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Breast Cancer clinical trials

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NCT ID: NCT06403917 Not yet recruiting - Breast Cancer Clinical Trials

Evaluation of Breast Cancer Screening Program at Assiut Governorate

Start date: June 1, 2024
Phase:
Study type: Observational

1. To evaluate the ability of breast clinical examination as screening tool to detect early and advanced stages of breast cancer. 2. To determine the percentage of breast cancer confirmed cases among women screened at women health campaign in Assiut governorate. 3. To determine drop out from referral system among screening program. 4. Identify the healthcare providers knowledge about breast cancer and screening tools, perception, practice and barriers in delivering the program

NCT ID: NCT06403904 Recruiting - Breast Cancer Clinical Trials

Assessing Clinical Features and Outcome of Breast Cancer in PALB2 Mutation Carriers: the Palbreast Study

PALBREAST
Start date: October 2, 2023
Phase:
Study type: Observational

The Modena hereditary breast cancer group identified 3498 BRCA test candidates affected by breast cancer (BC). Among those, 392 were BRCA1/2 positive (11.2%). Since 2018, the site started to analyze eligible BC patients by multi gene panel (MGP) test. Fifty hundred sixty BRCA negative patients have been recalled, whereas other 934 were firstly analyzed by MGP. Totally, among 1494 BC patients analyzed by MGP test, 33 were PALB2 mutation carriers (2%). By involving the Italian Society of Genetic Oncology and 11 European Institutions, it is calculated to identify about 300 PALB2 mutation carriers. PALB2 is a breast cancer susceptibility gene that encodes the BRCA2- interacting protein. Mono-allelic mutations of PALB2 are associated with an increased risk for breast and ovarian cancer in women, prostate cancer in men, and pancreatic cancer in both gender. Women with no family history of breast cancer have a cumulative risk of 33%, compared to 58% in women with two or more family members with breast cancer. Several studies with populations ranging from to 54 to 362 individuals aimed to describe breast cancer phenotypic characteristics in PALB2 mutation carriers. Some of these studies suggested an association with triple-negative phenotype, older age at diagnosis (>30 years), tumor size > 2 cm, negative HER2 status, lymph nodes positive and bilaterality. Nevertheless, results among different studies are contradictory and no data on prognosis of these patients are reported. Furthermore, the clinical potential of PARP inhibition beyond currently approved indications to additional patients whose tumors have (epi)genetic changes affecting homologous recombination repair raises new interest in PALB2 mutations as molecular target. Primary objectives is to study the incidence and mortality rates of gPALB2 Breast Cancer.

NCT ID: NCT06402435 Not yet recruiting - Breast Cancer Clinical Trials

SBRT, Chemotherapy, and AK112 Neoadjuvant Therapy for Luminal-type Breast Cancer

Start date: September 1, 2024
Phase: Phase 2
Study type: Interventional

Studies have indicated that the improvement in pathological complete response (pCR) is significantly correlated with luminal breast cancer patients' overall survival (OS). Patients with luminal breast cancer have poor efficacy for neoadjuvant chemotherapy. The combination of neoadjuvant therapy with immunotherapy and chemotherapy has been demonstrated to enhance the pCR rate of luminal-type breast cancer patients, increasing it from 13-15% to approximately 24%. Therefore, how to further improve the pCR rate of luminal-type breast cancer became the main objective of this study. Stereotactic radiotherapy (SBRT) not only kills tumor cells directly, but also kills the distant unirradiated tumor cells by promoting the cross-initiation of tumor-specific CD8+ T cells, a phenomenon known as the abscopal effect. Our research team has recently discovered that the triple therapy model of SBRT + anti-vascular targeting + anti-PD-1 was safe and efficacious in lung cancer patients. Ivonescimab (AK112) is an anti-PD-1/VEGF-A bispecific antibody. In order to improve the pCR, a single-arm, open, phase II clinical study was proposed to explore the safety and efficacy of SBRT+AK112+chemotherapy, a neoadjuvant treatment modality, in the treatment of luminal breast cancer.

NCT ID: NCT06401590 Completed - Breast Cancer Clinical Trials

Sensitivity and Predictive Value of Frozen Section of Sentinel Lymph Node Biopsy in Post Neoadjuvant Setting

Start date: March 15, 2022
Phase:
Study type: Observational

Axillary lymph node status is one of the most important prognostic factors in primary breast carcinomas. Sentinel lymph node biopsy has been increasing in post neoadjuvant setting when axillary nodes show good clinical and radiological response. It allows to determine the axillary lymph node status, which if negative, saves the patient from axillary dissection (AD) and its potential complications. To assess tumor response to neoadjuvant chemotherapy in the SLN, pathological evaluation is the gold standard. Response to neoadjuvant systemic therapy is an excellent predictor of outcome, and achievement of pathological complete response (PCR) in the SLN is a prognostic predictor of long-term outcome with significantly better disease-free survival and overall survival. Post-treatment isolated tumor cells (ITCs) and micro metastases predict worse survival compared with the same findings in the non-neoadjuvant setting. Histologically partial response to therapy, is characterized by small clusters and individual tumor cells set in hyaline stromal fibrosis. Most false negative cases had metastatic foci identified exclusively on permanent sections and are not due to a true diagnostic interpretation error. The timing of further axillary surgery, immediate or a subsequent operation should be routinely discussed at centers using intraoperative assessment of the sentinel lymph nodes, along with the potential for negative intraoperative findings and positive nodes on final pathology.

