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Breast Neoplasms clinical trials

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NCT ID: NCT03022864 Enrolling by invitation - Chronic Pain Clinical Trials

Accurate Diagnosis System for Postoperative Chronic Pain Based on fMRI

Start date: October 2016
Phase: N/A
Study type: Observational [Patient Registry]

Postoperative pain is an ideal model for study on acute pain changing into chronic pain. The functional imaging of magnetic resonance can reflect the extent and character of pain exactly and the structural imaging of it can be a sign of the change. By analyzing fMRI results of participants with acute pain and following them up for three months, the investigators expect to find objective indicators for acute pain changing into chronic pain and give preventive analgesia for people with high risk of chronic pain.

NCT ID: NCT03022162 Completed - Neuropathic Pain Clinical Trials

Prevalence of Paclitaxel Induced CIPN-Related Pain and CIPN in Indian Patients With Breast Cancer

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

Since its introduction in the 1970s, Paclitaxel has been used as an effective anticancer agent against lung, breast, ovarian, leukopenia and liver cancer. But, Paclitaxel-induced peripheral neuropathy is the major dose-limiting side effect of paclitaxel.Paclitaxel induced peripheral neuropathy most commonly presents as 1. Pain 2. Burning, 3. Tingling ("pins and needles" feeling) or electric/shock-like pain, 4. Hyperalgesia, 5. Allodynia, 6. Increased sensitivity to cold or heat These symptoms are classically seen symmetrically in the distal extremities (glove and stocking distribution). Most adverse effects associated with chemotherapy are ameliorated after cessation of the therapy, but CIPN may persist in the longterm, with 30 % patients having CIPN related symptoms beyond 6 months after completion of chemotherapy7.Understanding the epidemiology of neuropathic pain in breast cancer patients has high clinical and public health significance.

NCT ID: NCT03021200 Recruiting - ColoRectal Cancer Clinical Trials

Laser Fluorescence in Cancer Surgical Treatment

Start date: July 12, 2016
Phase: N/A
Study type: Interventional

The use of fluorescence for real-time evaluation of organ and tissue vascularization and lymph node anatomy is a recent technology with potential for the surgical treatment of cancer. The real-time analysis of tissue vascularization allows immediate identification to the surgeon of areas with greater or lesser blood circulation, favoring surgical decision making and prevention of complications related to tissue ischemia (necrosis, dehiscences and infections). It is a technology with potential application in the areas of Digestive Surgery, Repairing Plastic Surgery in Oncology, Head and Neck Surgery. In addition, fluorescence can be used as a method to identify lymph node structures of interest in the oncological treatment of patients with urologic, gynecological and digestive tumors. Introduced by Pestana et al. In the late 2000s, the perfusion mapping system through intraoperative indocyanine assisted laser angiography (SPY Elite System © LifeCell Corp., Branchburg, N.J.) had its initial application in repairing surgery after breast cancer treatment. The method proved to be useful in the prevention of ischemic and infectious complications in cancer surgery. Pestana, in a prospective clinical series of 29 microsurgical flaps used in several reconstructions, observed a single case of partial loss of the flap, the present technology having a relevant role in intraoperative decision making. In the same year, Newman et al. The first application of the system in breast reconstruction surgery. In an initial series of 10 consecutive cases of reconstruction with microsurgical flaps, in 4 cases the system allowed the intraoperative identification of areas of low perfusion, thus changing the surgical procedure. According to the authors, there was a 95% correlation between indocyanine laser assisted and subsequent development of mastectomy skin necrosis, with sensitivity of 100% and specificity of 91%. Similarly, Murray et al. Evaluated the intraoperative perfusion, however, of the areola-papillary complex in patients submitted to subcutaneous mastectomies with satisfactory results in terms of predictability of cutaneous circulation. Other authors in larger clinical series and evaluating other procedures have observed valid results in terms of prevention of complications. Vascular perfusion of anastomoses and fistulas following bowel surgery for cancer remain a serious and common complication. These fistulas can be caused by insufficient perfusion of the intestinal anastomosis. Intraoperative angiography with indocyanine assisted laser can be used to visualize the blood perfusion following intravenous injection of the indocyanine green contrast. Several groups reported the ability to assess blood perfusion of the anastomotic area after bowel surgery. Although they studied retrospectively, Kudszus and colleagues described a reduction in the risk of revision due to fistula in 60% of patients whose anastomosis was examined using laser fluorescence angiography compared to historically paired patients without this method. The same principle can be used to evaluate the tubulized stomach to be transposed to the cervical region after subtotal esophagectomy. Currently, fluorescence-guided sentinel lymph node mapping has been studied in breast cancer as well as investigative character in colorectal cancer, skin cancer, cervical cancer, vulvar cancer, head and neck, lung cancer, penile cancer, cancer Endometrial cancer, gastric cancer and esophageal cancer. These early studies demonstrated the feasibility of this methodology during surgery. Comparison of laser fluorescence images on blue dyes indicate that fluorescence images can replace blue dyes because they exceed them due to increased tissue penetration depth and absence of staining in the patient and cleaning of the operative field. To date, there are no clinical studies involving intraoperative perfusion mapping and identification of lymph node structures with the SPY Elite System © system or other platforms (Pinpoint or Firefly) in Brazil that evaluate the Brazilian population. In an objective way the influence of this technology as predictive in the better or worse evolution of the oncologic surgery as well as in the prevention of the local ischemic complications by means of intraopeal change of conduct

