View clinical trials related to Breast Neoplasms.
Filter by:The goal of this clinical trial is to evaluate the efficacy of investigator's choice of chemotherapy, either alone or in combination with everolimus, in treating patients with locally recurrent inoperable or metastatic triple-negative breast cancer, luminal androgen receptor (LAR) subtype with PI3K/AKT/mTOR (PAM) pathway mutation, as the first-line treatment.
This is a Phase III open-label study to assess if camizestrant improves outcomes compared to standard adjuvant endocrine therapy for patients with ER+/HER2- early breast cancer with intermediate-high or high risk for disease recurrence who completed definitive locoregional therapy (with or without chemotherapy). The planned duration of treatment in either arm within the study will be 7 years.
Breast surgery may be overtreatment when there is a complete response to systemic neoadjuvant treatment as determined clinically and by imaging. However the reliability of imaging techniques (ultrasound, mammography and magnetic resonance) in identifying complete response varies in published studies and surgery remains the preferred method of detecting residual disease. The aims of this study are: 1. To assess the reliability of minimally invasive preoperative image-guided vacuum-assisted biopsy (VAB) in identifying residual breast in cT1-cT2-cT3, cN0-cN1 breast cancer patients, either with complete clinical/radiological response, or with residual breast disease <1 cm, after systemic neoadjuvant treatment. 2. To assess the reliability of minimally invasive preoperative image-guided needle biopsy in identifying residual axillary disease in cT1-cT2-cT3, cN0-cN1 breast cancer patients, either with complete clinical/radiological response, or with residual breast disease <1 cm, after systemic neoadjuvant treatment. After neoadjuvant treatment, and evaluation with ultrasound, mammography and magnetic resonance, VAB will be performed on the breast, and needle biopsy will be performed on the axillary lymph node of pre-treatment cN1 cases, previously marked with a magnetic clip. The biopsy findings will be compared with the surgical findings, consisting in quadrantectomy or mastectomy plus sentinel node biopsy (or separate removal of tagged lymph nodes if they do not coincide with the sentinel node(s)) to assess the ability of biopsy to identify residual disease.
This study will evaluate the safety and efficacy of trastuzumab deruxtecan (T-DXd) in participants with human epidermal growth factor receptor 2 (HER2)-low or HER2 immunohistochemistry (IHC) 0 (who are both hormone receptor [HR]-negative and HR-positive) unresectable and/or metastatic breast cancer.
Background: Breast cancer (BC) treatments usually include a combination of surgery, chemotherapy and radiation. These life-saving treatments cause high percentages of arm morbidity, which often lasts for months, or develops months after surgery. Arm and shoulder morbidity includes prolonged pain, restriction of movement, limitation of function and lymphedema (chronic progressive edema). All of these morbidities affect the quality of life (QOL) of the recovering patients and require lengthy care. Early detection of patients at risk and provision of proactive treatment can improve the recovery process from surgery and oncology treatments. Aim: To develop a screening tool for the early identification of women at high risk for prolonged arm morbidity following BC treatments (persistent pain, lymphedema, function deficits and decreased range of motion), validate the tool, and examine the efficiency of intervention based on the the use of the tool.
This is a randomized, controlled, open-label, phase II study to explore the efficacy and safety of Everolimus in combination with standard first-line endocrine therapy for the HR+/ HER2-SNF1 subtype of advanced breast cancer. The study was used to explore the efficacy of Everolimus in combination with standard endocrine therapy.
Patients who experienced neutropenia after receiving pegfilgrastim on day 1 of the first round are randomly assigned to either the control or experimental arm. Patients in the control arm continue pegfilgrastim injection on day 1 while patients in the experimental arm will receive pegfilgrastim injection on day 3 to see if changing the pegfilgrastim administration date from day 1 to day 3 starting from the second round of chemotherapy could reduce the incidence of neutropenia
This clinical trial aims to evaluate the efficacy, safety, and exploratory measures of liposomal doxorubicin and carboplatin combination therapy in the adjuvant setting for early stage triple negative breast cancer (TNBC) patients. The primary objective is to determine the effectiveness of liposomal doxorubicin and carboplatin in reducing the risk of recurrence for early stage TNBC patients. The secondary objectives involve characterizing the safety and toxicity profile of the combination therapy. Adverse events rates will be assessed using the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. The exploratory objectives of the study focus on evaluating changes in circulating tumor DNA (ctDNA). This measure will provide insights into the potential utility of ctDNA as a biomarker for treatment response and disease progression. By addressing these objectives, the study aims to contribute to the understanding of the benefits and risks associated with liposomal doxorubicin and carboplatin combination therapy in the adjuvant setting for early stage TNBC, potentially leading to improved treatment outcomes and patient care.
This study evaluates vaginal microbiome as a biomarker to improve vaginal and sexual health in women with breast cancer receiving endocrine therapy. Breast cancer is the most common cancer in United States women, aside from skin cancers. Endocrine therapy is standard treatment for 70% of invasive breast cancers, significantly affecting sexual health and often causing women to change their course of treatment or cease sexual activity. Changes in the vaginal microbiome, which is the collection of all microorganisms, such as bacteria, fungi, and viruses, that naturally live on and inside the body, are implicated in menopausal-related sexual health symptoms, but the vaginal microbiome (and associated immune responses) has not been explored as a biomarker for sexual health changes in hormone-related sexual health symptoms in breast cancer. A biomarker is a biological molecule found in blood, other body fluids, or tissues that is a sign of a normal or abnormal process, or of a condition or disease. Ribonucleic acid (RNA)-sequencing is a cost-effective method to analyze both human and microbial transcripts. The RNA that is sequenced from a standard biological sample such as a swab is a snapshot of the expression of many different cells and can be used to simultaneously measure the quantities of microbes, the overall expression of the human host, and the quantities of immune cells. Information gathered from this study may help researchers establish the vaginal microbiome as a biomarker and therapeutic target to improve the vaginal and sexual health of women with breast cancer receiving endocrine therapy.
This study is a post-marketing, observational, multicenter, prospective study. It will investigate the the safety and effectiveness of T-DM1 in the Chinese population in real-world clinical practice.