Active clinical trials for "Breast Neoplasms"

The study is to determine the prevalence of potential chemo-response related genes mutation in TNBC patients between pCR and SD/PD group, which achieved after NAC; and to evaluate potential relationship between these gene mutations and NAC-response in TNBC patients.Based on the results,we can further characterize TNBC from a phenotypical and molecular perspective, in order to identify potential new target agents and to individualize the treatment.

This is a single centre, observational and retrospective clinical study. The study group was about all HR positive postmenopausal breast cancer patients who were hospitalized between January, 2008 and October, 2010, and ever accepted AI therapy with the completed follow-up data.

Evaluating Multiparameter Gene Testing as a Predictor of Short Term Endocrine Therapy Response in Hormone Receptor Positive Breast Cancers

Millions of cancer patients every year receive chemotherapy with only a 20-60% probability of pathological response, while most experience adverse side effects that lower quality of life without prolonging it. Reliable identification of ineffective therapies can eliminate needless human suffering while increasing overall probability of positive response to treatment. Chemotherapy resistance profiling entails testing whether a patient exhibits strong resistance to a therapy prior to its final selection by the oncologist. However, there are no effective methods for quickly assessing patient chemotherapy resistance. Patient Derived Xenograft (PDX) models have replaced older Chemotherapy Sensitivity and Resistance Assays (CSRAs) to some degree, but both technologies suffer from long testing times, high cost, and/or low accuracy. Motility Contrast Tomography (MCT) has recently emerged as a technology that measures the biodynamic response of intact tumor biopsies to applied therapeutics by using Doppler detection of infrared light scattered from intracellular motions inside living tissue. Several small scale animal, xenograft, and human studies have shown this phenotypic profiling technique to be highly accurate in prediction of response and resistance to chemotherapy. This project will be the first human trial of biodynamic phenotyping to predict chemotherapy response among breast cancer patients. Specifically, the study cohort will include patients selected for neoadjuvant chemotherapy treatment, because this setting offers the opportunity for near-term outcome measurement at the time of post-chemo surgery. Pre-therapy fresh tumor specimens will be imaged using MCT, and the resulting bio-dynamic signatures will be compared to confirmed pathological response at the time of surgery. Observation of a high predictive value will provide the basis for expanded clinical trials and prompt commercialization of a biodynamic chemotherapy selection assay for breast and other cancer patients.

The objective of this prospective randomized study is to perform qualitative and quantitative comparisons between the insertion of traditional suction drains (Arm: Suction drain) versus the application of absorbable adaptive sutures (Arm: Adaptive suture) following simplex mastectomy or modified radical mastectomy in the light of the total volume of withdrawn serum from wound cavity, the extent of early postoperative analgesic requirements and quality of life.

Carriers of a BRCA mutation have a significantly increased risk to develop breast cancer in the course of their lives . They face a difficult choice: either a preventive removal of the breast(s) or an intensive inspection process. After primary treatment of breast cancer, patients will be followed for 5-10 years to diagnose recurrence or a new primary tumor in an early stage; to support the patient during hormonal treatment; to educate the patient about risk factors and healthy life style; and to provide psychosocial support. Currently, follow-up of breast cancer patients and surveillance of BRCA mutation carriers is offered in regular, one-to-one medical visits. Experience shows that in an individual visit it is often not possible to give all aspects that are important, enough attention. The group medical consultation (GMC) is a new form of medical visits where the physician or nurse practitioner performs a series of one-to-one consultations in the presence of 8 to10 other patients. A social worker accompanies this process. Patients in group consultations may gather more information because they learn from each other and there is relatively more time compared to a regular consultation. Research shows that both patients and caregivers are more satisfied with care after a group consultation compared to individual visits. After a GMC the participants from the breast cancer GMCs will be provided with a dedicated iPad for 3 months. Using this iPad, patients can contact the women they have met during the GMC as well as health care professionals by several communication channels, including virtual group meetings. This approach provides a unique combination of both social support and professional education concerning survivorship in an e-health environment.However, it is also known that group sessions may be counterproductive for some patients, for example because they are frightened by the stories of others. The goal of this study is to examine whether group visits (in combination with dedicated iPads) are beneficial to women with a BRCA mutation and for patients in follow-up after breast cancer.