NCT ID: NCT03018080 Completed - Male Breast Cancer Clinical Trials

Pilot Study of Paclitaxel Plus Pembrolizumab in Metastatic HER2-Negative Breast Cancer

PePPy
Start date: June 12, 2017
Phase: Phase 2
Study type: Interventional

The primary objective of this study is to assess the safety and feasibility of the following two regimens: Cohort A) phased regimen of pembrolizumab in which paclitaxel is followed by paclitaxel plus pembrolizumab and Cohort B) concurrent regimen of paclitaxel plus pembrolizumab. The primary safety objective is to evaluate the overall grade 3 or 4 treatment-related adverse event rate for each cohort and compare them to relevant historical controls.

NCT ID: NCT03017560 Completed - Cognitive Deficits Clinical Trials

Treating Verbal Memory Deficits Following Chemotherapy for Breast Cancer

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

The primary purpose of this study is to test the effects of a targeted, computerized cognitive training program on verbal memory in older women who have undergone chemotherapy treatment for early-stage breast cancer. As measured by neuropsychological assessment, this treatment will result in improved verbal memory. Secondarily, processing speed and naming abilities are expected to improve. Enhanced self-perception of cognitive ability is also expected.

NCT ID: NCT03017404 Completed - Breast Cancer Clinical Trials

A Dose Increase Finding Study of Doxorubicin Hydrochloride Liposome Injection for Patients With Breast Cancer

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

To study the maximum tolerated dose of Doxorubicin Hydrochloride Liposome Injection combination with cyclophosphamide and sequential treatment of docetaxel for patients with locally advanced breast cancer

NCT ID: NCT03014076 Completed - Breastcancer Clinical Trials

Immunotherapy Vaccine and Herceptin in Breast Cancer

Start date: January 2008
Phase: Phase 1
Study type: Interventional

The purpose of this trial is to determine if combination immunotherapy with HER2/neu GP2 peptide + GM-CSF vaccine and trastuzumab is safe and immunologically effective in treatment of patients with HER2/neu over-expressing breast cancer in the adjuvant setting. While not a primary endpoint, time to recurrence is measured for enrolled subjects. The objectives of the study are the following: - Assess safety and document local and systemic toxicity to combination immunotherapy with GP2 peptide + GM-CSF vaccine and trastuzumab - Evaluate the in vitro and in vivo immunologic responses to combination immunotherapy of GP2 peptide + GM-CSF vaccine and trastuzumab - Determine maximum tolerated dose and optimal biologic dose for the combination immunotherapy of GP2 peptide + GM-CSF vaccine and trastuzumab

NCT ID: NCT03013881 Completed - Breast Neoplasm Clinical Trials

A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of UB-921 in Healthy Volunteers

Start date: March 5, 2018
Phase: Phase 1
Study type: Interventional

The purpose of the study is to evaluate the safety, tolerability, and pharmacokinetics of escalating single-dose of UB-921 in healthy male volunteers.

NCT ID: NCT03013504 Completed - Clinical trials for HER2 Positive Breast Cancer

A Phase III Trial to Compare the Efficacy, Safety and Pharmacokinetics of HD201 to Herceptin® in HER2+ Early Breast Cancer Patients

TROIKA
Start date: February 19, 2018
Phase: Phase 3
Study type: Interventional

In the TROIKA study, the proposed biosimilar HD201 will be compared to its reference product Herceptin®. The aim of the study is to demonstrate equivalence of HD201 and Herceptin® in terms of efficacy, safety and pharmacokinetics.

NCT ID: NCT03012893 Completed - Breastcancer Clinical Trials

Identification of C7; Evaluations of 2 Sonographic Methods Using a Transverse and a Sagittal Scan.

Start date: December 2016
Phase: N/A
Study type: Interventional

To determine the accuracy of two techniques (transverse scan and sagittal scan) using ultrasonography to identify C7 spinous process compare to the fluoroscope (standard technique)