Neoadjuvant Dose-dense Chemotherapy for HR+/HER2- Breast Cancer Patients With High Proliferation Index
Studies have shown that dose-dense chemotherapy reduces the risk of recurrence and death of breast cancer patients comparing with standard-schedule chemotherapy. But some research data indicate that HR+/HER2- breast cancer patients benefit from dose-dense chemotherapy while some have negative results. How to identify HR+/HER2 breast cancer patients who are more likely to benefit from dose-dense chemotherapy is strongly necessary. Ki67 is a marker reflecting the proliferation of tumor cells. Breast cancer patients with high Ki67 are more likely to benefit from dose-dense chemotherapy. The purpose of this project is to investigate the efficacy and safety of neoadjuvant dose-dense chemotherapy for HR+/HER2- breast cancer patients with high proliferation index. At the same time, we will explore biomarkers, such as MammaPrint and BluePrint, to further identify patients who benefit more from neoadjuvant dose-dense chemotherapy.
NCT05728268 — Breast Cancer
Status: Recruiting
http://inclinicaltrials.com/breast-cancer/NCT05728268/
Early Breast Cancer Ultrasound-guided Visual-ICE Galil Cryoablation; Can Tumor Cell Death Induced by Cryoablation be Detected by Specific Circulating Markers?
The aim of our study is to examine the cryoimmunologic response and its mechanisms induced by US-guided cryoablation of small breast tumors (<2 cm) not eligible to neoadjuvant therapy. We will recruit 30 women who will undergo cryoablation and their results will be compared with a control group of 30 women, who will follow the same therapeutic pathway without performing cryoablation. All recruited patients will undergo an enrollment check, pre-cryoablation breast MRI and blood test to assess immune response, breast cancer US-guided cryoablation, post-cryoablation breast MRI and the same blood test to evaluate immunologic response. Within 21 days all patients will undergo breast surgery, with immuno-histopathological analysis on surgical specimen. At least 10 days after surgery the patient will undergo clinical breast examination, blood test to assess immune response and patient satisfaction questionnaire. Cryoablation treatment will be performed using a 14G cryoprobe under us-guidance for visualization of the ice ball surrounding the lesion. The ultrasound guide is used to ensure that the action affects the entire tumor and that therapeutic temperatures are reached in every part of the tumor. Pre- and post- cryoablation breast MRI will be performed on a 3T magnet to assess cryoablation rate of success. Artificial intelligence algorithms will also be used for this purpose. Cryoablation treatment efficacy will also be evaluated with ultrasound. The immunological fitness of cancer patients will be studied by flow cytometry, evaluating the presence of cytokines/chemokines relevant during anticancer immune response/tumor progression and for the presence of molecules released by cells during an immunogenic cell death. The goal of our study will be to demonstrate that cryoablation of breast cancer can induce an antitumor immune response. Therefore this approach could become an additional tool in the oncological treatment of breast cancer.
NCT05727813 — Stage I Breast Cancer
Status: Completed
http://inclinicaltrials.com/stage-i-breast-cancer/NCT05727813/
A Single-arm, Single-center Exploratory Clinical Study of Disitamab Vedotin Combined With Penpulimab as Neoadjuvant Therapy in the Treatment of HER2-low Early or Locally Advanced Breast Cancer
To evaluate the efficacy and safety of Disitamab Vedotin combined with Penpulimab as neoadjuvant therapy in patients with HER2-low early or locally advanced breast cancer
NCT05726175 — Breast Cancer
Status: Not yet recruiting
http://inclinicaltrials.com/breast-cancer/NCT05726175/
Large-area Low-level Laser Therapy for Breast Cancer-related Lymphedema: a Randomized, Placebo-controlled Study
This study is conducted to compare between efficacy of large and small area of low-level laser therapy (LLLT) in treatment of post mastectomy lymphedema. The change of severity of BCRL will be measured by the difference of circumference and skin thickness, detected by ultrasound. The influence on clinical symptoms, such as pain, shoulder mobility and hand function, are also investigated in the study.
