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Breast Neoplasms clinical trials

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NCT ID: NCT02627560 Completed - Breast Neoplasms Clinical Trials

The Effect of Topical Tranexamic Acid on Bleeding and Seroma Formation in After Undergoing Mastectomy

Start date: January 2016
Phase: Phase 4
Study type: Interventional

After surgical procedures, interventions to reduce postoperative bleeding are of great importance. In this study, the effect will be investigated of smearing tranexamic acid, which is designed for injection, directly onto the raw wound surface (topical application) created during surgery. Topical application allows a small amount of drug to reach a large wound area, higher drug concentration in the exposed wound surface but very low concentration in the body, and no risk of injury from needles. The researchers have recently shown that topically applicated tranexamic acid reduces bleeding in women who had two-sided breast reduction surgery. Now it will be studied whether topically applicated tranexamic acid reduces bleeding after breast surgery for breast cancer. After surgery for breast cancer patients may also experience problems with long lasting seroma. Therefore it will at the same time be investigated whether topical tranexamic acid reduces the development of seroma in these patients.

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.

NCT ID: NCT02625935 Completed - Breast Cancer Clinical Trials

Prospective Observational Study Evaluating Treatment Decision Impact of Prosigna® in Early Stage Breast Cancer Patients

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

This multicenter, prospectively designed study examines whether the Prosigna score influences physician and patient adjuvant treatment selection over and above currently used prognostic factors. This study also examines the impact of the test results on patients' reported outcomes, including their decisional conflict status and anxiety levels.

NCT ID: NCT02623751 Completed - Breast Cancer Clinical Trials

Study of KHK2375 in Subjects With Advanced or Recurrent Breast Cancer

Start date: November 2015
Phase: Phase 1
Study type: Interventional

The primary objective of the open-label, dose-escalation study is to investigate the safety of single-dose monotherapy and repeated-dose of KHK2375 combined with exemestane in female subjects with advanced or recurrent breast cancer. The secondary objective is to investigate the pharmacokinetics and efficacy.

NCT ID: NCT02622711 Completed - Breast Cancer Clinical Trials

Promoting Weight Loss Through Diet and Exercise in Overweight Women With Breast Cancer

InForma
Start date: November 2015
Phase: N/A
Study type: Interventional

The investigators aim to evaluate the effect of a 6-month intervention (counseling) focused on weight loss in a group of overweight or obese women previously treated for early breast cancer. Intervention is designed to improve adherence to a healthy diet or/and to increase physical activity and decrease sedentary time, taking advantage of a pedometer-like device.

NCT ID: NCT02622074 Completed - Clinical trials for Triple Negative Breast Neoplasms

Safety and Efficacy Study of Pembrolizumab (MK-3475) in Combination With Chemotherapy as Neoadjuvant Treatment for Participants With Triple Negative Breast Cancer (TNBC) (MK-3475-173/KEYNOTE-173)

Start date: January 27, 2016
Phase: Phase 1
Study type: Interventional

The purpose of this study is to evaluate the safety, tolerability and clinical activity of pembrolizumab (MK-3475) in combination with six chemotherapy regimens as neoadjuvant treatment for participants with triple negative breast cancer (TNBC).

NCT ID: NCT02621437 Completed - Breast Cancer Clinical Trials

Impact of Osteopathy on Pain After Breast Cancer Surgery

IPOD
Start date: February 2016
Phase: N/A
Study type: Interventional

Breast cancer can be painful following surgery or can develop later and remain persistent. Pain occurrence is frequent with 50% of women developing sequelae pain of varying intensity with an impact on the quality of life. One of the priorities of the 3rd French Cancer Plan is to preserve quality of life. Osteopathy, complementary therapy, may help to reduce inconvenience caused by the disease, treatments and their side effects (asthenia, anxiety and pain). The main objective is to assess the impact of osteopathic treatment on pain in patients following breast cancer surgery. The impact will be considered beneficial if the pain score (digital scale) in the intervention group is lower, by at least two points, than the pain score in the control group at the end of the study. This is a monocentric, randomized, parallel group, single-blind and prospective clinical trial.

NCT ID: NCT02620735 Completed - Breast Neoplasms Clinical Trials

Smart-phone Health Coaching Intervention to Promote Maintenance of Exercise in Breast Cancer Survivors:Protocol

iMOVE
Start date: December 2014
Phase: N/A
Study type: Interventional

While physical activity (PA) appears to play an important role in disease control and the promotion of long-term health and well-being of cancer survivors, the large majority of breast cancer survivors are not physically active. Addressing this problem requires exercise promotion and an additional method of supporting long term exercise adherence. In response, an innovative health coaching intervention which uses mobile technology (iMOVE) to promote long-term PA in breast cancer survivors (BrCa) was developed. Project description: 107 inactive BrCa survivors will be randomized to receive a 12-week exercise program (CONTROL) OR a 12 week exercise program plus a concurrent health coaching program (iMOVE) consisting of telephone-based coaching sessions and interactive software delivered through a smart-phone and Fit-bit (wearable fitness technology) (INTERVENTION). Information on the feasibility and acceptability of the methods and intervention and examine the impact on fitness (primary), patient-reported, anthropometric, and physical (secondary) outcomes will be collected. Impact and relevance: PA has increasingly been identified as a modifiable factor that has the potential to impact cancer outcomes and improve quality of life. iMOVE is an innovative intervention with the potential to promote and maintain physical activity for breast cancer survivors. This study will be the first step in the evaluation of iMOVE and will help to determine whether a larger randomized controlled trial is needed.

NCT ID: NCT02620280 Completed - Clinical trials for Invasive Ductal Breast Carcinoma

Neoadjuvant Therapy in TRIPle Negative Breast Cancer With antiPDL1

NeoTRIPaPDL1
Start date: April 2016
Phase: Phase 3
Study type: Interventional

This study that aims to evaluate the addition of MPDL3280A (atezolizumab) to carboplatin and nab-paclitaxel in patients with early high-risk and locally advanced triple negative breast cancer. compared to the control arm of carboplatin and abraxane. Half of participants will receive MPDL3280A in combination with carboplatin and abraxane, while the other half will receive only carboplatin and abraxane.