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Breast Neoplasms clinical trials

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NCT ID: NCT02028364 Completed - Breast Cancer Clinical Trials

Pet Imaging as a Biomarker in Hormone Refractory postmenopausaL Women

PEARL
Start date: January 12, 2014
Phase: Phase 2
Study type: Interventional

This is a prospective, single arm trial in which patients with locally advanced or metastatic endocrine receptor positive and HER2 negative breast cancer refractory to non-steroidal aromatase inhibitors (NSAI) will receive Everolimus 10mg orally daily given in conjunction with exemestane 25mg orally daily until disease progression or treatment discontinuation for any other reasons. The main objectives are to evaluate if early metabolic response (MR) using FDG-PET/CT is associated with progression free survival (PFS) and overall survival (OS) in this population. Tumour, metastatic lesions and blood samples will be collected during the treatment period in order to identify biomarkers predicting resistance to study treatment. Results will be correlated with the results of early FDG PET/CT data in order to better characterise the non-responders.

NCT ID: NCT02028221 Completed - Clinical trials for Breast Cancer Prevention

Phase II Study of Metformin for Reduction of Obesity-Associated Breast Cancer Risk

Start date: March 7, 2014
Phase: Phase 2
Study type: Interventional

Overweight and obesity are well established risk factors for breast cancer that develop after menopause. The increased postmenopausal breast cancer risk in women who are overweight or obese is likely to be attributed to multiple metabolic disturbances. Metformin is a commonly used medication in diabetics to stabilize blood sugar. Association studies and laboratory studies have shown its potential to reduce the risk for development of cancer, including breast cancer. Recent pilot clinical studies in breast cancer patients suggest that metformin may only be effective in overweight or obese women with metabolic disturbances. We propose to conduct a clinical study of metformin in overweight or obese premenopausal women with metabolic disturbances. Study participants will be randomly assigned to receive metformin or placebo for 12 months. The study will evaluate whether metformin can result in favorable changes in risk features that have been associated with increased breast cancer risk. The risk features that will be examined in our study include breast density, certain proteins and hormones, products of body metabolism, and body weight and composition. The study should help determine the potential breast cancer preventive activity of metformin in a growing population at risk for multiple diseases.

NCT ID: NCT02027818 Completed - Breast Cancer Clinical Trials

Study of the ICG Distribution in the Margins of Breast Cancer After Tumorectomy

Start date: January 2014
Phase: Phase 2
Study type: Interventional

We will observe if ICG fluorescence correlates with margins of breast tumours after iv injection of the contrast agent

NCT ID: NCT02027376 Completed - Clinical trials for Advanced Breast Cancer

Study of LDE225 (Sonidegib) in Combination With Docetaxel in Triple Negative (TN) Advanced Breast Cancer (ABC) Patients

EDALINE
Start date: May 2014
Phase: Phase 1
Study type: Interventional

This is a single-arm, open-label, phase Ib study. In this trial, patients with Triple Negative (TN) Advanced Breast Cancer (ABC) will be treated with increasing doses of LDE225 (sonidegib) and docetaxel to determine the Maximum Tolerated Dose (MTD), Dose Limiting Toxicity (DLT) and Recommended Phase II Dose (RP2D) of the combination. Eligible patients with hormonal receptors negative and Human Epidermal Growth Factor Receptor 2 (HER2) negative ABC will be included and treated with docetaxel intravenously in every three weeks cycles. LDE225 will be administered orally at three dose levels 400, 600 and 800mg one a day (QD) (a -1 dose level is included just in case dose de-escalation is needed). Treatment will be repeated on day 1 of a 21-day cycle until radiographic or symptomatic progression, unacceptable toxicity or withdraws informed consent. The investigators propose to develop a phase Ib trial with the combination of docetaxel with LDE225 in TN ABC patients to define the safety, tolerability and RP2D, as well as to have some information about the efficacy of the combination.

NCT ID: NCT02025712 Not yet recruiting - Clinical trials for Hormone Receptor Positive Malignant Neoplasm of Breast

Exemestane Plus Everolimus for Hormone-receptor Positive Metastatic Breast Cancer

Start date: n/a
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine whether exemestane plus everolimus are effective in the treatment of patients who have achieved disease stabilization after induction chemotherapy for hormone-receptor positive metastatic breast cancer.

NCT ID: NCT02025192 Completed - Clinical trials for HER2 Positive Metastatic Breast Cancers

A Study of Tucatinib (ONT-380) Combined With Capecitabine and/or Trastuzumab in Patients With HER2+ Metastatic Breast Cancer

Start date: December 31, 2013
Phase: Phase 1
Study type: Interventional

The purpose of this study is to determine the maximal tolerated dose (MTD) or recommended phase 2 dose (RP2D) of tucatinib (ONT-380) and to assess the safety and tolerability of tucatinib (ONT-380) combined with capecitabine alone, trastuzumab alone and with both capecitabine and trastuzumab in patients with HER2+ metastatic breast cancer.

NCT ID: NCT02023359 Completed - Breast Cancer Clinical Trials

Danish Observational Study of Everolimus Plus Exemestane in Hormone Receptor (HR) Positive, Human Epidermal Growth Factor 2 (HER2) - Metastatic Breast Cancer

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

An observational study in patients with advanced ER+, HER2 negative breast cancer, who are treated with everolimus and exemestane in combination. The objective of the study is to assess the safety pattern of everolimus in a real world setting.

NCT ID: NCT02023008 Terminated - Depression Clinical Trials

Interactive Gentle Yoga in Improving Quality of Life in Patients With Stage I-III Breast Cancer Undergoing Radiation Therapy

Start date: May 2014
Phase: N/A
Study type: Interventional

This pilot clinical trial studies interactive gentle yoga in improving quality of life in patients with stage I-III breast cancer undergoing radiation therapy. Interactive gentle yoga may improve the quality of life in patients with breast cancer undergoing radiation therapy.

NCT ID: NCT02022579 Active, not recruiting - Breast Cancer Clinical Trials

DCE-MRI and DWI for Detection and Diagnosis of Breast Cancer

ACRIN6702
Start date: January 2014
Phase: N/A
Study type: Interventional

A type of magnetic resonance imaging called diffusion weighted imaging (DWI) will be tested to define cancerous from non-cancerous lesions in the breast.

NCT ID: NCT02022202 Active, not recruiting - Clinical trials for Invasive Breast Cancer

Breast Cancer Genome Guided Therapy Study (BEAUTY)

BEAUTY
Start date: February 2013
Phase:
Study type: Observational

The purpose of this research study is to better understand the reasons why or why not breast cancers are destroyed by standard chemotherapy. This information will be used to develop new and better cancer therapies.