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Breast Neoplasms clinical trials

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NCT ID: NCT02655159 Terminated - Breast Neoplasms Clinical Trials

Study of Nab-paclitaxel (Abraxane®) Treatment in Patients With Metastatic Breast Cancer in Routine Clinical Practice

AMBER
Start date: January 2016
Phase: N/A
Study type: Observational

This is a national, multicenter, retrospective, observational post-authorization study (EPA-OD) study. The study will be conducted by reviewing the medical records of patients up to the start of the study. In each case, only data from before the start of the study will be obtained in order to ensure they are retrospective in nature, thus reflecting the regular use of nab-paclitaxel in clinical practice and avoiding interference with the physician's clinical practice. To ensure the observational nature of this study, these data will be collected whenever they are available in the patient's medical record, and so no diagnostic or therapeutic intervention outside regular clinical practice will be used.

NCT ID: NCT02654444 Completed - Breast Cancer Clinical Trials

Semi-Quantification of Her2/Neu Protein Expression in Formalin Fixed, Paraffin-Embedded Normal and Neoplastic Tissue

Start date: May 2013
Phase: N/A
Study type: Observational

The purpose of the study is the identification and quantification of protein expression level in breast cancer tissues. The imaging system is intended for diagnostic use as an aid to the pathologist in the detection, counting and classifying her2 immunohistochemical (IHC) stained samples.

NCT ID: NCT02654119 Active, not recruiting - Clinical trials for Stage IIB Breast Cancer AJCC v6 and v7

Cyclophosphamide, Paclitaxel, and Trastuzumab in Treating Stage I-II HER2/Neu Positive Breast Cancer After Surgery

Start date: December 11, 2015
Phase: Phase 2
Study type: Interventional

This phase II trial studies the side effects and how well cyclophosphamide, paclitaxel, and trastuzumab work when given after surgery in treating patients with stage I-II human epidermal growth factor receptor (HER2/neu) positive breast cancer (confined to the breast or the breast and lymph nodes under the arm). Drugs used in chemotherapy, such as cyclophosphamide and paclitaxel, 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. Monoclonal antibodies, such as trastuzumab, may interfere with the ability of tumor cells to grow and spread. Giving cyclophosphamide, paclitaxel, and trastuzumab after surgery may help prevent the cancer from coming back.

NCT ID: NCT02653755 Active, not recruiting - Clinical trials for Breast Cancer Radiation

The PRECISION Trial (Profiling Early Breast Cancer for Radiotherapy Omission): A Phase II Study of Breast-Conserving Surgery Without Adjuvant Radiotherapy for Favorable-Risk Breast Cancer

Start date: May 2016
Phase: Phase 2
Study type: Interventional

This research study is a way of gaining new knowledge about whether patients can omit radiation treatment after undergoing a lumpectomy, also known as "breast conserving surgery". In this trial, we are attempting to identify which patients may not need radiation.

NCT ID: NCT02652975 Completed - Metabolic Syndrome Clinical Trials

Anticancer Treatment of Breast Cancer Related to Cardiotoxicity and Dysfunctional Endothelium

ABCDE
Start date: September 2015
Phase: N/A
Study type: Interventional

Several cytotoxic regimens are related to endothelial cell damage and vascular toxicity. Endothelial dysfunction is implicated in the pathogenesis of all known cardiovascular diseases (CVD) and closely related to the metabolic syndrome. Both CVD and diabetes contributes importantly to total mortality and to breast cancer (BC) specific mortality. In the epidemiological part of the project, the investigators will determine the prevalence and incidence of cardiovascular and metabolic morbidity/mortality in early BC patients compared to the Danish background population. In the clinical part, the investigators will study the changes of endothelial function and metabolic parameters in BC patients receiving chemotherapy. With increasing number of BC survivors, long-term consequences of curative cancer treatment should be studied. The investigators hypothesize that cytotoxic therapy worsens metabolic parameters possibly through endothelial dysfunction. If this is true, the next step will be to evaluate how strict metabolic control will affect prognosis.

