View clinical trials related to Breast Neoplasms.
Filter by:Breast cancer is the most frequent tumor site among women in the world (FERLAY et al., 2015). In Brazil, estimates for the year 2017 indicate the occurrence of about 57,960 new cases (56.2 cases per 100,000 women); (Brazil - Ministry of Health, 2015). The increase in adjuvant therapies resulted in an estimated increase of 22 million cancer survivors worldwide (GOLDSTEIN et al., 2012). However, as survival rates increased, more women faced complications related to diagnosis and treatment (ABRAHMS et al., 2016). Adjuvant radiotherapy is a frequent treatment in breast cancer and fatigue it is the main adverse effects (HICKOK et al., 2005). Measures of intervention through physical activity have shown benefits in the increase of the functional capacity that generates a reduction of effort and decrease of the fatigue (MARKES et al., 2009). General Objective: To evaluate the influence of Mat Pilates on fatigue, quality of life, functional capacity, flexibility, lymphedema, radiodermatitis and depression, in the women with breast cancer and with an indication of adjuvant radiotherapy, at the Cancer Hospital III of the National Cancer Institute (INCA). After recruitment, women will be allocated randomly in: Intervention Group (Mat Pilates and usual activities) and Control Group (usual activities). Patients in the intervention group will be submitted to 10 sessions of Mat Pilates for a period of 5 weeks (from beginning to end of adjuvant radiotherapy). Patients assigned to the control group will not participate in the Mat Pilates program, but will maintain the usual exercises for upper limbs, guided by physiotherapists in the postoperative period. In both groups, patients will be submitted, functional capacity assessment, flexibility assessment, assessment of the presence of lymphedema, and questionnaire application of fatigue, quality of life, level of physical activity and depression. Will be performed a descriptive analysis of the population. Univariate logistic regression will be performed between the outcomes according to the exercise groups and also, for the possible confounding variables. The variables with p<0.20 will be selected for adjustment in the construction of the multiple logistic regression model. Those with p<0.05 and/or with clinical significance will be maintained in the model.
This study is designed to evaluate the safety, tolerability, PKharmacokinetic profile and treatment effect of pamiparib in Chinese participants with advanced high-grade ovarian cancer (including fallopian cancer or primary peritoneal cancer) and triple negative breast cancer in phase I, and to evaluate the efficacy and safety of pamiparib in Chinese participants with recurrent epithelial ovarian cancer (including fallopian cancer or primary peritoneal cancer), harboring germline breast cancer susceptibility gene 1/gene 2 (BRCA1/2) mutation in phase II.
Breast cancer related lymphedema (BCRL) is a debilitating and distressing condition affecting approximately one out of five breast cancer survivors. BCRL is a chronic swelling of the upper arm following axillary lymph nodes dissection, and it is associated to a significant functional, psychological and social morbidity, with an heavy impact on life quality. Several studies reported BCRL incidence between 6.7% and 62.5% for different population cohorts. Randomized clinical trials (RCTs) reported that sentinel lymph node biopsy (SLNB) when compared with axillary lymph node dissection (ALND) leads to a significant reduction in postoperative complications. However, the advent of SLNB does not solve the problem of BCRL with a concrete chance to develop a lymphedema after single SLNB around 7%. Health care cost of BCRL rehabilitative treatment is not available in literature yet. Few studies considered incidence, risk factors and treatment costs of BCRL among working-age women after breast cancer treatment, reporting that BCRL population had significantly higher rehabilitative medical costs ($14,877 to $23,167) with twice as much risk to develop BCRL complications, such as lymphangitis or cellulitis when compared to "BCRL free" population (OR = 2.02, P = .009). Axillary reverse mapping (ARM) procedure claims to map and preserve arm lymphatic drainage during ALND and/or during SLNB, reducing BCRL development. ARM is developed as result of assumption that arm's lymphatic pathway is not involved by metastatic tumor cells of the primary breast cancer. However, when the arm lymph node correspond to the SLN it should be removed for correct tumor staging, thus a lymphatic drainage disruption onset will be expected with BCRL risk increase. During the ARM procedure, a fluorescence imaging technique (photodynamic procedure) is useful for detecting lymphatic drainage of the upper limb and it allows in differentiating the fluorescent ARM node from the SLN identified by the radioguided technique (99mTC-Nanocoll).
