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Invasive Breast Cancer clinical trials

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NCT ID: NCT03709186 Completed - Clinical trials for Invasive Breast Cancer

Radiomic Markers for Breast Cancer Metastasis and Treatment Response Using MRI

Start date: October 1, 2018
Phase:
Study type: Observational [Patient Registry]

The primary aim of the study is to identify radiomic features as biomarkers of metastatic progression following primary therapy.

NCT ID: NCT03630913 Recruiting - Clinical trials for Invasive Breast Cancer

Sentinel Lymph Node After Neoadjuvant Chemotherapy in Breast Carcinoma

GANEA3
Start date: January 8, 2019
Phase: N/A
Study type: Interventional

Sentinel lymph node dissection (SLND) after NAC, aimed to reduce the rate of unnecessary axillary lymphadenectomy, is not a standard of care in case of patient with previously involved node before NAC because of a too high false negative rate (FNR). Clinical consequences of FNR of SLND after NAC are currently unknown. Consequently, contrary to adjuvant setting, a risk of SLND false negative case after NAC is not acceptable. GANEA3 aims to evaluate the results of an innovative multiparametric strategy combining (1) an identification before chemotherapy of a lymph node involvement using a metal clip and then its analysis after treatment, (2) the analysis of sentinel lymph node (SLN) after NAC, and (3) analysis of biological parameters of breast tumor before and after NAC, to predict axillary status after NAC. This will identify patients with initial lymph node involvement who could benefit from SLN after NAC without additional axillary dissection with a very low FNR (≤1%). The most "pathological" metastatic lymph node will be identified with a metal clip under ultrasound. They will then receive a NAC before breast and axillary surgery. An assessment of the NAC response at the breast and axillary will be performed by imagery. Then, all patients undergo the resection of the tagged axillary node with the metal clip, SLN detection and biopsy and a complementary axillary lymphadenectomy.

NCT ID: NCT03630653 Terminated - Clinical trials for Invasive Breast Cancer

Sentinel Lymph Node Procedure in Ipsilateral Invasive Breast Cancer Relapse

FIGARO
Start date: May 29, 2018
Phase: N/A
Study type: Interventional

Sentinel lymph node biopsy (SLNB) has become the standard procedure for staging of patients with clinically node-negative breast cancer. Breast-conserving surgery (BCS) has also been a standard treatment for patients with early breast cancer. However, approximately 10% of patients with BCS develop ipsilateral breast tumor recurrence (IBTR), and mastectomy or resection of the recurrent tumor is generally performed. There are no specific guidelines available regarding staging and treatment of the regional lymph nodes. However, the reported risk of axillary lymph node metastasis among patients with local recurrence after breast surgery and a previous negative sentinel node biopsy of 26 % is too high to be ignored. Moreover, evaluation of the regional lymph node basins might be helpful to decide on the indication for adjuvant radiotherapy and systemic treatment. For these reasons it seems sensible to perform a regional lymph node staging procedure in patients with locally recurrent breast cancer. In general practice, this would mean that patients with recurrent breast cancer and a previous negative sentinel node biopsy would receive an axillary lymph node dissection (ALND) and that patients with a previous ALND would receive no additional axillary staging. Lymphatic drainage after previous breast surgery and/or radiotherapy would be altered and it remains questionable whether SLNB at the time of surgery for IBTR (second SLNB) is technically feasible and ALND can safely be omitted. In this study, investigators propose for all patients the realization of SLNB procedure and systematically ALND whatever the results of SLNB analysis, only on patients previously treated with breast conservative surgery. The aim of this study is to evaluate on a homogeneous prospective multicentric cohort of patients the feasibility and the accuracy of a second SLNB procedure for IBTR.

NCT ID: NCT03595592 Active, not recruiting - Clinical trials for Invasive Breast Cancer

Neoadjuvant Treatment of HER2 Positive Early High-risk and Locally Advanced Breast Cancer

APTneo
Start date: September 7, 2018
Phase: Phase 3
Study type: Interventional

n the present study the neoadjuvant approach with the anti-HER2 trastuzumab and pertuzumab combined with carboplatin and paclitaxel will be used to compare the Event-Free Survival (EFS) in regimens with and without atezolizumab. Following the neoadjuvant part of the study, after surgery all patients will continue to receive trastuzumab and pertuzumab to complete one year of anti-HER2 therapy. Similarly, patients allocated to receive atezolizumab will continue atezolizumab to complete one year In addition, several IHC and molecular assays will be performed before and during the period of chemotherapy administration and at surgery with the goal of defining a marker of efficacy to be later validated in a larger adjuvant setting.