NCT ID: NCT02652923 Completed - Breast Cancer Clinical Trials

Contrast Ultrasound Detection of Sentinel Lymph Nodes

Start date: January 1, 2016
Phase: Phase 1/Phase 2
Study type: Interventional

This is a two part, open label, non-randomized trial of women with a breast cancer diagnosis scheduled for excisional surgery and sentinel lymph node (SLN) evaluation. Part 1 is a two-period, crossover, dose-finding study, which will be performed in 12 healthy female volunteers to determine the optimal dose as well as the safety and tolerability of the tissue-specific, contrast agent Sonazoid (GE Healthcare, Oslo, Norway) for human lymphatic applications. In Part 2 lymphosonographic SLN identification will be compared to that of isotope mapping during surgery on 90 female, breast cancer patients.

NCT ID: NCT02651844 Completed - Breast Cancer Clinical Trials

Mifepristone for Breast Cancer Patients With Higher Levels of Progesterone Receptor Isoform A Than Isoform B.

MIPRA
Start date: April 2016
Phase: N/A
Study type: Interventional

- Seventy per cent of breast cancers express estrogen (ER) and progesterone receptors (PR) and respond to endocrine treatment. - Actual therapy targets ER. - There is enough evidence that progestins participate regulating breast cancer growth. - Antiprogestins block cell proliferation and increase apoptosis in breast cancer models which express high levels of PRA. - Antiprogestins have been used to treat breast cancer patients that failed to other treatments; benefits were seen in selected patients. - Mifepristone (MFP) is currently used for medical abortion and for the treatment of Cushing disease. - MFP might exert agonistic effects when PRB isoform is activated by cAMP. This makes mandatory the evaluation of the PR isoform ratio in breast cancer patients in which MFP is a therapeutic possibility. Main Goal To evaluate if therapeutic doses of MFP exert beneficial effects on breast cancers expressing levels of PRA higher than those of PRB, evaluated as an inhibition in proliferation markers and/or an increase in apoptotic markers. - Eligibility - Postmenopausal women (one year after menses stop). - Women with tumors showing ratios of PRA/PRB higher than 1.5 and PR higher than 50%. - Women without previous treatment. - All clinical stages with tumors larger than 1.5 cm. - Patients without autoimmune diseases and/or asthma. - Study design - Open Interventional. - Twenty women will take MFP (200 mg) p.o. once /day during 14 days. As for preliminary studies, to reach this number the investigators will have to evaluate 80-100 patients. - Surgery is performed 14 days after treatment initiation, 24 hs after last dose. - PR isoform ratio will be evaluated by western blots (WB) in one core biopsy. Additional cores will be used for diagnosis, immunohistochemistry (IHC) of PR, Ki-67 and other markers. - At surgery samples will be frozen for molecular studies and fixed and processed for pathological evaluation. - Wilcoxon signed rank test will be used to evaluate differences in biomarker expression between core biopsy and surgical samples of each patient. - Blood will be collected before treatment initiation and prior to final surgery. - Mammographic and echographic studies will be carried out before and after treatment.

NCT ID: NCT02651610 Withdrawn - Clinical trials for Metastatic Breast Cancer

Taxane Therapy With or Without Bavituximab for the Treatment of HER2-Negative Metastatic Breast Cancer

Start date: December 2015
Phase: Phase 2/Phase 3
Study type: Interventional

The primary purpose of this research study is to see whether adding bavituximab (an investigational drug) to the standard chemotherapy drug taxane, will improve the results of the treatment for HER2-negative metastatic breast cancer.

NCT ID: NCT02651142 Recruiting - Breast Cancer Clinical Trials

Sentinel Lymph Node Biopsy With or Without Para-Sentinel Lymph Node Dissection in Breast Cancer

Start date: January 2015
Phase: N/A
Study type: Interventional

Sentinel lymph node biopsy(SLNB) is an established way of predicting axillary nodal metastasis in early breast cancer. We aim to determinethe,in a prospective randomized, controlled trial, effect of sentinel lymph node biopsy with para-sentinel lymph node(SLN) dissection versus sentinel lymph node biopsy without para-sentinel lymph node dissection on outcomes after breast surgery.

NCT ID: NCT02650817 Completed - Clinical trials for Metastatic Breast Cancer

Phase IB Study to Evaluate RAD1901 on the Availability of Estrogen Receptor Binding Sites in Metastatic Breast Cancer

Start date: April 1, 2016
Phase: Phase 1
Study type: Interventional

The purpose of this study is to visualize and quantify ER-binding sites during treatment with Elacestrant (RAD1901)