View clinical trials related to Breast Neoplasms.
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It is used with different treatment options such as chemotherapy, radiotherapy and surgery in the treatment of breast cancer, which is common in women among all cancers in the world. Side effects such as nausea, vomiting, neuropathy, oral nucositis, constipation, sleep problems, fatigue and alopecia occur due to chemotherapeutic agents applied in the treatment of breast cancer. Due to the lack of information and side effects related to cancer treatment, it negatively affects the adherence to treatment and self-care power of individuals. In this study, it was planned to examine the effect of training given for chemotherapy-related symptoms on self-care power and the management of chemotherapy side effects. Your study was planned as a single-center, randomized controlled quasi-experimental design. The research sample will consist of breast cancer patients aged between 18 and 65 years who were treated at Tekirdağ Namık Kemal University Hospital between July 2022 and April 2023 and accepted to participate in the study [26 intervention (experimental) group - 26 control group]. Intervention and control groups will be determined by using the random numbers table from the simple random sampling method, which is one of the probability sampling methods. In line with Orem's Self-Care Deficit Theory, a training booklet will be created for the management of chemotherapy side effects. Participants in the intervention (experimental) group of the study will be given training on chemotherapy side effects, which lasts 20-30 minutes at the first interview. Patient Information Form, Nightingale Symptom Evaluation Scale and Self-Care Behaviors Inquiry Form will be filled. Patients will be followed up for a total of 5 times during 4 cycles of chemotherapy and will be interviewed face-to-face at each chemotherapy cycle. Data collection tools will be filled in face-to-face interviews, the patient's side effects due to chemotherapy and the methods applied in the face of these side effects will be questioned, suggestions will be given for the control of chemotherapy side effects, and the patient's questions will be answered. No intervention will be applied to the participants in the control group of the study. In this study, it is thought that education and follow-up based on Orem's Self-Care Deficit Theory will contribute to the development of self-care behaviors and effective side-effect management in patients receiving chemotherapy for breast cancer.
The study is a nationwide, multicenter single-arm phase 2 study. The current phase 2 study investigates the efficacy of the combination of fulvestrant and alpelisib directly after progression on fulvestrant (either in first or second line, with or without previous use of CDK4/6-inhibitor) in patients with HR+ HER2- advanced breast cancer with PIK3CA mutated tumors. All eligible patients must have progressive disease on fulvestrant as latest treatment line. Previous treatment with a CDK4/6 inhibitor in first or second line is obligatory. After progressive disease is confirmed, it is important to continue fulvestrant (without CDK4/6 inhibition) during the screening period awaiting study enrollment. After study enrollment all participants will be treated with alpelisib and fulvestrant beyond progression. Follow-up time will be until progression or death or until a different oncolytic treatment has started (in case no progressive disease during previous fulvestrant and alpelisib treatment has been documented). Should participants discontinue due to reasons other than progression or death (e.g. toxicity), then they should still be evaluated for disease progression every 8 weeks as per protocol until progression, unless they do not wish to proceed with these screenings, or receive a different oncolytic treatment.
The objective of this study is to explore and evaluate the efficacy of tucidinostat combined with metronomic capecitabine in the treatment of metastatic triple-negative breast cancer.
Shared Decision Making on Care Pathways and alternative and complementary medicine (CAMs) : A Pilot Study. Study whose aim is to evaluate the feasibility of a study proposing a therapeutic education consultation leaning on the usual care pathway by estimating the recruitment capacity over 4 months as well as the acceptance rate of the study among patients diagnosed with breast cancer.
This is a Phase 2 study for patients with resected Stage I-III HER2+ breast cancer with detected molecular residual disease (MRD+) following standard neoadjuvant and locoregional therapy delivered with curative intent. In this study Patients will be treated with neratinib in addition to their standard T-DM1 adjuvant therapy. Neratinib will be administered orally at a dose of 160 mg daily for up to 12 months, or until the time of clinical recurrence, discontinuation due to toxicity, or withdrawal of consent. This study will have two stages, stage 1 would enroll up to 8 participants to clear the Minimal Residual Disease (MRD) and Stage 2 will enroll up to 5 participants. The purpose of this study is to determine if this study population would have a better outcome from adding neratinib to their standard T-DM1 adjuvant therapy.
This research study is being done to implement a screening program for prediabetes, diabetes, dyslipidemia and/or hyperlipidemia, and higher risk of cardiovascular disease in breast cancer survivors. This program will also help to direct individuals with risk factors to community and institutional resources for management.
To evaluate the efficacy and safety of sintilimab and bevacizumab biosimilar combined with pegylated liposomal doxorubicin in pretreated metastatic triple-negative breast cancer
This is a multi-site, global, open-label study that includes a phase 1b evaluation of elacestrant in combination with abemaciclib in women and men with with or without brain metastases from ER-positive, HER-2 negative breast cancer. Phase 1b is designed to select the recommended phase 2 dose and will be followed by a phase 2 evaluation of elacestrant in combination with abemaciclib in patients with active brain metastases from ER-positive, HER-2 negative breast cancer.
Breast cancer is the second most common invasive malignancy and the leading cause of cancer-related mortality in women. Overexpression of human epidermal growth factor receptor 2 (HER2) is observed in approximately 20% of breast cancers. Trastuzumab provided patients with HER2 overexpressing breast cancer a better outcome than chemotherapy alone. Trastuzumab and pertuzumab exert part of their activity based on antibody-dependent cell-mediated cytotoxicity (ADCC), mediated by natural killer (NK) cells. Trastuzumab (Herceptin®) is a recombinant DNA-derived humanized monoclonal antibody that selectively binds with high affinity to the extracellular domain of the human epidermal growth factor receptor 2 (HER2). Inhibits the proliferation of human tumor cells that overexpress HER2 and to mediate antibody-dependent cellular cytotoxicity (ADCC). Pertuzumab (Perjeta®) is a fully humanized monoclonal antibody and, like trastuzumab, is directed against the extracellular domain of HER2. It differs from trastuzumab because they bind to different domains. Due to their distinct mechanisms of action, the combination of pertuzumab and trastuzumab, is hypothesized to have complementary roles in treating HER2-overexpressing diseases. Natural killer cells are lymphocytes arising from CD34+ hematopoietic progenitor cells in the bone marrow. NK cells are identified as CD3-, CD56+ lymphocytes. These cells were identified on the basis of their ability to lyse tumor cells without prior sensitization. NK function is also regulated by cytokines such as IL-2, IL-15, IL-12 and IL-18. Our hypothesis is that the effect of trastuzumab and pertuzumab can be improved by regulating the efficiency of the ADCC activity through the infusion of ex-vivo activated allogenic NK cells. Objetives: Primary: To assess the safety and the tolerability of NK-ACT and trastuzumab/pertuzumab when used in combination. Secondary: To evaluate the initial clinical activity of NK-ACT concomitant with trastuzumab/pertuzumab. Exploratory Objectives: In vivo human NK cell biology: - To describe the mechanisms of action of the combination of ICTP and rastuzumab/pertuzumab. - To assess the biomarkers that might act as indicators of the immunemodulatory effect and anti-tumor activity of the combination.