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Metastatic Breast Cancer clinical trials

View clinical trials related to Metastatic Breast Cancer.

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NCT ID: NCT02682836 Completed - Clinical trials for Metastatic Breast Cancer

Physical Activity to Maintain Quality of Life and Physical Function in Women With Metastatic Breast Cancer: a Pilot Study

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

Metastatic breast cancer (MBC) is an incurable disease. Maintaining optimum quality of life is a major goal of care. There is a strong body of evidence that exercise can reduce or manage fatigue, depression and insomnia in breast cancer patients; however, the evidence base is overwhelmingly in early stage cancer patients. The purpose of this study is to see if a home-based, self-directed walking program can have similar benefits in women with an MBC diagnosis. The primary objective is to evaluate whether engagement in physical activity will reduce fatigue during active treatment for MBC (baseline to 3 months); this is the primary endpoint. Secondary objectives pertain to feasibility of recruitment and retention of study participants and measuring changes between baseline, 3 months and 6 months in additional quality of life measures. Exploratory analyses pertain to changes in p16INK4a levels and sarcopenia between baseline and 3 months. The design is a single arm intervention trial in 30 patients. Findings from this study will provide preliminary data for a grant application to test the physical activity intervention in a randomized controlled trial (RCT) in a large sample of women with metastatic breast cancer.

NCT ID: NCT02662868 Completed - Clinical trials for Metastatic Breast Cancer

Metastatic Breast Cancer in Brazil: Characterization of Patients and Treatments

Start date: June 2015
Phase: N/A
Study type: Observational

The purpose of this study is to describe demographics and socioeconomics characteristics associated to the diagnosis of metastatic breast cancer in Brazil.

NCT ID: NCT02657889 Completed - Breast Cancer Clinical Trials

Niraparib in Combination With Pembrolizumab in Patients With Triple-negative Breast Cancer or Ovarian Cancer

TOPACIO
Start date: April 15, 2016
Phase: Phase 1/Phase 2
Study type: Interventional

This Phase 1/2 study will evaluate the safety and efficacy of combination treatment with niraparib and pembrolizumab (MK-3475) in patients with advanced or metastatic triple-negative breast cancer or recurrent ovarian cancer. (KEYNOTE-162)

NCT ID: NCT02655952 Completed - Clinical trials for Metastatic Breast Cancer

Dose Escalating Study of Foxy-5 in Breast-, Colon- or Prostate Cancer Patients

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

The Wnt proteins belong to a family of proteins that have been demonstrated to play a role in the formation and dissemination of tumours. The present project focuses on the critical role of the Wnt-5a protein in the pathobiological processes that lead to metastatic cancer disease. WntResearch has identified a formylated 6 amino acid peptide fragment, named Foxy-5, which mimick the effects of Wnt-5a to impair migration of epithelial cancer cells and thereby acting anti-metastatic. The aim of the first clinical phase I study was to establish the recommended dose for a clinical phase II study and enable further development of Foxy-5 as a first in class anti-metastatic cancer drug. The study did not see any DLTs and therefore failed to reach maximum tolerated dose (MTD); no recommended phase II dose (RP2D) could therefore be established based on toxicity. The aim of this study is to continue to establish the safety profile of Foxy-5 in higher doses, and determine the RP2D for later stage development based on any observed DLT's/MTD and further analysis of the pharmacodynamic profile of Foxy-5 to determine the biological response dose (BRD).

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)

NCT ID: NCT02650752 Completed - Clinical trials for Metastatic Breast Cancer

Intermittent High-Dose Lapatinib in Tandem With Capecitabine for HER2 Overexpressed/Amplified Metastatic Breast Cancer With Central Nervous System (CNS) Metastases

Start date: January 6, 2016
Phase: Phase 1
Study type: Interventional

The purpose of this study is to see if capecitabine can be taken safely with different doses of lapatinib in patients with HER-2 positive breast cancer involving brain (brain metastases) and/or in spinal fluid (leptomeningeal disease).

NCT ID: NCT02649686 Completed - Clinical trials for Metastatic Breast Cancer

Durvalumab in Patients With HER-2 Positive Metastatic Breast Cancer Receiving Trastuzumab

Start date: May 17, 2016
Phase: Phase 1
Study type: Interventional

The purpose of this study is to find the highest dose of durvalumab that can be tolerated without causing very severe side effects when receiving standard treatment and to see what effects the study drug has on this type of cancer. The researchers doing this study are also interested in looking for markers that will help predict which patients are most likely to be helped by durvalumab when receiving standard treatment and what effects durvalumab has on this type of cancer.

NCT ID: NCT02632071 Completed - Clinical trials for Metastatic Breast Cancer

ACY-1215 + Nab-paclitaxel in Metastatic Breast Cancer

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

This is a non-randomized phase 1 trial designed to determine the MTD and evaluate the safety and tolerability of ACY-1215 with nab-paclitaxel. Based on the activity profile of ACY-1215 in breast cancer, corresponding biomarker availability with the HDAC6 MR score, and its potential synergy with taxanes, these data support the rationale for testing the ability of ACY-1215 to improve the response rate for patients with metastatic breast cancer in combination with standard taxane chemotherapy.

NCT ID: NCT02626039 Completed - Clinical trials for Metastatic Breast Cancer

Characterization & Comparison of Drugable Mutations in Primary and Metastatic Tumors, CTCs and cfDNA in MBCpatients

MIRROR
Start date: November 2013
Phase:
Study type: Observational

Characterization of the driver mutations in an individual metastatic breast cancer patient is critical for many reasons. Effective targeted therapies require identifying genomic alterations in the tumoral tissue. The scarce efficacy of many currently available targeted drugs may be due to the outbreak of resistant clones with different genotype that already present at the initiation of therapy. It is well known the intra-tumor heterogeneity with genetic and non-genetic factors considered as the origin of the tumor cell-clon composition. The acquisition of multiple mutations (driver and passenger), altogether with the stage of differentiation, according to the cancer stem cell hypothesis, confers to the tumor cells clinically important properties, such as resistance to therapies and seeding abilities. Moreover, there is a current challenge in establishing whether the metastatic cells arise from the most aggressive and dominant clone in the primary tumor or the metastasic tissue diverges with substantial genetic changes very early in the evolution of the disease. Primary and metastatic tumor may have a close clonal relationship or evolve in parallel and acquire different genomic alterations. In the real life, it is plausible that both models coexist with different predominance according to the tumoral tissue and etiology. The study hypothesizes that breast cancer metastases and primary tumors could harbor different genomic profiles related to genomic regions of interest in a clinically relevant proportion of metastatic breast cancer patients. Moreover, the genomic aberrations found in the metastatic breast cancer tissue could also be detected in CTCs and circulating free DNA. If true, CTCs and circulating free DNA would be convenient, non-invasive, easily accessible sources of genomic material for the analysis of mutations and other genomic aberrations.

NCT ID: NCT02626013 Completed - Clinical trials for Metastatic Breast Cancer

Real-world Evidence Prospective Study on the Effect of Nab-paclitaxel Treatment on the Clinical Outcomes and HRQoL in Patients With MBC in Greece

ABReast
Start date: April 12, 2016
Phase:
Study type: Observational

This non-interventional study aims at assessing the impact of nab-paclitaxel on the clinical outcomes and the health-related QoL (HRQoL) of this heavily burdened and difficult-to-treat population. Notably, the data generated in the context of this study will serve as complementary evidence to that of the tightly and strictly controlled pre-registration clinical trial setting, which is of essential importance especially in patient populations with diseases of complex and heterogeneous biology, such as breast cancer.