View clinical trials related to Breast Cancer.
Filter by:Due to breathing and other motions, tumours, such as breast and lung cancer, as well as their surrounding organs (e.g. the heart), move, which poses a challenge for radiotherapy treatment. Reducing or even stopping breathing, e.g. by irradiating during inspiration, is a way to decrease tumour and organ motion resulting in a reliable target coverage with smaller margins. These smaller margins can result in a better sparing of normal tissues. Furthermore, in some patients, during inspiration, the heart may move away from the target volume making it possible to better spare the heart. Finally, during inspiration, the lung volume is larger and the lung density is lower, which can lead to a lower dose to the surrounding normal lung tissue. Reduction of radiation dose to normal tissues leads to less radiation-induced toxicity. This makes treating breast and lung cancer patients in breath hold (BH) conditions an attractive strategy. Standard BH durations in RT treatment are around 20 seconds, which is not enough to perform a complete CBCT. The health status of lung cancer patients is generally worse compared to breast cancer patients, making it more difficult to treat this patient group during breath hold. Nasal High Flow Therapy (NHFT) is a non-invasive system that provides controlled oxygen concentrations and low levels of positive pressure via a nasal interface. NHFT improves oxygenation in diverse patient groups, and is increasingly used as an alternative to mechanical ventilatory support. It has been shown to be a safe device in several clinical situations and patient populations, such as COPD patients, but also in apneic conditions under general anesthesia.
Accurate staging is of great importance in patients with clinically locally advanced primary breast cancer (LABC, stage III) or locoregional recurrent (LRR) breast cancer for making a correct treatment plan. According to current guidelines, staging is performed with positron emission tomography (PET) using the 2-[18F]fluoro-2-deoxy-D-glucose ([18F]FDG) PET tracer, combined with diagnostic computed tomography (CT). However, previous studies have shown that this technique (with the current PET tracer) might not be sufficient for accurate staging. Specifically in low grade, estrogen receptor positive (ER+) breast cancer metastases can be missed due to the low metabolic activity, leading to low uptake of [18F]FDG. Therefore, there is a clinical need to improve staging procedures. 16α-[18F]-fluoro-17β-estradiol ([18F]FES), an ER-targeted PET tracer, allows imaging of ER+ tumor lesions regardless of their metabolic activity. Patients with clinically LABC and LRR have a 25-50% risk of distant metastases. Correct identification of distant metastases allows adaptation of the treatment plan to avoid burdensome treatment with surgery, systemic and radiotherapy in order to maintain quality of life. In case of oligometastases, correct identification increases the likelihood for cure with local treatment. In the current study we will compare disease staging with [18F]FES- and [18F]FDG PET in patients with clinically LABC/LRR breast cancer. Objective: To determine whether [18F]FES PET/CT improves staging for women with clinically LABC or LRR, ER+/HER2- breast cancer as compared to standard [18F]FDG PET/CT. Study design: Multicenter prospective study with invasive measurements. Study population: 20 LABC and 20 LRR ER+/HER2- breast cancer patients. Main study parameters/endpoints: To determine the percentage of patients with a correctly changed treatment plan according to information obtained from [18F]FES PET/CT compared to [18F]FDG PET/CT at staging and at 6 months of follow-up; to determine the percentage of metastatic lesions detected and missed with [18F]FES PET/CT compared to [18F]FDG PET/CT (at staging and during follow-up). Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Patients will receive an intravenous cannula for tracer injection and blood sampling, causing potentially transient discomfort at the site of the cannula insertion. Tumor biopsy will be performed from an easy accessible lesion and the most frequent complications that can occur are discomfort, bleeding and (local) infection. The risk of complications from a tumor biopsy is considered low: 0.24-1.6% and 0.11-0.48% for major complications and mortality, respectively. Radiation exposure from a [18F]FES PET and [18F]FDG PET scan usually ranges between 4-11 mSv and 7-8 mSv, respectively. Radiation exposure from a diagnostic CT scan ranges between 8-14 mSv. The total radiation burden is considered justifiable when compared to the information that can be obtained from this study, in this patient group with breast cancer. Imaging with [18F]FES PET may improve staging for patients with breast cancer as it may show tumor lesions that could not be identified with [18F]FDG PET, the current standard for staging. If this is the case, the initial treatment goal and intensity can be adjusted which can have beneficial effects for the patient.
This study (also known as IMpassion050) will evaluate the efficacy and safety of atezolizumab compared with placebo when given in combination with neoadjuvant dose-dense anthracycline (doxorubicin) + cyclophosphamide followed by paclitaxel + trastuzumab + pertuzumab (ddAC-PacHP) in patients with early HER2-positive breast cancer (T2-4, N1-3, M0).
