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Breast Cancer clinical trials

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NCT ID: NCT04535895 Withdrawn - Breast Cancer Clinical Trials

Simultaneous Integrated Boost Technique in Breast Cancer Radiotherapy

Start date: April 16, 2020
Phase: N/A
Study type: Interventional

Adjuvant radiotherapy after breast conserving surgery has been shown to improve both local control and overall survival. Dose escalation of the tumor bed by addition of a boost after whole breast radiotherapy reduces the risk of local recurrence in invasive breast cancer. Simultaneous integrated boost (SIB) techniques have been shown to provide more conformal treatment plans than conventional sequential boost, in addition, SIB enables a reduction in the overall treatment time by 1 week compared to conventional boost techniques. The proposed study is aimed at evaluating radiation-induced toxicity in patients treated with breast-conserving surgery in combination with radiotherapy using SIB technique.

NCT ID: NCT04535492 Withdrawn - Breast Cancer Clinical Trials

Technology-Based Cancer Screening Intervention

Start date: January 4, 2022
Phase: N/A
Study type: Interventional

The primary purpose of this research study is to contribute to generalized knowledge on how to increase screening for patients at risk of missing their recommended cancer preventive care by using a newly developed predictive model and analytic tool to improve shared decision-making for these patients. The goal of the clinical trial is to evaluate (prove) the effectiveness of this shared-decision making support tool developed in EPIC on the rate of recommended cancer screening in practice. It contributes to knowledge on what specific methods can increase patient adherence to recommended preventive care and reduce disparities.

NCT ID: NCT04512261 Withdrawn - Breast Cancer Clinical Trials

TOPAZ: Tucatinib in COmbination With Pembrolizumab And TrastuZumab in Patients With HER2-Positive Breast Cancer Brain Metastases

TOPAZ
Start date: June 1, 2022
Phase: Phase 1/Phase 2
Study type: Interventional

This is a single arm, open label trial to assess the safety and efficacy of tucatinib in combination with pembrolizumab and trastuzumab for the treatment of HER2+ breast cancer brain metastases (BCBM). A total of 33 patients with untreated or previously treated and progressing HER2+ BCBM not requiring urgent central nervous system (CNS)-directed therapy will be enrolled. The study will determine the recommended dose of tucatinib in this combination and assess the efficacy of this combination in controlling CNS disease in patients with HER2+ BCBM.

NCT ID: NCT04487912 Withdrawn - Breast Cancer Clinical Trials

Dynamics and Tracer Distribution of Tilmanocept in Early Stage Breast Cancer

Start date: November 24, 2020
Phase: Phase 4
Study type: Interventional

A sentinel node procedure is recommended for patients with early stages of breast cancer to exclude metastases to local lymph nodes. This procedure is done with a "tracer" which is injected near to the tumor and drains to these nearby lymph nodes. The first draining lymph node(s) are called "sentinel" node(s). These sentinel nodes are excised by the surgeon for microscopic investigation using a detection probe. This study aims to further document the distribution and dynamics of a recently approved new tracer called Tilmanocept and comparing it with the standard used tracer (nanocolloid) to determine whether there is a significant difference between both products (which are both approved for clinical use in this scenario in the European Union). This will be done by randomly assigning patients between injection of Tilmanocept or Nanocolloid and making scans on multiple (3) time points.

NCT ID: NCT04449809 Withdrawn - Breast Cancer Clinical Trials

Exercise Regimen Designed to Improve Functional Mobility, Body Composition, and Strength After Breast Conservation Therapy for Women With Early Stage Breast Cancer

EXERT-BC
Start date: September 2021
Phase: N/A
Study type: Interventional

The purpose of this research study is to find out if a monitored group exercise program can increase strength, muscle mass and ability to move in women after treatment for early stage breast cancer.

