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Breast Neoplasms clinical trials

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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.

NCT ID: NCT06361264 Recruiting - Clinical trials for Stage IV Breast Cancer

Clinical Study of Personalized Chemotherapy for Breast Cancer With Low Doses of Cyclophosphamide

Start date: November 1, 2018
Phase: Early Phase 1
Study type: Interventional

The goal of this study is to evaluate the safety and clinical efficacy of personalized chemotherapy with low doses of cyclophosphamide administered taking into account the reparative cycle of tumor cells in participants with breast cancer (stage IV or disease progression). The main question it aims to answer is: Does personalized chemotherapy of breast cancer with low doses of cyclophosphamide, taking into account the reparative cycle of tumor cells, lead to a significant reduction in tumor size and improvement in the visual status of controlled tumor foci relative to their initial state? During the preparatory stage, a tumor sample from participant is harvested intraoperatively. The primary culture is obtained from this tumor tissue sample. Repair cycle time is estimated, and the day when tumor cells are synchronized at the cell cycle G2/M phase is identified. The schedule of administering cyclophosphamide and DNAmix complex composite preparation is calculated according to the resulting time points. According to the elaborated regimen, the participant receives 4 intravenous cyclophosphamide injections at the dose of 300 mg/m2 in combination with 4 injections of 1-12 mg of DNAmix administered into prominent tumor nidi and lymph depots. The participant receives from 2 to 6 courses of therapy. The interval between courses is 21 days.

NCT ID: NCT06361056 Recruiting - Breast Cancer Clinical Trials

Mobile Health App to Promote Participation of Black Women in Breast Cancer Clinical Trials

Start date: May 2, 2022
Phase: N/A
Study type: Interventional

This study explores the overall feasibility, impact, and satisfaction of using the "mHealth app" on clinic workflow for Black or African American women diagnosed with breast cancer. The "mHealth app" which can be used as a platform to share clinical trial education and communication, was created and tested in previous steps of this study.

NCT ID: NCT06360809 Recruiting - Breast Cancer Clinical Trials

Prehabilitation Exercise Program in Breast Cancer: Effects on Quality of Life and Tumor Microenvironment (PEP_BC)

PEP_BC
Start date: March 22, 2024
Phase: N/A
Study type: Interventional

To improve the health and quality of life of breast cancer (BC) patients, researchers are focusing on prehabilitation strategies like physical exercise, preparing patients both mentally and physically for clinical and surgical procedures, potentially reducing complications. Physical exercise is also recognized as pivotal in optimizing chemotherapy. It can improve blood flow and oxygen supply in the microenvironment of the tumor (MT), potentially enhancing chemotherapy effectiveness. Although previous research has shown the benefits of preoperative exercise combined with chemotherapy in various cancer types, including BC, further investigation is needed into the exact effects of prehabilitation exercise (PE) on MT physiology. This study aims to provide valuable insights into the potential benefits of PE for BC patients and its impact on the tumor microenvironment. The hypothesis is that PE in BC patients will improve their quality of life, reduce fatigue, increase muscle mass, decrease fat mass, and enhance physical fitness. Additionally, beneficial acute hemodynamic changes, particularly increased blood flow following PE sessions, and hemodynamic adaptations involving higher levels of oxygenated hemoglobin, increased blood flow, greater oxygen saturation, and a higher metabolic rate of oxygen, are expected. The study will include 76 participants aged 18-65 years, meeting specific criteria such as a diagnosis of hormone receptor-positive BC, no medical contraindications for exercise, no metastatic cancer, and no structured exercise in the last six months. These participants will be randomly assigned to a PE group or a control group. The study will consist of three phases: Phase 1 involves pre-intervention assessments, Phase 2 includes a 4-week PE intervention with three weekly sessions, and Phase 3 encompasses post-intervention and post-surgery assessments. The 4-week PE intervention in Phase 2 will include strength and aerobic training. Quality of life and fatigue assessments will use questionnaires, and measurements will be made for fat mass, lean mass, bone density, and cardiorespiratory fitness. Strength measurements will be taken, and shoulder mobility will be evaluated. Hemodynamics of the MT will be assessed using a hybrid device combining Near-Infrared Spectroscopy and Diffuse Correlation Spectroscopy with ultrasound.

