View clinical trials related to Breast Neoplasms.
Filter by: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.
RATIONALE: Aromatase inhibitor therapy is used in treating postmenopausal women who have hormone-dependent breast cancer. It is not yet known what effect aromatase inhibitor therapy has on blood vessel function. PURPOSE: This clinical trial is studying the effect of aromatase inhibitor therapy on blood vessel function in postmenopausal women with breast cancer.
The purpose of this study is to determine the safety profile, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), of oral vorinostat in combination with oral capecitabine given on days 1-7 and 15-21 of a 28 day cycle in patients with advanced breast cancer, using RECIST criteria. This study was originally intended to be a phase 1/phase 2. The protocol was amended to make this study a phase 1 only.
RATIONALE: Antiemetic drugs, such as aprepitant, may help lessen or prevent nausea and vomiting in patients undergoing chemotherapy. PURPOSE: This randomized clinical trial is studying aprepitant to see how well it works compared to placebo in preventing nausea and vomiting in patients undergoing chemotherapy for breast cancer.
Docetaxol plus capecitabine regimen is the standard treatment for the anthracycline-pretreated patients with advanced breast cancer. Cisplatin is an important drug for advanced breast cancer and potential effective drug for triple negative breast cancer.The study primary objective:Assess ORR,TTP,TTF and 2 year PFS rate between docetaxol+capecitabine and docetaxol+cisplatin. The second objective:Assess the safety and QOL.
This study is being done to see if lymph nodes that drain the arm also drain the breast. An axillary lymph node dissection removes lymph nodes under the arm. It is done to help prevent cancer cells from spreading to the rest of the body. Usually, about 12 to 15 nodes are removed. They are then examined to see if they have cancer cells. Removing these lymph nodes has some side effects. The most common is lymphedema. This is the build-up of fluid in the arm. This study will tell us if it may be possible in the future to identify lymph nodes that just drain the arm. Leaving those nodes may help to reduce the rate of lymphedema for future patients.
This single arm study will assess the efficacy and safety of preoperative treatment with Avastin combined with Herceptin-based chemotherapy in patients with primary inflammatory HER2-positive breast cancer. Patients will be treated with a total of 8 cycles of pre-operative chemotherapy + Avastin + Herceptin. The anticipated time on study treatment is 3-12 months, and the target sample size is <100 individuals.
This is a standard Phase 1b and 2a, multi-center, study design that will examine the safety, tolerability, maximum tolerated dose, and overall response rate of tivozanib (AV-951) and paclitaxel in a breast cancer.
We hypothesized that subjects with CYP2D6*10 alleles may have a lower steady state levels of endoxifen due to reduced conversion of tamoxifen to endoxifen. Primary objectives: - To determine the steady state pharmacokinetics of tamoxifen and its metabolites - To test the effects of genetic polymorphisms of CYP2D6 on plasma concentration of tamoxifen and its metabolites in hormone receptor positive women who are taking tamoxifen as adjuvant treatment for breast cancer.
Our hypothesis is that the addition of ShearWave Elastography (SWE) to a conventional breast ultrasound examination provides useful information for the radiologist when imaging lesions in the breast, as compared to conventional grayscale ultrasound alone.