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Breast Neoplasms clinical trials

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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: NCT01271725 Completed - Breast Neoplasms Clinical Trials

LUX-Breast 2; Afatinib in HER2 (Human Epidermal Growth Factor Receptor)-Treatment Failures

Start date: May 24, 2011
Phase: Phase 2
Study type: Interventional

The general aim of this study is to investigate the efficacy and safety of afatinib (BIBW 2992) alone and in combination with weekly paclitaxel or weekly vinorelbine (in patients who progress on afatinib monotherapy within this trial) as treatment in patients with HER2-overexpressing, metastatic breast cancer, who failed HER2-targeted treatment in the neoadjuvant or adjuvant setting

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: NCT01268150 Completed - Clinical trials for Metastatic Breast Cancer ( HER2 Negative)

A Study of Single-Agent Eribulin Mesylate as First-Line Therapy for Locally Recurrent or Metastatic Human Epidermal Growth Factor Receptor Two (HER2) Negative Breast Cancer

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

The purpose of this study is to assess the efficacy and safety of single-agent eribulin mesylate for first-line treatment of subjects with locally recurrent or metastatic breast cancer.

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: 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: NCT01265927 Completed - Breast Neoplasms Clinical Trials

A Study Inhibiting Telomerase to Reverse Trastuzumab Resistance in HER2+ Breast Cancer

Start date: January 2011
Phase: Phase 1
Study type: Interventional

A study to evaluate safety and biologic effects of giving GRN163L in combination with trastuzumab in patients diagnosed with HER2+ metastatic breast cancer that is resistant to therapy with trastuzumab.

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.

NCT ID: NCT01264562 Completed - Breast Cancer Clinical Trials

Cognition in Breast Cancer Patients: The Impact of Cancer-related Stress

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

The study will investigate the impact of cancer-related stress and its consequences (acute and posttraumatic stress symptoms, altered cortisol secretion) on cognitive function in breast cancer patients. The hypothesis that stress associated with the cancer diagnosis and the cancer treatment is a major cause of cognitive dysfunction in breast cancer patients shall be evaluated.

NCT ID: NCT01263613 Completed - Breast Cancer Clinical Trials

Feasibility Study of Biomarkers of Response to Neoadjuvant Paclitaxel in Locally Advanced Breast Cancer

Start date: December 2010
Phase: Early Phase 1
Study type: Interventional

The purpose of this study is to determine if the investigators are able to locate and measure certain characteristics in breast cancer tumors that have been treated with paclitaxel that may correlate to how well the cancer will respond to the chemotherapy.