View clinical trials related to Breast Cancer.
Filter by:This study will assess if the presence of immune system cells in and around the tumor impacts tumor shrinkage in patients receiving neoadjuvant chemoimmunotherapy for triple-negative breast cancer.
The Mind programme for cancer patients was developed by this project PI through the integration of ACT, mindfulness and CFT components specifically adapted to the needs of a cancer population. This intervention aims at improving well-being, preventing subsequent distress, and promoting adaptation to the disease and posttreatment period. A recent pilot study presented preliminary findings on this intervention, suggesting high acceptability and efficacy in improving self-reported psychological health in breast cancer patients undergoing Radiotherapy treatment. Nevertheless, this study's small sample size, methodology (inactive control group), and exclusive reliance on self-reported data limit the interpretation and generalization of results, creating an avenue for the optimization and further testing of the programme through more robust and reliable methods. The aim of this project is therefore to optimize the Mind programme taking into consideration the results from its pilot study and to conduct a Randomized Controlled Trial on the efficacy of the intervention in improving not only mental health outcomes but also biological markers, as well as on its cost-effectiveness, in women with breast cancer. The superiority of the Mind programme will be compared to a support group intervention through the analysis of changes in cancer-specific quality of life, depressive symptoms and anxiety severity, psychological experiences, and immunological and epigenetics markers related to mental health and breast cancer prognosis. All participants will receive the intervention that shows better results.
This aims to clinically validate, on a large population, a tumor detection aid software which has already been trained on a representative French population (from several hospital centers and liberals from several departments in the west and east of France). This population consists of 1000 patients who have been treated for breast cancer (histologically proven by breast biopsy) and whose investigators have mammograms performed at the time of diagnosis. The control population consists of the unaffected breast of each patient (with the exception of the rare cases of bilateral cancers). This innovative software has the main feature of recognizing healthy breast tissue, allowing the radiologist to focus on breast tissue at risk, improving the management of medical time and the management of "difficult" files.
This is an investigator-initiated randomized controlled, open-label, multicenter, prospective Phase 2 clinical study. Patients with stage II-III HR +/HER2 + breast cancer were randomly divided into two groups at a ratio of 1:1. The experimental group received pyrotinib combined with trastuzumab, dalpiciclib and letrozole; the control group received trastuzumab combined with pertuzumab, docetaxel and carboplatin. The main study objective was to evaluate the efficacy and safety of neoadjuvant therapy for HR +/HER2 + breast cancer in the two groups.
In this study, color Doppler ultrasound diagnostic instrument and electronic grip device were used to determine the best grip strength of patients with tumor PICC catheterization, formulate precise and standardized grip strength training guidance for them, provide personalized functional exercise health education, and observe the impact of precise grip strength training guidance on Peripheral central venous catheter-associated thrombosis. To provide a reference for clinical prevention of Peripheral central venous catheter-associated thrombosis in the future.
Rationale: MagTrace® will be implemented as standard of care for sentinel lymph node biopsy, since it has several advantages compared to a radioactive technique. However, MagTrace® is known to interfere with MRI during follow-up imaging when using 2 mL. No data is available for patients who received 1 mL of MagTrace®, as is described in our current protocol. A contrast enhanced mammography (CEM) could be an alternative for MRI if it still shows artefacts. Objective: The primary objective in this trial is to evaluate the use of MRI and contrast enhanced mammography after using MagTrace® to perform a sentinel node biopsy. Study design: Prospective trial in an outpatient clinic setting. Study population: Patients who were included in the previous MagTrace study will be asked to participate in this subsequent trial. Study procedure: Participants will undergo MRI and CEM as standard 1-year follow-up. Since the MagTrace study started in August 2021 and finished in February 2022, this trial will start August 2022 to February 2023. Main study parameters/endpoints: To evaluate the use of MRI and CEM, the following primary endpoints will be assessed: Visibility and size of artefacts undergoing MRI and CEM and its consequences of the quality for image assessment. Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Since MagTrace® will be implemented as standard localisation technique for breast conserving surgery and sentinel lymph node biopsy in Zuyderland MC, the information obtained from this trial is essential for the follow-up planning of all breast cancer patients. Therefore, the burden for the patients (undergoing extra imaging) will be in proportion to the added value of this trial.
