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Clinical Trials

SURVIVORSHIP CLINIC:
E13111 - Establishing and Testing a Breast Cancer Survivorship Program at TTUHSC-Paul L. Foster School of Medicine in El Paso (Program #2) - 250 patients allowed; 200 required for completion; 44 new DSRIP, 48/200 enrolled; 2 withdrawals
VOCs:
E14039 - Development of a Novel Non-Invasive Diagnostic Method for Early Detection of Breast Cancer Using Cancer Specific                   Volatile Organic Compounds (VOCs) in Urine - 2 patients approved for accrual; 10 patients required for completion; 0/10 enrolled
NOVARTIS:
E13045 - “A phase III randomized, double blind, placebo controlled study of BKM120 with fulvestrant, in postmenopausal women with hormone receptor-positive HER2-negative AI treated, locally advanced or metastatic breast cancer who progressed on or after mTOR inhibitor based treatment.” - 5 patients approved for accrual; 2 patients enrolled; 1 screen failure, 11 patients screened
METABOLIC SYNDROME:
E##### - "Effect of chemotherapy on markers of metabolic syndrome in early breast cancer." - 100 patients approved for accrual; 38 patients enrolled; 4 screen failures; 2 withdrawals
NIH:
E##### - "BRCA1 and BRCA2 Mutations and Triple Negative Disease in Hispanic/Latino Breast Cancer Subjects" - 110 patients approved for acrual; 56 patients enrolled; 54 more to enroll
BAYER:
E11102 - “ A Phase III Randomized, Double-blind, Placebo-controlled Trial Comparing Capecitabine Plus Sorafenib Versus Capecitabine Plus Placebo in the Treatment of Locally Advanced or Metastatic HER2-Negative Breast Cancer” - 3 patients enrolled; 1 completion; 2 follow-up Study Closed for Accrual
AMGEN:
E13058 - "A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Long-term Safety and Efficacy of Darbapoetin Alfa Administered at 500 micro-grams Once-Every-3-Weeks in Anemic Subjects With Advanced Stage Non-small Cell Lung Cancer Receiving Multi-cycle Chemotherapy." - 5 patients approved for enrollment Study Closed  
CELLDEX:
E##### - “A Randomized Multicenter Pivotal Study of CDX-011 (CR011-vcMMAE) in Patients with Metastatic, GPNMB Over-Expressing, Triple-Negative Breast Cancer” Pending Approval to Open
PHARM-OLAM:
E##### - “A Randomized Phase 3 Study of the Efficacy and Safety of Glufosfamide Compared with Fluorouracil (5-FU) in Patients with Metastatic Pancreatic Adenocarcinoma Previously Treated with Gemcitabine Pancreatic study” Pending Approval to Open
NOVARTIS:
E##### - “A Phase II, single arm study of the use of steroid-based mouthwash to prevent stomatitis in postmenopausal women with advanced or metastatic hormone receptor positive breast cancer being treated with everolimus plus exemestane” Pending Approval to Open 
AMGEN:
E13031 - "Randomized, single-blind study to estimate the effect of patient education on reported bone pain in breast cancer patients receiving chemotherapy and pegfilgrastim." Summary: “The purpose of this study is to learn more about whether viewing an educational DVD can affect reported bone pain in  breast cancer patients who are being treated with chemotherapy and Neulasta®. Neulasta® is used to help prevent decreased white cell count and  strengthen a patient’s immune system during chemotherapy, but a side-effect of this medication is bone pain.”- 10 patients approved for enrollment; 6 patients enrolled; 12 patients screened
SWOG 1007:
E13068 - "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. RxPONDER: A Clinical Trial Rx for Positive Node, Endocrine Responsive Breast Cancer." -10 patients approved for enrollment; 3 patients enrolled on step 1; 2 patients enrolled on step 2; 1 withdrawal
SWOG 1202:
E13112 - "A Randomized Placebo-Controlled Phase III Study Of Duloxetine For Treatment of Aromatase Inhibitor (AI)-Associated   Musculoskeletal Symptoms in Women with Early Stage Breast Cancer"- 10 patients approved for enrollment; 1 patient enrolled; 5 patients screened
CTSU CALGB-80802:
E13110 -  "Phase III Randomized Study of Sorafenib Plus Doxorubicin Versus Sorafenib in Patients with Advanced Hepatocellular Carcinoma (HCC)" - 10 patients approved for enrollment; 0 patients enrolled; 0 patients screened
SPOC TISSUE BANK:
E##### - "Banking of Tissue and Establishing Continuous Cell Lines and Xenografts from Neoplasia" -5000 patients approved for enrollment; 198 enrolled patients
SWOG 1207:
E##### - “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. e3 Breast Cancer Study- evaluating everolimus with endocrine therapy.”
INCB 18424-268:
E##### - “A Randomized, Double-Blind, Phase 2 Study of Ruxolitinib or Placebo in Combination With Capecitabine in Subjects With Advanced or Metastatic HER2-Negative Breast Cancer”
SWOG 0221:
E13086 - “Phase III Trial of Continuous Schedule AC + G Vs. Q 2 Week Schedule AC, Followed by Paclitaxel Given Either Every 2 Weeks or Weekly for 12 Weeks as Post-Operative Adjuvant Therapy in Node-Positive or High-Risk Node Negative Breast Cancer."   - 3 patients approved for enrollment; 2 patients enrolled; 3 patients in follow-up
SWOG0927:
E12116 - "A Randomized Placebo-Controlled Trial of Omega-3-Fatty Acid for the Control of Aromatase Inhibitor-Induced Musculoskeletal Pain and Stiffness in Women with Early Stage Breast Cancer, Phase III" -10 patients approved for enrollment; 1 patients enrolled
 
 
 
 
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