NCT ID: NCT04350957 Withdrawn - Breast Cancer Clinical Trials

Low-dose Imaging Technique (LITE)

Start date: August 24, 2020
Phase: N/A
Study type: Interventional

The purpose of this study is to compare the diagnostic accuracy of a breast MRI when using a smaller dose of contrast compared to a full dose of contrast. Each patient will be injected with a low-dose and standard dose of Gadavist® acquired on two separate days. Both low-dose and standard-dose images for each patient will allow matched comparison for comprehensive quantitative evaluation. To evaluate these diagnostic methods we need volunteers who are willing to allow us to take a number of different MRI pictures of their breasts. The scans we are asking you to volunteer for now is for research purposes only and will have no effect on the medical care you receive from your doctors.

NCT ID: NCT04292860 Withdrawn - Breast Cancer Clinical Trials

Reverse Axillary Mapping in Breast Radiation Treatment Planning

Start date: May 2021
Phase:
Study type: Observational

The goal of this prospective study is to investigate the role of axillary reverse mapping (ARM) in radiation therapy planning of patients with breast cancer. Lymphedema is a common side effect after surgery and radiation therapy for breast cancer. The use of ARM is becoming more routine in surgery to differentiate the upper extremity lymphatics (UELs) from the breast axillary drainage to preferentially spare the UELs and reduce the rates of lymphedema.

NCT ID: NCT04281355 Withdrawn - Breast Cancer Clinical Trials

Individualized Locoregional Treatment of Initially Biopsy-proven Node-positive Breast Cancer After Primary Systemic Therapy

INDAX
Start date: January 1, 2021
Phase: Phase 3
Study type: Interventional

In clinically node-positive (cN+) breast cancer, preoperative systemic therapy (PST) is common. With increasing rates of complete tumour eradication, there is a need for de-escalation of locoregional treatment in the interest of decreased morbidity. In order to individually adapt postoperative therapies, axillary staging is crucial. Axillary lymph node dissection (ALND) comes at a high risk of arm morbidity. There is extreme divergence in the use of less extensive staging methods, i.e. targeted lymph node biopsy (TLNB), sentinel node biopsy (SNB) or both (TAD), and in the use of subsequent locoregional treatment, since prospective data are largely lacking. The main purpose of the European INDAX trial is to implement de-escalated staging and evaluate which regional treatment, individually adapted to the response after PST, is oncologically safe but least harmful. Population: cN+ breast cancer patients receiving PST, recruited 2021-2025. Staging by TLNB, TAD or SNB. Intervention: Negative staging (ypN0, Randomisation A, N=1433): no regional treatment. Positive staging (ypN+, Randomisation B, N=1513): no ALND but regional radiotherapy (rRT). Control: Randomisation A: rRT only. Randomisation B: ALND plus rRT. Outcome: Invasive disease-free survival (non-inferiority), arm morbidity and quality of life. Drug tests in whole-tumour organoid cultures, algorithm-based digital image analysis and gene expression analysis are performed to improve response prediction, facilitate tailoring of PST and increase eradication rates.

NCT ID: NCT04232319 Withdrawn - Breast Cancer Clinical Trials

Feasibility and Effectiveness of a Sleep Hygiene Education Program for Sleep Issues in Breast Cancer Survivors

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

The proposed research will assess the feasibility and preliminary effectiveness of a Sleep Hygiene Program for Breast Cancer Survivors. Participants will complete assessments related to sleep issues, participate in a Sleep Hygiene Program, and complete another assessment post-intervention.

NCT ID: NCT04220476 Withdrawn - Breast Cancer Clinical Trials

CIMER: Combined Immunotherapies in Metastatic ER+ Breast Cancer

CIMER
Start date: March 4, 2020
Phase: Phase 2
Study type: Interventional

Women with Hormone Receptor (HR)+ Human Epidermal growth factor Receptor (HER)2- metastatic breast cancer are eligible to a randomized trial. Patients receiving standard first line therapy for metastatic HR+ Breast cancer(BC) (letrozole+palbociclib) are randomly assigned to also receive Stereotactic Body Radiation Therapy(SBRT) to each metastatic lesion.