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Breast Neoplasms clinical trials

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NCT ID: NCT02404506 Terminated - Breast Cancer Clinical Trials

Eribulin as 1st Line Treatment in Elderly Patients With Advanced Breast Cancer

Start date: August 17, 2015
Phase: Phase 2
Study type: Interventional

Breast cancer is the most frequent malignancy in women, world-wide the leading cause of cancer mortality. One of the strongest risk factors for developing breast cancer is age, with a prevalence approaching 7% in women >70 years; more than 40% of breast cancer patients are older than 65 years. Although the survival rate has increased in the last years, about one third of patients will relapse with distant metastases. Treatment for patients with metastatic breast cancer is palliative, therefore maintaining or improving quality of life. The use of taxanes and anthracyclines as first line chemotherapy regimen for metastatic breast cancer is widely accepted. Both taxanes and anthracyclines have considerable side effects, especially in elderly patients. Eribulin, a synthetic analogue of a chemotherapeutically active compound derived from the sea sponge Halichondria okadai, acts as an inhibitor of microtubule dynamics. It is registered as palliative chemotherapy in advanced breast cancer after anthracyclines and taxanes. Studies with eribulin treatment have shown similar efficacy compared to anthracyclines and taxanes, but less toxicity. Those studies showed that often the dose of eribulin had to be reduced during treatment due to toxicity without compromising the efficacy of the treatment. The main objective of the trial is to explore the efficacy of a reduced starting dose of eribulin as first-line treatment in elderly metastatic breast cancer patients. The secondary objective of the trial is to investigate the safety of eribulin in those patients. Eribulin mesilate 1.1mg/m2 i.v. will be administered intravenously every 3 weeks on day 1 and day 8 until progressive disease.

NCT ID: NCT02395627 Terminated - Breast Neoplasms Clinical Trials

Reversing Therapy Resistance With Epigenetic-Immune Modification

Start date: May 4, 2015
Phase: Phase 2
Study type: Interventional

The investigators propose a randomized two arm trial, using Simon's 2-stage design, in ER+ patients with therapy resistant breast cancer to test the optimal sequence and dosing of epigenetic immune priming in hormone therapy resistance breast cancer. A third arm (Arm C) will include ER-negative patients who will follow the concurrent priming, but exclude tamoxifen. The two arms all include vorinostat, tamoxifen, and pembrolizumab to evaluate - Sequential priming - begin pembrolizumab in Cycle 1 (Arm B and Arm C) and, - Concurrent priming with maximal dosing of both epigenetic and immune modulators- begin pembrolizumab on day 1 in Cycle 2 (Arm A)

NCT ID: NCT02389764 Terminated - Breast Cancer Clinical Trials

Nintedanib For HER2-Negative Metastatic Inflammatory Breast Cancer (MIBC)

Start date: June 22, 2015
Phase: Phase 2
Study type: Interventional

The goal of this clinical research study is to learn if Ofev® (nintedanib, also called BIBF1120) can help to control IBC. The safety of this drug will also be studied. This is an investigational study. Nintedanib is commercially available and FDA approved for the treatment of certain types of lung disease. Its use in this study is investigational. The study doctor can explain how the study drug is designed to work. Up to 44 participants will be enrolled in this study. All will take part at MD Anderson.

NCT ID: NCT02384746 Terminated - Breast Cancer Clinical Trials

Phase I Study of the Combination of MLN9708 and Fulvestrant

Millennium
Start date: June 2, 2015
Phase: Phase 1
Study type: Interventional

Participants in this study will have been diagnosed with advanced breast cancer that has become worse while being treated with fulvestrant. Participants will have estrogen-receptor positive disease, and have completed menopause. There is information from research labs which suggests that drugs that work like MLN9708 help kill breast cancer cells that have been treated with fulvestrant. The purpose of the study is to determine the proper dose as well as the good and bad effects of MLN9708 when it is given in combination with fulvestrant. The Investigators also want to learn more about how the drug combination affects tumor cells. The amount of MLN9708 participants receive will be determined by when they enter this study. Three different doses will be given to different participants. The Investigators expect to enroll a total of 12-18 people.

