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CLINICAL TRIAL SEARCH RESULTS

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 Number: 201404107 Principal Investigator: Ademuyiwa, Foluso
Title: A Co-clinical Trial in Triple Negative Breast Cancer Patients with Genoproteomic Discovery
Description: This research proposal investigates a potential new standard of care for patients with curable TNBC using a combination of docetaxel and carboplatin in the neoadjuvant setting....MORE
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 Number: 201311126 Principal Investigator: Ademuyiwa, Foluso
Title: Neoadjuvant Phase II Trial of Paclitaxel in Combination with BKM120 in Endocrine Resistant Clinical Stage II or III Estrogen Receptor-Positive and HER2 Negative Breast Cancer
Description: The purpose of this research study is to find out what effects, good and/or bad, the drug BKM120 in combination with paclitaxel has on you and your breast cancer. Paclitaxel has been approved by the U.S. Food and Drug Administration (FDA) to treat breast cancer after other chemotherapies have been ...MORE
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 Number: 201306103 Principal Investigator: Ademuyiwa, Foluso
Title: A Phase I Dose Escalation Study of POL6326 with Eribulin in Patients with Relapsed, Triple Negative and Hormone Refractory ER Positive Metastatic Breast Cancer
Description: The CXCR4/CXCL12 axis is important in metastatic breast cancer with regard to proliferation, invasiveness and metastasis, particularly cell homing to, and survival in, distant sites including lung, liver, bone, and bone marrow....MORE
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 Number: 201302004 Principal Investigator: Tenenbaum, Marissa
Title: A Prospective Randomized Trial to Assess Perfusion and Patient Satisfaction in Nipple-Areola Mastectomy with Immediate Reconstruction
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 Number: 201301106 Principal Investigator: Ma, Cynthia
Title: Phase II Trial of Neoadjuvant PD 0332991, a Cyclin-Dependent Kinase (Cdk) 4/6 inhibitor, in Combination with Anastrozole in Women with Clinical Stage 2 or 3 Estrogen Receptor Positive and HER2 Negative Breast Cancer
Description: The purpose of this research study is to find out what efects, good and/or bad, the drug PD 0332991 in combination with anastrozole (with or without goserelin) has on the patinet and their breast cancer....MORE
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 Number: 201209135 Principal Investigator: Ma, Cynthia
Title: A Phase II Study of Neratinib in Metastatic HER2 Non-amplified but HER2 Mutant Breast Cancer
Description: This phase II study will test cancer to see if it has a HER2 mutation and, if so, see how HER2 mutated cancer responds to treatment with neratinib....MORE
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 Number: 201106403 Principal Investigator: Zoberi, Imran
Title: Intensity Modulated Radiation Therapy for Breast Cancer: A Phase I Feasibility Study
Description: The purpose of this study is to find out about the effectiveness and safety of a new way of delivering radiation therapy. Standard treatment for you cancer includes radiation therapy. In this study we will give you radiation therapy through a system called Intensity Modulated Radiation Therapy. I...MORE
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 Number: 201105445 Principal Investigator: Ma, Cynthia
Title: A phase 1 trial of BKM 120, a novel oral selective phosphatidylinositol-3-kinase (PI3K) inhibitor, in combination with fulvestrant in postmenopausal women with estrogen receptor positive metastatic breast cancer
Description: The purpose of this research study is to learn about the safety of BKM120 and fulvestrant when the two drugs are given together, to see what effects the combination of BKM120 and fulvestrant has on the body and on tumors, and to determine the highest safest dose of BKM120 that can be given in combin...MORE
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 Number: RTOG 1119 Principal Investigator: Zoberi, Imran
Title: Phase II Randomized Study of Whole Brain Radiotherapy in Combination with Concurrent Lapatinib in Patients with Brain Metastasis from Her2-Positive Breast Cancer A Collaborative Study of RTOG and KROG
Description: The purpose of this research study is to compare the effects of adding lapatinib to standard whole brain radiation therapy (WBRT) on you and your cancer. The study will try to find out whether WBRT or lapatinib plus WBRT is better at safely improving tumor control. In this study, you will receive ei...MORE
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 Number: CTSU S1007 Principal Investigator: Naughton, Michael
