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Breast Neoplasm clinical trials

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NCT ID: NCT04893421 Recruiting - Breast Neoplasm Clinical Trials

Magnetic Occult Lesion Localization Instrument (MOLLI) Guidance System for Breast Lesion Localization

Start date: May 16, 2021
Phase: N/A
Study type: Interventional

The proposed trial is a non-randomized, multi-center, sequential arm registry evaluating clinical, and health economic outcomes following treatment with the Magnetic Occult Lesion Localization Instrument (MOLLI), an approved instrument for Breast Conserving Surgery (BCS) in patients with non-palpable lesions. All patients who have an area of concern in the breast and are identified by their physician as good candidates for BCS are eligible to participate. Patients will eventually be enrolled across 4 surgical sites (Sunnybrook Health Sciences Centre - primary site, Princess Margaret Cancer Centre, St. Joseph's Healthcare, and North York General Hospital) over a 2 year period. Patient and system-related outcome measures will first be collected using the centre-specific standard of care (Wire-Guided Localization or Radioactive Seed Localization for BCS) to establish a baseline. Subsequently, centers will transition to the MOLLI system, recording corresponding outcomes to be used for temporal comparison. The overall objective of this study is to evaluate clinical and health economic outcomes with MOLLI compared to standard-of-care approaches.

NCT ID: NCT04861220 Not yet recruiting - Breast Neoplasm Clinical Trials

Surgical Pre-habilitation in Breast Cancer.

Start date: May 3, 2021
Phase: N/A
Study type: Interventional

The National Cancer Institute estimated 625 thousand new cases of cancer (excluding cases of non-melanoma skin cancer) in Brazil for each year between 2020-2022. In 2018, there were 2.1 million new cases of breast cancer in the world, being the first in the ranking of cancers in women. Practices in healthy eating and exercise can protect and / or decrease the risk of breast cancer and improve treatment results. Breast cancer treatments cause cardiovascular changes due to age-related factors, pre-existing chronic diseases and comorbidities such as obesity, smoking and dyslipidemia. Obesity is associated with the development of several types of cancer, including breast cancer. Therapies for breast cancer have a strong association with impaired cardiac function, ranging from permanent, transient cardiotoxic effects and changes in lipid metabolism. In addition to the cardiotoxic effects, the pathophysiology of cancer and treatment favor the appearance of muscle changes, such as sarcopenia. There is sufficient evidence to support that exercise improves fitness before, during and after the completion of cancer treatment. Pre-qualification in cancer treatment is an opportunity to increase physiological reserves before neoadjuvant therapies or surgery, with the intention of improving results and accelerating recovery. It can be composed of physical exercises, nutritional interventions, and psychosocial. Excess weight or depletion are factors that negatively influence surgical and cancer outcomes. In view of the evidence, the aim of this project is to evaluate the effectiveness of physical exercise in a surgical pre-habilitation program for women diagnosed with breast cancer undergoing cancer treatment with a curative therapeutic proposal at the National Cancer Institute in Rio de Janeiro. This is a randomized clinical trial, where patients will be randomly allocated to the Intervention Group and the Control Group. The patients in the intervention group will be instructed to practice physical exercises at home until the date of surgery and those in the control group will only be instructed to maintain their usual activities. All patients will be guided individually by a nutritionist with a view to a healthier nutritional status and control of comorbidities.

NCT ID: NCT04824599 Recruiting - Breast Neoplasm Clinical Trials

Pectoral Nerves Block vs Wound Infiltration for Partial Mastectomy - a Prospective Randomized Trial.

Start date: February 19, 2021
Phase: N/A
Study type: Interventional

Pectoralis nerves plane block (PECS) first described by Blanco in 2011 has become part of postoperative pain management in breast surgery, thoracic surgery and thoracic trauma. The combination of low complication risk and easiness in mastering of PECS block has made it an interesting alternative to thoracic epidural anesthesia (TEDA) and paravertebral blockade (PVB) for pain treatment after breast surgery. Several studies showed good results when PECS was compared to PVB. PECS blockade however is a procedure requiring some resources in the operating room. An alternative approach is to inject local anesthetics (LA) in the operation field by the surgeon. The hypothesis' tested in this study is primarily: that PECS blockade is superior to LA being injected by surgeon in the operating field measured by end points such as: post-operative pain, post-operative analgesics use, post-operative nausea or vomiting (PONV) and length of stay in the post anesthesia care unit (PACU).

