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Breast Cancer clinical trials

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NCT ID: NCT04968964 Recruiting - Breast Cancer Clinical Trials

Treatment Monitoring of Patients Receiving CDK 4/6 Inhibitors for Hormone Receptor (HR) Positive, HER2 Negative Metastatic Breast Cancer (MBC) With or Without the Addition of DiviTum® Serum Thymidine Kinase 1 (TK1) Activity Testing

Start date: March 7, 2022
Phase: N/A
Study type: Interventional

Historically, serial testing of patients with metastatic breast cancer has included a combination of physical exam, symptom evaluation, laboratory testing, and imaging. Circulating tumor biomarkers are sometimes also incorporated. Frequent testing with numerous diagnostics at each time point is a significant burden to patients and to healthcare systems. The DiviTum® TKa assay measures TK1 activity. Numerous studies have illustrated the prognostic nature of plasma or serum TK1 activity level in metastatic cancer. The investigators hypothesize that the incorporation of data from DiviTum® TKa measurement into the treatment monitoring schema will be associated with physician desire to change the near-term usage and/or timing of other routine restaging tests, including either standard tumor imaging or tumor marker testing. Given the relatively low rate of disease progression in this first-line population, it is expected that most of this change will be an intended reduction in scheduling of routine treatment surveillance testing with increase in intervals of subsequent tumor restaging imaging by at least 4 weeks. Secondarily, the consequences of rescheduling of routine surveillance testing may ultimately result in an absolute reduction in the number of some tests used during the time period examined.

NCT ID: NCT04967976 Recruiting - Breast Cancer Clinical Trials

Breast Mesh Used in Two-staged Breast Reconstruction

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

This is the first prospective randomized and controlled study on the efficacy and safety of TiLOOP® Bra mesh in patients with expander-implant breast reconstruction. The investigators hypothesize that incoporating TiLOOP Bra mesh with tissue expanders will reduce the rates of capsular contraction, improve the efficiency of expansion and provide better aesthetic result.

NCT ID: NCT04967352 Recruiting - Breast Cancer Clinical Trials

Predicting Chronic Pain Following Breast Surgery

Start date: July 19, 2021
Phase:
Study type: Observational

Breast surgery, which includes mastectomy, breast reconstructive surgery, or lumpectomies with sentinel node biopsies, may lead to the development of chronic pain and long-term opioid use. In the era of an opioid crisis, it is important to risk-stratify this surgical population for risk of these outcomes in an effort to personalize pain management. The opioid epidemic in the United States resulted in more than 40,000 deaths in 2016, 40% of which involved prescription opioids. Furthermore, it is estimated that 2 million patients become opioid-dependent after elective, outpatient surgery each year. After major breast surgery, chronic pain has been reported to develop anywhere between 35% - 62% of patients, while about 10% use long-term opioids. Precision medicine is a concept at which medical management is tailored to an individual patient based on a specific patient's characteristics, including social, demographic, medical, genetic, and molecular/cellular data. With a plethora of data specific to millions of patients, the use of artificial intelligence (AI) modalities to analyze big data in order to implement precision medicine is crucial. We propose to prospectively collect rich data from patients undergoing various breast surgeries in order to develop predictive models using AI modalities to predict patients at-risk for chronic pain and opioid use.

NCT ID: NCT04965688 Recruiting - Breast Cancer Clinical Trials

Systems Biology Guided Therapy for Breast Cancer Positive for Oestrogen Receptor After Aromatase Inhibitor and CDK Inhibition

SPOCK
Start date: August 8, 2021
Phase: Phase 2
Study type: Interventional

There are several approved and guideline-recommended treatments for metastatic, estrogen receptor-positive breast cancer that has progressed on an aromatase inhibitor and a CDK4/6 inhibitor. Right now, doctors do not have a good way of choosing between these treatments. Scientists we work with have come up with ways to use the biology of the tumor to try to predict which treatment is best. This study is being done to test if those predictions are right and to learn more about these tumors to design better treatments in the future.

