99mTc-MY6349 SPECT/CT Imaging in Trop2-positive Triple-negative Breast Cancer
Human trophoblast cell-surface glycoprotein antigen 2 (Trop2) is a membrane surface receptor that plays an important role in the occurrence and development of tumors. Studies have shown that Trop2 is highly expressed in a variety of cancers (such as breast cancer, lung cancer, gastric cancer, colorectal cancer, pancreatic cancer, prostate cancer, cervical cancer, head and neck cancer, and ovarian cancer, etc.) and is related to the proliferation, invasion, and metastasis of tumor cells. and other processes related. According to statistics, more than 80% of breast cancer patients highly express Trop2, and high expression of Trop2 is positively correlated with shortened survival and poor prognosis of cancer patients. In this study, a single-domain antibody targeting Trop2 was selected to prepare a new nuclear medicine molecular probe 99mTc-MY6349, so as to monitor the expression level of Trop2 in patients' systemic tumors through SPECT/CT imaging. Breast cancer patients who intend to use gosatuzumab for subsequent treatment can first undergo 99mTc-MY6349 SPECT/CT imaging to detect Trop2 expression levels in systemic tumors. Subsequently, 18F-FDG PET/CT imaging was performed to compare and detect the distribution of primary tumors and systemic metastases in patients with breast cancer. This study analyzes the heterogeneity of Trop2 expression levels within the primary tumor and the heterogeneity of expression levels in systemic metastases, thereby providing a basis for testing whether the patient is suitable for subsequent treatment and conducive to the formulation of subsequent treatment plans.
NCT06104085 — Breast Cancer
Status: Recruiting
http://inclinicaltrials.com/breast-cancer/NCT06104085/
Cognitive Rehabilitation and Psychosocial Intervention Through a Stepped Digital Ecosystem in Breast Cancer: A Randomized Clinical Trial.
This study investigates the effectiveness of integrating a cognitive rehabilitation module into a digital psychosocial intervention for recently diagnosed breast cancer patients. The trial involves 176 participants, with one group receiving the ICOnnecta't program (stepped psychosocial intervention) and the other receiving ICOnnecta't with an additional cognitive stepped intervention called ICOgnition. ICOgnition has three levels of intervention including cognitive screening and monitoring, psychoeducation, and online cognitive training. Assessments of the study outcomes will be conducted at baseline, 3 months, 6 months, and 1 year, measuring cognitive functioning, emotional well-being, medication adherence, work functioning, and overall quality of life. The study aims to improve understanding of efficient ways to detect cognitive dysfunction in cancer patients and assess the benefits and feasibility of this early intervention for managing cognitive impairment in breast cancer patients.
NCT06103318 — Breast Cancer
Status: Not yet recruiting
http://inclinicaltrials.com/breast-cancer/NCT06103318/
Organoid-Guided Functional Precision Therapy Versus Treatment of Physician's Choice in Previously Treated HER2-negative Advanced Breast Cancer: A Phase II, Multicenter, Open-label, Randomized Controlled Trial
This is a phase II, multicenter, open-label, randomized controlled trial to compare the efficacy of organoid-guided treatment (OGT) to treatment of physician's choice (TPC) in previously treated, HER2-negative locally advanced or metastatic breast cancer. The study will seek to provide evidence for utilizing patient-derived organoid (PDO) model to personalize treatment strategies and inform clinical care for advanced breast cancer. Subjects randomized to the OGT group will undergo PDO generation and receive treatment dictated by subsequent PDO drug sensitivity screening. Subjects randomized to the TPC group will receive empirical therapy as selected by the treating physician.
NCT06102824 — Advanced Breast Cancer
Status: Recruiting
http://inclinicaltrials.com/advanced-breast-cancer/NCT06102824/
Diagnostic Biomarkers Exploration of Breast Cancer From Serum and Urine
The goal of this observational study is to find the diagnostic biomarkers in serum and urine from early breast cancer patients. The main questions it aims to answer are: - compare the different biomarkers in serum and urine from breast cancer patients, benign lesions and healthy population. - construct the best diagnostic model by machine learning to distinguish breast cancer and non-breast cancer patients. Participants, including breast and non-breast cancer patients will be asked to provides blood and urine during their diagnosis and treatment process without changing the original treatment. When necessary, specimens will be collected during the surgery，without affecting pathological diagnosis.
NCT06102018 — Breast Neoplasm Female
Status: Recruiting
http://inclinicaltrials.com/breast-neoplasm-female/NCT06102018/
Breast Cancer Resiliency Through Exercise Program (B-REP): Pilot Study
The study will use a cross-sectional study design with a follow-up 2-arm randomized controlled trial with that has assessments at baseline, post-intervention (i.e., Week 12), and 3-months post-intervention (i.e., Week 24). The 2 arms are the 12-week intervention and a health education control among 60 Black breast cancer survivors.
