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Breast Neoplasms clinical trials

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NCT ID: NCT04102722 Recruiting - Clinical trials for Breast Cancer Screening

Safety and Performance of the Multi-Modal UltraSound Tomography (MUST) Device in Breast Cancer Screening

Start date: January 14, 2020
Phase: N/A
Study type: Interventional

This is a single-center, pilot study being conducted to evaluate the safety and performance of the investigational device (MUST) in detecting malignant lesions in breast tissue.

NCT ID: NCT04102618 Terminated - Breast Cancer Clinical Trials

A Window-of-opportunity Study of Pelareorep in Early Breast Cancer

AWARE-1
Start date: March 29, 2019
Phase: Early Phase 1
Study type: Interventional

The purpose of this study is to find out if pelareorep in combination with different therapies helps to reduce the growth of breast cancer cells and increase the immune system's response to cancer. This study will also help to understand what this treatment does to the tumor. In addition, the safety of the combination treatments with pelareorep will be evaluated.

NCT ID: NCT04101851 Recruiting - Breast Cancer Clinical Trials

Omission of SLNB in Triple-negative and HER2-positive Breast Cancer Patients With rCR and pCR in the Breast After NAST

Start date: January 13, 2021
Phase: N/A
Study type: Interventional

Currently, axillary surgery for breast cancer is considered as staging procedure that does not seem to influence breast cancer mortality, since the risk of developing metastasis depends mainly on the biological behaviour of the primary (seed-and-soil model). Based on this, the postsurgical therapy should be considered on the basis of biologic tumor characteristics rather than nodal involvement. Improvements in systemic treatments for breast cancer have increased the rates of pathologic complete response (pCR) in patients receiving neoadjuvant systemic therapy (NAST), offering the opportunity to decrease, and perhaps eliminate, surgery in patients who have a pCR. The investigators designed a clinical trial in which only patients with the highest likelihood of having a pCR after NAST (triple-negative or HER2-positive breast cancer) will be included and type of surgery will be defined according to the response to NAST rather than on the classical T and N status at presentation. In the planned trial, axillary surgery will be eliminated completely (no axillary sentinel lymph node biopsy [SLNB]) for initially cN0 patients with radiologic complete remission (rCR) and a breast pCR as determined in the lumpectomy specimen. The trial design is a multicenter single-arm study with a limited number of patients (N=350) which might give practice-changing results in a short period of time, sparing the time and the costs of a randomized comparison. Patients will be recruited in European countries (Austria, Germany, Italy, and Spain) over a period of 48 months.

NCT ID: NCT04101656 Recruiting - Breast Cancer Clinical Trials

Accelerated Partial Irradiation of the Breast: New Altered Fractionation

Start date: October 15, 2019
Phase:
Study type: Observational

The aim of this observational study is to evaluate a dose fractionation scheme for APBI using external radiotherapy with modulated intensity technique (IMRT), with the possible impact on the quality of life of patients as it decreases the treatment number of sessions and improves the efficiency and accessibility.

NCT ID: NCT04098926 Completed - Breast Cancer Clinical Trials

Highly Accelerated Dose-Integrated Radiotherapy in 5 Fractions in Breast Cancer

HAI-5
Start date: January 2015
Phase: N/A
Study type: Interventional

Adjuvant radiotherapy in breast cancer improves local control, also in the elderly. Hormonal therapy in hormone sensitive tumors improves results but can not substitute radiotherapy. Improved local control leads to less breast cancer related morbidity and mortality, also in an older population (Schonberg, JCO, 2011). Unfortunately, in older patients with lower life expectancy, adjuvant radiotherapy is often omitted. Following reasons are invoked: - frailty of the patient - fear for toxicity - impaired mobility, rendering transportation and positioning more difficult - dependency for transportation to and from the radiotherapy departement - negative cost effectiveness ratio, due to high cost (especially for complex techniques and long schedules) and lower benefit (lower life expectancy) Hypofractionation is feasible without increased toxicity, and combines better local control with patient comfort and lower costs. Further lowering the number of fractions (from 15-21 to 5) will further improve patient comfort, but is challenging when different doses are needed in the same target volume. This problem is addressed using advanced techniques permitting dose-integration. In the elder with cancer, several unrecognized geriatric problems, including depression and cognitive impairment, can be detected by CGA . Some problems do interact with cancer treatment. In this study screening and assessment is provided to support patients and to develop an inventory of radiotherapy obstacles. Our study includes breast cancer patients, ≥70 years old, referred for adjuvant radiotherapy after surgical treatment. A schedule of 5 fractions is offered, encompassing different targets of treatment.