This research is being done to learn more about whether or not Korean American women will improve the screening practices for breast and cervical cancer if subjects receive education and follow-up from community health workers. The education materials may be given via online or in-person. Primary Hypothesis: e-CHEC-uP will be as efficacious as the original CHEC-uP in promoting mammogram and Pap test screening among Korean immigrant women (KIW) at 6 months. Objectives: (1) To develop a web-based platform of the health literacy education component of the original CHEC-uP intervention; (2) To evaluate the acceptability and usability of the web version of the health literacy education in a user testing sample of 10 KIW; and (3) To conduct a pilot study to test the preliminary efficacy of the web version of CHEC-uP (e-CHEC-uP) in 40 KIW.
Using a pilot 1-arm pre-post design, investigators will implement an intervention that is personalized, low burden (the majority of interactions are telephone coaching sessions), and delivered during the initial survivorship transition. To determine the feasibility of the intervention 48 community-dwelling rural breast cancer survivors (BCS) (ages 40 and older) will receive the intervention. The 12-week intervention consists of three home-based face-to-face consultations with the therapist, 9 weekly habit tele phone coaching sessions, and the use of implementation intentions, environmental modifications, and tailored text messages to support physical activity and dietary habit formation and address unmet needs.
The purpose of this research study is to learn about the effects that standard of care endocrine therapies have on the immune system's response to cancer by looking at the number and types of immune cells present and how they function in women with early stage estrogen receptor positive (ER+) breast cancer.
The aim of the present randomized double-blinded placebo-controlled clinical trial is to investigate if melatonin can protect against acute radiation dermatitis in patients with early breast cancer receiving radiation therapy, and whether this has an impact on the patients' quality of life.
Breast cancer patients with ipsilateral supraclavicular lymph node metastasis are defined as Ⅲc stage (N3) according to the newly published 8th AJCC TNM staging system. No concret guide line was supported to such patients. It is still pending whether to exert supraclavicular lymph node dissection to breast cancer patients with ipsilateral supraclavicular lymph node metastasis. To evaluate the clinical significance and complication of supraclavicular lymph node dissection for breast cancer patients with ipsilateral supraclavicular lymph node metastasis, the investigators randomize patients into two groups, one group is supraclavicular lymph node dissection with radiotherapy group, the other group is radiotherapy group.
Chemotherapy-induced alopecia (CIA) is one of the most common and emotionally distressing side effects of cancer therapy. In this study we sought to assess the feasibility and the effectiveness of scalp cooling system DigniCap® to prevent alopecia in primary breast cancer patients receiving an anthracycline containing adjuvant chemotherapy (CT). A prospective two-stage design clinical trial conducted at a single Institution of women with primary breast cancer scheduled to receive anthracycline with or without taxane-based adjuvant CT. Patients were enrolled from July 2014 to November 2016, with ongoing annual follow up for 5 years. The scalp cooling period initiated approximately 30 minutes before CT. Scalp temperature was to be maintained at 3-5°C throughout CT and for 90 to 120 minutes afterward, depending on the CT drug and dose.
Scientific context: With more than one million cases per year, breast cancer is the most common female cancer. All treatments such as surgery, chemotherapy, radiotherapy or hormone therapy lead to major changes patients' lifestyle. These treatments can lead to a decrease of physical activity due to fatigue and also changes in the diet. Sometimes, chemotherapy induces nutritional aversions and can cause weight gain that is known to increase the risk of recurrence. Cognitive complaints are also frequent, in particular in patients who received chemotherapy and can also lead to quality of life's alteration Fatigue assessed with prevalence between 70 % and 100 % is usually a part of a series of symptoms including anxiety, depression, pain, sleep disturbance, decreased activity level, nutritional changes and pre-existent comorbidities. These symptoms can lead to an alteration of the quality of life. The chemotherapy involves disturbances at physiological, psychological and social levels and eating disorders leading to changes in eating habits which can lead to weight loss or weight gain. To limit these deleterious changes in lifestyle, increased physical activity, specialized counseling and nutritional monitoring may be recommended. According to current knowledge there is no prospective study that evaluated different lifestyle changes according to different types of patients and the appearance of the installation of these symptoms during the patient pathway. Research hypothesis: the study hypothesis is that description of the evolution of the quality of life and, physical, nutritional and cognitive parameters in a population of patients with non-metastatic breast cancer will better characterize these patients in order to propose an appropriate and personalized rehabilitation intervention.The investigators propose this feasibility study consisting of 2 cohorts of patients according to the adjuvant therapy given (+/- chemotherapy) after the primary breast surgery.