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Breast Neoplasms clinical trials

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NCT ID: NCT04882371 Completed - Breast Cancer Clinical Trials

Comparison of MRI With PET / CT in the Evaluation of Response to Neoadjuvant Therapy Based on the Molecular Subtypes of Breast Cancer

Start date: January 1, 2018
Phase:
Study type: Observational

The current study aims to determine the diagnostic accuracy of Magnetic Resonance Imaging (MRI) and Positron Emission Tomography- Computed Tomography (PET-CT) in predicting a pathological response of molecular subtypes of breast cancer to neoadjuvant chemotherapy (NAC).

NCT ID: NCT04881929 Recruiting - Breast Cancer Clinical Trials

Study of KN026 in Combination With Docetaxel as Neoadjuvant Therapy in HER2-positive Breast Cancer

Start date: August 9, 2021
Phase: Phase 2
Study type: Interventional

This is an open-lable, multicenter, and single arm phase II trial to evaluate treatment with KN026 plus docetaxel as neoadjuvant therapy in patients with early-stage (T1c or 2, N1, M0; T2 or 3, N0, M0) or locally advanced (T1c or 2 or 3, N2, M0; T3N1M0; T1c or 2 or 3, N3a or 3b, M0) HER2-positive breast cancer. The subjects will receive KN026 30 mg/kg IV + Docetaxel 75/m2 every 3 weeks for four cycles prior to surgery.

NCT ID: NCT04881604 Completed - Breast Neoplasms Clinical Trials

Adjustable Compression Wrap Versus Compression Sleeve to Control Breast Cancer-related Lymphedema

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

This is a randomized clinical trial, in which the use of an Adjustable compression wrap as a compressive therapy to control the upper limb volume of with lymphedema women secondary to breast cancer will be investigated, in comparison to the use of a compression sleeve conventionally used. It is expected that Adjustable compression wrap will be more effective than standard treatment for the control of lymphedema, in addition to promoting a better quality of life and functionality for women.

NCT ID: NCT04880369 Withdrawn - Breast Cancer Clinical Trials

Phytoestrogens and Breast Cancer - Effects of Phytoestrogens on Markers of Disease Progression and Gene Expression

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

The aim is to investigate if soy isoflavones and lignans affect markers of disease progression and gene expression among breast cancer patients receiving neo-adjuvant treatment in a three arm, double-blinded, randomized placebo-controlled trial (RCT) comparing: soy isoflavone supplementation, lignan supplementation, and placebo.

NCT ID: NCT04879888 Completed - Clinical trials for Breast Cancer Female

Personalized Vaccine for Cancer Immunotherapy

Start date: August 2016
Phase: Phase 1
Study type: Interventional

Due to their genetic instability, breast tumors that do not express receptors for Estrogens, Progestagens or amplify the Her2 / neu oncogene [called triple-negative breast cancer (TNTC)] and other tumors such as melanoma, non-small cell lung cancer, accumulate numerous mutations that make them highly resistant to different regimens of chemo- or radiotherapy, thereby generating high morbidity and mortality. However, immunology can turn the genetic instability of tumors into the Achilles' tendon. Evidence of this has been revealed in Phase I clinical studies in patients with melanoma and lung cancer in an advanced stage of metastasis treated with Ipilimumab (anti-CTLA4) to decrease immunosuppression, in whom peptides containing mutations presented in Major Complex molecules Histocompatibility of Class I (HCM I) of the tumor itself results in their recognition as "foreign" neo-antigens leading to the efficient destruction of the tumor by anti-tumor CD8 + T lymphocytes that are amplified when they are vaccinated with these peptides. For this reason, the identification of non-synonymous mutations of single amino acid and vaccination with 25 amino acid peptides that incorporate these mutations (synthetic vaccines) is emerging today as an alternative for immunotherapy of cancers responsible for high mortality in humans. In an approach that takes 16 weeks, today, it is possible to go from the analysis of the tumor's transcriptome (which allows identifying the universe of tumor mutations) to the patient's vaccination with a personalized vaccine that contains neo-antigens of his tumor. TNBC is the most aggressive breast tumor, representing around 25% of breast cancers in our environment. While generally, at least 30% of women with other types of metastatic breast cancer survive 5 years after diagnosis, most patients diagnosed with metastatic CMTN die within this time. The lack of selective therapies and the poor prognosis of patients with NTMC make their therapeutic management difficult, so the implementation of new therapies for this type of tumor is the main focus of researchers who seek more effective and selective treatments to improve the life expectancy of patients without compromising their quality of life. The genetic instability and high rate of mutations of the TNBC most likely favor the generation of neo-epitopes. Still, due to the immunosuppressive environment of the tumor, it escapes the immunosurveillance of the immune system. Despite the high mortality induced by this tumor, a percentage of patients treated with neoadjuvant chemotherapy with agents such as Doxorubicin and Cyclophosphamide (AC) + Taxanes respond to this chemotherapy regimen. In particular, the anti-tumor effect of AC is attributed to two things: (i) the direct cytotoxic effect on the tumor cell, (ii) the immunostimulation of T lymphocytes promoted by Immunogenic Cell Death (ICM) selectively induced by these drugs. Therefore, in this project, we propose to carry out the first clinical study in Colombia of vaccination of patients with TNBC with synthetic peptides that contain mutations of their own tumor to evaluate the immunogenicity and safety of this type of personalized vaccine as a therapeutic alternative for this tumor. Achieving the specific objectives set out in this project would mean that we have been validated in Colombia the experimental design necessary to identify unique epitopes in tumors and demonstrate the safety and immunogenicity of these vaccines. We consider that having achieved the above; we will have taken an important step towards the implementation in our country of the use of this type of vaccine for immunotherapy not only of TNBC but of other tumors such as glioblastoma, gastric, esophagus, and pancreas, highly fatal due to its high mutation rate.

