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NCT ID: NCT03817814 Enrolling by invitation - Breast Cancer Clinical Trials

Decisions of Young Women With Breast Cancer Regarding Fertility Preservation Before Cancer Treatment and Family Building After Treatment

Start date: January 18, 2019
Study type: Observational

This study will help the researchers learn more about factors that affect the decisions about fertility preservation and family building made by young women with breast cancer.

NCT ID: NCT03719833 Enrolling by invitation - Breast Cancer Clinical Trials

Sentinel Lymph Node Biopsy After Neoadjuvant Treatment in Breast Cancer Patents

Start date: September 21, 2018
Study type: Observational [Patient Registry]

This clinical trial is designed as observational study of overall duration of 8-9 years, but the first results and conclusions could be achieved in 3-4 years. In the first phase, that would last 3-4 years, the investigators will form three predetermined groups of breast cancer patients that would be monitored in the second phase for 5 postoperative years. All patients involved in this trial would undergo defined protocol. All patients participating in this trial and all members of investigation team would be completely introduced to plan and aims of this trial. Two main hypothesis of this trial are that SLNB does not have negative impact on clinical outcomes (locoregional recurrence and overall survival) in initially node-positive patients who achieved complete clinically axillary remission after neoadjuvant systemic treatment and that lymph node status after neoadjuvant treatment is significantly more relevant prognostic factor than nodal status at the time of diagnosis. Therefore, the aim is to establish that sentinel lymph node biopsy, in node positive breast cancer patients that achieve clinical remission after neoadjuvant treatment, is reliable approach for sugical axillary management. Data would be collected individually for each patient and recorded on appropriated forms. After data completion, leading investigator would import encoded data in register. Data collected in this trial would be used for publications.

NCT ID: NCT03686098 Enrolling by invitation - Breast Cancer Clinical Trials

The Malaysian Soy and Mammographic Density Study

Start date: November 19, 2018
Phase: N/A
Study type: Interventional

Globally, breast cancer is the most common cancer and the main cause of deaths due to cancer. This is attributed to changes in reproductive habits as well as an increasingly sedentary lifestyle, with low physical activity and diets rich in saturated fats but low in fiber. While the main focus in many Asian countries is to improve survival from breast cancer by encouraging early detection of the disease and improving access to cancer treatment, it does not reduce the number of women who will be diagnosed with breast cancer in the years to come. Currently, there is an urgent need to develop effective strategies to prevent breast cancer in Asia and beyond. Soy may be an important dietary strategy for breast cancer prevention. Compared to women in the West, Asian women consume up to 10-fold more soy in their diet, which may, in part, explain their lower risk of breast cancer. Soybeans are rich in isoflavones, which can mimic estrogenic activity. In the body, it competes with estrogen and binds to estrogen receptor sites, thereby reducing the effect of estrogen and possibly lowering breast cancer risk. Consistently, research has shown that Asian postmenopausal women who have high soy diets are less likely to be diagnosed with breast cancer. However, researchers have not been able to show that postmenopausal women can reduce their breast cancer risk by increasing soy intake as part of their diets. There are several reasons why these studies have failed to see an effect despite the body of evidence indicating that soy may be protective. Firstly, these are studies of Caucasian women who may have never been exposed to soy, particularly in adolescence, where soy may have the greatest impact. Also, these studies have used soy isoflavone supplements, rather than traditional soy foods made from whole soybeans, which may affect how soy is metabolized in the body. Lastly, the way in which mammographic density measurements were obtained previously could have negatively influenced the study results, such as the use of digitized images of mammogram films rather than raw digital images and the use of semi-automated methods that may be subject to human error and reader variability. Therefore, a well-designed intervention study among Asian women living in Asia, using suitable mammographic density measures as a surrogate marker of breast cancer risk, will best answer these remaining gaps in our knowledge about the soy-breast cancer relationship.

NCT ID: NCT03607552 Enrolling by invitation - Breast Cancer Clinical Trials

Non-contrast DWI for Supplemental Screening

Start date: July 16, 2018
Study type: Observational

Diffusion-weighted imaging (DWI) is a short (under 5 minutes) non-contrast MRI technique that has shown promise for the detection and characterization of breast cancer. Our preliminary data has shown that DWI holds potential for detecting mammographically and clinically-occult breast cancers. However, current technical limitations reduce the sensitivity of DWI for screening applications. The identification of a screening tool to complement mammography that is more accurate than ultrasound and faster, less expensive, and safer than conventional contrast-enhanced MRI would have significant clinical impact by improving the early detection of cancer in women with dense breasts. We hypothesize that an optimized DWI approach will enable detection of mammographically occult breast cancer in women with dense breasts with high sensitivity and low false positive rate.

NCT ID: NCT03580395 Enrolling by invitation - Breast Cancer Clinical Trials

Apatinib in Neoadjuvant Therapy for Patients With Breast Cancer

Start date: June 1, 2017
Phase: Phase 2/Phase 3
Study type: Interventional

To verify the role of apatinib in neoadjuvant therapy for breast cancer, the investigators designed a prospective, randomized, parallel-controlled phase II/III trial, to investigate the efficacy and safety of apatinib combined with TP (paclitaxel + cisplatin) or TP regimen alone as neoadjuvant therapy for stage II-III breast cancer treatment. 100 cases of eligible patients were diagnosed by core needle biopsy and immunohistochemistry, with the molecular subtypes of triple-negative, HER2+ or Luminal B, evaluated by pathological complete remission (pCR), objective response rate (ORR), adverse events, disease free survival (DFS) and OS, aiming at providing a new way for neoadjuvant therapy in breast cancer and anti-angiogenic treatment of malignant tumors.

