View clinical trials related to Breast Neoplasms.
Filter by:The investigator developed this protocol to accurately assess lymph node response to neoadjuvant chemotherapy in clinical stage N1 (cN1) breast cancer patients. Accuracy of sentinel lymph node biopsy (SLNB) alone and in combination with the removal of wire-localized-clip-marked nodes will be analyzed. New model to predict lymph node pathological complete remission (pCR) so as to safely avoid axillary lymph node dissection in cN1 breast cancer patients is sought for.
The purpose of this study is to evaluate the safety of BBB disruption using the ExAblate 4000-system Type 2 in patients with Her-2 positive breast cancer metastases in the brain.
This study will compare the analgesic effects of midpoint transverse process to pleura (MTP) block to control as well as thoracic paravertebral block.
A single-center, phase II, single-arm, feasibility study to evaluate PLD (Caelyx®) as an adjuvant chemotherapy regimen in patients with early-stage luminal B breast cancer. The primary endpoint will be to evaluate the feasibility of adjuvant PLD (Caelyx®) for each individual subject. The regimen will be considered feasible if that subject is able to achieve relative dose intensity (RDI) of at least 85% of the 8 cycles of treatment. Caelyx® should be administered intravenously at a dose of 20 mg/m2 once every two weeks for 8 courses.
The purpose of this study is to compare the effect of low intensity vibration (LIV) delivered for 10 minutes twice daily for 12 months on skeletal muscle function, in terms of energetic capacity measured by power generation on a stationary bicycle, among patients with early stage breast cancer planned to initiate aromatase inhibitor therapy who do not currently participate in regular exercise, compared to a wait- listed control.
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.
This is a phase III, single-center, prospective, open-label, randomized,controlled study
The CARTIER study is a randomized, multicenter, open-label clinical trial comparing, in elderly patients with cancer under anti-tumoral treatment, two different cardiotoxicity prevention strategies: primary (intensive cardiovascular monitoring focused on prevention and early diagnosis and treatment of cardiotoxicity based in cardio-onco-hematology teams involved in cancer patient care) vs. secondary (current clinical practice where intensive cardiovascular monitoring is not routinely performed and cardiotoxicity patient care is based on the onco-hematologist criteria). The primary endpoint is to determine whether this primary prevention englobing cardiovascular monitoring plus intensive multidisciplinary management is superior to the current clinical practice in reducing all cause mortality. Other secondary objectives of the study are to analyze the impact of this intensive cardiovascular monitoring strategy on the incidence of cardiovascular mortality, oncological mortality, hospitalization and/or urgent care due to cardiovascular complications, hospitalization and/or urgent oncological care due to cancer complications, tumor progression and cost-effectiveness analysis. A total of 514 patients ≥ 65 years old diagnosed with any of the following onco-hematological cancers, colon, breast, lymphoma, chronic lymphoma leukemia, chronic myeloid leukemia or myeloma, undergoing standardized anti-tumoral treatment, will be recruited. The incidence of primary and secondary outcomes will be measured at 2 and 5 years
PRIMARY STUDY OBJECTIVES: To evaluate dosimetric outcomes in tumor bed boost irradiation in patients undergoing breast conservative surgery using three different surgical techniques SECONDARY OBJECTIVES- Evaluation of cosmesis in patients prior to radiotherapy, at the time of completion of radiotherapy and 6 months post completion of radiotherapy STUDY DESIGN: Three arm, Prospective Observational Trial TREATMENT REGIMEN: Group A- Patients who underwent open cavity Breast Conservative surgery(BCS) Group B- Patients who underwent closed cavity BCS Group C- Patients who underwent oncoplasty All patients will first receive external beam Radiotherapy to the whole breast to a dose of 40 Grays /15#/3 weeks. The patients will then be planned for boost radiation to the tumor bed to a dose of 12.5 Grays/5#. RECRUITMENT TARGET: 20 Patients The sample size has not been calculated as this is a pilot study. Twenty patients will be accrued for the purpose of this study PRIMARY ENDPOINT 1. Dosimetric Measurement - Seroma cavity volume (ccs). - PTV volume (ccs). - Ratio between the PTV volumes to the whole breast volume - Radiation Conformity Index (RCI) - Dose Homogeneity Index (DHI) - Ratio of dose received by 95% of PTV volume to the dose received by 5% of PTV volume - Dose received by several normal structures; normal ipsilateral breast tissue, contralateral breast, ipsilateral lung, contralateral lung, and heart 2. Cosmesis Measurement - prior to starting radiotherapy, - at the time of conclusion of radiotherapy - 6 months post completion of radiotherapy
Triple negative breast cancer (TNBC) represents about 15% of breast cancers and is characterized by the lack of expression of estrogen receptor (ER), progesterone receptor (PR), and HER-2 non-amplification. Women with TNBC tend to be younger, African American, and BRCA-1 germline carriers. The hallmark of this subtype is early metastatic recurrences with a peak frequency 1-2 years. Prognosis for metastatic TNBC is especially poor with median survival of about 1 year as compared to about 2-4 years with other types of metastatic breast cancer. The primary objective of the phase I part of this study is to determine the safety, tolerability and maximum tolerated dose of leflunomide in women with previously treated TNBC (or ER+ , HER2-neg MBC in Phase I). The primary objective of the phase 2 part of this study is to determine the efficacy of leflunomide in patients with TNBC. Leflunomide, which will be taken daily by mouth, is an inhibitor of dihydroorotate dehydrogenase (DHODH). This proposal will test if DHODH is a novel target for a particular subset of women with metastatic TNBC.