NCT ID: NCT06356519 Recruiting - Breast Cancer Clinical Trials

Real-world Effectiveness and Safety Study of Sacituzumab Govitecan in Chinese Metastatic Breast Cancer

Start date: March 1, 2024
Phase:
Study type: Observational

The aim of this trial is to explore the real-world effectiveness and poteintial predictors of Sacituzumab Govitecan in Chinese metastatic breast cancer patients.

NCT ID: NCT06355440 Recruiting - Clinical trials for Breast Neoplasm Female

Pilot Study of Financial Navigation Program for Improving Financial Toxicity Among Breast Cancer in China

Start date: March 18, 2024
Phase: N/A
Study type: Interventional

The goal of this pilot study is to access the feasibility and impact of a financial navigation program on improving financial toxicity among patients with breast cancer in China. The main questions it aims to answer are: - Is the intervention feasible and acceptable among participants? - Does the intervention enhance participants' cost-related health literacy? - Does the intervention reduce participants' financial toxicity? Researchers will compare the financial navigation program with usual oncology care to preliminarily evaluate its effectiveness. Participants will receive comprehensive information support, including: - Strategies on patient-physician costs discussion - Skills for inquiring and tracking treatment-related costs - Basic knowledge about health insurance - Guidance on accessing and applying for financial assistance - Suggestions for returning to normal life and work - Strategies for holding a financial-related family meeting

NCT ID: NCT06352567 Recruiting - Breast Cancer Clinical Trials

Symptoms Associated With Chemotherapy-Induced Peripheral Neuropathy

Start date: January 18, 2024
Phase:
Study type: Observational

Breast cancer remains the most frequent type of cancer globally. Nevertheless, the increased rate of disease-free survival of breast cancer brought the specific need of managing of short and long-term side effects of multimodal treatment. Chemotherapy-induced peripheral neuropathy (CIPN) is one of the most debilitating conditions which is characterized by a wide variety of experienceable symptoms by patients that need to be addressed in detail. Therefore, in this cross-sectional study, it was aimed to assess the potential symptoms associated with CIPN of patients with breast cancer who underwent systemic chemotherapy. In addition, it was aimed to assess the potential associations between experienced symptoms of CIPN and sociodemographic (age, body mass index etc.) and clinical features (mean exposed dose, type of surgery (if any) etc.).

NCT ID: NCT06351865 Recruiting - Breast Cancer Clinical Trials

Feasibility Study to Evaluate the Use of Patient Reported Complications After Digital Consent

PRC
Start date: March 7, 2024
Phase:
Study type: Observational

Patient report complication data to our best knowledge has not been studied yet in electronic consent. This study is a feasibility study to assess whether patients will reliably report their complications, the quality of this reporting and whether the information provided in the consent form matches up to their experience. This data will then be used to improve the consent process and evaluate whether the Patient Initiated Follow Up (PIFU) model is effective or if it leads to underreporting of problems.

NCT ID: NCT06346470 Recruiting - Breast Cancer Clinical Trials

The Effect of Web-Based Breast Self-Examination Education

Start date: February 19, 2024
Phase: N/A
Study type: Interventional

Breast cancer is the most common type of cancer among women. Reasons such as diagnosing breast cancer at an early stage increases the chances of treatment and survival, and the fact that the masses are largely noticed by the individual themselves, point to the importance of breast self-examination (BSE) . BSE skill is among the nursing skills. When the literature was examined, it was seen that the web-based education method was frequently used for cognitive skills during nursing education, but its use was limited for psychomotor skills training. It was determined that in BSE training, in addition to traditional education, methods such as concept maps and peer-supported education were used, but web-based education methods were not used. It is thought that the study will contribute to the literature in these aspects.