NCT ID: NCT04965064 Recruiting - Breast Cancer Clinical Trials

Trial of Neratinib Plus Capecitabine in Subjects With HER2-Negative Metastatic Breast Cancer With Brain Metastases and Abnormally Active HER2 Signaling

Start date: September 23, 2022
Phase: Phase 2
Study type: Interventional

The purpose of this research is to look at the safety and effectiveness of a HER2-targeted therapy neratinib when given with capecitabine, a chemotherapy, for breast cancer patients with brain metastases whose tumors were HER2-negative by standard tests but showed abnormal HER2 activity based on the CELsignia results.

NCT ID: NCT04962529 Recruiting - Breast Cancer Clinical Trials

Breast Cancer Liquid Biopsy Trial

Start date: September 28, 2020
Phase:
Study type: Observational

The purpose of this study is to continue to develop a liquid biopsy (minimally invasive blood test) that can be used to confirm if breast cancer has spread throughout the body and if this liquid biopsy test can provide comparable information to a highly invasive tissue biopsy. The knowledge gained in this study could be used in future studies to confirm cancer recurrence using a safe and minimally invasive procedure. The research will consist of looking for tumor cell(s) circulating in the blood stream and if they are present to characterize them so that more information about the disease can be collected. This information may help us to better understand how to fight cancer.

NCT ID: NCT04962425 Recruiting - Breast Cancer Clinical Trials

Risk Assessment Model of Trastuzumab-related Cardiotoxicity in Breast Cancer Patients

Start date: January 8, 2021
Phase:
Study type: Observational

According to the existing clinical data in our hospital, retrospective study was conducted to screen the risk factors with predictive value for TRC(trastuzumab-related cardiotoxicity) risk, and to construct the risk prediction model for TRC.

NCT ID: NCT04961307 Recruiting - Breast Cancer Clinical Trials

Evaluation of Heart Function in Breast Cancer Patients Using Trastuzumab

Start date: July 5, 2019
Phase:
Study type: Observational

By dynamically observing the changes of echocardiogram and biomarkers in breast cancer patients using trastuzumab, evaluate the effect of trastuzumab on cardiac function; determine the sensitivity of echocardiography and biomarker indicators And specificity, explore effective and specific early warning indicators, and provide technical support for the evaluation of the cardiac safety of anti-tumor drugs.

NCT ID: NCT04960839 Recruiting - Breast Cancer Clinical Trials

Prophylactic Irradiation to the Contralateral Breast for BCAs Patients

PICB
Start date: January 1, 2023
Phase: N/A
Study type: Interventional

Breast cancer is the most common cancer in women worldwide, with high mortality. About 5% to 10% of breast cancers are hereditary. Most inherited cases of breast cancer are associated with germline mutations in genes, such as BRCA1, BRCA2 and PALB2. The cumulative breast cancer risk for BRCA1, BRCA2 or PALB2 mutation carriers was high. Besides the increased breast cancer risk for the inherited mutation carriers, the risk of subsequent contralateral breast cancer for the mutation carriers with breast cancer was also significantly increased. Contralateral prophylactic mastectomy was usually recommended to the breast cancer patients with BRCA mutation. However, many breast cancer patients refused the contralateral prophylactic mastectomy, due to the surgical injury, potential surgical complications, deleteriously affected body image and sexuality. Solid evidence validated that radiotherapy after surgery resulted in a reduced local recurrence for three times lower than surgery alone. It is thought that radiation would eliminate the microscopic tumors which may already exist in the breast. Thus, we proposed that for the breast cancer patients with BRCA1, BRCA2 or PALB2 deleterious germline mutations, prophylactic irradiation to the contralateral breast may reduce the risk of subsequent contralateral breast cancer. And we would like to further compare the effect of prophylactic irradiation to the published data from traditional prophylactic contralateral mastectomy.

NCT ID: NCT04949776 Recruiting - Breast Cancer Clinical Trials

Artificial Intelligence in Breast Cancer Screening Programs in Córdoba (AITIC)

AITIC
Start date: March 1, 2022
Phase: N/A
Study type: Interventional

The use of artificial intelligence software in breast screening (Transpara®) makes it possible to identify studies with a very low probability of cancer. The hypothesis raised in this work is that reading strategies based on artificial intelligence (single or double reading only of cases with a score> 7 with Transpara®), allow reducing the workload of a screening program by more than 50 % with respect to the standard reading of the program (double reading of all cases without Transpara®), without presenting inferiority in terms of detection rates and recalls of the program, both with the use of 2D digital mammography and with the use of tomosynthesis or 3D mammogram.