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Breast Cancer clinical trials

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NCT ID: NCT01984892 Terminated - Breast Cancer Clinical Trials

Treatment of Solid Tumors With Intratumoral Hiltonol® (Poly-ICLC)

Hiltonol
Start date: November 2013
Phase: Phase 2
Study type: Interventional

The purpose of this study is to test the safety of a course of injections containing Poly-ICLC in patients with advanced solid tumors that can be easily and safely reached with a needle. Poly-ICLC is a compound that has been used to help the body in its fight against cancer.

NCT ID: NCT01980277 Terminated - Breast Cancer Clinical Trials

Phase Ib/II Study of LY2780301 in Combination With Weekly PACLITAXEL in HER2-metastatic Breast Cancer

TAKTIC
Start date: January 2014
Phase: Phase 1/Phase 2
Study type: Interventional

The overall rationale of this study evaluating tolerance and efficacy of LY2780301 in combination with paclitaxel in HER2-negative, inoperable locally advanced or metastatic breast cancer (MBC) is based on : - the medical need in this population with either hormonal-resistant or unsensitive and/or rapidly progressive disease - the preclinical evidences for involvement of PI3K/AKT pathway in tumor progression and drug resistance, including taxanes as well as its potential reversion by AKT inhibition - the high level of frequency of PI3K/AKT activation in HER2-negative MBC - the in vitro and in vivo preclinical activity of LY2780301, and its synergistic combination with various anticancer agents, including taxanes - the favourable profile of tolerance of LY2780301 in phase I trial Weekly paclitaxel is conventionally administered at 80 mg/m²/week and is a standard treatment in breast cancer (BC) As described above, LY2780301 500 mg once daily has been established as the RP2D in phase I single agent trial. Evidence of pharmacodynamic activity was noted at 400-500 mg QD. Conservatively, the first dose level to be explored will be LY2780301 400 mg QD and paclitaxel 70 mg/m²/week.

NCT ID: NCT01954706 Terminated - Breast Cancer Clinical Trials

Exercise to Prevent Aromatase Inhibitor Side Effects in Breast Cancer Patients

BCS2
Start date: November 2013
Phase: N/A
Study type: Interventional

Hormone receptor-positive tumors are the most common breast cancers in postmenopausal women, and drug therapies, which block the production or effects of estrogen, are the mainstay of treatment in these patients. Due to their effectiveness in postmenopausal women, aromatase inhibitors (AIs) are the standard of care for long-term estrogen suppression in these patients. Estrogen deficiency, however, results in multiple side effects. Some of the most common side effects in women taking AIs are joint and muscle aches, which promote physical deconditioning. Because of the long term use of AIs in postmenopausal breast cancer patients and the improvements in cancer-related outcomes that are observed with their use, identifying methods to reduce these side effects to maintain adherence to treatment is important. Exercise interventions in breast cancer patients also improve quality of life and reduce fatigue. Understanding the role of exercise in AI side effect prevention will allow us to translate these findings into therapy guidelines.

NCT ID: NCT01952054 Terminated - Breast Cancer Clinical Trials

Denosumab for Breast Cancer With Bone Mets

Start date: February 9, 2015
Phase: Phase 2
Study type: Interventional

The goal of this clinical research study is to learn if denosumab in combination with a hormonal drug can help lower the number of circulating tumor cells (CTCs) in patients with breast cancer that has spread to the bone. The safety of this combination will also be studied. This is an investigational study. Denosumab is FDA approved and commercially available to prevent bone-related events caused by breast cancer that has spread to the bone. Using denosumab to lower CTCs in patients with breast cancer that has spread to the bone is investigational. You may have the option of continuing denosumab after the study ends. Up to 35 patients will take part in this study. All will be enrolled at MD Anderson.

NCT ID: NCT01938651 Terminated - Breast Cancer Clinical Trials

Ultra High Field MRI and MRS Techniques in Diagnosing Breast Cancer

Start date: January 2013
Phase: N/A
Study type: Interventional

This pilot clinical trial studies ultra-high field magnetic resonance imaging (MRI) and magnetic resonance spectroscopy (MRS) techniques in diagnosing breast cancer. New diagnostic procedures may be a more sensitive way to detect breast cancer.

