View clinical trials related to Breast Neoplasms.
Filter by:The study will evaluate the utility of hypoxic exercise training to improve cardiovascular and metabolic health among obese breast cancer survivors. While participants exercise, a lower fraction of inspired oxygen will be used to simulate a higher altitude. This approach removes the mechanical strain needed to sustain moderate-to-vigorous exercise intensity which is believed to support exercise tolerance. Participants are randomized to either the treatment (walking+simulated-altitude) or control (walking under normoxic conditions).
This research is being done to determine whether exercise while receiving doxorubicin or Adriamycin chemotherapy for breast cancer can reduce the cardio-toxic effects of this treatment on the heart and improve other outcomes related to cancer such as tumor markers, nausea, fatigue and the ability to tolerate chemotherapy.
Breast cancer is the most prevalent cancer in women and annually accounts for 10% of new malignancies worldwide. In mainland China, approximately 169,000 females are diagnosed with breast cancer every year and constitute 12.25% of the breast cancer incidents worldwide. Additionally, 30% of early breast cancer turns metastatic, which is often incurable. Different from women with early breast cancer, women with metastatic breast cancer(MBC)must receive lifelong treatment, experience higher levels of emotional/physical distress, and feel frequent uncertainty about their health/possible death. They are also challenged to manage distressing adverse effects induced by different adjuvant treatments and experience heavy self-care demands during the transition period from being a patient to being a survivor. Thus, specific interventions to help women with metastatic breast cancer to recover from this traumatic event have been designed, and one of these is supportive-expressive group therapy(SEGT).SEGT has been found to achieve improvement in anxiety, depression, quality of life (QoL), family functioning, and satisfaction with treatment. However, the effect of SEGT on survival is inconsistent. Initial studies examining SEGT have reported a mean survival advantage of 18 months, however, these findings could not later be replicated.Yet, no study has reported a survival disadvantage for those given SEGT. In addition, we found no published articles on the application of SEGT among women with MBC in China. Owing to this dearth of previous research, it is unclear whether this therapy would exhibit positive effects within Chinese culture. Thus, we developed a "Be Resilient to Breast Cancer"(BRBC) program that is culturally tailored for Chinese females with MBC. This program was adapted from SEGT and is designed to increase resilience(defined as the capacity to bounce back after encountering a traumatic event) and QoL, decrease emotional and physical distress(allostatic load), and eventually prolong longevity. To better adapt to Chinese culture, we added education hosted by professional staff (e.g., clinical psychologists, dietician, Chinese medicine practitioner, etc.)in an effort to foster self-efficacy to combat symptoms (such as pain, fatigue, intrusive thoughts, etc.) through knowledge and technics (such as breath control, meditation, etc.),and to help patients gain a sense of control in their life. Second, trained mentors, who were breast cancer survivors themselves, were added to the group discussion to create non-hierarchical, reciprocal relationships through the sharing of experiences with those facing similar challenges. These mentors also provided women with first-hand information about treatment and offered suggestions to combat barriers to recovery.
Study Design and Treatment: This is a multicenter phase II trial, with an initial exploratory run-in-phase, to evaluate the efficacy and safety of pembrolizumab in combination with gemcitabine in patients with HER2-negative ABC that have previously received anthracyclines and taxanes (unless clinically contraindicated). In hormone receptor positive patients, previous treatment with 2 or more lines of hormone therapy will also be required. Patients must have at least one measurable lesion that can be accurately assessed at baseline and is suitable for repeated assessment by CT, MRI or plan X-ray. Approximately 53 patients (up to a maximum of 65 patients depending on the results of the run-in-phase) will be included in this trial.
The overall study objective is to evaluate the effectiveness and safety of Trastuzumab emtansine (T-DM1) and Pertuzumab under real-world disease conditions in the Spain, and specifically in patients treated under compassionate use or early access program
This randomized phase III trial studies how well mindfulness meditation or survivorship education work in improving behavioral symptoms in younger stage 0-III breast cancer survivors. Behavioral interventions, such as mindfulness meditation, use techniques to help patients change the way they react to environmental triggers that may cause a negative reaction. Survivorship education after treatment may reduce stress and improve the well-being and quality of life of patients with breast cancer. Mindfulness meditation or survivorship education may help improve the health behaviors of younger breast cancer survivors.