- The purpose of this study is to evaluate the efficacy and safety of the application of bevacizumab combined neoadjuvant chemotherapy in HER2-negative breast cancer.

Objectives: Primary objectives: • The investigators aim to conduct a questionnaire survey in a South-East Asian tertiary institution, to assess whether breast cancer patients and their physicians would consider the use of three different kinds of genetic tests currently available to breast cancer patients: BRCA1/2 germline testing, CYP2D6 genotyping and Oncotype DX® testing. Secondary objectives: To explore factors which might influence their decisions on genetic testing, including: Acceptability of the tests and anti-cancer management based on the test results Reliability and affordability of the test Ability of the test to influence treatment decisions Broader implications of the test, e.g., psychosocial, financial impact Study design: Cross-sectional study, Survey Questionnaires were developed for 3 categories of individuals: Patients with early stage breast cancer Healthcare professionals caring for breast cancer patients Medical students /cancer researchers The questionnaires for patients and medical students/cancer researchers are similar. The questionnaires contain a brief section on demographic information, interest in and past experience with genetic testing. Three hypothetical situations are described to determine if participants will agree to BRCA1/2 testing, CYP2D6 genotyping and Oncotype DX® testing, respectively. 18 categorical 'yes'/ 'no' questions explore reasons for their decisions. Each scenario requires a short, hand-written response. The questionnaire for healthcare professionals contains a brief section on demographics and past experience with genetic testing. Three hypothetical situations are described to determine if healthcare professionals will recommend their patients for BRCA1/2 testing, CYP2D6 genotyping and Oncotype DX® testing, respectively. 12 categorical questions explore the reasons for their decision, and physicians are required to rank these in order of importance. Distribution of questionnaires: Questionnaires will be handed out to agreeable participants on the following occasions: Patients- National University Health System Cancer Centre Level 3 amp; 4 waiting areas Medical students - before or after lectures, or at personal contact Cancer researchers - before or after lectures, or at personal contact Healthcare professionals - before or after NUHS breast tumour board, or at personal contact Due caution will be exercised to ensure that the questionnaire is only handed out to subjects who are aged 21 years and above. No subject identity will be collected for these questionnaires. Rationale and Hypothesis: BRCA1/2 germline testing, CYP2D6 genotyping and Oncotype DX® testing have all been approved for use in clinical practice, but controversy still exists surrounding their utility, and apart from BRCA1/2 mutation testing in high-risk individuals, genetic tests are not routinely performed in Singapore. BRCA1/2 germline mutation testing is performed in individuals at high risk for hereditary cancer. CYP2D6 genotype testing predicts the benefit of adjuvant tamoxifen therapy; poor and intermediate metabolisers of tamoxifen may have a higher risk of breast cancer recurrence due to lower efficacy of tamoxifen because of less efficient conversion of tamoxifen to endoxifen, the active metabolite of tamoxifen. Oncotype DX® testing is a gene-expression profiling test performed on a formalin-fixed paraffin embedded tumour specimen, to predict the risk of breast cancer recurrence and guide decisions on adjuvant chemotherapy. Understanding the attitudes of patients and medical professionals toward these genetic tests may help to guide medical oncologists in their clinical recommendations and utilization of these tests in breast cancer patients.

Recently, the investigators face "on the edges" for treatment decision to decide adjuvant systemic treatment, especially for patients who show discordance between stage and tumor biology. The aim of this study was to compare the prognostic relevance of the TNM staging system and intrinsic subtype in breast cancer patients who received curative surgery.

Insomnia is common in Breast cancer patients during adjuvant therapy with aromatase inhibitor. However it is difficult to establish whether it is due to the knowledge of the disease or the treatment administred. The investigators designed a cohort study in which questionnaires for the assessment of sleep quality (Pittsburgh Sleep Quality Index and Insomnia Severity Index), anxiety (State and Trait Anxiety Inventory), depression (Beck Depression Inventory), for the quality of life in general (Functional Assessment of Cancer Therapy) and for the evaluation of RLS (Restless Legs Syndrome Rating Scale) will be prospectively administered to patients with early breast cancer at baseline and during adjuvant treatment with aromatase inhibitors. As secondary aims the investigators will also evaluate dietary and lifes' factors, born turn over and BMI.