NCT ID: NCT04767464 Enrolling by invitation - Breast Cancer Clinical Trials

Feasibility of Providing a Purpose Renewal Intervention for Cancer Survivors Via Virtual Groups

Start date: March 1, 2021
Phase: N/A
Study type: Interventional

The Compass Course (CC) is a group intervention designed for individuals with Breast Cancer. Over the course of 8 face-to-face group sessions, the CC is designed to help participants reclaim a sense of self-grounded purpose in daily life, defined as intentional use of time and energy in ways that align with one's values, strengths, and sources of personal meaning (e.g., inner compass) in the moments that compose a day. Because of COVID-19, in-person groups are discouraged and so we need to identify new ways to provide group-based interventions that are feasible and efficacious.

NCT ID: NCT04660929 Recruiting - Breast Cancer Clinical Trials

CAR-macrophages for the Treatment of HER2 Overexpressing Solid Tumors

Start date: February 2, 2021
Phase: Phase 1
Study type: Interventional

Phase 1, first-in-human, open label study of CAR macrophages in HER2 overexpressing solid tumors.

NCT ID: NCT04652609 Not yet recruiting - Breast Neoplasm Clinical Trials

Preventing Chemotherapy-induced Peripheral Neuropathy Using PRESIONA Exercise Program

Start date: January 1, 2021
Phase: N/A
Study type: Interventional

The aim of this study is to determinate if therapeutic exercise with blood flow restriction (BFR) during neoadjuvant chemotherapy potentialy neurotoxic could prevent the onset of chemotherapy induced peripheral neuropathy (CIPN) comparing to usual care.

NCT ID: NCT04644848 Recruiting - Breast Neoplasm Clinical Trials

Ultrasonographic Axillary Localization

Start date: December 15, 2020
Phase: N/A
Study type: Interventional

Breast cancer is the most common cancer of women. Surgery for early breast cancer includes axillary lymph nodes staging. Axillary surgery may lead to intractable complications like permanent arm swelling. Axillary sentinel lymph node biopsy (SLNB) has been introduced to minimize the incidence of these complications. Several methods are routinely used for identification of the sentinel node during operation. Some of these methods necessitate facilities that are not universally available; specially in countries with limited resources. In its simplest form, SLNB using the methylene blue dye technique has an identification rate of 88-94%. If the sentinel node can not be identified, full axillary dissection may be required and the risk of arm swelling is increased. The objective of this study is to maximize the identification rate of the sentinel node thus avoiding the need for extensive axillary surgery. The investigators assumed that preoperative tattooing of the suspicious lymph node during ultrasonographical imaging may help the surgeon in localizing the sentinel lymph node. In this study, the sonographer will perform preoperative tattooing of the suspicious node. The surgeon will perform SLNB by the methylene blue dye. The sensitivity of ultrasonographical tattooing relative to SLNB will be calculated. The study will determine if the tattooing technique may localize additional nodes that are missed by the methylene blue.

NCT ID: NCT04640220 Recruiting - Breast Neoplasm Clinical Trials

Improvement of Range of Motion in Frozen Shoulder in Breast Cancer Survivors

Start date: October 26, 2020
Phase: N/A
Study type: Interventional

The prevalence of shoulder joint disease is high in breast cancer patients. The cause of adhesive capsulitis is not clearly identified. However, the following are known as relevant factors that are the restriction of the use of the arm after surgery, inflammation due to autoimmune action, radiation therapy, and adhesion of the surgical site. The purpose of this study is to compare and analyze the effect of intrathecal steroid injection in breast cancer survivors with adhesive capsulitis.

NCT ID: NCT04583124 Recruiting - Breast Neoplasm Clinical Trials

Adjusting the Dose of Therapeutic Exercise to Prevent Neurotoxicity Due to Anticancer Treatment (ATENTO)

Start date: September 30, 2020
Phase: N/A
Study type: Interventional

The purpose of this study is to determine whether a multimodal program based on therapeutic exercise and vagal activation techniques for newly diagnosed breast cancer women has better results in terms of neurotoxicity prevenion before or during medical treatments.

NCT ID: NCT04489173 Recruiting - Breast Neoplasm Clinical Trials

TAS102 in Patients With ER-positive, HER2-negative Advanced Breast Cancer

Start date: September 25, 2020
Phase: Phase 2
Study type: Interventional

This is a multicenter phase 2 study evaluating the efficacy and safety of trifluridine/tipiracil in women with metastatic or locally advanced breast cancer not amenable to curative treatment by surgery or radiotherapy.