NCT ID: NCT03579979 Enrolling by invitation - Breast Cancer Clinical Trials

Sentinel Lymph Node Biopsy in Breast Cancer Surgery Using ICG

Start date: May 31, 2018
Phase: N/A
Study type: Interventional

This clinical trial is a prospective, multicenter, self-controlled clinical study. In order to meet the requirements of this plan, 130 breast cancer patients need the sentinel lymph node biopsy with novel near-infarred fluorescence imaging system produced by Beijing digital precision medical technology co., LTD. The fluorescence molecular imaging of indocyanine green (ICG) on imaging detection and the control group, routine medical using methylene blue test .The safety and efficacy of fluorescence and staining in sentinel lymph node biopsy of breast cancer were compared.

NCT ID: NCT03476226 Enrolling by invitation - Breast Cancer Clinical Trials

Cognitive Dysfunction and Breast Cancer Coping Strategies Impact on QOL

Start date: November 18, 2017
Phase: N/A
Study type: Interventional

The purpose of this study is to determine whether patients experience a better quality of life when they have received education about coping strategies for cognitive dysfunction.

NCT ID: NCT03407040 Enrolling by invitation - Breast Cancer Clinical Trials

Generation of Cancer Antigen-Specific T-cells From Human Induced Pluripotent Stem Cells (iPSC) for Research and Potential FutureTherapy

Start date: January 30, 2018
Study type: Observational

Background: Researchers want to test if certain cells can be re-programmed into stem cells. Stem cells can keep reproducing for a long time. Cells made by stem cells can be turned into different types of cells. These include cancer-fighting cells, skin cells, etc. The stem cells generated in this study will be used to make specific tumor-fighting cells that can recognize different types of mutations in cancer cells. They may also help identify new tumor mutations that may not have been identified yet. Objectives: To test if a certain type of tumor-fighting cells can be re-programmed into stem cells. Eligibility: Participants in another Surgery Branch protocol who are at least 16 years old Design: Participants already gave samples of blood and/or tumor tissue in the other protocol. They do not need to come back to the clinic or give any other samples. Participants will give consent for their samples to be used in this study. Researchers will obtain cells from the samples. They will grow those cells in the lab. They will create stem cells from them. Researchers will do genetic tests on the samples. Most tests will not show important health results. But if they do, the participant will be invited to talk to a genetic counselor and get more detailed testing to confirm the results. Some of the samples and results will be stored indefinitely. They may be used in future research. No personal information will be stored with them.

NCT ID: NCT03294330 Enrolling by invitation - Breast Cancer Clinical Trials

SPY-X: A Study to Assess the Feasibility of Using SPY Alone for Sentinel Node Localization for Melanoma or Breast Cancer

Start date: October 11, 2017
Phase: Phase 3
Study type: Interventional

The objective of this study is to determine if fluorescence lymphangiography can be used alone to localize sentinel nodes in patients with melanoma or breast cancer. The hypothesis is that sentinel nodes can be identified using only indocyanine green (ICG) and fluorescence lymphangiography, without the need for technetium99 and a gamma probe.

NCT ID: NCT03194997 Enrolling by invitation - Breast Cancer Clinical Trials

Pilates and Dance to Breast Cancer Patients Undergoing Treatment

Start date: January 1, 2019
Phase: N/A
Study type: Interventional

Breast cancer is one of the most common types of cancer in Brazil, and its treatment, namely surgery, chemotherapy, radiotherapy or hormone therapy, has consequences and side effects that significantly affect the quality of life and associated physical and psychological factors. The practice of physical activity, in turn, may play a beneficial role in these factors, and help the recovery of the patient in relation to the consequences of the treatments. Two types of physical activity can be addressed in the context of breast cancer; Dance and the Pilates method. Thus, the objective of the present study will be to analyze the impact of Pilates practice and dance on quality of life and on psychological and physical factors in patients undergoing adjuvant treatment of breast cancer. Patients older than 18 years who are in adjuvant treatment, namely, chemotherapy, radiotherapy and / or hormone therapy at the Oncology Research Center - CEPON, will be invited to be part of the study. With a randomized clinical trial of three arms, the patients will be submitted to 16 weeks of intervention, and randomized in 3 groups: (A) belly dance protocol group; (B) Pilates method protocol group, and (C) control group who will continue with their routine activities. Sample randomization will be conducted in confidence by one of the researchers in a specific computer program. Information about personal and clinical characteristics, quality of life, psychological factors (depressive symptoms, body image, self-esteem, optimism, perceived stress, fatigue, pain, sexual function and sleep quality) and physical factors (cardiorespiratory fitness, balance , Posture, upper limb functionality and presence of lymphedema). All information will be collected before and after the intervention period. Statistical analysis will use the statistical package SPSS - IBM, version 20.0. Firstly, descriptive statistics (mean, standard deviation and percentage) will be used in order to know the data, and then the Anova two way test with repeated measurements and Sydak Comparison Test, in order to analyze the data. Groups of the Pilates method, of the dance and control group. Significance level of 5%.