View clinical trials related to Breast Neoplasms.
Filter by:RATIONALE: Drugs used in chemotherapy, such as cyclophosphamide, docetaxel, and doxorubicin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving combination chemotherapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. It is not yet known which chemotherapy regimen is more effective in treating breast cancer. PURPOSE: This randomized phase II trial is studying cyclophosphamide given together with docetaxel to see how well it works compared with cyclophosphamide given together with doxorubicin in treating women with newly diagnosed breast cancer that can be removed by surgery.
Cancer cells need to be able to make new blood vessels in order to keep growing. This is called angiogenesis. In a laboratory setting, the drug itraconazole was shown to help stop the growth of new blood vessels (anti-angiogenesis). It is hoped that itraconazole will prevent new blood vessels from forming in humans too. The purpose of this study is to look at how the body processes and breaks down itraconazole (called pharmacokinetics). This study will also measure markers in your blood to see if itraconazole stops new blood vessels from forming. The safety of itraconazole will also be tested to see what effects (good and bad) it has on you and your breast cancer.
This is an adjuvant, open, prospective, randomized study to compare: A. Individually tailored and two weekly dosed epirubicin + cyclophosphamide followed by a three weeks break followed by biweekly and tailored docetaxel (dtEC→dtT) given every second week, to B. Fixed dosed and three weekly epirubicin, cyclophosphamide and 5-fluorouracil, followed by fixed dosed and three weekly docetaxel (FEC→T). Patients with primary node-positive or high risk lymph node negative breast cancer will be eligible for the study. The primary objective of the phase 3 study is to compare breast cancer relapse-free survival (BCRFS) between the dtEC→dtT and FE100C→T. To detect a five-year BCRFS difference of 0.710 to 0.790 about 1000 patients per arm will be needed. They will be recruited during four years and followed another two years for breast cancer events. Secondary objectives are to compare 1. Distant disease-free survival (DDFS) 2. Event-free survival and 3. Overall survival 4. Health-related quality of life and toxicity analyses according to CTC 5. Outcome in relation to tumour biological factors and polymorphism patterns 1. RFS in relation to the Sorlie classes using immunohistochemical markers and/or gene expression profiling comparing A vs B arm 2. RFS with receptor positive disease (analyzed in the local laboratories as described in the CRFs and also analyzed as continuous variables) in the comparison between the A- and B- arms. 3. RFS with high and low proliferation, respectively, (analyzed in the local laboratories as described in the CRFs and also analyzed as a continuous variable, or centrally analyzed), in the comparison between the A- and B-arms. 4. RFS in relation to HER-2/neu status (analyzed in the local laboratories as described in the CRFs) in the primary cancers in the comparison between the A- and B-arms and analyzed whether trastuzumab was given in sequence or concurrently. 5. RFS analyzed in relation to other molecular markers (e.g. gene expression profiling/ sequencing) in the primary cancers and SNPs signatures in normal DNA (related to toxicities for EC/FEC and docetaxel components, respectively, and given dose levels and outcome in relation to these factors and in relation QoL) to outcome per arm. 6. RFS analyzed in relation to tumour associated lymphocytes and Y-box binding protein in the comparison between the A- and B-arms. Tumour tissue will be obtained and stored for studies of prognostication and therapy prediction. Last patient randomized was September 2011.
RATIONALE: Monoclonal antibodies, such as trastuzumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. PURPOSE: This phase II trial is studying the side effects of trastuzumab and to see how well it works in treating older women with early-stage breast cancer.
This study aim was to determine the safety and efficacy of R1507 in combination with letrozole in patients with advanced breast cancer. In the first part of the study a cohort of patients with advanced breast cancer received letrozole 2.5mg po daily in combination with R1507 16mg/kg every 3 weeks.
RATIONALE: Ondansetron may help lessen or prevent nausea and vomiting in patients undergoing stem cell transplant. PURPOSE: This phase II trial is studying how well ondansetron works in preventing nausea and vomiting in patients undergoing stem cell transplant.
RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Lapatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as trastuzumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Studying samples of tumor tissue and blood from patients may help doctors understand how well these drugs can be carried to the brain. PURPOSE: More definitive knowledge of the penetration of chemotherapeutic and other agents into the brain is necessary for the future rational design of drug and drug regimens that target brain metastases. This clinical trial is studying how well capecitabine, cyclophosphamide, doxorubicin, gemcitabine, lapatinib, paclitaxel, trastuzumab, or vinorelbine penetrates brain tumors.
RATIONALE: Ground flaxseed may prevent breast cancer in premenopausal women at increased risk of developing primary breast cancer. PURPOSE: This randomized clinical trial is studying how well flaxseed works in preventing breast cancer in premenopausal women at risk of breast cancer.
The purpose of this study is to compare the efficacy and toxicities of hypofractionation radiotherapy with conventional fractionation radiotherapy in breast cancer patients treated with mastectomy.It is hypothesized that the efficacy and toxicities are similar between the two groups.
This is a phase 2, open-label, multicenter, 2-arm study of bosutinib administered in combination with exemestane versus exemestane alone. This is a 2-part study consisting of a safety lead-in phase and randomized phase 2 portion. Subjects in part 1 will receive bosutinib and exemestane daily, and will be closely monitored for 28 days. If no safety concerns arise, then future eligible subjects will be randomly assigned to the main phase of the study. They will either receive bosutinib daily combined with daily exemestane, or daily exemestane alone for a specified period of time. Subjects will be followed up for survival after treatment discontinuation.