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Breast Cancer clinical trials

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NCT ID: NCT03738605 Not yet recruiting - Breast Cancer Clinical Trials

Vaginal Laser Therapy in Breast Cancer Survivors

Start date: November 25, 2018
Phase: N/A
Study type: Interventional

This study evaluates the efficacy of vaginal CO2 laser therapy in breast cancer survivors with symptoms of Genitourinary Syndrome of Menopause. Half of participants will receive active laser therapy, while the other half placebo therapy.

NCT ID: NCT03737500 Recruiting - Breast Cancer Clinical Trials

Standard Silicone-based vs. B-Lite® Light Weight Breast Implant After Total Mastectomy and Radiotherapy for Breast Cancer

BLITE-01
Start date: June 1, 2018
Phase: N/A
Study type: Interventional

Reconstructive surgery with breast implants after total mastectomy for breast cancer is invariably related to several possible complications, such as atrophy of surrounding tissues, skin thinning, capsular contracture, wound dehiscence and inframammary fold break. Such complications are promoted by elastic properties of tissues and their response to gravity forces exerted on breast implant weight, leading to microischaemic events. A poor cosmetic outcome may result up to breast implant exposure, and its removal may become necessary, thus compromising the quality of breast reconstruction. These complications are further favoured by post-mastectomy radiotherapy (PMRT), since irradiation could enhance microischaemia of peri-prosthetic soft tissues and muscle, with subsequent inadequate healing, fibrosis and thinning. Since PMRT has been associated to improved loco-regional control in node-positive breast cancer patients, its use has increased in recent years. On one hand, PMRT has improved loco-regional control but, on the other hand, it has increased the failure rate of breast reconstruction after total mastectomy. Change of timing in breast reconstruction (immediate vs. two-staged by use of tissue expander) has not decreased the complications rate after PMRT. Currently the failure rate of breast reconstruction after total mastectomy and PMRT ranges from 0% to 40%. The present study will recruit 80 participants affected by breast cancer candidated to total mastectomy with immediate breast reconstruction and subsequent PMRT or total mastectomy with reconstruction by tissue expander, subsequent PMRT and then definitive reconstruction with breast implant. Participants will be randomized in two experimental arms: 40 patients will receive final reconstruction by the use of standard silicone-based breast implant and the other 40 patients will receive B-Lite® light weight breast implant. Participants will be followed up at 1, 6, 12 and 24 months, and all patients will undergo breast MRI at 6 months. The primary goal of the present study is to evaluate the failure rate of breast reconstruction (i.e. the need of re-intervention for breast implant removal). Secondary end-points include the overall complications rate, MRI evaluation of breast implant and surrounding tissues, cosmetic outcomes and quality of life including participants' satisfaction with breast reconstruction.

NCT ID: NCT03735680 Not yet recruiting - Breast Cancer Clinical Trials

A Study to Evaluate ONM-100, an Intraoperative Fluorescence Imaging Agent for the Detection of Cancer

Start date: February 28, 2019
Phase: Phase 2
Study type: Interventional

This study is to evaluate diagnostic performance, safety and timing of post-dose imaging of ONM-100, an intraoperative fluorescence imaging agent for the detection of cancer in patients with solid tumors undergoing routine surgery.

NCT ID: NCT03735550 Recruiting - Breast Cancer Clinical Trials

Effectiveness of Liquid Crystal Contact Thermography in Detecting Pathological Changes in Female Breasts

Start date: February 1, 2017
Phase:
Study type: Observational

The study is designed to evaluate the effectiveness of liquid crystal contact thermography in detecting pathological changes in female breasts compared to standard diagnostic methods.

NCT ID: NCT03735082 Recruiting - Breast Cancer Clinical Trials

Apatinib Combined With Paclitaxel and Carbopatin Intensive Regimen in Neoadjuvant Therapy for Locally Advanced Triple-negative Breast Cancer

Start date: November 1, 2018
Phase: Phase 2
Study type: Interventional

The purpose of this study is to assess the efficacy and safety of Apatinib Combined With Paclitaxel and Carbopatin Intensive Regimen in Neoadjuvant Therapy for Locally Advanced Triple-negative Breast patients

NCT ID: NCT03734432 Not yet recruiting - Breast Cancer Clinical Trials

IGAR-Breast TeleOp Trial

IGAR-Breast-TO
Start date: January 1, 2019
Phase: N/A
Study type: Interventional

The aim of this study is to answer the question: can the IGAR-Breast safely and effectively perform teleoperative breast biopsies? This is a prospective, pilot trial. 5-10 participants will be selected by the radiologist and the success of biopsy analyzed. In addition the number of adverse events, device events and procedural deviations will be assessed to determine safety and efficacy.

NCT ID: NCT03734029 Not yet recruiting - Breast Cancer Clinical Trials

DS-8201a Compared to Treatment of Physician's Choice for Participants With a Certain Kind of Breast Cancer That Has Spread or Cannot be Surgically Removed [DESTINY-Breast04]

Start date: December 2018
Phase: Phase 3
Study type: Interventional

The reason for this trial is to compare DS-8201a to other treatments being used for breast cancer. DS-8201a is a new medicine for breast cancer that has not been approved yet by the Food and Drug Administration. It is made of a drug and an antibody. Each participant has a 2 out of 3 chance of receiving the new medicine.

NCT ID: NCT03733106 Not yet recruiting - Breast Cancer Clinical Trials

Prospective Trial of Digital Breast Tomosynthesis (DBT) in Breast Cancer Screening.