NCT06100263 — Breast Cancer Female
Status: Not yet recruiting
http://inclinicaltrials.com/breast-cancer-female/NCT06100263/
A Multicenter, Randomized, Open-lable, Single-dose, Two-cycle, Double-cross Bioequivalence Study Comparing the Pharmacokinetic Profile of LY01612 and CAELYX® in Chinese Subjects With Advanced Breast Cancer
A multicenter, randomized, open-lable, single-dose, two-cycle, double-cross bioequivalence study comparing the pharmacokinetic profile of LY01612 (Doxorubicin hydrochloride liposome injection) and CAELYX® in Chinese subjects with advanced breast cancer
NCT06098599 — Advanced Breast Cancer
Status: Completed
http://inclinicaltrials.com/advanced-breast-cancer/NCT06098599/
Prospective Study of MRI-based Radiomics in Breast Cancer
The goal of this prospective study is to develop MRI-based models representing tumor microenvironment in participants with invasive breast cancer. The main purpose of this study is to analyze the association of diffusion-, T2-, and dynamic contrast-enhanced T1-weighted images of 3T MRI before treatment with the immunohistochemical reactivity of tumor microenvironment including the extracellular matrix and immune cells of core-needle biopsy specimens For this purpose, investigators extract 16145 radiomic features from the intratumoral and peritumoral regions on MRI of participants with invasive breast cancer before treatment.
NCT06095414 — Breast Cancer
Status: Completed
http://inclinicaltrials.com/breast-cancer/NCT06095414/
Comparing Level 1 Compression Sleeves With Routine Care in Preventing Breast Cancer-related Arm Lymphedema :An Open-label, Single-center, Randomized Controlled Phase II Clinical Trial
It is estimated that there are 420,000 newly diagnosed breast cancer patients in China in 2020. With surgery, radiotherapy, chemotherapy, endocrine, targeted therapy and other treatment methods going hand in hand, the outcome of breast cancer patients has been greatly improved. However, along with the comprehensive treatment of breast cancer, there will also be some corresponding complications, including breast cancer-related lymphedema （BCRL）， is one of the most common and serious complications. the incidence of BCRL in the patients with axillary dissection11% -57%, average 28%, Arm lymphedema seriously affect the quality of life of breast cancer patients, is known as the last kilometer of breast cancer patients to return to society. The related risk factors mainly include surgery, radiotherapy, body mass index, (BMI), etc. Accordingly, a series of measures appeared to prevent the occurrence of BCRL, including surgical and non-surgical methods, The main surgical methods include lymphatic microsurgical preventing healing approach (LYMPHA), and axillary reverse mapping to retain arm lymph nodes.the LYMPHA technology requires skilled microsurgery technology, or multidisciplinary participation, which will prolong the operation time.The retention of arm lymph nodes may involve tumor safety.Non-surgical methods include elastic sleeve wearing, functional exercise, arm resistance training, manual drainage, etc. The manual drainage is time-consuming and requires therapist participation, and the evidence that resistance training can prevent edema is insufficient.The elastic cuff has been proven to effectively prevent the occurrence of BCRL, and it can prevent the accumulation of extracellular fluid caused by surgery, chemotherapy and radiation therapy, and gravity factors. A randomized controlled study (CTRI / 2017 / 12 / 010762) released by Paramanandam VS et al, Tata Memorial Hospital, tertiary Cancer Center, Mumbai, India, that wearing compression sleeves (20-25mmHg) can reduce and delay the occurrence of arm swelling in the first year after breast cancer surgery. However, the higher pressure sleeves still has a negative impact on patients' quality of life and patient compliance. Ochalek K have shown that the primary pressure sleeves (15-20mmHg) is also effective in preventing the occurrence of lymphedema, but the randomized controlled study has a small sample size and insufficient evidence.
NCT06095323 — Breast Cancer-related Arm Lymphedema
Status: Recruiting
http://inclinicaltrials.com/breast-cancer-related-arm-lymphedema/NCT06095323/
Surgical or Medical Treatment of Breast Cancer Metastasis: A Multicentre Observational Study
The liver represents the third most common site of breast cancer (BC) metastases behind the lymphatics and bone. The primary treatment for BCLM remains chemo-therapy and, more recently, targeted immunotherapy. The role of liver resection in BCLM remains controversial. The primary aim of the study is to compare the efficacy of liver resection vs. medical therapy alone in Breast Cancer Liver Metastasis (BCLM) patients.
NCT06093022 — Breast Cancer
Status: Recruiting
http://inclinicaltrials.com/breast-cancer/NCT06093022/
IIT2023-09-Chung-UpfrontTAD: Upfront TAD/SNB in Patients With Clinical T1-2N0 ER+ Her2- Breast Cancer With Ultrasound Detected Nodal Metastases
The purpose of the study is to determine the recurrence rates and survival of patients with clinical T1-2N0 ER+/Her2- invasive breast cancer who have biopsy proven image detected nodal disease treated with upfront lumpectomy or mastectomy with TAD followed by adjuvant therapy. This is a prospective, single arm phase II clinical trial. Patients will be screened and enrolled per eligibility criteria. Patient, tumor, and treatment data will be documented.
NCT06092892 — Breast Cancer
Status: Not yet recruiting
http://inclinicaltrials.com/breast-cancer/NCT06092892/