View clinical trials related to Breast Neoplasms.
Filter by:The hypothesis of this trial are that: - avoiding axillary surgery does not worsen the outcome of patients with small breast cancer the absence of the pathological information on the risk of recurrence given by nodal status is not worsening outcome of these patients - pre-operative imaging of the axilla can identify patients with clinically relevant nodal burden. The aims of this prospective randomized study are: - to verify whether, in presence of a negative preoperative axillary assessment, SLN can be spared - to verify whether, in presence of a negative preoperative axillary assessment, the decision on adjuvant medical treatment can be taken according only to the biology of the tumour without the prognostic information achieved by SLNB on the nodal status - to verify whether, in presence of a negative preoperative axillary assessment, the patients' quality of life can be improved by a less invasive surgical procedure.
Lymphedema is the result of accumulation of fluid and other elements in tissue spaces because of an imbalance between the production of fluid interstitial and transport. Lymphedema can cause significant physical and psychological morbidity. Prevalence of lymphedema in patients after breast cancer surgery is 12-60% and the incidence is 12-26%.Psychological and social consequences of secondary lymphedema related breast cancer have been little recognized and documented. Although, it have performed many studies related secondary lymphedema it not found sufficient evidence in the literature to suggest the most effective treatment. There is some evidence suggesting that compression therapy and manual lymphatic drainage can improve lymphedema but more studies are needed. The aim of this research is to to evaluate the clinical effect of multimodal treatment (compression bandaging and manual lymph drainage) versus applying manual lymphatic drainage in women with arm lymphedema after breast cancer surgery.
This will be a randomized, double blind, vehicle-controlled evaluation of the effectiveness and safety of HylaCareTM. The study will employ the patient as her own control, a commonly used method for the evaluation of topical dermatologic agents. Each patient will be randomized blindly as to whether the study serum will be applied to the medial or lateral portion of the treated breast, using the nipple as the dividing line. The product and placebo will also be applied to the contra-lateral breast in the same fashion, as a further control. The study drug and placebo will be applied three (3) times daily.
The primary objective of the study is to assess the progression-free survival (PFS) of veliparib in combination with carboplatin and paclitaxel (C/P) compared to placebo plus C/P in participants with a Breast Cancer Gene 1 or 2 (BRCA1; BRCA2) mutation in Human Epidermal Growth Factor Receptor 2 (HER2)-negative metastatic or locally advanced unresectable breast cancer. The secondary objectives of the study are to assess overall survival (OS), clinical benefit rate (CBR) through the end of Week 24, objective response rate (ORR) and PFS on subsequent therapy (PFS2) in participants treated with veliparib in combination with C/P versus placebo in combination with C/P.
This multicenter, randomized, double-blind study will estimate the efficacy, safety and tolerability of ipatasertib combined with paclitaxel compared with placebo combined with paclitaxel in participants with inoperable locally advanced or metastatic triple-negative breast cancer (mTNBC), as measured by progression-free survival (PFS) in all participants and in participants with phosphatase and tensin homolog (PTEN)-low tumors.
This study will determine whether CT-P6 and Herceptin are equivalent in patients with early-stage breast cancer undergoing neoadjuvant chemotherapy. Our hypothesis is that the pathologic complete response rate will be equivalent in patients treated with neoadjuvant CT-P6 or Herceptin. Patients will receive 8 cycles of neoadjuvant systemic therapy and up to 10 cycles of therapy in the adjuvant setting.
