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Breast Cancer clinical trials

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NCT ID: NCT01980823 Completed - Breast Cancer Clinical Trials

Pre-Surgical Trial of the Combination of Metformin and Atorvastatin in Newly Diagnosed Operable Breast Cancer

Start date: October 2013
Phase: Early Phase 1
Study type: Interventional

The purpose of this study is to determine the effects of combining metformin and atorvastatin treatment in patients with newly diagnosed breast cancer during the interval between breast biopsy and surgery. This study is designed to assess whether tumor proliferation, as measured by the natural log expression of Ki-67 staining of breast tumor cells, is reduced following approximately 2 weeks of treatment with the combination of metformin plus atorvastatin in patients with newly diagnosed breast cancer.

NCT ID: NCT01978756 Completed - Breast Cancer Clinical Trials

Outpatient Clinic for Late Outcome for Breast Carcinoma in MAASTRO Clinic.

Start date: March 2013
Phase: N/A
Study type: Observational

In order to evaluate the late outcome in patients curatively treated for breast cancer, a special outpatient clinic will be developed. There are two main purposes of the outpatient clinic. The first purpose is evaluating the results of the radiation treatment by mapping A) late toxicity and B) tumour control and survival. The second purpose is that this outpatient clinic for late outcome will also function as a pilot for a new CAT (Computer Assisted Theragnostics, abbreviated CAT project) in which multiple late outcome variables will be recorded. In this pilot we want to investigate whether physical presence of the patient on the outpatient clinic, allowing physical examination, has any added value to the questionnaires filled in by the patient at home. The ultimate aim of this new CAT project is to use these multicentric data to develop models for predicting both oncological outcome and late side effects. Insight in the beneficial and adverse effects of a certain treatment using these predictive models, will be required choose the optimal treatment for the individual patient using a shared decision making process.

NCT ID: NCT01975831 Completed - Breast Cancer Clinical Trials

A Phase 1 Study to Evaluate MEDI4736 in Combination With Tremelimumab

Start date: December 19, 2013
Phase: Phase 1
Study type: Interventional

This was a Phase 1, open-label, nonrandomized, multicenter study of durvalumab and tremelimumab in subjects with advanced cancers who were not eligible for, declined, or failed standard treatment. The primary study objective was to determine the maximum tolerated dose (MTD) and safety profile of the durvalumab and tremelimumab combination. Secondary objectives were to evaluate the pharmacokinetics (PK) and immunogenicity of durvalumab and tremelimumab, and the antitumor activity (tumor response, progression-free survival [PFS], and overall survival [OS]) of the durvalumab and tremelimumab combination. (Note: Collection of PK and immunogenicity samples was removed by amendment; analysis was not done.) Exploratory objectives were to evaluate the biological activity of the durvalumab and tremelimumab combination.

NCT ID: NCT01975558 Completed - Breast Cancer Clinical Trials

The Radiation Metabolic Signature of Patient Undergoing Radiotherapy. A Pilot Study

Start date: June 26, 2014
Phase:
Study type: Observational

Rationale: Local radiotherapy applied in the treatment of tumors changes the metabolic profile in the exposed area and/or systemically and specific radiation biomarkers can be identified in the respective matrices. Purpose: This is a pilot study to verify in humans the results obtained from two animal models exposed to ionizing gamma-radiation. The classification of patients results from the treatment volume of radiotherapy for cancer disease. Two patient groups with breast cancer undergoing high-dose radiotherapy are selected and compared to control group of age matched healthy women.

NCT ID: NCT01974856 Completed - Breast Cancer Clinical Trials

A Prospective Observational Study of Clinical Outcomes for the NanoString® Technologies Prosigna™ Gene Signature Assay

Start date: October 2013
Phase: N/A
Study type: Observational

The primary objective of this study is to assess the extent to which the Prosigna™ Breast Cancer Prognostic Gene Signature Assay affects the medical oncologist's treatment recommendations regarding adjuvant chemotherapy and actual treatments received for patients with early-stage breast cancer.

NCT ID: NCT01973660 Completed - Breast Cancer Clinical Trials

PAM50 HER2-enriched Phenotype as a Predictor of Response to Dual HER2 Blockade in HER2-positive Early Breast Cancer

PAMELA
Start date: October 2013
Phase: Phase 2
Study type: Interventional

Non-randomized, open label, multicentric translational research study in women with untreated invasive breast carcinoma eligible for primary surgery (Stage I-IIIA). The aim of PAMELA is to test the hypothesis that PAM50 HER2-enriched (HER2-E) subtype better predicts response to neoadjuvant dual anti-HER2 blockade, with or without endocrine therapy, compared to traditional clinical HER2 classification. Furthermore, we posit that characterization of gene expression patterns may identify profiles of those who may be safely spared chemotherapy.