Title: A Phase III, Randomized Clinical Trial of Standard Adjuvant Endocrine Therapy +/- Chemotherapy in Patients with 1-3 Positive Nodes, Hormone Receptor-Positive and HER2-Negative Breast Cancer with Recurrence Score (RS) OF 25 or Less
Description: Currently many women with breast cancer are treated with endocrine therapy. Many women also receive chemotherapy. No one really knows which patients with lower Recurrence Scores need to get chemotherapy. Some women may be getting chemotherapy who do not need it. These women may be exposed to sid...MORE
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 Number: CTSU E2108 Principal Investigator: Margenthaler, Julie
Title: A Randomized Phase III Trial of the Value of Early Local Therapy for the Intact Primary Tumor in Patients with Metastatic Breast Cancer
Description: We do not know if local (i.e. surgery and/or radiation) treatment of the tumor of the breast will help patients with metastatic breast cancer live longer or not. The purpose of this study is to compare the good and bad effects of a new approach that includes surgery plus radiation to the standard a...MORE
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 Number: CTSU B-43 Principal Investigator: Zoberi, Imran
Title: A Phase III Clinical Trial Comparing Trastuzumab Given Concurrently with Radiation Therapy and Radiation Therapy Alone for Women with HER2-Positive Ductal Carcinoma In Situ Resected by Lumpectomy
Description: This study is being done to compare the effects, good and/or bad, of adding the drug trastuzumab (also called Herceptin®) to breast radiation therapy. Radiation therapy is the standard treatment for patients with DCIS. This study will find out if adding trastuzumab to breast radiation therapy is mor...MORE
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 Number: CTSU ACOSOG A221102 Principal Investigator: Aft, Rebecca
Title: Randomized Double-Blind Placebo Controlled Study of Subcutaneous Testosterone in the Adjuvant Treatment of Postmenopausal Women with Aromatase Inhibitor Induced Arthralgias
Description: It is well known that treatment with an aromatase inhibitor (AI) can cause side effects that result in symptoms such as joint pain and stiffness, which can interfere with activities of daily living. In some patients, the treatment has to be stopped because of these symptoms. The purpose of this stud...MORE
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 Number: CALGB S1207 Principal Investigator: Naughton, Michael
Title: Phase III Randomized, Placebo-Controlled Clinical Trial Evaluating the Use of Adjuvant Endocrine Therapy +/- One Year of Everolimus in Patients with High-Risk, Hormone Receptor-Positive and HER2/neu Negative Breast Cancer (S1207)
Description: The purpose of this study is to see whether treatment with everolimus plus hormone treatment after chemotherapy will increase the time without your cancer returning. The current standard treatment after chemotherapy is hormone treatment alone. Everolimus is a drug currently approved by the U.S. Food...MORE
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 Number: CALGB NSABP B-47 Principal Investigator: Ademuyiwa, Foluso
Title: A Randomized Phase III Trial of Adjuvant Therapy Comparing Chemotherapy Alone (Six Cycles of Docetaxel Plus Cyclophosphamide or Four Cycles of Doxorubicin Plus Cyclophosphamide Followed by Weekly Paclitaxel) to Chemotherapy Plus Trastuzumab in Women with Node-Positive or High-Risk Node-Negative HER2-Low Invasive Breast Cancer
Description: The main purpose of this study is to learn if adding a targeted therapy, trastuzumab (Herceptin), to standard treatment with chemotherapy for early stage, HER2-low breast cancer, will prevent breast cancer from returning....MORE
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 Number: CALGB A011106 Principal Investigator: Ma, Cynthia
Title: ALTernate approaches for clinical stage II or III Estrogen Receptor positive breast cancer NeoAdjuvant TrEatment (ALTERNATE) in postmenopausal women: a phase III study
Description: This study aims to definitively identify patients with estrogen receptor positive tumors that don’t need chemotherapy despite being larger in size....MORE
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 Number: CALGB 49805 MA.17R Principal Investigator: Naughton, Michael
Title: A Double Blind Randomization to Letrozole or Placebo for Women Previously Diagnosed with Primary Breast Cancer Completing Five Years of Adjuvant Aromatase Inhibitor Either as Initial Therapy or After Tamoxifen
Description: This study is for patients who have previously taken tamoxifen or have taken five years of an aromatase inhibitor without any prior tamoxifen. The purpose of this study is to find out whether taking an aromatase inhibitor, a type of hormone therapy, for more than 5 years is better than taking it...MORE
