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Breast Neoplasms clinical trials

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NCT ID: NCT03404752 Recruiting - Breast Cancer Clinical Trials

Pegfilgrastim-gema Compared to Pegfilgrastim-roche for Prevention of Induced Neutropenia in Breast Cancer Patients.

Start date: August 2015
Phase: Phase 3
Study type: Interventional

This is a randomized, multicentre, Phase 3 study. Patients will be randomly assigned to the Study drug or its comparator. The study will be blinded for the staff members in charge of the endpoint assessment.

NCT ID: NCT03402997 Completed - Breast Cancer Clinical Trials

Tissue Resistivity in Breast Cancer Patients

Start date: December 15, 2017
Phase:
Study type: Observational

The resistivity measurements will be done by introducing a needle-probe into fresh healthy, peritumoral, and tumoral ex vivo tissues.

NCT ID: NCT03401385 Recruiting - Clinical trials for Non-small Cell Lung Cancer

First-in-human Study of DS-1062a for Advanced Solid Tumors (TROPION-PanTumor01)

Start date: January 31, 2018
Phase: Phase 1
Study type: Interventional

This study is one single group of participants with non-small cell lung cancer (NSCLC) who have not been cured by other treatments. It is the first time the drug has been used in humans. There will be two parts and a sub-study. The primary purpose of the parts are: - Dose Escalation: To investigate the safety and tolerability and to determine the maximum tolerated dose (MTD) and the recommended dose for expansion (RDE) of DS-1062a - Dose Expansion: To investigate the safety and tolerability of DS-1062a in additional solid tumors This study is expected to last approximately 6 years from the time the first participant is enrolled to the time the last subject is off the study. Study sites are located in both the United States and Japan. The number of treatment cycles is not fixed in this study. Participants who continue to benefit from the study treatment may continue, unless: - they withdraw - their disease gets worse - they experience unacceptable side effects. The primary purpose of the sub-study is to compare the effectiveness of steroid versus non-steroid mouthwash as prophylaxis against oral mucositis/stomatitis in participants receiving DS-1062a. The sub-study is a randomized study that will include approximately 76 participants enrolling into the Dose Expansion part.

NCT ID: NCT03401359 Recruiting - Clinical trials for Breast Cancer Stage IV

The Resistance and Immune Response to Palbociclib in Breast Cancer

Start date: October 24, 2017
Phase: N/A
Study type: Interventional

The investigators propose to conduct a biomarker and molecular profiling study in longitudinally paired tumor biopsies and serum from patients with Hormone Receptor positive (HR+) metastatic Breast Cancer (BC) treated with Palbociclib in combination with endocrine therapies.

NCT ID: NCT03401034 Completed - Breast Cancer Clinical Trials

Influence of Lifestyle, Inflammatory Biomarkers, and Genetic Factors on Long-term Breast Cancer Prognosis

Start date: August 1, 2002
Phase: N/A
Study type: Observational

The MARIEplus study is a prospective cohort of breast cancer patients recruited into the MARIE (Mamma Carcinoma Risk factor InvEstigation) study, a population-based case-control study of breast cancer conducted in two German study regions, Hansestadt Hamburg and Rhine-Neckar-Karlsruhe (RNK) region. Participants were identified through participating clinics and the Hamburg cancer registry between January 1st, 2001 and September 30th, 2005 in Hamburg and between August 1st, 2002 and July 31st, 2005 in the RNK study region. Patients were aged 50-74 years at histologically confirmed primary invasive (stages I to IV) or in situ breast tumor (stage 0). Comprehensive information on demographic, socio-economic, and lifestyle factors was collected at multiple time points: at recruitment by a standardized face-to-face interview and at follow-up median 6 years as well as 11 years later using computer assisted telephone interview. Vital status was assessed in 2009 and again in 2015 via the population registries and causes of death were obtained from death certificates and coded according to the 10th revision of the International Statistical Classification of Diseases and Related Health Problems (ICD-10). Information on the clinical course was abstracted from medical records to verify clinical events either self-reported in follow-up interviews or reported by treating physicians. The studies were approved by the ethics committee of the University of Heidelberg and the University of Hamburg and conducted in agreement with the Helsinki Declaration. Written informed consent was provided by all participants at baseline and during follow-up. The primary objectives of this study are - To assess the association of modifiable lifestyle factors and personal factors, including BMI, diet, physical activity, tobacco and alcohol use, menopausal hormone therapy, socioeconomic status, with breast cancer survival, overall and according to tumor type, after accounting for established prognostic factors. - To examine the influence of genetic variants on breast cancer relapse and survival - To assess the association of lifestyle factors and their changes in the course of survivorship on subsequent breast cancer prognosis. - To assess the individual and combined association of inflammation/metabolic biomarkers as well as changes in their serum levels with subsequent breast cancer prognosis overall and according to tumor type. - To assess whether and to what extent the associations between breast cancer prognosis and lifestyle factors and/or their changes are mediated by circulating biomarker levels.

