View clinical trials related to Breast Neoplasms.
Filter by:This phase II trial studies how well 3'-deoxy-3'-18F fluorothymidine (18F-FLT) positron emission tomography (PET)/computed tomography (CT) works in predicting response in patients receiving chemotherapy and undergoing surgery for breast cancer that has spread from where it started to nearby tissue or lymph nodes. Diagnostic procedures, such as 18F-FLT PET/CT, may help in learning how well chemotherapy works to kill breast cancer cells before surgery and help doctors plan the best treatment.
Multidrug resistance (MDR) is a cause of treatment failure in many cancer patients. MDR refers to a phenotype whereby a tumor is resistant to a large number of natural chemotherapeutic drugs. Having prior knowledge of the presence of such resistance would decrease morbidity from unsuccessful therapy and allow for the selection of individuals who may benefit from co-administration of MDR inhibiting drugs. The Tc-99m labeled single photon emitting radiotracers sestamibi and tetrofosmin have shown some predictive value. However, positron-emitting (PET) radiotracers, which allow for dynamic, quantitative imaging, hold the promise of more accurate and specific identification of MDR tumors. Objective: To obtain human safety data, to demonstrate imaging feasibility with FPAC, to obtain human biodistribution and to obtain preliminary evidence of breast tumor uptake concordance with response to therapy.
1. This randomized clinical trial compares a four component behavioral sleep intervention group to an attention control healthy eating group 2. The behavioral sleep intervention is designed to reduce fatigue in women with stages I-IIIA breast cancer receiving anthracycline-based chemotherapy 3. The intervention uses an Individual Sleep Promotion Plan to promote daytime activity and nighttime sleep,and to decrease physchological and symptom distress 4. The healthy eating group receives equal time and attention and information on healthy eating 5. All participants receive a research nurse visit 2 days prior to each chemotherapy treatment, and 30, 60, 90 days after the last treatment, and one-year after the first treatment. 6. Adherence to the intervention is calculated at each time 7. Reliable and valid instruments are used, including wrist actigraphy
In this protocol we combine two available and reliable treatments - lumpectomy and RFA. This combination method will provide for excision of the cancer as routinely accomplished and ablation of the cancer bed (lumpectomy site) to ensure negative margins without removing large volumes of tissue. This combined open technique will allow for full histologic analysis of the primary tumor and margin. Because no extra tissue is removed from the breast to generate negative margins it will result in better cosmesis than re-excision to obtain negative margins.
The primary objective of this study is to determine if estrogen receptor-targeted therapy with fulvestrant used in combination with Everolimus is an effective and safe therapy for women with hormone receptor positive metastatic breast cancer after failure of aromatase inhibitor therapy.
Over the last 3 decades, a steady shift has occurred in the management of breast cancer. Because it was traditionally viewed as a local disease, many advocated the use of radical surgery to achieve maximum survival benefit. This view has been slowly replaced by a broader biologic view that recognizes the often systemic nature of breast cancer, even when it appears to be localized to the breast. Results from randomized clinical trials have demonstrated that less extensive surgery, or lumpectomy plus radiation therapy, are optimal for local management of early breast cancer. In addition to the less radical approach to surgical treatment of breast cancer, other randomized clinical trials have established the value of postoperative systemic therapy in improving overall survival by eradicating micrometastatic disease, the major cause of mortality from breast cancer. Despite the well-documented benefits of adjuvant systemic therapy, it is not effective in preventing death from breast cancer in all patients who are candidates for such treatment. The worth of such therapy can only be judged in retrospect upon disease relapse, a time when breast cancer is nearly always incurable. Currently, there are few reliable methods to predict the success or failure of a particular postoperative treatment modality, and better ways to predict and optimize outcome are needed. Combination endocrine therapy: Using endocrine agents with different mechanisms of action together has the potential advantage of more effectively blocking ER signaling, thus improving the efficacy of such agents against breast cancer. In the past, attempts to combine endocrine agents for ER-positive breast cancer have had mixed results, depending on the setting and the patient population studied. Endocrine agents without any agonist effect could potentially be used in combination with aromatase inhibitors, under the rationale that the combination would maximally blockade estrogen receptor signaling, thus potentially improving the antitumor effect. Fulvestrant (FASLODEX) is a pure estrogen antagonist with no known agonist effect; thus, it has the potential to provide additional benefit when combined with an aromatase inhibitor. This concept provides the rationale for using the combination of anastrazole and fulvestrant in this study.
RATIONALE: Studying samples of urine in the laboratory from women with breast cancer may help doctors learn whether tamoxifen and aromatase inhibitors alter the metabolism of estrogens. PURPOSE: This clinical trial is studying the effect of tamoxifen or an aromatase inhibitor on estrogen metabolism in women undergoing treatment for newly diagnosed breast cancer.
The purpose of this study is to determine the dose-limiting toxicity (DLT), maximum tolerated dose (MTD) and recommended Phase II dose of ixabepilone in combination with capecitabine in Japanese participants with metastatic breast cancer.
The primary purpose of this study is to identify the maximum tolerated dose (MTD) of both intravenous and oral panobinostat plus trastuzumab. The study will evaluate safety and efficacy of the combination in adult female patients with HER2+ metastatic breast cancer
Anthracycline-taxane based chemotherapy regimens are recommended mainly by current guidelines for neoadjuvant application of systemic treatment. The addition of other cytotoxic agents, e.g. antimetabolites, vincaalkaloids, or platinum salts resulted in marginal increase in efficacy, but was associated also with an increase in toxicity. Recently, only the addition of the Her-2 antibody trastuzumab has significantly improved pathologic response rate. Therefore, two major strategies are followed in current research projects: - To improve the selection of patients according to their tumors' sensitivity to chemotherapy. - To implement small molecules with specific mechanism of action. Within the GeparQuinto trial, the first strategy is followed by: - The PREDICT substudy. A gene signature specific for the response to anthracyclines and taxanes will be prospectively evaluated for its ability to identify patients with chance higher than 50% for a pCR. The results may leed to a better risk-benefit ratio for the use of conventional chemotherapy. - Adapting further chemotherapy to the response of the tumor to the first couple of chemotherapy cycles. Based on the previous experience made by the GeparTrio study, patients not responding early have a low chance to respond with a pCR irrespective of the type of chemotherapy. So, if further chemotherapy is planned, therapy should be selected according to a favorable toxicity profile. The second strategy is followed by investigating in three parallel group comparisons the efficiency of three distinct small molecules which appear to be generally active in breast cancer: - Bevacizumab, an inhibitor of the VEGF pathway targeting tumor neo-angiogenesis. - Lapatinib, an inhibitor of the Her-1 and Her-2 receptor tyrosine kinase. - RAD001 (Everolimus), an inhibitor of the mTOR molecule, a central controller of tumor cell growth and angiogenesis and chemosensitizer. Treatment for patients participating in the GeparQuinto study will be allocated according to the Her-2 status of the tumor as well as according to the sonographic response after the first 4 cycles of treatment. Experimental therapy with bevacizumab, lapatinib, and everolimus (RAD001) will be randomly added in distinct settings.