NCT ID: NCT02380209 Terminated - Breast Cancer Clinical Trials

An Early Phase Clinical Trial to Evaluate the Feasibility of CEST MRI in Patients With Early Stage Breast Cancer

Start date: August 2014
Phase: Phase 0
Study type: Interventional

Evaluate the feasibility of translating preclinical Chemical Exchange Saturation Transfer (CEST) MRI protocol designed to estimate tumor extracellular pH (pHe) to a clinical MRI scanner in women with early stage breast cancer. Assays are used to quantify tumor acidosis.

NCT ID: NCT02379585 Terminated - Clinical trials for HER2-positive Breast Cancer

Fasting on Newly Diagnosed Breast Cancer

STEFNE
Start date: January 2013
Phase: Phase 1/Phase 2
Study type: Interventional

This study is to see how safe the use of short-term fasting is in breast cancer patients who will receive chemotherapy before undergoing surgery and to examine if the use of short-term fasting will decrease the side effects of chemotherapy and how much a tumor shrinks while receiving chemotherapy.

NCT ID: NCT02378558 Terminated - Breast Neoplasms Clinical Trials

A Trial of a New Magnetic Breast Marking Clip

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

This small pilot will allow surgeons to perform wireless breast lumpectomies using a new magnetic technology. This is a continuation of a previous project testing the technology, and the breast surgeons comfort level using this new technology. The aim of this project is to develop a new technique for surgical excision of lesions either through surgical biopsy or lumpectomy. The current standard of care involves placing a needle then slender wire through the lesion under image guidance by a radiologist. The surgeon then removes the lesion using the wire as a guide. This new technique would place a magnet through the lesion under image guidance by a radiologist. The surgeon would then use the MagneProbe in the operating room to locate the magnet and remove the lesion. This new technique would eliminate the use of a wire that protrudes from a patient's breast. This wire is usually placed on the day of surgery, prior to the procedure. The goal of this new technique is to eliminate wire placement and increase patient comfort throughout the day of her surgery.

NCT ID: NCT02375048 Terminated - Cancer of Breast Clinical Trials

Randomized Study on Postmenopausal Women With Early Stage Breast Cancer: WBI Versus APBI

Start date: January 19, 2015
Phase: Phase 2
Study type: Interventional

Selected patients with early stage breast cancer undergone conservative surgery were randomized in two arms: Hypofractionated Whole Breast Irradiation versus Accelerated Partial Breast Irradiation.

NCT ID: NCT02374099 Terminated - Breast Neoplasms Clinical Trials

Study to Assess the Efficacy and Safety of the Epigenetic Modifying Effects of CC-486 (Oral Azacitidine) in Combination With Fulvestrant

Start date: March 13, 2015
Phase: Phase 2
Study type: Interventional

The purpose of this study to Assess the Efficacy and Safety of the Epigenetic Modifying Effects of CC-486 (Oral Azacitidine) in Combination With Fulvestrant in Postmenopausal Women with estrogen receptor positive (ER+), human epidermal growth factor receptor 2 (HER2-) Metastatic Breast Cancer Who Have Progressed on an Aromatase Inhibitor (AI).

NCT ID: NCT02370264 Terminated - Clinical trials for Stage IV Breast Cancer

Questionnaires in Identifying Upper Extremity Function and Quality of Life After Treatment in Patients With Breast Cancer

Start date: October 1, 2012
Phase: N/A
Study type: Interventional

This pilot clinical trial studies questionnaires in identifying arms, shoulder, and neck (upper extremity) function and quality of life after treatment in patients with breast cancer. Patients may experience arms, shoulder, and neck impairments that negatively affect their functioning and quality of life after cancer-related treatment. Studying upper extremity function and quality of life in patients after breast cancer treatment may help doctors determine the prevalence and severity of long-term functional impairments and the relationship between the perception of impairments due to breast cancer treatment and its' impact on quality of life.