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Breast Neoplasms clinical trials

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NCT ID: NCT05975437 Enrolling by invitation - Breast Cancer Clinical Trials

Effectiveness of Personalized Surveillance and Aftercare for Breast Cancer

NABOR
Start date: March 6, 2023
Phase:
Study type: Observational [Patient Registry]

Surveillance and aftercare for curatively treated primary breast cancer patients is currently mostly 'one-size-fits-all', but can be personalized based on patients' risk of recurrence (depending on patient-, tumor- and treatment-related characteristics) and their personal needs and preferences. The use of personalized surveillance (PSP) and personalized aftercare plans (PAP) based on individual risks and needs might reduce unnecessary burden to the patient, increase quality of life and lower the costs of follow-up. The NABOR study will examine the effectiveness of personalized follow-up care, consisting of personalized surveillance (PSP) and personalized aftercare plans (PAP) incorporating individual recurrence risks and personal needs of breast cancer patients. The main question it aims to answer is: 'what is the effectiveness of personalized surveillance (PSP) and aftercare plans (PAP), compared to current follow-up care, on cancer worry and self-rated overall quality of life (EQ-VAS)'. Also the effect of PSP and PAP on health-related quality of life (EQ-5D), societal participation, risk perception, patient satisfaction, patients' need for support, shared decision-making, health care costs and resource use, cost-effectiveness, and number and severity of the detected recurrences will be investigated. Next, the uptake and appreciation of the personalized plans and related factors (patient, caregiver, hospital and societal/financial) will be evaluated. Patients participating in the study will have to fill in several questionnaires and give consent for requesting data from the Netherlands Cancer Registry and from their electronic health records (EHR). The use of personalized surveillance (PSP) and personalized aftercare plans (PAP) will be implemented stepwise over a period of nine months in ten participating hospitals. To collect observations of both pre- and post-transition to PSP and PAP, each hospital will include patients during the nine months before and after its transition to personalized care. In the future, the results of this project, i.e. the developed tools, can also be used for personalization of survivorship care for other cancer survivors. More broadly, all findings will be actively shared with interested healthcare professionals and other interested parties in the Netherlands.

NCT ID: NCT05923268 Enrolling by invitation - Clinical trials for Breast Cancer Female

Molecular Imaging of HER2 Expression in Breast Cancer Using [99mTc]Tc-G3-(G3S)3C Before Chemo/Targeted Therapy

Start date: June 4, 2023
Phase: N/A
Study type: Interventional

The study should evaluate distribution of [99mTc]Tc-G3-(G3S)3C in patients with primary HER2-positive and HER2-negative breast cancer

NCT ID: NCT05904730 Enrolling by invitation - Breast Cancer Clinical Trials

Phase I Clinical Trials Investigating the Potential Efficacy of Axitinib in Patients With a BRCA 1/2 Mutations

Start date: July 11, 2023
Phase: Phase 1
Study type: Interventional

This Clinical Trial is investigating the potential efficacy of axitinib after genetic testing in BRCA 1/2 Mutation patients, regardless of HER2 expression, who have progressed after at least one line of standard treatment or for whom there is no consensus treatment approach. The use of Axitinib may help physicians plan for more effective patient care in combination with existing treatment protocols.

NCT ID: NCT05876390 Enrolling by invitation - Breast Cancer Clinical Trials

Impact of Regional Anesthesia on Chronic Post-operative Pain

IRACPoP
Start date: September 1, 2022
Phase:
Study type: Observational

Approximately 55,000 cases of breast cancer are diagnosed in Italy every year and the first-line therapy for carcinoma in situ, stage I, II and IIIA is surgical removal of the tumour. The incidence of chronic pain after breast cancer surgery is confirmed around 30%. This study aims to evaluate the impact of loco-regional anesthesia techniques in the context of multimodal analgesia in the prevention of chronic pain post-oncological breast surgery

NCT ID: NCT05836246 Enrolling by invitation - Clinical trials for Acute Myocardial Infarction

The Development of Quantitative Ultrasound Imaging Software Platform

Start date: September 1, 2020
Phase:
Study type: Observational [Patient Registry]

The goal of this observational study is to compare the image differences between conventional ultrasound and artificial intelligence-based ultrasound software in conscious adults. The main question it aims to answer is to evaluate the effectiveness by determining that the new image analysis method is considered valid if it helps to identify more than 30% of histological characteristics. Participants will undergo the examination using the two methods mentioned earlier after signing the consent form.