PROSPECTS
Start date: November 19, 2018
Phase: N/A
Study type: Interventional

The accuracy of standard two dimension digital mammography (2DDM) in breast cancer screening is limited because of superimposition of normal breast structures onto a two dimensional image. Mammography signs of breast cancer may be obscured, resulting in delay in the diagnosis of breast cancer. Conversely, superimposition of normal tissues may produce features on mammography which are suspicious for cancer and lead to recall for further tests. Digital breast tomosynthesis (DBT) is a new x ray mammography technique which provides three dimensional information to the film reader, overcoming many of the interpretation problems due to tissue superimposition. Studies of DBT + 2DDM in screening have shown increased cancer detection rates and lower false positive recall rates. There may be increased costs related to the technology and reading times. The aim of this study is to measure the impact and cost effectiveness of DBT + 2DDM in routine screening compared to standard 2DDM.100,000 women wil be recruited using NHS BSP screening sites. At each site, through a clinic randomization process, half of the participants will undergo standard screening with 2DDM (the control group) and half will undergo screening using DBT+2DDM.

NCT ID: NCT03731845 Not yet recruiting - Breast Cancer Clinical Trials

Evaluation of Individual Sensitivity to the Gonadotoxicity of Chemotherapy in Young Patients With Breast Cancer

ESIGON
Start date: November 2018
Phase: N/A
Study type: Interventional

Over the past decade, advances in diagnosis and treatments have dramatically increased the rates of cure for young patients with cancer. As a consequence, a new population of cancer survivors has emerged whose fertility is compromised after cancer therapy. Indeed, gonadotoxicity is a well-known long-term side effect of cancer treatment in young patients having survived malignant diseases. More than 80% of women of childbearing age, treated for breast cancer with standard protocol of neoadjuvant (4 cycles of 5-fluorouracile - epirubicin- cyclophosphamide (FEC) and 4 cycles of docetaxel) or adjuvant chemotherapy (3 FEC and 3 docetaxel), show an alteration of their ovarian reserve 2 years after completion of the treatment, as a result of chemotherapy-related follicular loss. Therefore, according to the extent of the follicular damages, the gonadal function may vary from moderate to severe diminished ovarian reserve (DOR) and possibly to the ultimate stage of premature ovarian insufficiency (POI). Investigators propose a multicentric and prospective study of a cohort of young women with breast cancer to evaluate whether genetic polymorphisms, previously identified as being correlated with age at menopause in the healthy population, are associated with the intensity of the follicular decline following chemotherapy in young breast cancer survivors.

NCT ID: NCT03731026 Not yet recruiting - Breast Cancer Clinical Trials

The LightPath® and 68Ga-RM2 in Breast Cancer Study

Start date: November 30, 2018
Phase: Phase 3
Study type: Interventional

This study is a prospective, open-label study to examine the performance of the LightPath® Imaging System using the PET tracer 68Ga-RM2 in patients scheduled for and/or undergoing wide local excision (WLE) with or without sentinel lymph node biopsy (SLNB) or complete axillary lymph node dissection(cALND) for breast cancer with an ER-positive invasive primary cancer. The study consists of 3 sequential groups: Group 1 (N=20 patients): Torso, i.e. base of skull to thighs, PET/CT imaging and axillary gamma probe measurements (using a collimator) of 68Ga-RM2 to: determine the optimal scan time-window post-injection; to extrapolate the optimal dose for resolution against axillary background signal on gamma probe measurements (first 6 patients); and the value of 68Ga-RM2 PET/CT imaging for breast cancer staging (all 20 patients). Group 2 (N=10 patients): Intraoperative LightPath® imaging with 68Ga-RM2 to familiarise site with procedure and interpretation of intraoperative scans,validate the dose and timings determined from Group 1, and optimise LightPath® Imaging parameters such as acquisition resolution and duration. Group 2 scans will acquire LightPath® images of both intact and incised cancer specimens for post-operative standardised, controlled assessment. Group 2 will use the optimal scan time-window and 68Ga-RM2 activity extrapolated from at least the first 6 patients in Group 1. The dose of 68Ga-RM2 will be determined to optimise the intra-operative imaging and axillary gamma probe measurements. Group 3 (N=50 patients): Intraoperative LightPath® imaging with 68Ga-RM2 to measure agreement between LightPath® images and post-operative histopathology. Group 3 scans will acquire LightPath® images of intact and incised cancer specimens for post-operative standardised, controlled assessment. Group 3 will use the optimal scan time-window and 68Ga-RM2 activity extrapolated from the first 6 patients in Group 1 with the optimised imaging parameters, and dose developed from Group 2. The intraoperative LightPath® Images will be used to inform the surgeons about detectable residual cancer in an attempt to achieve better guided cancer surgery and complete tumour excision with clear WLE resection margins The study site will use the local criteria considered standard of care to guide decisions to act on positive margins. Lightpoint Medical will provide guidance to act on LightPath® Images in the Instructions forUse (IFU). It will be at the Investigator's discretion to choose whether to act based upon the intraoperative LightPath® Images. In Group 3,the resection margin status of the WLE specimen, cavity shavings (if any) and the metastatic status of axillary (sentinel) lymph nodes as measured with the LightPath® Imaging System will be compared with histopathology results. A positive margin on histology will be defined as - Invasive carcinoma: positive: ink on tumour; close: <1mm; negative ≥1mm - Ductal carcinoma in situ (DCIS)or pleomorphic lobular carcinoma in situ (LCIS) (if present): positive: ink on tumour; close: <2mm; negative ≥2mm.