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Breast Neoplasms clinical trials

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NCT ID: NCT06380803 Recruiting - Surgery Clinical Trials

Surgical Skill Labs for Robotic Mastectomy and Educational Program Using a Surgical Guide by Artificial Intelligence

ROMCAPO+AI
Start date: April 29, 2021
Phase:
Study type: Observational

The goal of this prospective study is to investigate the satisfaction, NASA-Task Load Index (TLX), and surgical proficiency of a robotic breast surgery education program using cadaver or porcine models, as well as to develop an AI-based surgical guide for utilization within the educational program in trainees for robotic breast surgery. The main question[s]it aims to evaluate : - Satisfaction questionnaire of a educational program - NASA-TLX of a educational program - global evaluative assessment of robotic skills (GEARS) of a robotic breast surgery for surgical proficiency Participants will participate the educational program and fill out a satisfaction questionnaire and NASA-TLX. The tutor evaluates GEARS for 15 minutes at the beginning and end of training. After the development of the surgical guide based on AI, researchers will compare a training group with or without surgical guide to see the effect of the surgical guide.

NCT ID: NCT06379880 Recruiting - Breast Neoplasms Clinical Trials

Impact on Quality of Life and Health of the CONTINUUM+ CONNECT Remote Monitoring Solution

FEGALA
Start date: April 25, 2024
Phase: N/A
Study type: Interventional

FEGALA is a comparative, multicenter, randomized, prospective, open-label study comparing the results observed at 3 months (± 15 days) on the EORTC QLQ-C30 scale in a group of patients with metastatic cancer followed on an outpatient basis and benefiting from the CONTINUUM+ CONNECT solution (with or without nursing support at home) versus comparable patients benefiting from conventional monitoring.

NCT ID: NCT06378944 Recruiting - Breast Cancer Clinical Trials

Selective Sentinella Lymph Node Biopsy With Indocyanine Green in Patients With Breast Cancer

INSEAN
Start date: January 1, 2024
Phase:
Study type: Observational [Patient Registry]

The current observational study aims to perform the sentinel lymph node in breast cancer in the usual way with technetium 99 and add a second tracer, indocyanine green. The objective is to evaluate the detection rate of the lymph node with indocyanine green compared to the usual technique.

NCT ID: NCT06378294 Recruiting - Breast Cancer Clinical Trials

Locoregional Control With Radiotherapy of Breast Cancer Patients With MACrometastases Treated With MAstectomy (MACMA)

MACMA
Start date: April 20, 2021
Phase:
Study type: Observational [Patient Registry]

Sentinel lymph node biopsy (SLNB) is the standard procedure to stage the axilla in clinically node-negative invasive breast cancer (IBC) patients undergoing upfront surgery. The ACOSOG-Z0011 and the AMAROS trial demonstrated that SLNB with or without radiotherapy provided equivalent local control and survival to axillary lymph node dissection (ALND) in early-stage breast cancer patients with 1 or 2 positive SLNs. However, the ACOSOG-Z0011 trial did not included patients treated with mastectomy, and the AMAROS trial only included 17% of mastectomy patients. The investigators conduct an observational cohort study of early stage breast cancer patients receiving upfront mastectomy with 1 or 2 macrometastases after SLNB. The study aim to demonstrate a 5-year disease-free survival of not less than 80% when ALND is omitted and replaced by axillary radiotherapy, and determine the axillary recurrence rate.

NCT ID: NCT06375798 Recruiting - Breast Cancer Clinical Trials

Clinical Study of Breast Conserving Surgery Combined With Intraoperative Radiotherapy for Early Breast Cancer

Start date: November 19, 2020
Phase:
Study type: Observational [Patient Registry]

A Single-center, open, prospective study,for analyzing the local recurrence rate, the incidence of incision complications and the aesthetic effect of intraoperative radiotherapy in early breast cancer patients after breast-conserving surgery.

NCT ID: NCT06375707 Recruiting - Clinical trials for Advanced Breast Cancer

Efficacy and Safety of Ribociclib in Combination With NSAI Versus Physician's Choice of Chemotherapy Sequential Endocrine Therapy in HR+/HER2- Advanced Breast Cancer

Start date: January 9, 2024
Phase: Phase 2
Study type: Interventional

Evaluate the efficacy and safety of Ribociclib in combination with NSAI versus physician's choice of chemotherapy sequential endocrine therapy in HR+/HER2- advanced breast cancer.