This trial will evaluate the use of immunotherapy and PARP inhibition in a population with incurable advanced breast cancer associated with a germline BRCA mutation or HDR-defect. The main objective is to examine overall response rate of pembrolizumab (immunotherapy) in combination with Olaparib (PARP inhibitor) in advanced BRCA-mutated or Homology-directed repair (HDR)-defect breast cancer.
This pilot trial evaluates in vivo megestrol acetate (MA) modulation of steroidal receptors in advanced breast cancer.
In addition to axillary lymph node (ALN), internal mammary lymph node (IMLN) chain is also the first-echelon nodal drainage site for metastasis and it provides important prognostic information in breast cancer patients. However, decision about local treatment of IMLN is still being made based on ALN status. The 2016 National Comprehensive Cancer Network Guidelines recommend internal mammary lymph node irradiation for patients with more than 4 positive ALNs (category 1), and strongly consider irradiation for patients with 1 to 3 positive ALNs (category 2A). Therefore, there will be patients in positive ALN subgroup who just face complications of an unnecessary radiation to IMLN and there will be patients in negative ALN subgroup who do not receive adjuvant radiation therapy they really need. Thus, these inclusion criteria of National Comprehensive Cancer Network might lead to over-treatment and under-treatment. Internal mammary sentinel lymph node biopsy (IM-SLNB) provides a less invasive method of assessing the IMLN than surgical dissection. However, low visualization rate of IM-SLN has been a restriction of IM-SLNB. A modified radiotracer injection technique was established in our previous study. This technique could significantly improve the IM-SLN detection rate. The investigators have validated the accurate of the hypothesis and the modified radiotracer injection technique in the previous study. For axillary sentinel lymph node biopsy, the success rate and the accuracy are the most important technical indicators. The relatively lower false-negative rate is a precondition for the widely application of SLNB. Axillary SLNB needs to be accomplished with the cooperation of multi-disciplinary teamwork, including the breast surgery, the radiologist, the nuclear medicine doctor and the pathologist, in order to obtain a better success rate and a lower false-negative rate. Our previous studies confirmed that the modified radiotracer injection technique can greatly improve the IM-SLN detection rate. However, whether the IM-SLNB based on the modified radiotracer injection technique has a low false negative rate or not still need to be confirmed by a further validation research. Furthermore，recently, the investigators propose that if IM-SLN is the only metastatic lymph node and there would be no positive node else in IMLN chain, the radiotherapy and its associated complications could be avoided in these patients. On the other hand, if there is the presence of metastatic non-sentinel lymph node (NSLN) in IMLN chain after IM-SLNB, it is important to predict the risk of IM-NSLN metastasis in IM-SLN positive patients. As there is currently no such model, a predictive model for IM-SLN positive patients to avoid radiotherapy is needed in this situation. Therefore, a new study will be conducted to verify the issues above. In the current study, all the participants (18~70 years of age) would have the preoperative pathology of invasive breast cancer and positive fine-needle aspiration result in their clinical or ultrasonic suspicious axillary lymph node. 99mTc-labeled sulfur colloid was injected into the parenchyma under the ultrasound guidance 3 to 18 hours before surgery. Two syringes of 9.25 to 18.5MBq 99mTc-labeled sulfur colloid in 0.5 to 0.7mL volume were injected at the 6 and 12 o'clock positions 0.5 to 1.0 cm from areola (about 2.0~4.0 cm from the nipple). IM-SLNB was performed in all participants with IMSLN visualized on preoperative lymphoscintigraphy and/or detected by the intra-operative gamma probe. All hotspots in the internal mammary basin were harvested and intra-operative identification of the IM-SLN was based on gamma probe detection. The IM-SLN was sectioned along the long axis into two blocks and all blocks were tested by the frozen section and the touch imprint cytology intra-operatively. Those participants with positive intra-operative results received IMLN dissection. Finally, all the IM-SLN blocks and IM-NSLN dissected were assessed post-operatively by H&E and Cytokeratin 19 stained immunohistochemistry. The conclusion would be drawn through the results mentioned above.
A non-randomized, mono-centric, prospective interventional study that will assess the efficacy of the loco-regional anesthesia PECS on the rate of chronic pain, 6 month after a patient will have either received a mastectomy or a mastectomy associated with axillary nodes dissection, and/or a reconstruction by prosthesis.