NCT05725265 — Breast Cancer Lymphedema
Status: Recruiting
http://inclinicaltrials.com/breast-cancer-lymphedema/NCT05725265/
Evaluation of the Use of a Diagnostic Assistance Tool of Prognostic and Predictive Marker Scoring System in Breast Cancer
The main objective of this study is to evaluate and compare the diagnostic performance of a diagnostic assistance tool for analysis of 5 prognostic and predictive markers of breast cancer (HER2, Ki67 Index, Mitoses, Estrogen Hormone Receptor, Hormone Progesteron receptors hormone of Progesteronereceptor) integrating an automatic analysis algorithm compared to a reference (gold standard defined as the rereading by at least two different anatomopathologists according to the standard method of care) in order to show the non-inferiority of the automatic analysis algorithm compared to this gold standard.
NCT05724407 — Breast Cancer
Status: Not yet recruiting
http://inclinicaltrials.com/breast-cancer/NCT05724407/
The Effect of Aerobic Exercise Based Telerehabilitation Program on Upper Extremity Functıonality, Cognitive Status and Quality of Life in Patients With Survival Breast Cancer
The aim of this study is to determine the effect of telerehabilitation-based aerobic exercises on upper extremity functionality, cognitive status and quality of life in patients with survival breast cancer.
NCT05720858 — Breast Cancer
Status: Recruiting
http://inclinicaltrials.com/breast-cancer/NCT05720858/
Clinical, Histopathological, Molecular and Experimental Characterization of Liver Metastases From Patients With Breast Cancer.
The goal of this observational study is to learn about breast cancer liver metastasis in patients who met the following criteria: - female; - be ≥ 18 years of age on the day of signing informed consent; - confirmed diagnosis of breast cancer liver metastases. Newly diagnosed patients with de-novo liver metastases are eligible; - be planned for liver surgery. The main questions it aims to answer are: 1. To characterize the tumour cells and their microenvironment in the liver metastases at the transcriptomic and protein single-cell level; 2. To determine the levels and patterns of immune infiltrates in liver metastases from BC patients; 3. To identify biological features associated with the histopathological growth patterns in liver metastases. 4. To create patient-derived xenografts (PDX) and organoids (PDO) from liver metastases isolated from patients with BC; 5. To perform a histopathological and molecular comparison of liver metastases, PDX and PDO isolated from the same patient Participants will be willing and able to provide written informed consent for this study and tissue samples for research purposes.
NCT05720676 — Breast Cancer
Status: Not yet recruiting
http://inclinicaltrials.com/breast-cancer/NCT05720676/
A Prospective, Multicenter Randomized Controlled Trial(RCT) of the da Vinci® SP™ Surgical System vs Open Surgery in Nipple Sparing Mastectomy (NSM) Procedures
This study evaluates the safety and effectiveness of the da Vinci SP Surgical System compared to Open NSM in Nipple Sparing Mastectomy procedures.
NCT05720039 — Breast Cancer
Status: Recruiting
http://inclinicaltrials.com/breast-cancer/NCT05720039/
A Multicenter, Randomized, Double-Blind, Parallel-Controlled Phase Ⅲ Clinical Study to Compare the Efficacy and Safety of SYSA1901 vs Pertuzumab (Perjeta®) in the Neoadjuvant Therapy of HER2-Positive Breast Cancer
This is a phase Ⅲ, double-blind, randomized, parallel-controlled, multicenter equivalence study to compare the efficacy and safety of SYSA1901 + trastuzumab + docetaxel vs. Perjeta® + trastuzumab + docetaxel in the participants with early-stage or locally advanced HER2-positive and HR-negative breast cancer with a primary tumor > 2 cm.
NCT05720026 — HER2-positive Breast Cancer
Status: Recruiting
http://inclinicaltrials.com/her2-positive-breast-cancer/NCT05720026/
Effects of Kombucha Intervention on Emotional Distress and Sleep Quality in Breast Cancer Survivors
Effects of Kombucha Intervention on Emotional Distress and Sleep Quality in Breast Cancer Survivors.
NCT05717972 — Sleep
Status: Recruiting
http://inclinicaltrials.com/sleep/NCT05717972/