NCT ID: NCT03566394 Not yet recruiting - Clinical trials for Invasive Breast Cancer

Prophylactic Gabapentin for Taxane-Induced Arthralgia and Myalgia Syndrome in Breast Cancer Patients Undergoing Adjuvant Chemotherapy

Start date: July 2, 2018
Phase: Phase 2/Phase 3
Study type: Interventional

Taxane-induced arthralgia and myalgia syndrome (TAMS) is one of the most common side effects of taxane chemotherapy. This prospective randomized controlled trial will evaluate the efficacy of gabapentin administered prophylactically on days -2 to +5 during the taxane-portion of chemotherapy for adjuvant breast cancer patients on reducing TAMS. This will be compared to observation alone.

NCT ID: NCT03564782 Completed - Clinical trials for Invasive Breast Cancer

Examining Bioactivity of PVSRIPO in Invasive Breast Cancer

Start date: June 30, 2019
Phase: Early Phase 1
Study type: Interventional

This is a pilot study to examine PVSRIPO bioactivity in tumor tissue after intratumoral administration of PVSRIPO in women with invasive breast cancer.

NCT ID: NCT03497702 Recruiting - Breast Cancer Clinical Trials

Neo-adjuvant Chemotherapy With Letrozole in Patients With Estrogen Receptor Positive/HER-2 Negative Breast Cancer

NeoChAI
Start date: May 8, 2017
Phase: Phase 2
Study type: Interventional

This is an exploratory interventional study that initiates chemotherapy with letrozole in patients with estrogen receptor positive/HER2-negative breast cancer preoperably.

NCT ID: NCT03437915 Withdrawn - Breast Cancer Clinical Trials

BrUOG 351: PRE-OPERATIVE APBI USING NIBB

351
Start date: March 2019
Phase: N/A
Study type: Interventional

Partial breast irradiation is typically performed after surgical removal of the tumor. Partial breast irradiation allows for focused radiation to the area from which the cancer was removed, sparing breast tissue from the potential bad effects of radiation compared to radiating the whole breast, which was the standard of care for many years. This study is evaluating the use of partial breast irradiation with NIBB performed before surgery instead of after surgery.This should allow researchers to target the cancer even more accurately and result in less normal breast tissue receiving radiation which may cause less side effects and/or a better cosmetic outcome. In this study partial breast treatment will be given with NIBB in 5 treatments over about 1 week. Surgical removal of the tumor will then be performed between 4-12 weeks following radiation treatment. Researchers believe that participant's risk of complications from surgery will not be higher after getting these radiation treatments than it would have been if participants had surgery first, but that is one of the things researchers are studying.

NCT ID: NCT03387553 Active, not recruiting - Breast Cancer Clinical Trials

HER2 Directed Dendritic Cell Vaccine During Neoadjuvant Therapy of HER2+Breast Cancer

Start date: June 6, 2018
Phase: Early Phase 1
Study type: Interventional

The purpose of this study is to learn more about how to treat patients with HER-2/neu positive invasive breast cancer (IBC). HER-2/neu is a type of protein that is known to be over-expressed in aggressive breast cancer. The study drug for this trial is DC1 study vaccine which is a HER2-sensitized dendritic cell (DC) study vaccine. This study vaccine is made from the participant's blood cells collected from a procedure called leukapheresis. Dendritic cells are immune cells that can tell the immune system to fight infection. In laboratory testing and from previous studies in participants, these cells may also help the immune system attack tumors such as breast cancer.

NCT ID: NCT03381092 Recruiting - Clinical trials for Invasive Breast Cancer

Sentinel Lymph Node Biopsy in Clinically Node-negative Early Breast Cancer Patients After Neoadjuvant Chemotherapy

Start date: December 22, 2017
Phase:
Study type: Observational

This is a prospective, single-center, non-randomized, non-controlled observational study.