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 Number: ACOSOG Z11102 Principal Investigator: Margenthaler, Julie
Title: Impact of Breast Conservation Surgery on Surgical Outcomes and Cosmesis in Patients with Multiple Ipsilateral Breast Cancers (MIBC) (Z11102)
Description: The purpose of this research study is to see if removing only the tissues from the 2 or 3 cancers in your breast (breast conservation surgery) in combination with radiation to the breast, instead of removing your entire breast (mastectomy) is safe in keeping your cancer from coming back in your brea...MORE
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 Number: 201406045 Principal Investigator: Ma, Cynthia
Title: A Randomized, Double-Blind, Phase 2 Study of Ruxolitinib or Placebo in Combination with Capecitabine in Subjects with Previously Treated Advanced or Metastatic HER2-negative Breast Cancer
Description: The purpose of this research study is to find out if the study medication, ruxolitinib (also known as Jakafi® or INCB018424) is safe and effective when given in combination with a chemotherapy called capecitabine or Xeloda® in women who have certain types of breast cancer. The primary purpose of thi...MORE
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 Number: 201404077 Principal Investigator: Ma, Cynthia
Title: A Randomized Multicenter Pivotal Study of CDX-011 (CR011-vcMMAE) in Patients with Metastatic, GPNMB Over-Expressing, Triple-Negative Breast Cancer (The “METRIC” Study)
Description: The purpose of this study is to see whether CDX-011 is effective in treating patients who have advanced Triple-Negative Breast Cancer (TNBC; i.e., tumors lacking expression of estrogen, progesterone and HER2 receptors) that contains gpNMB, and to examine the side effects associated with CDX-011 trea...MORE
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 Number: 201312074 Principal Investigator: Ademuyiwa, Foluso
Title: A Phase 2, Randomized, Double Blind, Placebo Controlled, Multicenter Study of Efficacy and Safety of Enzalutamide in Combination With Exemestane in Patients With Advanced Breast Cancer That Is Estrogen or Progesterone Receptor Positive and HER2 Normal
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 Number: 201311119 Principal Investigator: Ma, Cynthia
Title: A Phase I, multi-center, non-randomized, open-label, dose escalation design study to characterize safety, tolerability, pharmacokinetics and maximum tolerated dose of BAY 1125976 in subjects with advanced solid tumors
Description: The purpose of this study is to identify the most appropriate dose of the study drug BAY1125976 (in terms of tolerability), and secondly to see if it is efficient to treat advanced solid tumors, especially metastatic breast cancers....MORE
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 Number: 201310163 Principal Investigator: Bose, Ron
Title: A Study of Neratinib Plus Capecitabine Versus Lapatinib Plus Capecitabine in Patients With HER2+ Metastatic Breast Cancer Who Have Received Two or More Prior HER2-Directed Regimens in the Metastatic Setting (NALA) (PUMA-NER-1301)
Description: The purpose of this study is to test the safety and benefit of an investigational drug, called neratinib. The study will compare the effects (good and bad) between the treatment with neratinib + capecitabine and lapatinib + capecitabine....MORE
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 Number: 201304002 Principal Investigator: Ma, Cynthia
Title: A Phase 1, Multi-Center, Open-Label, Dose-Escalation, Safety, and Pharmacokinetic Clinical Study of Intravenously Administered MM-302 Monotherapy and in Combination with Trastuzumab with or without Cyclophosphamide in Patients with Advanced HER2 Positive Breast Cancer
Description: The purpose of this study is to evaluate MM-302 in subjects with advanced HER2+ breast cancer....MORE
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 Number: 201110186 Principal Investigator: Ademuyiwa, Foluso
Title: A Randomized Phase 2 Study of the Efficacy and Tolerability of Veliparib in Combination with Temozolomide or Veliparib in Combination with Carboplatin and Paclitaxel Versus Placebo Plus Carboplatin and Paclitaxel in Subjects with BRCA1 or BRCA2 Mutation and Metastatic Breast Cancer
Description: The main purpose of the study is to determine if patients with metastatic breast cancer do better with veliparib in combination with temozolomide or carboplatin and paclitaxel with or without veliparib....MORE
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 Number: 201012844 Principal Investigator: Zoberi, Imran