NCT ID: NCT04098783 Completed - Breast Cancer Clinical Trials

Health Belief Model Based Nursing Interventions on Lymphedema Prevention

Start date: May 15, 2016
Phase: N/A
Study type: Interventional

Aim: The study was performed to examine effects of Health Belief Model based nursing interventions given at home visits on prevention of lymphedema in women having breast surgery. Methods: The study had an experimental design. 72 women receiving radiotherapy after breast surgery, of whom 37 formed the intervention group and 35 formed the control group. The study had an experimental design. Data were collected with a personal information questionnaire, Quick-Disabilities of the Arm, Shoulder and Hand Score (Q-DASH), European Organization for Research and Treatment of Cancer Quality of Life for Breast Cancer 23 (EORTC QLQ-BR23), Strategies Used by Patients to Promote Health (SUPPH), Arm Circumference Form at three home visits at three-month intervals. Hypotheses of the study 1. Extremity function restrictions will be lower in the intervention group than in the control group. 2. Self-efficacy levels will be higher in the intervention group than in the control group. 3. Functions improving the quality of life will be higher in the intervention group than in the control group. 4. There will be fewer symptoms reducing the quality of life in the intervention group than in the control group. 5. The incidence of lymphedema will be lower in the intervention group than in the control group. 6. The mean cost of the intervention group at home visits, will be lower than in the control group. What does this paper contribute? - Nurses can play an effective role in enabling women undergoing breast surgery to acquire behavior of lymphedema prevention. This may reduce treatment costs. - Future research should evaluate collaborative models of care in general practice aimed at improving lymphedema prevention for women undergoing breast surgery. - Policymakers should consider introducing funding measures for breast cancer survivors by nurses.

NCT ID: NCT04098640 Enrolling by invitation - Breast Cancer Clinical Trials

Molecular Profiling in Young (<50 Years of Age) Patients With Metastatic Breast Cancer

Start date: September 2019
Phase: N/A
Study type: Interventional

Breast cancer is the most common cancer in women worldwide, especially in developed countries. In developing countries, including South Korea, the incidence and mortality rate of breast cancer is rapidly increasing. One of the most important characteristics of breast cancer in South Korea, as well as in other Asian countries, is the younger onset of disease compared to Western. Medical treatment of breast cancer is evolving rapidly, incorporating immune checkpoint blockades and molecularly targeted agents. However, data and knowledge are still limited in terms of molecular characteristics of Asian breast cancer, compared to that of Western countries, and this remains a major hurdle for drug development in Asian breast cancer patients. The primary objective of this study is to elucidate the genetic characteristic of young (<50 years of age) Korean patients with metastatic breast cancer using FoundationOne CDx.

NCT ID: NCT04097756 Completed - Clinical trials for Advanced Breast Cancer

A Phase I Study of LX-039 Tablets

Start date: January 7, 2020
Phase: Phase 1
Study type: Interventional

This is a phase I dose escalation and expansion study in patients with ER+, HER2- advanced breast cancer to explore the tolerance, PK/PD(pharmacokinetics/pharmacodynamics) profiles and preliminary anti-tumor activity of different doses of LX-039 tablets. The trial consists of two parts, dose escalation and dose expansion. Part 1 is the dose escalation phase with initial 6 dose groups, and "3 + 3" design is used to explore MTD of the drug; Part 2 is the dose expansion phase with 2 ~ 3 doses selected for expansion according to the escalation results of Part 1, and more subjects are enrolled to further observe the tolerance and preliminary anti-tumor activity of the drug. After the completion of dose expansion, the recommended phase II dose (RP2D) will be determined after discussion based on the obtained tolerance and PK/PD data.

NCT ID: NCT04095689 Suspended - Clinical trials for Triple Negative Breast Cancer

Docetaxel Chemotherapy and Pembrolizumab Plus Interleukin-12 Gene Therapy in Triple Negative Breast Cancer

INTEGRAL
Start date: March 17, 2021
Phase: Phase 2
Study type: Interventional

The purpose of this research study is to test the safety and effectiveness of docetaxel chemotherapy and pembrolizumab plus adenoviral-mediated interleukin-12 (ADV/IL-12) gene therapy in patients with anthracycline-refractory, triple negative breast cancer (TNBC).

NCT ID: NCT04095390 Recruiting - Clinical trials for Metastatic Breast Cancer

A Phase Ⅱ Trial of Pyrotinib Combination With CDK4/6 Inhibitor SHR6390 in Patients Prior Trastuzumab-treated Advanced HER2-Positive Breast Cancer

INPHASE
Start date: September 30, 2019
Phase: Phase 2
Study type: Interventional

The study is being conducted to evaluate the efficacy, safety and tolerability of pyrotinib combination with CDK4/6 Inhibitor SHR6390 in advanced HER2-Positive breast cancer patients who prior trastuzumab-treated.