NCT ID: NCT06401421 Not yet recruiting - Breast Cancer Clinical Trials

EXActDNA-003 / NSABP B-64: Study of Molecular Residual Disease Detection in Breast Cancer (MRD)

Start date: May 2024
Phase:
Study type: Observational

The EXActDNA-003 study will prospectively enroll participants who are planning to undergo chemotherapy for high-risk, early breast cancer, who are willing to provide tissue and blood specimens for circulating tumor DNA (ctDNA) analysis. Participants will be followed for up to 5.5 years.

NCT ID: NCT06401304 Recruiting - Breast Cancer Clinical Trials

Oncologic, Cosmetic and Patient Reported Outcomes in Value-Based Breast Surgery (OnCoPRO Value)

OncoPROValue-1
Start date: January 1, 2020
Phase:
Study type: Observational

The study aspires to provide outcomes on surgery, quality of life and time-to-event outcomes following the development and validation of a standardised surgical assessment tool in a shared decision-making framework for patients with pre-invasive or invasive breast cancer with breast conservation.

NCT ID: NCT06401005 Not yet recruiting - Breast Cancer Clinical Trials

SBRT, Chemotherapy, and AK112 Neoadjuvant Therapy for Triple-negative Breast Cancer (TNBC)

Start date: September 1, 2024
Phase: Phase 2
Study type: Interventional

Studies have indicated that the improvement in pathological complete response (pCR) is significantly correlated with triple-negative breast cancer(TNBC)patients' overall survival (OS). Patients with TNBC have poor efficacy for neoadjuvant chemotherapy. The combination of neoadjuvant therapy with immunotherapy and chemotherapy has been demonstrated to enhance the pCR rate of TNBC patients, increasing it from 45% to approximately 60%. Therefore, how to further improve the pCR rate of luminal-type breast cancer became the main objective of this study. Stereotactic radiotherapy (SBRT) not only kills tumor cells directly, but also kills the distant unirradiated tumor cells by promoting the cross-initiation of tumor-specific CD8+ T cells, a phenomenon known as the abscopal effect. Our research team has recently discovered that the triple therapy model of SBRT + anti-vascular targeting + anti-PD-1 was safe and efficacious in lung cancer patients. Ivonescimab (AK112) is an anti-PD-1/VEGF-A bispecific antibody. In order to improve the pCR, a single-arm, open, phase II clinical study was proposed to explore the safety and efficacy of SBRT+AK112+chemotherapy, a neoadjuvant treatment modality, in the treatment of TNBC.

NCT ID: NCT06400563 Not yet recruiting - Breast Cancer Clinical Trials

MRg-NIRS Imaging System Breast Cancer Trial

MRg-NIRS
Start date: July 1, 2024
Phase: N/A
Study type: Interventional

This trial is a study of 20 women with breast cancer to evaluate the addition of MR-guided (MRg) near-infrared spectroscopy (NIRS) with and without contrast, as part of a program to improve clinical management of women receiving breast magnetic resonance imaging (MRI).

NCT ID: NCT06399276 Not yet recruiting - Breast Cancer Clinical Trials

4:3 Intermittent Fasting Intervention in Adults With Breast Cancer and Overweight or Obesity

Start date: June 2024
Phase: N/A
Study type: Interventional

This is a 3 month single arm pilot and feasibility study designed to examine the impact of an intermittent fasting lifestyle weight loss intervention on pre-specified clinical milestones (change in body weight, adherence to the fasting program, and moderate-to vigorous physical activity, MVPA) in adults with overweight and obesity and breast cancer after they have completed their cancer treatment. The investigators will also evaluate feasibility of recruitment and retention of study participants, safety of the intervention, and obtain feedback from participants to improve the program. Participants will receive a 3 month lifestyle weight loss program focusing on a 4:3 intermittent fasting paradigm (3 modified fast days per week) and support to increase physical activity to 150 minutes per week. Outcome measures will be assessed at the end of the 3 month intervention (primary endpoint) and after a 3 month weight maintenance follow up phase.

NCT ID: NCT06398067 Not yet recruiting - Breast Cancer Clinical Trials

Stress Management Intervention Among Breast and Gynecologic Cancer Patients in Viet Nam

Start date: June 2024
Phase: N/A
Study type: Interventional

Psychological distress is common among Vietnamese cancer patients but often underestimated and not detected by professionals due to lack of time and overload of clinical work. Currently no established, evidence-based intervention exists to help address the mental health needs of cancer patients in Viet Nam besides the 'Stronger Together' peer mentoring intervention model that the investigators piloted in 2021-2023. The goal of this 2-arm, parallel, single-blind randomized controlled trial (RCT) is to pilot and evaluate the Vietnamese Self Help Plus (vSH+) stress management intervention among breast and gynecologic cancer patients in Viet Nam. Aim 1- the investigators pilot the adapted vSH+ intervention. After recruitment and screening, participants are randomized into either the intervention (vSH+) or enhanced usual care (EUC) study arms. Participants are invited to attend an in-person informational session (IS) specific to their study arm, where informed consent is obtained. Aim 2- the investigators assess the potential effectiveness of the vSH+ intervention. Quantitative surveys of study outcomes measures are administered at three timepoints: T0 (baseline, in-person, during info-sessions); T1 (1-2 weeks post-intervention, via phone); and T2 (3 months post-intervention, via phone). Aim 3- the investigators conduct a qualitative process evaluation, via in-depth interview (IDIs) and focus group discussions (FGDs), to assess the acceptability and feasibility implementing and scaling up the vSH+ intervention model. Satisfaction surveys will be administered during vSH+ sessions and in-depth interviews (IDIs) will be conducted following the conclusion of the intervention. IDIs wil also be conducted with Facilitators, in addition to evaluation surveys during vSH+ sessions and supportive supervision sessions. Between T1 and T2, the investigators will conduct IDIs with Healthcare Workers and focus group discussions with Caregivers.