NCT ID: NCT06374745 Recruiting - Breast Cancer Clinical Trials

An Integrated Algorithm for Surgical Intervention in Chronic Lymphedema After Breast Cancer Treatment: The Basel Lymphedema Protocol

Start date: January 2, 2015
Phase:
Study type: Observational

The primary objective of the investigators is to develop an integrated algorithm for surgical treatment of chronic lymphedema after breast cancer surgery. This will be achieved by retrospectively analysing a subgroup of patients who had breast cancer-related surgery prior to lymphedema.

NCT ID: NCT06371508 Recruiting - Breast Cancer Clinical Trials

Breast Cancer and Breast Self-examination Education

Start date: February 1, 2024
Phase: N/A
Study type: Interventional

According to a news published by the World Health Organization (WHO); More than 2.3 million cases of breast cancer occur each year, making it the most common cancer among adults. In 95% of all countries, breast cancer is the first or second cause of female cancer death. In 2020, 2.3 million women worldwide were diagnosed with breast cancer and 685,000 deaths occurred (WHO, 2023; https://www.who.int/news/item/03-02-2023-who-launches-new-roadmap- on-breast-cancer). In our country, breast cancer ranks first among the most common cancer types in women, and the number of breast cancer cases in women in 2020 was recorded as 74 638 (IARC, 2023). As a result of this situation, WHO (2023) published the Global Breast Cancer Initiative Framework to save 2.5 million lives from breast cancer by 2040. This published framework includes health promotion for early detection, timely diagnosis and comprehensive management of breast cancer. One of the most effective ways to reduce breast cancer mortality and morbidity rate is early diagnosis. It is important to determine early diagnosis and signs and symptoms of cancer before they appear. Early diagnosis of breast cancer is possible with breast self-examination (BSE), clinical breast examination and mammography (Kayar, 2019). Breast self-examination is an important examination method in terms of detecting changes in breast tissue and preventing subsequent complications (Abo Al-Shiekh et al., 2021). It is also an easy-to-apply, cheap and non-invasive method. In our country, it is recommended that women regularly perform breast self-examination every month after the age of 20, women between the ages of 20 and 40 should have a clinical breast examination every two years, and women between the ages of 40 and 69 should have a clinical breast examination every year and have a mammogram every two years (Ministry of Health, 2019). . There are studies showing that fear of breast cancer has a positive and negative impact on early diagnosis behaviors (Champion et al., 2004; Yavan et al., 2010). Champion et al. (2004) stated that women with moderate breast cancer fear had a high rate of early detection behavior, whereas low and high fear levels had a negative effect on behavior. In the study conducted by Yavan et al. (2010) on 188 women, 2% of the women. They found that 3 of them had regular BSE and 78.7% of them had never had a mammography. In addition, 85% of the women included in the study stated that they had a fear of breast cancer due to a family history of breast cancer, being diagnosed with breast cancer, and the presence of risk factors. Study results show that fear of breast cancer affects screening results. Therefore, our aim in the study is; To determine the effect of breast cancer and BSE training given to women on breast cancer fear and BSE skills.

NCT ID: NCT06367088 Recruiting - Clinical trials for Triple-negative Breast Cancer

Cadonilimab Combined With Chemotherapy as First or Second Line Treatment in Recurrent or Metastatic Triple Negative Breast Cancer

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

The prognosis of recurrent and metastatic triple negative breast cancer (TNBC) is poor, and chemotherapy is still the main treatment for TNBC. Some studies have shown that combination therapy of antibodies targeting cytotoxic T-lymphocyte antigen-4 (CTLA-4) and programmed cell death-1 (PD-1) significantly improves clinical benefit over PD-1 antibody alone. However, broad application of this combination has been limited by toxicities. Cadonilimab is a humanized immunoglobulin G1 bispecific antibody targeting PD-1 and CTLA-4. It mutates to eliminate Fc receptor and complement-mediated cytotoxic effects. The purpose of this study is to evaluate the efficacy and safety of Cadonilimab combined with chemotherapy as a first or second-line treatment of recurrent and metastatic TNBC. This study is a multicenter, single arm, phase II, non randomized, open label, Simon two-stage design. It is planned to enroll 27 late stage TNBC patients.

NCT ID: NCT06365788 Recruiting - Clinical trials for Triple Negative Breast Neoplasms

Bicalutamide and Abemaciclib in Inoperable or Metastatic Androgen Receptor-positive Triple-negative Breast Cancer

ABBICAR
Start date: April 8, 2024
Phase: Phase 2
Study type: Interventional

This study has as goal to evaluate the use of abemaciclib and bicalutamide in androgen receptor positive metastatic triple negative breast cancer.