A Proof-of-Concept Study Evaluating a 4:3 Intermittent Fasting Weight Loss Intervention in Adults With Breast Cancer and Overweight or Obesity
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.
NCT06399276 — Breast Cancer
Status: Not yet recruiting
http://inclinicaltrials.com/breast-cancer/NCT06399276/
Phase II Study Serplulimab Combined With Neoadjuvant Chemotherapy for Early-stage Estrogen Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative (ER+/HER2-) Breast Cancer
The goal of this clinical trial is to learn if serplulimab is effective in early HR+/HER2- breast cancer. It will also learn about the safety of serplulimab. The main questions it aims to answer are: Does serplulimab combined with neoadjuvant chemotherapy improve the pCR rate of early HR+/HER2- breast cancer? What medical problems do participants have when receiving serplulimab? Researchers will compare the effect of serplulimab combined with chemotherapy to the effect of chemotherapy reported in literature. Participants will: Receive serplulimab plus chemotherapy every 3 weeks for 6 cycles; All patients will receive surgery, and the primary end point is a pathological complete response at the time of definitive surgery; After definitive surgery, the participants will receive adjuvant serplulimab every 3 weeks for up to 3 cycles.
NCT06394661 — Breast Cancer
Status: Not yet recruiting
http://inclinicaltrials.com/breast-cancer/NCT06394661/
Utilizing Label-free Raman Spectroscopy for Discrimination Between Breast Cancer Tumor and Adjacent Tissues in Patients After Neoadjuvant Treatment
After neoadjuvant therapy, the primary lesion in breast cancer patients may experience tumor regression, which increases the difficulty of distinguishing between breast cancer and adjacent tissues. Raman spectroscopy is a form of scattering spectroscopy, which offers rapid and sensitive analysis, delivering detailed biochemical information and molecular signatures of internal molecular components within the sample. This study aims to discern between cancer and adjacent tissues after neoadjuvant therapy in breast cancer patients using label-free Raman spectroscopy.
NCT06394050 — Diagnosis
Status: Not yet recruiting
http://inclinicaltrials.com/diagnosis/NCT06394050/
A Crossover Randomized Controlled Trial to Investigate the Acceptability and Efficacy of Cecebot, a Conversational Agent for Insomnia After Breast Cancer
This clinical trial evaluates the effect of conversational agent, Cecebot, on improving insomnia in stage I-III breast cancer survivors. Sleep disturbance ranks among the top concerns reported by breast cancer survivors and is associated with poor quality of life. Many breast cancer survivors also have decreased physical activity, which may also have a negative impact on sleep and quality of life. Cognitive behavioral therapy for insomnia (CBTi) and physical activity interventions have individually been reported to improve sleep and to have a positive impact on quality of life. Cecebot is a personalized short messaging service (SMS)-based behavioral intervention that combines CBTi and physical activity strategies that may improve sleep for breast cancer survivors.
NCT06392789 — Insomnia
Status: Recruiting
http://inclinicaltrials.com/insomnia/NCT06392789/
Real-world Study of Incadronate in Breast Cancer Patients With Metastatic Bone Disease: clinIcal Efficacy and Safety
This is a real-world study to explore the efficacy and safety of incadronate in the treatment of breast cancer patients with bone metastases.
NCT06392217 — Breast Cancer
Status: Recruiting
http://inclinicaltrials.com/breast-cancer/NCT06392217/
Avidination for Radionuclide THerapy (A.R.THE.) in Nonpalpable Breast Cancer
This is an interventional, open-label, non comparative phase 2 trial enrolling patients with nonpalpable breast cancer
NCT06390241 — Breast Cancer
Status: Not yet recruiting
http://inclinicaltrials.com/breast-cancer/NCT06390241/
DiviTum®TKa: A Biomarker Assay for Efficacy in HR+ Metastatic Breast Cancer Patients
The purpose of this study is to explore the clinical utility of routinely measuring thymidine kinase activity (TKa) in HR+ metastatic breast cancer patients receiving treatment with any approved endocrine therapy either alone or in combination with any approved CDK4/6 inhibitor.
NCT06388122 — Metastatic Breast Cancer
Status: Recruiting
http://inclinicaltrials.com/metastatic-breast-cancer/NCT06388122/
Dose-limiting Toxicities of Paclitaxel in Breast Cancer Patients: Studying Interactions Between Pharmacokinetics, Physical Activity, and Body Composition: an Observational Pilot Study.
This study looks into how a common breast cancer treatment, paclitaxel, can sometimes cause severe side effects that make it hard for patients to continue treatment. These side effects can significantly affect a patient's quality of life and even impact their recovery and overall health costs. What's interesting about this research is that it considers how a patient's lifestyle, specifically their physical activity levels and body makeup (like how much muscle and fat they have), might influence these side effects. The researchers are doing a detailed study with 40 women receiving paclitaxel treatment, tracking how the drug is processed in their bodies and how their body composition and physical activity might play a role in the side effects they experience. They are using a special method to monitor drug levels in the blood and are also keeping tabs on the patients' health and physical activity through questionnaires and modern tracking devices. The goal here is twofold: first, to better understand why these side effects happen to some people and not others, and second, to develop a model that can predict who might be at higher risk for these side effects based on their body composition, lifestyle, and how their body handles the drug. This could lead to more personalized treatment plans that could help reduce the risk of severe side effects and improve the overall treatment experience for patients with breast cancer. In simpler terms, this research is trying to find a way to make breast cancer treatment with paclitaxel safer and more comfortable by considering how a person's lifestyle and body type might affect their reaction to the drug. This could make a big difference in helping patients complete their treatment successfully and with a better quality of life.
NCT06387901 — Breast Cancer
Status: Not yet recruiting
http://inclinicaltrials.com/breast-cancer/NCT06387901/
Registry of Patients Undergoing Cryoablation for Early Stage Breast Cancer
This study evaluates the side effects and outcomes of patients who undergo cryoablation for early stage breast cancer.
NCT06387173 — Early Stage Breast Carcinoma
Status: Recruiting
http://inclinicaltrials.com/early-stage-breast-carcinoma/NCT06387173/
A Open-label, Randomized, Multicenter Phase III Study of ESG401 Versus Treatment of Physician's Choice in Patients With Locally Advanced or Metastatic HR+/HER2- Breast Cancer Who Had Failed at Least One Line of Chemotherapy
The aim of this study is to evaluate the efficacy and safety of ESG401 in patients with unresectable locally advanced or metastatic HR+/HER2- breast cancer.
NCT06383767 — Metastatic Breast Cancer
Status: Not yet recruiting
http://inclinicaltrials.com/metastatic-breast-cancer/NCT06383767/