Title: A Phase I/II Study Evaluating the Maximum Tolerated Dose, BioequivalencePharmacokinetics, Safety, and Efficacy of Hyperthermia and Thermodox (Lyso-Thermosensitive Liposomal Doxorubicin) in Patients with Local-Regional Recurrent Breast Cancer
Description: The purpose of this research study is to evaluate the effects of ThermoDox® in combination with therapeutic heating of the chest wall in the treatment of recurrent regional breast cancer. The United States Food and Drug Administration has approved therapeutic heat for the treatment of breast cancer...MORE
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 Number: 201209143 Principal Investigator: Cyr, Amy
Title: A prospective, randomized trial of sentinel lymph node biopsy versus no additional staging in patients with clinical T1-T2 N0 M0 invasive breast cancer and negative axillary ultrasound
Description: The purpose of this study is to determine if axillary ultrasound can be used instead of sentinel lymph node biopsy to detect spread of the breast cancer to the lymph nodes under the arm without compromising patient treatments or outcomes. The obvious advantage of using axillary ultrasound instead of...MORE
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 Number: 201104345 Principal Investigator: Colditz, Graham
Title: Repository of Archival Human Breast Tissue (RAHBT)
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 Number: 201203103 Principal Investigator: Goodman, Melody
Title: Communication Preferences for Genome Sequencing Results in Breast Cancer Patients
Description: {articipants are invited to participate in this research study if they are a part of the Young Women’s Breast Cancer Program. The purpose of this research study is to learn more about how best to return genetic information to women who have been diagnosed with breast cancer at a young age....MORE
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 Number: 201205055 Principal Investigator: Wildes, Tanya
Title: Clinical and Biological Predictors of Chemotherapy Toxicity in Older Adults
Description: The goal of this project is to develop questions and blood tests to understand the individual’s risk of side effects that can be used in daily oncology practice. This information will make it possible to weigh the risks and benefits of cancer treatment based on factors other than chronological age. ...MORE
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 Number: 201209135A Principal Investigator: Ma, Cynthia
Title: A Phase II Study of Neratinib in Metastatic HER2 Non-amplified but HER2 Mutant Breast Cancer ANCILLARY BANKING PROTOCOL ENTRY
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 Number: 201102394 Principal Investigator: Colditz, Graham
Title: St. Louis Breast Tissue Registry
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 Number: 201102358 Principal Investigator: Stewart, Sheila
Title: The Role of Senescent Fibroblasts in Tumor Initiation and Progression Epithelial-Stromal Interactions in the Progression of Non-Invasive to Invasive Breast Cancer
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 Number: 201102244 Principal Investigator: Ma, Cynthia
Title: Longitudinal Cancer Genome Profiling Using Sequential Tissue Biopsies in Patients with Breast Cancer
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 Number: 201101961 Principal Investigator: Aft, Rebecca
Title: Effect of Neoadjuvant Chemotherapy on Breast Cancers, Bone Marrow Cancer Cells, and Circulating Cancer Cells
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 Number: NSABP DP-1 Principal Investigator: Tabchy, Adel
Title: NSABP Biospecimen Discovery Project
Description: The purpose of this study is to discover genetic and protein changes associated with cancer. This should lead to better ways to prevent, detect, and treat cancer and, perhaps, other health problems as well....MORE
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 Number: 201107282 Principal Investigator: Colditz, Graham
Title: Intermediate Markers of Breast Cancer Risk
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 Number: 201212038 Principal Investigator: Khwaja, Shariq
Title: Breast Cancer in Women under 40 years: Evaluation of Patient-, Tumor-, and Treatment-related Prognostic Factors
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 Number: 201210126 Principal Investigator: Cyr, Amy
Title: Identification of Invasive Lobular Carcinoma Sentinel Lymph Node Metastases by Immunohistochemistry
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 Number: 201108305 Principal Investigator: Olsen, Margaret
Title: Immediate vs. Delayed Reconstruction and Breast Cancer Surgery Complications
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