TITLE: Randomized Controlled Evaluating the Role of Exercise in Women Undergoing Treatment for Breast Cancer Yoga and Quality of life: Yoga is based on the practice of physical postures, breathing techniques and meditation. Philosophically, it aims at increasing the body's ability to master the mind with the goal of spiritual awareness and connection. A randomized trial of yoga in women with breast cancer undergoing radiation therapy demonstrated an improvement in impact of events scale at 3 months suggesting that the more intrusive thoughts at 1 month the greater the finding of meaning in cancer by 3 months. Randomized studies have demonstrated evidence of yoga improving the emotional well being of women with breast cancer and improving their distressed mood, thus providing a buffering effect on QOL. The main beneficial effects demonstrated are on social functioning. Among patients not receiving chemotherapy, yoga appears to enhance emotional well-being and mood and may serve to buffer deterioration in both overall and specific domains of QOL. EVALUATION TOOLS- European Organisation for Research and Treatment of Cancer-Quality of Life Questionnaire (EORTC QLQ-C30 & BR-23) Brief Fatigue Inventory VAS (Pain score) Spirituality Questionnaire Pulmonary function test Objective assessment STUDY ENDPOINTS- Primary end points- Disease free survival Secondary end points- Quality of life & Improvements in overall survival STUDY DESIGN TREATMENT PLAN - All newly diagnosed cases with stage I-III of breast cancer who present to Tata Memorial Hospital will be randomly assigned to perform either a set of 'Yogic and Routine Exercises (referred to as exercise I) or Routine Exercises'(referred to as exercise II)./ Patients will begin the exercises within a week of starting treatment. Both arms of the study will receive a training session one hour per day for the first week, during which they will be instructed to practice daily and maintain a daily log. The other evaluation tools will be used as per the assessment time line (enclosed).The exercises in the Exercise I arm (Yoga and conventional exercises) will be upgraded within the next 2 days to Phase II. Patients will be allowed to attend a minimum of four out of seven days in Phase I and II. Patients will be assessed at 6 months for compliance to phase II exercises. Only if patients are fulfilling the criteria for accuracy, sequence and duration of phase II exercises, will they be taught phase III exercises. Patients who are unable to do phase II exercises at 6 months will be re taught phase II exercises. These patients will then be re assessed at 1 year for up gradation to phase III. Six months after completion of phase III exercises, patients will be assessed for compliance to phase III exercises. Patients will also undergo an objective assessment at 1 year. An additional up gradation will be after completion of adjuvant therapy at 6 months. Patients will be followed up for a period of 5 years. DFS will be measured from the time of randomization to either progression or death. Quality of life will be measured at baseline and every six monthly using the functional assessment cancer therapy- quality of life. Quality of Life analysis at 400 patients will be performed with appropriate correction for multiple analyses applied. STATISTICAL ANALYSIS- For an expected 50% 5 year disease free survival (DFS) for the control group, the expected 5 years DFS for the intervention group will be 60%. With a two-sided analysis, and at 80% power and 95% confidence to detect a 10% difference between the arms, the sample size would be 761 patients. Assuming a 10% loss to follow up, a total of 850 patients would be accrued. We expect to complete accrual in 3 year. RANDOMIZATION AND STRATIFICATION- Randomization for intervention will be done centrally from Clinical Research Secretariat and patient will be stratified by Menopausal status: Pre + Peri or Post Neoadjuvant or adjuvant treatment Stage of disease: I/II/III ANALYSIS- Disease Free Survival (DFS) will be calculated from the date of randomization to the date of local, regional or distant relapse or death from any cause and will be censored at the last date of follow up for the patients that are alive and disease free or have been lost to follow up. Overall Survival (OS) will be calculated from the date of randomization to the date of death or censored at the date of last follow up for the patients who are alive or lost to follow up. DFS and OS will be evaluated using Kaplan Meier and compared by Log-rank test. The Cox proportional hazard model will be used to assess the impact of intervention after correction for stratification, menopausal status and age.
This is a Phase II, open-label study that evaluates the safety and efficacy of IMMU-132 alone and in combination with carboplatin in patients with triple-negative breast cancer. IMMU132 will be administered once-weekly for the first 2 weeks of 3-week treatment cycles. For those patients assigned to also receive carboplatin, will receive it on the same schedules starting 30 minutes after the completion of IMMU-132 administration. Patients may receive up to a maximum total of 8 cycles.
Steroid Aromatase Inhibitors and Non-Steroid Aromatase Inhibitors in Late Stage Breast Cancer is the recommended scheme in National Comprehensive Cancer Network (NCCN) guideline. In the past controlled clinical trials with small sample.
This study is designed to randomly assign breast cancer patients requiring and agreeing to chemotherapy into two groups. One group will be receive an exercise prescription aimed at increasing physical activity by a minimum of 10 MET (metabolic equivalent task) hours per week. The other group will not receive a exercise prescription but their activity will be recorded. The hypothesis is that participants that are most active will exhibit improved chemotherapy completion rates, improved fitness, less fatigue and lower levels of markers for inflammation in their blood.