View clinical trials related to Breast Neoplasms.
Filter by:The overall hypothesis is that the combination of a low dose of the antiestrogen Raloxifene with omega-3 fatty acids will exert a synergistic breast cancer chemopreventive effect due to the crosstalk of their downstream cellular effects leading to decreased proliferation and increased apoptosis of premalignant mammary cells. Based on the investigators hypothesis that upregulation of functional estrogen receptors in the premalignant lesions is also responsible for the development of hormone independent tumors, the investigators postulate that the combination of antiestrogens and omega-3 fatty acids will reduce the development of both hormone-dependent and -independent tumors. At present, there are no known interventions able to decrease the development of hormone-independent tumors, which are more prevalent, more aggressive, leading to the patient's demise. In addition, the investigators postulate that this approach will be safe since it will combine a lower and hence a less toxic dose of Raloxifene with the administration of omega-3 fatty acids which are known to have health benefits, i.e., reduction in cardiovascular risk, beyond their possible chemo preventive effect in breast cancer.
In the MDACC/BrUOG neoadjuvant trial with weekly paclitaxel followed by Fluorouracil Plus Doxorubicin and Cyclophosphamide (FAC), the pathologic complete response (pCR) rate in HER2(-) patients was 20%. The investigators' goal is to develop an induction chemotherapy regimen that will have a pCR rate above 30% in patients with HER2(-) disease. Based on a 1-sided 95% confidence interval using normal approximation with an expected pCR rate of at least 35%, approximately 28 patients are required for each cohort. With an assumed pCR rate of at least 35%, the investigators will have approximately 70% statistical power to conclude, with 90% certainty, that the pCR rate with the novel regimen exceeds 20%. The study will accrue approximately 60 patients in two cohorts with an inevaluable rate that does not exceed 10%.
This is an open-label, four-arm, Phase I, dose escalation study to evaluate the safety and tolerability and to determine the optimal tolerated regimen (OTR) of pazopanib in combination with epirubicin or doxorubicin in patients with advanced solid tumors. Patients will be enrolled in cohorts of 3 to receive escalating doses of pazopanib and epirubicin or doxorubicin. Dose escalation schemas for each study arm are described in the protocol. For each arm, the OTR will be defined as the highest dose combination of the agents where no more than one out of six patients experiences a dose-limiting toxicity. Twelve additional patients in each arm will be studied with the OTR to evaluate toxicity and pharmacokinetics. This will allow an assessment of potential drug-drug interactions. Antitumor activity will be assessed using RECIST criteria.
The purpose of this study is to compare 3D mammography with digital mammography in women with dense breasts for the detection and evaluation of masses and/or breast cancer.
The purpose of this study is to determine how well changes can be determined in malignant masses from ultrasound scans.
HER2 is a protein that sits on the surface of breast cancer cells in some people. Because you are one of these people, your breast cancer is called "HER2-positive." The HER2 protein is involved in the growth of your breast cancer. Certain drugs can interfere with the ability of the HER2 protein to cause breast cancer growth. Trastuzumab is one of these drugs. You must have already received trastuzumab as treatment for your breast cancer to be considered for this study. Other drugs are being studied in women with HER2-positive breast cancer. Lapatinib (Tykerb™) blocks signals that stimulate HER2-positive breast cancers to grow. The FDA approved lapatinib for use with capecitabine (Xeloda™) in patients who have metastatic breast cancer that has grown or spread after treatment with trastuzumab. Capecitabine was approved by the FDA in 1998 for treating metastatic breast cancer. Capecitabine is a pill that blocks the way cancer cells multiply and grow. Usually, this medicine is taken twice a day for fourteen days. Then, patients do not take the pill for seven days. With this schedule and dose, some patients have had side effects that interfered with their comfort. We have used mathematical models to recommend a new schedule of capecitabine. In animals, 7 days of treatment with capecitabine followed by a 7-day break was safer and more active against breast cancer. The purpose of this study is to find out what effect (both good and bad) capecitabine has on you and your breast cancer when given in this new schedule and combined with lapatinib.
"Translation" of the current "basic science" information related to physical activity into patient intervention programs is needed. This translation is critical to providing benefit to the maximum number of patients. Little is known about the determinants of physical activity among breast cancer patients undergoing hormonal therapy and few studies have attempted to evaluate an exercise behavior change program aimed to improve exercise adherence among such patients. The proposed project will evaluate use of an innovative behavioral and psychosocial intervention to increase physical activity among breast cancer patients.
