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Breast Cancer clinical trials

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NCT ID: NCT01273415 Completed - Breast Cancer Clinical Trials

Usefulness of Ki67 Index in Hormone Receptor-positive Breast Cancer

Start date: August 2010
Phase: N/A
Study type: Observational

Gene expression studies have identified at least four molecularly distinct subtypes of breast cancer including two biologically distinct ER-positive subtypes of breast cancer: luminal A and luminal B (with luminal B tumors having poorer outcomes than luminal A tumors). Although some luminal B tumors can be identified by their expression of HER2, the major biological distinction between luminal A and B is the proliferation signatures, including genes such as CCNB1, MKI67, and MYBL2, which have higher expression in luminal B tumors than in luminal A tumors. The high cost of gene expression profiling has limited its incorporation into general clinical practice. To date, there is no available IHC-based surrogate assay that can distinguish between luminal A and luminal B tumors. We hypothesized that the IHC determination of the Ki67 index as well as ER, PgR, and HER2 status is able to distinguish the luminal B subtype of breast cancers from the luminal A subgroup.

NCT ID: NCT01272817 Completed - Breast Cancer Clinical Trials

Nonmyeloablative Allogeneic Transplant

Mini-allo
Start date: October 2001
Phase: N/A
Study type: Interventional

Allogeneic transplant from a matched sibling for the treatment of a variety of illnesses including bone marrow failure states, leukemias, myelodysplastic or myeloproliferative syndromes, lymphoma, or myeloma using a nonmyeloablative preparative regimen.

NCT ID: NCT01272570 Completed - Breast Cancer Clinical Trials

Oral Health and Oral Health-Related Quality of Life in Early Stage Breast Cancer Survivors

Start date: September 2010
Phase: N/A
Study type: Observational

The 3 Specific Aims are (1) To determine the prevalence, incidence and severity of oral conditions in postmenopausal early stage breast cancer survivors within the first 18 months of adjuvant Aromatase Inhibitor(AI) therapy, (2) To determine the oral health quality of life among postmenopausal early stage breast cancer survivors who are receiving AI therapy, (3) To determine the utilization of dental care among postmenopausal women receiving AIs with a history of early stage BCa over time. The hypothesis for this pilot study is that AIs negatively impact oral health and oral health quality of life in the setting of breast cancer survivors. Further, we hypothesize that dental visits are underutilized in women with BCa undergoing adjuvant AI therapy.

NCT ID: NCT01271738 Completed - Breast Cancer Clinical Trials

Evaluating and Comparing Two Surgical Methods for Treatment of Early Stage Breast Cancer

Start date: September 2009
Phase: N/A
Study type: Interventional

The goal of this study is to compare two different types of breast surgery. In the first type, the doctor removes only the tumor. In the second type, the doctor removes the tumor and some of the tissue around the tumor called margins. The amount of breast tissue removed is similar. The removal of the tumor only has up to 40% chance of reoperation because the tumor is too close to the margin. The primary goal of this study is to see if the additional margins can decrease the need to return to the operating room. Both types of surgery are well accepted, and participating in the study would not give you a better chance to cure the cancer. At present, most breast surgeons remove the tumor without the additional margins. For all patients who have this operation, there is a high incidence of return to the operating room for margins re-excision: as many as 40% as patients can have a re-operation. At present, we do not know if taking the additional margins prevents the cancer from returning in the breast or not. If the cancer comes back in your breast, this is a recurrence and your breast will have to be removed (mastectomy).

NCT ID: NCT01269346 Completed - Breast Cancer Clinical Trials

Eribulin With Trastuzumab as First-line Therapy for Locally Recurrent or Metastatic HER2 Positive Breast Cancer

Start date: December 2010
Phase: Phase 2
Study type: Interventional

This is a multicenter phase 2 study designed to evaluate the safety and efficacy of eribulin mesylate in combination with trastuzumab as first line treatment in female subjects with locally recurrent or metastatic human epidermal growth factor receptor (HER2) positive breast cancer.

NCT ID: NCT01267877 Completed - Breast Cancer Clinical Trials

Patient Perception of Mammogram Guidelines

Start date: March 2010
Phase: N/A
Study type: Interventional

The purpose of this study was to determine attitudes regarding the 2009 USPSTF Guidelines for breast cancer screening for women in their 40's and assess the effect of one of two newspaper articles on their attitudes. The population studied was women seeing their private gynecologist for annual exams in the 39-49 year old age group.

