FES-PET for Patients Treated on NCI Protocol 8762
Breast CancerA significant number of all invasive breast cancers are hormone sensitive and may be candidates for treatment with hormonal therapy. This project will assess the ability and usefulness of imaging hormone-receptor status in breast cancer with positron emission tomography (PET) and 6α-[18F]fluoro-17β-estradiol (FES), an estrogen analogue in patients who are scheduled to be treated with hormonal therapy given in combination with a selective allosteric inhibitor of AKT protein kinase (MK2206) .
Tissue Procurement Protocol for Patients Undergoing Treatment for Early-Stage Breast Cancer
Breast CancerThrough the investigators' Breast Care Center at the University of Michigan Comprehensive Cancer Center, the investigators treat approximately 75 patients per year with neoadjuvant chemotherapy. The majority of the remainder of patients with stage II and III disease undergo treatment with adjuvant chemotherapy either on a clinical protocol or as standard of care. There is a subset of women with ER positive disease who do not receive chemotherapy because of favorable tumor characteristics. This tissue procurement protocol is designed to systematically collect tissue, urine and blood specimens on patients undergoing neoadjuvant systemic therapy or adjuvant chemotherapy, serially following treatment, and/or at the time of disease recurrence in order to investigate mechanisms underlying development of metastatic disease, to identify predictors of response and resistance to therapy, and to test potential new therapies for breast cancer using a combination of patient-derived xenograft creation and new microfluidic technologies.
Predicting Response and Toxicity in Patients Receiving Lonafarnib for Breast Cancer
Breast CancerThis is a tumor and serum collection study for patients with advanced breast cancer receiving treatment with lonafarnib.
To Evaluate the Characteristics of a Breast Cancer
Breast CancerThe purpose of this pilot study is to determine the prevalence of markers of chronic and cycling hypoxia and reactive species stress (oxidative and nitrosative) in the breast cancer tumor microenvironment. The study is based around four cornerstone features of the pathologic microenvironment - Hypoxia, Reactive Species (reactive oxygen and nitrogen species), HIF-1 and VEGF, which we term the HRHV axis. Fifty breast cancer patients with planned surgical excision will be administered the hypoxia marker drug, EF5, 24-36 hr prior to surgical excision. EF5 is a non-therapeutic drug and provides no direct benefit to those patients enrolled in this pilot study. Tissues obtained intra-operatively will be snap frozen and subsequently analyzed for EF5 binding. Immunohistochemical analysis of a cohort of immunohistochemical and urine markers that depict the HRHV axis will be examined. The association of the markers with the presence of hypoxia, as determined by EF5 positivity, will be determined. Data from this pilot study will be used to establish the prevalence of markers of the HRHV axis in breast cancer. This information will be crucial for future human trials in which the HRHV axis is therapeutically targeted.
Positron Emission Tomography in Monitoring Treatment Response in Women With Newly Diagnosed Breast...
Adult Women With a New Diagnosis of Invasive Breast Cancer (Have Not Undergone Treatment)This study will investigate the sensitivity and specificity of FLT-PET/CT in primary breast cancer detection and in the use of FLT-PET in monitoring how well a breast tumor respond to treatment. We will compare this technique with other imaging modalities as well as with tissue collection (during a biopsy). We will recruit women with a newly diagnosed invasive breast cancer, who are able to tolerate undergoing a PET/CT (possibly two scans) scan,
Patterns of Care in Hormone-receptor Positive, Advanced Breast Cancer
Breast CancerThe purpose of this study is to characterize the current patterns of care for patients with hormone-receptor-positive, advanced breast cancer who have failed one prior endocrine therapy in Brazil. To investigate patient-related, disease-related and physician-related characteristics that correlate with the use of either endocrine treatment or chemotherapy in such patients. And to evaluate patients' understanding of the treatment options and their participation in the choice.
Survey in Post-menopausal Women Followed up After Treatment With Anastrozole as Adjuvant Therapy...
Breast CancerThe purpose of this survey is to describe long-term tolerance as seen under current conditions of use for anastrozole.
Patient's Anastrozole Compliance to Therapy Programme
Breast CancerApproximately 60 specialised clinics and 420 office based gynaecologists or oncologists will participate in this in practice evaluation program (NIS). The clinic and approximately 7 office based physicians will collaborate within their breast centre networks to conduct this program. A breast centre network should be able to recruit in this program approximately 80 patients (approximately 40 patients per year). It is planned to enroll approximately 4674 patients in this NIS (2337 patients per arm). The patient population will include postmenopausal women with hormone-receptor positive primary breast cancer scheduled for upfront adjuvant endocrine treatment with anastrozole according to the current standard medical procedures.
National Breast Cancer and Lymphedema Registry
Breast CancerLymphedemaThe purpose of the National Breast Cancer Lymphedema Registry is to collect health information in order to study the lymphedema as a complication of breast cancer treatment. The investigators hope to learn whether early diagnosis will help to prevent lymphedema or, if it does occur, to reduce the severity.
A Correlative Study for Predicting Response and Toxicity in Patients Receiving Chemotherapy for...
Breast CancerThe proposed trial provides a unique opportunity in that it combines genomic, proteomic, and pharmacogenomic assessments in patients receiving the most commonly used chemotherapies for advanced breast cancer. To date no other trial has analyzed gene and protein expression at the same time points in the same patient, combined with clinical outcome. Similar to previous attempts to predict response based on expression of a single gene or protein, the researchers expect that neither genomic or proteomic profiling alone will be sufficient to optimize therapy. Rather, the researchers expect an iterative process that combines information gleaned from both platforms, modified to avoid toxicity based on pharmacogenomics.