The purpose of the study is to learn more about the quality of life and satisfaction with breast cancer surgical treatment and education from patient reported outcome data. The data and information obtained from breast cancer patients can be invaluable in counselling patients with a new diagnosis of breast cancer on their expected outcomes and results. The hypothesis is that using prospectively obtained data to guide surgical decision-making and optimize access to surgical procedures would improve the treatment of patients and would most likely positively impact the health-related quality of life in patients.
This study will evaluate the safety, pharmacokinetic (PK), pharmacodynamic (PD) activity, and preliminary anti-tumor activity of GDC-9545 as a single agent and in combination with palbociclib and/or luteinizing hormone-releasing hormone (LHRH) agonist in participants with advanced or metastatic estrogen receptor (ER)-positive (human epidermal growth factor receptor 2 [HER2]-negative) breast cancer.
Breast cancer is one of the most serious threat to women's health of malignant tumors, also the most common causes of cancer death in women.Triple-negative breast cancer (TNBC) refers to the immunohistochemical detection of estrogen receptor (ER), progesterone receptor (PR), human epidermal growth factor receptor-2 (Her-2) are negative.Compared with other types of breast cancer, TNBC has a high degree of invasion,local recurrence and metastasis. Also,TNBC can not use endocrine therapy and lack of molecular targeting for Her-2 target therapy.Meanwhile other biological agents are too expensive,so the current clinical therapy only can use in China is chemotherapy,the average survival time is about 2 years. Fortunately,due to the impact of traditional Chinese medicine(TCM) in China, the majority of breast cancer patients have received varying degrees of TCM treatment, and because of TNBC patients can not be more mature endocrine therapy and anti-molecular targeted therapy Benefits, Chinese medicine play an important role in TNBC patients.TCM regulate immune function, inhibit tumor growth, Anti-recurrence and metastasis, to extend the survival of patients with tumor, and relative to chemotherapy drugs and molecular targeted drugs,improve the quality of life.In addition ,comparing with the biological agents,Chinese medicine prices are relatively low,and can be worth using widely. With the development of evidence-based medicine, and gradually recognize the importance of comprehensive treatment of breast cancer, Cancer Treatment Model has been proposed,.That is, to take Chinese medicine, surgery, radiotherapy and chemotherapy, endocrine therapy and biological immunization and other standardized, individualized comprehensive treatment. The introduction of evidence-based medicine into the field of research, will be beneficial to the objective evaluation of TCM syndrome differentiation in the treatment of refractory breast cancer in the characteristics and advantages in order to promote the use of. This study based on TCM syndrome differentiation and treatment, and adopts multi-center, randomized, double-blind and controlled research methods to evaluate whether the intervention of traditional Chinese medicine can improve the TNBC patients with disease-free survival (DFS), overall survival(OS),and the best time to intervene in traditional Chinese medicine; also the establishment of the exact effect, obvious advantages and evidence, can be promoted in line with clinical practice of the program, the formation of refractory breast Cancer and Western medicine combined with clinical path, and relying on the national clinical research base of Chinese medicine information platform, the construction of clinical information management cloud platform, the formation of active medical service process, the establishment of refractory breast cancer combined with clinical prevention and treatment center, improve the life quality level of TNBC patients. The study contains 5 locations,including Longhua Hospital, Shuguang Hospital,Yueyang Hospital,Zhejiang Traditional Chinese Medicine Hospital and Fudan University Cancer Hospital.Considering of the results of the study at MD Anderson Cancer Center in foreign countries showed that the 3-year survival rate of TNBC patients was significantly shorter than that of non-TNBC patients (74% vs.89%, P <0.01) To be at least 10% survival rate.At the same time, considering the case lost rate of 20%, calculated by PASS software, the number of samples for each group of 310 cases, a total of 620 cases of cohort study. According to whether to take traditional Chinese medicine,all the participants are divided into exposure group and non-exposure group, the number of observations per group is 310. Before the research, all participants needs to fill in the informed consent form, investigators introduce the clinical research related matters to them and record the basic situation. The Chinese medicine exposure group take Chinese medicine(San Yin Decoction ) besides of original Western medicine , non-exposed group only received Western medicine treatment, a total of two years.All results are recorded in the CRF table,and use SPSS18.0, Stata10.0 and other statistical software for data to analysis.