NCT ID: NCT05787249 Enrolling by invitation - Breast Cancer Clinical Trials

Improving Utilization of Supplemental Breast MRI Screening for Women With Extremely Dense Breasts

Start date: October 4, 2023
Phase: N/A
Study type: Interventional

The goal of this study is to increase MRI utilization among women with extremely dense breasts. The main question it seeks to answer is whether nudging of the provider, patient, or both increases the uptake of MRI among this group, and whether this effect differs between Black and White women.

NCT ID: NCT05760755 Enrolling by invitation - Clinical trials for Breast Cancer Female

Stick Together - Pilot Intervention Study

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

This pilot study investigates the acceptability and feasibility of 'Stick Together', a self-guided online intervention, for younger women with breast cancer and their cohabiting partners.

NCT ID: NCT05734950 Enrolling by invitation - Clinical trials for Breast Cancer Female

Biological Characteristics of Older Women (> 70 Years) With ER Positive, HER2 Negative Early Breast Cancer

BOLD-70
Start date: July 21, 2022
Phase:
Study type: Observational

This study is investigating the biological characteristics of early oestrogen receptor (ER) positive, human epidermal growth factor receptor 2 (HER2) negative breast cancer (BC) in older woman (aged > 70 years) who were treated with adjuvant endocrine treatment (ET). It will use surgical tissue previously collected as part of routine care from patients aged 70 years or older at diagnosis with ER positive, HER2 negative stage I-III BC treated The Royal Marsden NHS Foundation Trust (RMH). The overarching aim of this study is to define the biological characteristics of early BC in older women in terms of tumour microenvironment (TME), molecular and genomic features. This analysis will include assessment of tumour infiltrating lymphocytes (TILs), and gene expression profiling with NanoString using the Breast Cancer 360 (BC360TM) assay measuring ribonucleic acid (RNA) expression signatures of genes involved in proliferation, endothelial, angiogenesis, cytotoxicity, stroma, inflammatory chemokines, and apoptosis. This analysis will examine various biological pathways, aiming to inform suitability for certain treatments including cyclin-dependent kinase inhibitors (CDKi), chemotherapy, immunotherapy, or targeted treatments such as phosphoinositide 3-kinases (PI3K) inhibitors, or deoxyribonucleic acid (DNA) damage response.

NCT ID: NCT05645536 Enrolling by invitation - Breast Cancer Clinical Trials

Safety Extension Study for Subjects With HR+, HER2- Breast Cancer for Subjects Who Have Completed the OVELIA Study

Start date: December 28, 2022
Phase: Phase 3
Study type: Interventional

TOL2506A (OVELIA) is a Phase 3, single arm, open-label study evaluating the effectiveness of TOL2506 in suppressing ovarian function in premenopausal women with HR+, HER2-negative breast cancer and men with HR+ breast cancer. The TOL2506A-EXT study described here is a safety extension study to assess and collect long-term data on the ongoing safety and tolerability of TOL2506 in combination with tamoxifen or an AI for up to 4 years.

NCT ID: NCT05628870 Enrolling by invitation - Breast Cancer Clinical Trials

A Trial of HRS-1358 Tablets in Metastatic or Local Advanced Breast Cancer

Start date: February 7, 2023
Phase: Phase 1
Study type: Interventional

The study is being conducted to evaluate the safety and tolerability of HRS-1358 monotherapy in patients with metastatic or locally advanced breast cancer in order to estimate the Dose-Limiting Toxicity (DLT), Maximum Tolerated Dose (MTD) and select the Recommended Phase 2 Dose (RP2D).