NCT ID: NCT03400254 Withdrawn - Breast Cancer Clinical Trials

Gedatolisib, Hydroxychloroquine or the Combination for Prevention of Recurrent Breast Cancer ("GLACIER")

GLACIER
Start date: February 26, 2019
Phase: Phase 1/Phase 2
Study type: Interventional

This clinical trial will assess the safety and early efficacy of the role of gedatolisib and hydroxychloroquine in early-stage breast cancer patients with residual disease and evidence of disseminated tumor cells (DTCs) on bone marrow aspirate after neoadjuvant chemotherapy (NACT) and definitive surgery.

NCT ID: NCT03400215 Recruiting - Breast Cancer Clinical Trials

Gradient-Echo Spectroscopic Imaging Study of Saturated Fat and Breast Cancer

Start date: July 23, 2018
Phase: N/A
Study type: Interventional

The role of fat in breast cancer development and growth has been studied extensively using body mass index, a measure of whole body fatness, and dietary fat intake in a number of epidemiological studies. However, there is a paucity of studies, on an individual level, to assess the role of breast fat itself in breast cancer due to lack of a non-invasive and fast measurement method. Since breast fibroglandular cells are surrounded by breast fat cells, the characteristics of breast fat may have a stronger relationship with breast cancer development, as supported by recent studies showing that a majority of breast cancer develops at the interface between fibroglandular tissue and adipose tissue. However, it is not trivial to study the role of breast fat, mainly due to the lack of a non-invasive and fast measurement method sensitive enough to important features of breast fat, such as types of fat.Recently, we have developed a rapid MRI method, referred to as Gradient-echo Spectroscopic Imaging (GSI), to measure fatty acid composition during clinical breast MRI exams. GSI can provide map of saturated fat and unsaturated fats in the breast adipose tissue without performing tissue biopsy. Our pilot study found that the postmenopausal women with aggressive breast cancer, known as invasive ductal carcinoma, have a significantly higher percentage of saturated fat in their breast adipose tissue than the postmenopausal women with only benign lesions.

NCT ID: NCT03398057 Completed - Clinical trials for Effect of Health Education Regarding Screening Tools of Breast Cancer

Effect of Health Education on Female Teachers' Knowledge and Practices Regarding Early Breast Cancer Detection and Screening in the Jazan Area: A Quasi-Experimental Study

Start date: November 20, 2017
Phase: N/A
Study type: Interventional

The purpose of this study is to assess the effectiveness of health education in improving the knowledge and practices of female teachers regarding screening tools and the early detection of breast cancer.

NCT ID: NCT03397537 Completed - Clinical trials for Highly Endocrine Responsive Operable Breast Cancer

Neoadjuvant Endocrine Therapy in Breast Cancer

Start date: September 2012
Phase: Phase 2
Study type: Interventional

The study aimed to compare the duration to complete or partial response (CR/PR) and the overall response rates (ORR) after six months of neoadjuvant endocrine therapy between pre-menopausal group and post-menopausal group with highly endocrine responsive operable mammary carcinoma.

NCT ID: NCT03396445 Active, not recruiting - Solid Tumor Clinical Trials

Study of Boserolimab (MK-5890) as Monotherapy and in Combination With Pembrolizumab (MK-3475) in Adults With Advanced Solid Tumors (MK-5890-001)

Start date: February 18, 2018
Phase: Phase 1
Study type: Interventional

The purpose of this study is to assess the safety and pharmacokinetics of boserolimab (MK-5890) when administered alone and in combination with pembrolizumab (MK-3475) in adults with advanced solid tumors. The initial course of boserolimab monotherapy or boserolimab plus pembrolizumab combination therapy will be for up to 35 administrations (approximately 2 years). The safety and pharmacokinetics of boserolimab when administered with pembrolizumab, pemetrexed and carboplatin in adults with non squamous non-small cell lung cancer (NSCLC) and boserolimab when administered with pembrolizumab and nab-paclitaxel in adults with triple-negative breast cancer (TNBC) will also be assessed.