This study is to assess the efficacy and safety of olaparib monotherapy versus olaparib in combination with an inhibitor of ATR (Ataxia-Telangiectasia Mutated (ATM) and Rad3-related protein kinase (Ceralasertib [AZD6738]) and olaparib monotherapy versus olaparib in combination with an inhibitor of WEE1 (adavosertib [AZD1775]) in second or third line setting in patients with Triple-negative breast cancer (TNBC) prospectively stratified by presence/absence of qualifying tumour mutation in genes involved in the homologous recombination repair (HRR) pathway. Treatment arms are olaparib monotherapy, olaparib+ Ceralasertib and olaparib+adavosertib. The study subject population will be divided into Stratum A, Stratum B, and Stratum C. Due to the different schedules of administration of each of the treatment options as well as their different toxicity profiles, the study is not blinded. Study has two stage consent process- stage 1 consent (molecular screening for HRR defects) and stage 2 consent (main study). Patients with TNBC and with known qualifying BRCAm, non BRCAm HRRm and non HRRm status will be offered the option of consenting to the main part of the study within the 28-day screening period. Following the ISRC meeting on 17 April 2019 a recommendation was made to close the adavosertib+olaparib treatment arm across all biomarker strata. Patients receiving treatment with adavosertib+olaparib treatment were offered the opportunity to continue treatment on olaparib monotherapy at the approved dose (300 mg bd). Following the closure of this arm the total number of patients randomised will be lower (approximately 350 patients). Approximately 300 patients will be randomised (using randomisation ratio 1:1) to 2 ongoing treatment arms plus an additional 47 patients to a 3rd arm (olaparib+adavosertib) prior to the arm being discontinued.
The aims of the study are to compare the recovering period between a group of patients with conventional sedation, a group using hypnosis as sedation during the surgery and a third group using hypnosis as a relaxation method and preparation but enjoying a classic sedation for their surgery. Comparaison of pain ( different types of pain), consumption of pain killers ,anxiety and fatigue on day0,1, 8 after surgery and every. 3 months during the first 2 years of follow up. Comparisons are also performed in substudies defined by treatments modalités. Inflammatory parameters s ( CRP_ C reactive protein, NLR- ( neutrophils to lymphocyte ratio) are measured on Day 0, 1, 8 and also salivary Immunoglobulins and different endocannabinoids.
This is an open-label, single-arm pilot study evaluating the antitumor activity and safety of niraparib as neoadjuvant therapy in participants with Human epidermal growth factor receptor 2 (HER2)-negative and breast cancer susceptibility gene mutant (BRCAmut) localized breast cancer (primary tumor >=1 centimeters [cm]). Breast magnetic resonance imaging (MRI), breast ultrasound, and tumor core biopsy will be performed at the screening (Days -28 to -1). Participants will receive niraparib (200 milligrams [mg] orally [PO]) treatment daily for 28 days (Cycle 1) and then will undergo breast ultrasound at the end of Cycle 1 on Day 28. Based on breast ultrasound reports, the participants will either discontinue the study (disease progression) or will continue niraparib treatment (complete response [CR], partial response [PR] or stable disease [SD]) for an additional cycle (Cycle 2). A breast MRI and breast ultrasound will be performed at the end of Cycle 2. Approximately 21 participants will be enrolled in this study and the study duration will be approximately 2 years.
Primary Objective: • Determination of pathologic complete response (pCR) rates Secondary Objective: - Determination of cardiac toxicity as measured by: composite of LVEF, longitudinal strain and troponin. - Breast conservation rates - Overall survival Study Design - Approximately 34-74 patients with Her2 positive, Stage II-regional IV breast cancer will be enrolled. - Patients will be stratified by ER/PR status. - They will be randomized to ddACTHP vs TCHP. - Initially, 17 patients will be randomly assigned to each treatment arm. - If 3 or fewer patients have a pCR, then that arm will be terminated and no further patients will be entered on that treatment arm. - If 4 or more patients obtain a pCR, 20 additional patients (total of 37 patients) will be randomized to that treatment arm. - If 11 or more patients out of 37 have a pCR, the treatment will be of interest for further study.