In recent years, the incidence rate of breast cancer has remained high. In China, breast cancer is the malignant tumor with the highest incidence rate among women. Although the research and development of various targeted drugs and the improvement of clinical treatment system have effectively improved the 5-year survival rate of breast cancer patients in China, the clinical treatment effect of breast cancer is still unsatisfactory. It is speculated that the main reasons for the poor clinical efficacy of breast cancer are drug tolerance, recurrence, distant metastasis, etc., which further leads to some limitations in the exploration of clinical drug development and regulatory mechanism. Paclitaxels are common chemotherapeutic drugs, which have been widely used in the treatment of breast cancer, ovarian cancer and some lung cancer. In2005, albumin binding paclitaxel was approved by FDA for the treatment of breast cancer patients. It is highly hydrophobic and requires a mixture of polyethylene castor oil and ethanol. These solvents will increase the toxic reactions of patients treated with paclitaxel, including severe allergic and anaphylactic reactions, and irreversible peripheral neuropathy, usually requiring the use of corticosteroids and antihistamines in advance.In order to further confirm the advantages of albumin binding paclitaxel and common paclitaxel chemotherapeutic drugs in neoadjuvant chemotherapy of breast cancer, this project intends to explore albumin binding based on different molecular types of breast cancer (luminal a, B, HER2 +, triple negative) An observational study on the efficacy of neoadjuvant chemotherapy with a-paclitaxel and common paclitaxel chemotherapeutic drugs. Randomized grouping confirmed the effectiveness of albumin binding paclitaxel replacing common paclitaxel in neoadjuvant chemotherapy of breast cancer with different molecular types, providing evidence-based medical evidence for the selection of paclitaxel chemotherapeutic drugs based on breast cancer molecular types. At the same time, the patients with poor efficacy among the patients who selected the neoadjuvant chemotherapy scheme for breast cancer according to the guidelines of NCCN and CSCO were screened for clinical transformation research (including basic experimental research, follow-up intensive treatment selection, and providing basis for entering other drug clinical trials). For the patients who achieved the clinical efficacy of PCR with neoadjuvant chemotherapy, we further analyzed the reasons to explore a better scheme of neoadjuvant chemotherapy.
This study aims to evaluate the comparative risk of dementia/Alzheimer's disease onset between patients treated with medications that target specific metabolic pathways and patients treated with alternative medications for the same indication.
The study described in this protocol is a Phase 1, single center clinical trial to evaluate the safety and potential of [18F]GEH121224 as a PET radiotracer for the diagnostic imaging of HER2 positive breast cancer lesions. A group of 6 patients will be selected to perform a dosimetry study with [18F]GEH121224 followed by another group of 6 patients in a test-retest study. The results of this study will provide crucial information to guide the development of [18F]GEH121224 for the detection of HER2 status in advanced breast cancer patients. This study will use established methods for characterizing the radiation dosimetry, biodistribution and basic pharmacokinetics of a radiotracer.
T-REX is a randomized multicenter, non-inferiority trial. Aim: To evaluate whether regional radiotherapy may safely be omitted in clinically node negative breast cancer patients with one or two sentinel node macrometastases and an estrogen receptor positive, HER2-negative tumor. Leading to an improved quality of life and reduced side effects, without worsening recurrence free survival at five years. Intervention: Patients will be randomized to locoregional radiotherapy towards the breast/chestwall and regional lymph nodes vs. to a de-escalated radiotherapy. In the intervention arm no lymph node irradiation will be given. Radiotherapy is still given to the remaining breast after breast conserving surgery, but no radiotherapy is given after mastectomy. Sample size: 1350 patients Primary end-point: Recurrence free survival at five years. Gene expression analysis: For all patients gene expression analysis for the gene signatures ARTIC, POLAR and OncotypeDX will be performed in collaboration with Exact Sciences, and related to risk of recurrence and benefit of adjuvant radiotherapy.