic distensibility as part of the echocardiographic examination and exercise capacity through cardiopulmonary exercise testing. QoL and fatigue will be assessed in a questionnaire, compliance with exercise training through monitoring and patient preference at 3 and 6 months will be evaluated through an interview. Cardiovascular risk factors will be assessed through body composition, 24h ambulatory blood pressure monitoring, 24h electrocardiogram and the analysis of established blood markers. Women and men aged 18 years and older with histologically confirmed breast cancer or lymphoma (ECOG grade 0-2) who are Anth-bC naïve and with reasonable life expectancy will be included in the study. The exercise programme is part of onco-rehabilitation programmes at the Inselspital Bern, the Spital AG Thun and the Bürgerspital Solothurn. Programmes last for 12 weeks and offer two supervised sessions per week (@ 60-90 min). They usually contain an endurance component (e.g. 40 min of cycling) and a strength, agility or relaxation component. Patients are encouraged to complete a third exercise session per week at home or elsewhere. Home-based training and general physical activity will be assessed by a questionnaire and an activity monitor. A total of 120 patients will be recruited. Measurements will be performed at baseline, after 3 months (week 13) and after 6 months (week 26).

NCT ID: NCT03849573 Completed - Breast Cancer Clinical Trials

A Web-Based Tool to Improve Breast Cancer Survivorship

Start date: May 29, 2019
Phase: N/A
Study type: Interventional

The purpose of this study is to examine the efficacy of a psychosocial eHealth intervention on the proposed primary outcomes, hormone therapy adherence and health related quality of life (HRQoL), in breast cancer survivors. The intervention components include mindfulness-based stress reduction, breast cancer knowledge, stress awareness and management, social support, and enhanced communication. The intervention will be delivered via an online application over an 8-week period. Participants are randomized into either an intervention application (described above) or a control application (health information and general health promotion strategies). Aside from having access to the online application for the recommended 8 weeks with weekly online focus groups, participation in this study includes four assessments: baseline (at the beginning of the research study), post-intervention (8 weeks after baseline), a 6-month follow-up and a 12-month follow-up.

NCT ID: NCT03847818 Not yet recruiting - Clinical trials for HER2-positive Breast Cancer

Neoadjuvant Study of Pyrotinib and Trastuzumab Plus Chemotherapy in Patients With HER2 Positive Breast Cancer

Start date: March 1, 2019
Phase: N/A
Study type: Interventional

This is a prospective, open-label,multicenter Phase II study for evaluating the efficacy and safety of neoadjuvant pyrotinib and trastuzumab plus chemotherapy as neoadjuvant treatment in HER2 positive early stage or locally advanced breast cancer.