The study is aimed to confirm that letrozole + PD 0332991 is safe and tolerable and to assess the effect of the combination on advanced breast cancer
Sentinel lymph node (SLN) mapping is the standard of care for the surgical staging of breast cancer. We propose a method of SLN mapping based on the use of invisible near-infrared fluorescent light that has significant advantages for both patient and surgeon. The present study is a 6-patient pilot study designed to optimize clinical workflow with the new imaging system.
Rationale: Whole breast irradiation with 50 Gy after lumpectomy has been shown to reduce the local recurrence rate with a factor 3 to 4. An additional boost of 16 Gy to the tumorbed has been shown to improve the local control rate even further. However, this boost dose appears to reduce not only the local recurrences in the tumorbed, but also elsewhere in the breast, suggesting that the boost may not always be delivered at the correct region. In addition, even with the boost dose of 16 Gy, the local recurrence rate in young patients is still quite high - with the majority of recurrences in the tumorbed. Consequently, further improvement of the local control, especially in young women, is still an important aim to pursue, in order to maintain breast conserving therapy (BCT) as an acceptable treatment option in young women. One way to improve local control may be to increase the dose [Young Boost Trial], but also to improve the definition of the tumorbed, i.e. the target volume for boost irradiation. Objective: The aim of this study is to investigate the effect of incorporating a contrast-enhanced (CE)-CT-thorax in the target volume delineation process on 1) the coverage of the tumorbed by the 85% isodose, 2) the size of the irradiated boost volumes, and 3) the interobserver variation in target volume delineation. Study design: A CE-CT scan of the thorax will be made prior to surgery, with the patient in radiation treatment position. After breast conserving surgery, patients will be referred for post-operative radiotherapy according to the standard guidelines. Prior to radiotherapy, a standard CT thorax scan will be made for treatment planning. The planning target volume (PTV) for the boost will be delineated according to the MAASTRO protocol, by three independent observers (PTV-1A-C), using the planning CT only. Delineation of the boost will be repeated after 3D registration of the pre-operative CT scan with the planning CT-scan (PTV-2A-C). Thereafter, consensus will be obtained for the PTV-1A-C and the PTV-2A-C, resulting in one PTV-1 and one PTV-2 for each patient. Radiation treatment plans (RT-plans) will subsequently be designed for PTV-1 and PTV-2. Coverage of the treatment plans by the 85% isodose for both PTV-1- and PTV-2, and the irradiated volumes (percentage of the volume receiving 95% or more (V95)) will be calculated. Patients will be treated with the treatment plan for PTV-2. Study population: 60 breast cancer patients, to be treated with BCT, with a mass visible on mammography and/or ultrasound > 0.5 cm, without contraindications for a CE-CT-thorax scan will be included. Intervention: < 3 weeks prior to lumpectomy a CE-CT-thorax scan will be made of the entire thorax, with the patient in the same position as planned during the post-operative radiotherapy. Intravenous contrast will be given according to the standard thorax protocol of MAASTRO clinic. Main study parameters/endpoints: Primary endpoints are: 1. The percentage of the PTV-2 receiving < 85% of the dose, if treated with the RT-plan for PTV-1. 2. Difference in V95 for the RT-plan designed for PTV-1- versus for PTV-2. Other endpoints will be interobserver variation, as measured by 1) percent volume overlap; 2) difference in standard deviation of the average PTV-1 and PTV-2; 3) center of mass assay. Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Patients will only be included after written informed consent. The preoperative CE-CT-thorax-scan yields little additional radiation exposure, which will however be negligible compared to the radiation treatment to be given because of the breast cancer. In addition, there is a small risk on an allergic reaction to the intravenous contrast, and on renal complications. Therefore, renal function will be checked prior to giving contrast. A kreatinine clearance < 60 ml/min will be a contra-indication for contrast. The pre-operative CT-scan will be made in MAASTRO clinic, requiring an additional visit to MAASTRO clinic. A possible benefit may be that the pre-operative CE-CT thorax may improve the definition of the target volume, and thereby reduce the risk on a local recurrence.