NCT ID: NCT04879849 Completed - Clinical trials for Carcinoma, Non-Small-Cell Lung

A Study of TAK-676 With Pembrolizumab After Radiation Therapy to Treat a Number of Cancers

Start date: September 9, 2021
Phase: Phase 1
Study type: Interventional

In this study, adults with non-small-cell lung cancer (NSCLC), triple-negative breast cancer (TNBC) and squamous-cell carcinoma of the head and neck (SCCHN) will be treated with TAK-676 and pembrolizumab following radiotherapy. The main aims of this study are to check if people are improving after treatment with TAK-676, getting side effects from these combined treatments, and how much TAK-676 people with these cancers can receive without getting unacceptable side effects from it. Participants will receive radiotherapy, then at least 40 hours later will receive pembrolizumab followed by TAK-676 slowly through a vein (infusion). Participants will receive an infusion of pembrolizumab at the same dose every 3 weeks. Different small groups of participants will receive lower to higher doses of TAK-676 on specific days of a 21-day cycle. This study will be happening at sites in North America.

NCT ID: NCT04879680 Completed - Breast Cancer Clinical Trials

Indocyanine Green Fluorescence-guided Sentinel Node Biopsy in Breast Cancer Within a North African Population: a Retrospective Study

Start date: April 2016
Phase:
Study type: Observational

Background Radio Isotopes and Blue dye alone or in combination are the most commonly used tracer agents in sentinel Node Biopsy for early breast cancer. Recent studies have found fluorescence method using Indo Cyanine Green as a promising technology with fewer disadvantages. This study represents the first within a North African setting. Methods Retrospective analysis of our database that includes patients with clinically node-negative breast cancer scheduled for breast surgery and SN biopsy between 2016 and January 2021. Patients who underwent detection using fluorescence-ICG were included in this study.

NCT ID: NCT04879264 Not yet recruiting - Clinical trials for Breast Cancer Female

Sleep Disorders Prior to and During a Course of Radiotherapy for Breast Cancer

RADIO-SLEEP
Start date: June 1, 2021
Phase: N/A
Study type: Interventional

The main goal of the study is to evaluate sleep disorders in breast cancer patients prior to and during a course of radiotherapy in terms of severity of sleep disorders, distress for the patients and use of sleeping drugs, in order to evaluate the potential effect of habituation to radiotherapy during the course of treatment and generate hypotheses thereof. The patients will be asked to complete a questionnaire prior to radiotherapy, after 5 and 15 fractions of radiotherapy, and at the end of radiotherapy. The questionnaire includes questions regarding symptoms, distress, sleep disorders and sleeping drugs. In addition, a questionnaire regarding the use of smartphones / tablets will be completed prior to radiotherapy. Forty-eight patients with documented start of radiotherapy and with a documented completed questionnaire at baseline and at least one completed questionnaire after start of radiotherapy should be subjected to statistical analysis. Assuming that 5% of patients do not fulfil these requirements, a total of 51 patients should be enrolled to this study.

NCT ID: NCT04878666 Recruiting - Breast Cancer Clinical Trials

Prospective Assessment of Quality of Life in Patients With Locally Recurrent Breast Cancer and Hyperthermic Radiotherapy

UKT HT03_1
Start date: August 1, 2020
Phase:
Study type: Observational [Patient Registry]

Prospective assessment of Quality of Life in patients with locally recurrent breast cancer after close R0, R1 or R2 resection or local inoperability and hyperthermic radiotherapy.

NCT ID: NCT04877912 Recruiting - Breast Cancer Clinical Trials

Accurate, Rapid and Inexpensive MRI Protocol for Breast Cancer Screening

Start date: September 17, 2020
Phase:
Study type: Observational

The purpose of this study is to test an innovative MRI breast cancer screening method in women with mammographically dense breasts as well as other women with moderately increased cancer risk. MRI, combined with other methods of risk assessment, has potential to significantly improve sensitivity to cancer in dense breasts and detect cancer in all cases at a much earlier stage, with far fewer interval cancers than mammography. Previous tests of MRI sensitivity show that this screening could significantly increase the likelihood of detecting invasive cancers resulting in decreased mortality from breast cancer. Suspicious lesions will be defined by the clinical interpretation of the breast MRI images performed by the attending breast radiologists. Based on the radiologist determination that the MRI findings are suspicious (these findings include masses, non-mass enhancement and foci), suspicious lesions will be assigned a Bi-Rads code specifying whether additional work up or biopsy is necessary. These are Bi-Rads codes 0, 4 and 5. False positive diagnosis should be minimized as all attending physicians reading breast MRI at this institution are fellowship trained in breast imaging.