NCT ID: NCT01934114 Terminated - Breast Cancer Clinical Trials

NIR Hypoxia Imaging of Breast Tumor Response to Neoadjuvant Chemotherapy in Vivo

Start date: August 2010
Phase: N/A
Study type: Observational

The purpose of this study is to determine whether an experimental alternative imaging method, Near Infrared Spectroscopy (abbreviated as NIR), can be used with a controlled respiratory system to examine the breasts for cancer. The NIR system uses light beams to produce an image or picture of the inside of the breast. The respiratory system will help researchers get more information about the breast tissue by changing the amount of oxygen the tissue receives during NIR imaging.

NCT ID: NCT01929941 Terminated - Breast Cancer Clinical Trials

An Open-Label Study of a Novel JAK-inhibitor, INCB047986, Given in Patients With Advanced Malignancies

Start date: September 2013
Phase: Phase 1
Study type: Interventional

This is an open-label study of INCB047986 given to two distinct groups of patients (Group 1 and Group 2) with advanced malignancies. The purpose of the study is to evaluate the safety, tolerability and pharmacokinetics of INCB047986 and to determine the maximum tolerated dose of INCB047986 in combination with gemcitabine and nab paclitaxel in a select group of patients with solid tumors. Each patient group will participate in a phase of the study which is divided into two parts. The patient groups will be enrolled in a sequential manner starting with Patient Group 1. Patient Group 1 Group 1 will be comprised of patients with advanced malignancies who will receive INCB047986 as monotherapy. Part 1: Dose Escalation Phase - This phase will evaluate the safety, tolerability and pharmacokinetics (PK) of INCB047986 when given as described to patients with advanced malignancies. A goal of Part 1 will be to identify the maximally tolerated dose (MTD) of INCB047986 and/or other dose(s) that are tolerated doses and produce a substantial pharmacologic effect. These doses will be used in Part 2 of the study. Part 2: Expansion Phase - This phase will further explore the safety, tolerability, PK, and preliminary clinical activity of INCB047986 using the doses identified in Part 1. Group 2 Group 2 will be in subjects with advanced or metastatic pancreatic cancer, breast cancer or urothelial cancer. Part 1: Dose Optimization Phase - This phase will identify the MTD of INCB047986 in combination with gemcitabine and nab-paclitaxel in patients with advanced or metastatic solid tumors. Specifically, these will be patients with pancreatic adenocarcinoma (first or second line), triple-negative breast cancer (second line) or urothelial cancer (second line). Part 2: Expansion Phase - This phase will explore the safety, tolerability, PK, biomarkers, and preliminary clinical activity of the dose regimen(s) identified in Part 1. Patients enrolled in this phase will be limited to those with advanced or metastatic pancreatic cancer.

NCT ID: NCT01928615 Terminated - Breast Cancer Clinical Trials

A Study of Subcutaneously Administered Herceptin (Trastuzumab) in Patients With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Early Breast Cancer

LISAH
Start date: September 2013
Phase: Phase 2
Study type: Interventional

This open-label, randomized crossover study evaluated the quality of life, efficacy, and safety of subcutaneous Herceptin (trastuzumab) injected either into the thigh or the upper arm of participants with early HER2-positive breast cancer.

NCT ID: NCT01902823 Terminated - Breast Cancer Clinical Trials

Effect of Cancer Nurse Navigators on Patient Outcomes

Start date: November 2011
Phase: Phase 2/Phase 3
Study type: Interventional

There is widespread anecdotal evidence that Cancer Nurse Navigators (CNNs) are highly valued by cancer patients, but no studies have evaluated the effects of CNNs on important patient-reported outcomes or indicators of quality of care. This study has two aims: 1. To assess the feasibility of studying the impact of Aurora CNN Program. 2. To pilot test the effects of CNN services on patient-reported outcomes and indicators of quality of care.

NCT ID: NCT01900730 Terminated - Breast Cancer Clinical Trials

Study of Valproic Acid (VPA) vs Placebo to Shorten Time of Indwelling Pleural Catheter

Start date: July 31, 2014
Phase: Phase 2
Study type: Interventional

The goal of this clinical research study is to learn if receiving valproic acid (VPA) compared to a placebo can reduce the amount of time you will need to have an indwelling pleural catheter compared to the standard of care, which involves using an indwelling pleural catheter alone. VPA is designed to stop cancer cells from dividing and maturing. This may cause the cancer cells to become less malignant and cause less pleural fluid production. A placebo is not a drug. It looks like the study drug but is not designed to treat any disease or illness. It is designed to be compared with a study drug to learn if the study drug has any real effect.