NCT ID: NCT01972984 Completed - Breast Cancer Clinical Trials

Feasibility Study of Presurgical Hormone Therapy (Anastrozole) in Breast Cancer Patients

NEO ER 11-05
Start date: October 2012
Phase: Phase 2
Study type: Interventional

1. Women with operable breast cancer with a 2-8 week preoperative waiting period will accept preoperative therapy trials and specifically taking a standard drug for breast cancer such as anastrozole in this study 2. Short term anastrozole treatment will induce measurable changes in biomarker levels (ER, PR, Her2, Ki67) within the tumor. 3. Degree of response to short term anastrozole varies with a) duration of treatment and b) breast cancer subtype (based on initial pre-treatment biomarker status)

NCT ID: NCT01969448 Completed - Breast Cancer Clinical Trials

Study to Assess Perfusion and Patient Satisfaction in Nipple-Areola Mastectomy With Immediate Reconstruction

NASSM
Start date: March 28, 2013
Phase: N/A
Study type: Interventional

The investigators hypothesize that nipple-areola skin sparing mastectomy (NASSM) performed through an inframammary incision has a superior blood supply relative to a lateral oblique incision. Moreover, by minimizing complications and optimizing aesthetic outcomes, the investigators believe it will be associated with significantly higher patient reported outcome scores. The addition of information gained by use of intraoperative laser-assisted fluorescent angiography (measured with the Spy Elite imaging device) will reduce complication rates by directing intraoperative resection of ischemic tissue and limiting the volume of immediate implant placement in instances where real time imaging would suggest compromised perfusion. These quantifiable, objective measures will justify the use of NASSM and immediate implant placement coupled with intraoperative laser-assisted fluorescent angiography in prosthetic based breast reconstruction despite longer operative times.

NCT ID: NCT01969253 Completed - Breast Cancer Clinical Trials

A Prospective Observational Study of Lymphedema in Breast Cancer With Axillary Lymph Node Dissection

Start date: May 2012
Phase: N/A
Study type: Observational

Over the past few years, several studies have been made on various outcomes about the incidence of lymphedema. Because the outcomes can be came out differently each study by measurement, criteria, treatment period, treatment method and morbid extremities of lymphedema. Therefore it is required for understanding about the incidence, risk factor and physical progress for to be treated and prevented of lymphedema. Also it is necessary that to understand characteristics of lymphedema measurements and to establish diagnostic criteria of lymphedema through comparative study. The aim of this study was to analyze the incidence and risk factor of lymphedema through prospectively observation, and to determine effects on the quality of life of lymphedema after breast cancer surgery with ALND.

NCT ID: NCT01967823 Completed - Breast Cancer Clinical Trials

T Cell Receptor Immunotherapy Targeting NY-ESO-1 for Patients With NY-ESO-1 Expressing Cancer

Start date: October 24, 2013
Phase: Phase 2
Study type: Interventional

Background: The National Cancer Institute (NCI) Surgery Branch has developed an experimental therapy for treating patients with cancer that involves taking white blood cells from the patient, growing them in the laboratory in large numbers, genetically modifying them, and then giving the cells back to the patient. In a previous study the NCI Surgery Branch used the anti-ESO-1 gene and a type of virus (retrovirus) to make these tumor fighting cells (anti-ESO-1 cells). About half of the patients who received this treatment experienced shrinking of their tumors. In this study, we are using a slightly different method of producing the anti-ESO-1 cells which we hope will be better in making the tumors shrink. Objectives: The purpose of this study is to see if these tumor fighting cells (genetically modified cells) that express the receptor for the ESO-1 molecule on their surface can cause tumors to shrink and to see if this treatment is safe. Eligibility: - Patients 15 years old and older with cancer that has the ESO-1 molecule on their tumors. Design: - Work up stage: Patients will be seen as an outpatient at the National Institutes of Health (NIH) clinical Center and undergo a history and physical examination, scans, x-rays, lab tests, and other tests as needed - Leukapheresis: If the patients meet all of the requirements for the study they will undergo leukapheresis to obtain white blood cells to make the anti ESO-1 cells. {Leukapheresis is a common procedure which removes only the white blood cells from the patient.} - Treatment: Once their cells have grown the patients will be admitted to the hospital for the conditioning chemotherapy, the anti-ESO-1 cells and aldesleukin. They will stay in the hospital for about 4 weeks for the treatment. - Follow up: Patients will return to the clinic for a physical exam, review of side effects, lab tests, and scans about every 1-3 months for the first year, and then every 6 months to 1 year as long as their tumors are shrinking. Follow up visits take up to 2 days.