NCT ID: NCT01267552 Completed - Breast Cancer Clinical Trials

Study of Axillary Lymphadenectomy Without Drainage for Breast Cancer

Start date: July 2000
Phase: Phase 2/Phase 3
Study type: Interventional

To study the safety of not draining the axilla, after breast conserving surgery and full axillary lymphadenectomy.

NCT ID: NCT01267110 Completed - Clinical trials for Breast Cancer Screening

Engaging Diverse Underserved Communities to Bridge the Mammography Divide

Start date: September 2010
Phase: N/A
Study type: Interventional

Breast cancer is the second most common cause of cancer death in the U.S.1 in spite of being preventable, easily detectable, and curable.2-11 Breast screening continues to be underutilized by the general population and especially by traditionally underserved minority populations. Two of the least screened minority groups are American Indians/Alaska Natives (AI/AN) and Latinas. American Indian/Alaska Native women have the poorest recorded 5-year cancer survival rates of any ethnic group and the lowest (or near-lowest) screening rates for major cancers.12 Furthermore, breast cancer is the number one cause of cancer mortality among Latina women.13 While breast cancer screening rates have increased nationally, there has been an increase in the gap in breast cancer screening utilization between individuals from minority versus majority racial/ethnic groups.

NCT ID: NCT01266486 Completed - Breast Cancer Clinical Trials

Effect of Metformin on Breast Cancer Metabolism

Start date: May 2011
Phase: Phase 2
Study type: Interventional

Metformin, a drug that has been used since the 1950's in the treatment of diabetes, has recently generated great interest in its anticancer effects based on in vitro, in vivo and clinical studies. This study assesses the pharmacodynamic effects of metformin on breast cancer metabolism. The trial design is based on a 2 centre study 'Early Antiangiogenic Response to Bevacizumab in Primary Breast Cancer' that is about to successfully complete recruitment in Oxford and Mount Vernon hospitals. The study takes advantage of the 2 week window between the first clinic visit and commencement of neoadjuvant chemotherapy. Metformin will be given to patients for at least 2 weeks prior to neoadjuvant chemotherapy with a set of 3 breast core biopsies, a PET-CT scan and blood tests carried out before and after this 2 week period of treatment. Patients will also receive a drink of heavy (deuterated) water, a safe and stable isotope commonly used in clinical lipid metabolism studies, the evening prior to both sets of core biopsies. Having completed the first 2 weeks of metformin patients will have the option of continuing metformin until completion of chemotherapy, at the discretion of the trial physician. The core biopsies will then be used to assess for changes in: - immunohistochemical staining; - gene profiles; - uptake of heavy water into tumour fatty acids using mass spectrometry techniques. The aim is to identify potential biomarkers of response to metformin (and other future cancer metabolism drugs).

NCT ID: NCT01265654 Completed - Breast Cancer Clinical Trials

Reasons for Changing HOrmonal Therapy of Advanced Breast Cancer

HOT ABC
Start date: January 2011
Phase: N/A
Study type: Observational

Breast cancer is the leading type of cancer in women. Although big advance in diagnostics and treatment of early and breast cancer has been made in recent years breast cancer still has a significant mortality rate. A number of treatment modalities exist for postmenopausal women with advanced breast cancer. The treatment modality is chosen based on patient and tumour characteristics. Hormonal treatment is preferred and recommended in women with hormone sensitive breast cancer (ESMO, CECOG and NCCN guidelines). Tumor markers are an established method of monitoring systemic therapies in various cancers. Tumor markers CA 15-3 and CEA are used in clinical practice to monitor treatment efficacy of metastatic breast cancer. Blood levels of tumor markers are widely used to assess response/progression to treatment and guide therapy change. Treatment efficacy is assessed by imaging methods in clinical studies. Change of therapy in clinical study is usually done when progression based on RECIST criteria is found. Hormonal treatment has slower onset of effect compared with chemotherapy that can last several weeks. Also when a new therapy is started spurious early rises may occur. Therefore rising levels of tumor markers during the first weeks of new hormonal therapy are not necessarily sign of progression and should not be the only guidance for treatment change. Evidence of treatment efficacy form clinical studies and treatment change is based on imaging techniques.