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Breast Cancer clinical trials

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NCT ID: NCT05037019 Withdrawn - Breast Cancer Clinical Trials

SIGNAL During a COVID-19 Pandemic

Start date: May 2020
Phase: N/A
Study type: Interventional

The standard treatment for early stage, estrogen-receptor positive breast cancer is lumpectomy and sentinel lymph node biopsy followed by 16-25 treatments of adjuvant whole-breast radiation therapy plus or minus hormone therapy. However, the COVID-19 pandemic has necessitated changes in the way breast cancer is treated in order to reduce contact between individuals, reduce spread of the novel coronavirus, and lessen the impact on health care resources. As elective surgeries are being cancelled, current pandemic guidelines recommend that patients be started on hormone treatment while waiting for surgeries to be re-instated. Only after this surgery occurs will patients receive radiation treatment, dramatically extending the time between diagnosis and end of treatment. Emergency pandemic guidelines in the UK and other countries recommend 5 fractions of pre-operative radiation therapy where appropriate. Based on previous work in the SIGNAL 1.0 and SIGNAL 2.0 clinical trials, the investigators are proposing treating patients with early stage breast cancers with one single fraction of stereotactic neoadjuvant radiation during the pre-operative waiting period. This will allow patients to complete radiation therapy upfront while reducing the number of patient visits to hospital. This will also allow investigators to evaluate the ability of single-fraction targeted radiation to induce a pathologic complete response.

NCT ID: NCT04917640 Withdrawn - Breast Cancer Clinical Trials

Registry for Accelerated Partial Breast Irradiation With (SBRT) or (IMRT)

Start date: June 2021
Phase:
Study type: Observational

This is a registry study that will be used to evaluate external beam radiation therapy methods for the accelerated treatment of breast cancer. Patients are being asked to take part in this registry because they have breast cancer and desire treatment with accelerated partial breast irradiation to be delivered by external beam methods.

NCT ID: NCT04880369 Withdrawn - Breast Cancer Clinical Trials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: NCT04828044 Withdrawn - Breast Cancer Clinical Trials

Microwave Ablation of Breast Tumors

Start date: September 2012
Phase:
Study type: Observational

The purpose of this protocol is to pathologically evaluate the amount of destruction of cancer cells by Microwave Ablation (MWA) in primary breast tumors.

NCT ID: NCT04762901 Withdrawn - Breast Cancer Clinical Trials

LCI-BRE-MTN-NIR-001:Ph I Study of Niraparib in Combo With Standard Chemo in Metastatic Trip Neg Breast Cancer

Start date: April 1, 2021
Phase: Phase 1
Study type: Interventional

This is an open-label, two-stage, multi-arm Phase 1 study designed to evaluate the safety and preliminary efficacy of combining niraparib with four standard chemotherapy regimens used to treat TNBC.

NCT ID: NCT04655183 Withdrawn - Breast Cancer Clinical Trials

Study of M4344 in Combination With Niraparib

Start date: December 1, 2020
Phase: Phase 1/Phase 2
Study type: Interventional

Study will include 3 parts. Aim of Part 1 of this study is to establish the maximum tolerated dose (MTD) and recommended dose for expansion (RDE) for M4344 (is an Ataxia Telangiectasia Mutated and Rad3-related [ATR] inhibitors) in combination with niraparib in participants with advanced solid tumors. Aim of Parts 2 and 3 of the study is to provide clinical proof-of-concept for the preclinically predicted synergistic efficacy of ATR and poly(ADP-Ribose) polymerase (PARP) inhibitors (PARPi) in defined populations of participants with advanced breast cancer (aBC) with DDR mutations with an unmet medical need.

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: 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.