Active clinical trials for "Breast Neoplasms"

Genetic polymorphisms of metabolic enzymes may influence the metabolism of Doxorubicin-Cyclophosphamide regimen in breast cancer patients. the investigators want to evaluate the frequency or incidence of the genetic polymorphisms of CYP2C19 and ALDH3A1 in breast cancer patients, and analyze the association between the genetic polymorphisms of CYP2C19 and ALDH3A1 and toxicities in breast cancer patients treated by Doxorubicin-Cyclophosphamide regimen therapy.

The purpose of this study is to evaluate efficacy and safety of CDK4/6 inhibitor Palbociclib in combination with Fulvestrant versus Fulvestrant in female patients with HR+/HER2- advanced breast cancer in a real world setting in China. Primary study endpoint: progression-free survival (PFS). Secondary study endpoints: overall survival (OS), overall response rate (ORR), clinical benefit rate (CBR), objective response duration (DOR) and safety.

Condition: patients with breast cancer. Intervention: spiritual support (relaxation + image guided + meditation) or relaxation in three consecutive meetings (day 2, 3 and 4), three days of intervention in the same week. The first day the participants will be evaluated if she meets the needs of the research and will answer questions about their indentification and spirituality. Type of study: intervention Study design: randomized controlled trial Masking: blind study. Randomization: sequence generated by SPSS (Statistical Package for the Social Sciences) version 15, organized in sealed envelopes by another qualified professional. The research ends in 2014 jun.

Docetaxel plus Capecitabine in anthracycline-pretreated metastatic breast cancer is a recommended scheme in National Comprehensive Cancer Network (NCCN) guideline. Vinorelbine plus Capecitabine is also effective in Metastatic Breast Cancer (MBC) in some clinical study with small sample.

Many patients with breastcancer in the past, were treated with TAC. These last years, there is more and more focus on the effects of chemotherapy, particularly in children treated with this. One of these effects is damage to the heart muscle, which ultimately might affect the pump-function of the heart . In adults, the effect of treatment with TAC on the heart, has not been previously investigated. The possibility exists that the adverse reactions in children are found in adults also could occur. Therefore we have initiated this trial.

Major Aims of study: To create a gene expression-based prognostic device that complements or exceeds the prognostic utility of conventional biomarkers of breast cancer outcome. To identify one or more clinical subgroups of patients for which the prognostic device outperforms, or substantially adds to, the prognostic performance of conventional markers that currently determine therapeutic strategies. Sub-Aims of study: Assess the prognostic value of the multiple gene expression signatures, alone and in combination, using a large cohort of breast cancer patients for which pathology, treatment and outcome is available. A "training" and "testing" design is proposed. Evaluate the utility of a prognostic device that measures gene expression levels from formalin-fixed paraffin-embedded specimens (FFPEs) of primary resected tumors. The investigators will utilize the Affymetrix Quantigene 2.0 Assay and/or the Illumina BeadXpress VeraCode DASL Gene Expression Assay (FDA-approved IVDMIA.) For specific clinical subgroups of patients/tumors, the investigators will mathematically identify additive or synergistic prognostic relationships between genes and gene signatures that, in combination, will yield maximal risk prediction (distant metastases-free survival) for patients. Compare the prognostic utility of the investigators device to that of the conventional prognostic variables that are currently used to determine therapeutic strategy. Incorporate the prognostic signatures into a practical prognosis algorithm that seeks to include conventional measures of outcome such as tumor size, histologic grade, nodal status, patient age, or Nottingham index, etc. The investigators hypothesize that adequate quality and quantity of tumor RNA may be extracted from archival paraffin-embedded tumor specimens for gene expression profiling, and that archival tumor-derived genomic signatures may be used as prognosticators or predictors in breast cancer.

The aim of the study is to assess whether early drainage removal in patients with less than 150ml of lymph in postoperative day 1 can reduce total lymphorrhoea

RATIONALE: Studying samples of blood and tumor tissue in the laboratory from patients with cancer may help doctors learn more about changes that occur in DNA and help doctors understand how patients respond to treatment. PURPOSE: This clinical trial is assessing how changes in genes affect disease progression in women with newly diagnosed or metastatic breast cancer.

The aim of the CHAT study ("An open-label, randomized Phase II study of Herceptin (trastuzumab), Taxotere® (docetaxel) and Xeloda (capecitabine) in combination, versus Herceptin (trastuzumab) plus Taxotere® (docetaxel), in patients with advanced and/or metastatic breast cancers that overexpress HER2") was to test the combination of Trastuzumab and Docetaxel with or without capecitabine as first-line therapy for HER2 positive locally advanced or metastatic breast cancer. Overall Response Rate was the primary endpoint of the CHAT study. This study failed to meet its primary objective of showing a difference between the treatment groups, with equivalent high response rates for the Trastuzumab plus Docetaxel and Trastuzumab, Docetaxel plus capecitabine arms. Secondary endpoints in the CHAT study were Progression-Free-Survival, Time-to-Progression, Overall Survival, duration of response and safety profile. Whilst analysis of the existing data is consistent with improvement with the triplet therapy, interpretation is compromised by the relatively short median follow-up of 24 months. In hindsight the statistical design was flawed by selection of a sub optimal primary endpoint and consequently data was collected and analysed early in relation to time-dependent endpoints. Beyond CHAT will permit capture of mature data for time-related endpoints. Time-to-Progression and Overall Survival are the co-primary endpoints for the Beyond CHAT protocol. The impact of treatment following the first progression, on survival, will be explored. Time-to-Progression will be defined from the time interval between the date of randomisation and the occurrence of progressive disease under therapy according to RECIST criteria. Overall Survival will be defined as the time from date of randomisation to date of death

RATIONALE: Studying samples of blood from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. PURPOSE: This study is looking at genetic susceptibility to cancer and interactions between genes and the environment in patients with breast cancer.