View clinical trials related to Breast Neoplasms.
Filter by:This pilot clinical trial studies Dakin's solution in preventing radiation dermatitis in patients with breast cancer undergoing radiation therapy. Radiation dermatitis is a skin condition in which the affected skin becomes painful, red, itchy, and blistered. Dakin's solution may help reduce dermatitis caused by radiation therapy.
This randomized clinical trial studies how well minocycline hydrochloride works in reducing chemotherapy induced depression and anxiety in patients with stage I-III breast cancer. Minocycline hydrochloride may prevent changes in memory and thinking and improve the quality of life of breast cancer patients receiving chemotherapy.
This is a pilot study to determine if there are changes in heart function following completion of radiation therapy for breast cancer as measured by cardiac magnetic resonance imaging (cardiac MRI) scans. Additional purposes of this study are to assess cardiac side effects from radiation treatment, evaluate cardiac MRI changes by radiation technique, and compare quality of life questionnaires.
This pilot clinical trial studies different types of energy balance interventions to see how well they work in increasing the physical activity levels of breast cancer gene-positive patients, Lynch syndrome-positive patients, chronic lymphocytic leukemia (CLL) survivors or family members of cancer survivors who are at high risk for cancer. Increasing exercise and eating healthy foods may help reduce the risk of cancer. Studying how well different types of interventions work in motivating cancer survivors or high-risk family members to increase exercise and healthy food choices may help doctors plan the most effective motivational program for cancer prevention.
Before anti-estrogens such as tamoxifen were developed to treat estrogen receptor (ER)-positive breast cancer, high-dose estrogen therapies were used. This seems counterintuitive since anti-estrogens block ER function, while estrogens increase ER function, but these therapies are effective to similar extents for the treatment of metastatic ER+ breast cancer. Estrogen therapies are most effective against cancers that develop resistance to anti-estrogens, likely because such cancers have adapted to grow without ER function, and restoring ER function (with estrogen) is damaging to the cancer cells. In some patients with ER+ breast cancer that becomes resistant to anti-estrogens, treatment with the estrogen 17B-estradiol induces tumor response. Furthermore, when 17B-estradiol-sensitive tumors eventually become resistant to 17B-estradiol, switching back to anti-estrogen therapy is often effective. These observations suggest that cancers can alternate between anti-estrogen-sensitive and 17B-estradiol-sensitive states. The investigators hypothesize that treatment with alternating 17B-estradiol / anti-estrogen therapies on a defined 8-week / 16-week schedule will more effectively prevent cancer growth than continuous treatment with either type of therapy in patients with metastatic anti-estrogen-resistant ER+ breast cancer.
The goal of this clinical research study is to learn if the study drug, alisertib, in combination with chemotherapy (paclitaxel), can shrink or slow tumor growth in women with hormone receptor (HR)-positive, HER2-negative or HR-negative, HER2-negative (triple negative) locally recurrent or metastatic breast cancer. The safety of alisertib in combination with paclitaxel will also be studied. The physical state of the patient, symptoms, changes in the size of the tumor, and laboratory findings obtained while on-study will help the research team decide if alisertib plus paclitaxel is safe and effective in patients with this type of breast cancer. Alisertib belongs to a group of drugs called Aurora kinase inhibitors. Alisertib blocks the activity of Aurora A kinase, a protein that is involved in tumor cell multiplication and survival. Aurora A kinase is expressed at higher than normal levels in many types of cancer, including breast cancer, and preclinical studies suggest that blocking the activity of this protein can lead to the death of cancer cells. Paclitaxel is a chemotherapy drug commonly used to treat many different kinds of cancer, including metastatic breast cancer. The reason to combine alisertib and paclitaxel is that in cancer therapy, combinations of drugs are often more effective as a treatment than either of the same drugs used alone.
This pilot clinical trial studies intensity-modulated accelerated partial breast irradiation (APBI) before surgery in treating older patients with estrogen receptor positive or progesterone receptor positive stage I breast cancer. APBI is a specialized type of radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Giving radiation therapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.
The primary objective of A-PLUS trial is to evaluate and compare the efficacy of induction BEEP (bevacizumab preconditioning followed by etoposide and cisplatin) followed by whole bran radiotherapy (WBRT) with WBRT alone in the controlling of brain metastases (BM) in metastatic breast cancer (MBC) patients who have not previously received WBRT. In past 2 years, the research team has demonstrated that BEEP regimen is a highly effective treatment for brain metastases of breast cancer progressing from WBRT by a multi-center phase II study (ClinicalTrials.gov Identifier: NCT01281696). The basic concept of preconditioning, as referred to starting bevacizumab 1 day before chemotherapy, is that the effect of bevacizumab induced tumor vascular normalization takes time to mature. The investigators hypothesized that as induction BEEP decreased the size of brain tumors, the effectiveness of WBRT would be maximized. The investigators expect this integrated approach will do greater benefit to MBC patients with BM, irrespective of subtype.
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.
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.