Receiving Adjuvant Trastuzumab. A randomized double-blind, placebocontrolled

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1 DST Study Protocol acronym Study Title Site Status Detail Determining the Cardiac Biomarker Profile in Breast Cancer Patients Cardiac Biomarker Receiving Adjuvant Trastuzumab Breast (Cabot) CABOT Therapy Feasibility Study of the Role of Stereotactic Body Radiotherapy for the Treatment of Early Stage Breast Breast CK Breast Study ARTEMIS Breast CLEE011A2301 (MONALEESA-2) MONALEESA-2 Clinicaltrials.gov number Cancer A randomized double-blind, placebocontrolled study of LEE011 in combination with letrozole for the treatment of postmenopausal women with hormone receptor positive, HER2- negative, advanced breast cancer who received no prior therapy for advanced disease NCT Breast IND.213 Breast LEGACY Breast MAC.15 (S1007) Breast MELO-D MELO-D Breast OCOG-2011-PETRA PETRA A Study of Reolysin For Patients With Advanced/Metastatic Breast Cancer NCT Establishment of a cohort of girls in breast cancer families The Ontario LEGACY Pilot Tamoxifen Citrate, Letrozole, Anastrozole, or Exemestane With or Without Chemotherapy in Treating Patients With Invasive RxPONDER Breast Cancer NCT Anti-Proliferation Effects of Vitamin D and Melatonin in Breast Cancer NCT Imaging With 111 Indium (111In)- Pertuzumab (PmAb) to Predict Response to Trastuzumab (TmAb) in Human Epidermal Growth Factor-2 (HER2) Positive Metastatic Breast Cancer (MBC) (PETRA) NCT

2 Breast OCOG-2012-LUMINA LUMINA Breast ONCOTYPE DX (BIANCO) Breast RTOG 1119 A Prospective Cohort Study Evaluating Risk of Local Recurrence Following Breast Conserving Surgery and Endocrine Therapy in Low Risk Luminal A Breast Cancer (LUMINA) NCT A Prospective Cohort Study to Evaluate the Oncotype DX Test in Early Stage Breast Cancer (sub study) Whole-Brain Radiation Therapy With or Without Lapatinib Ditosylate in Treating Patients With Brain Metastasis From HER2-Positive Breast Cancer NCT GI BO25114 JACOB GI CO.21 CHALLENGE A Double-Blind, Placebo-Controlled, Randomized, Multicenter Phase III Study Evaluating The Efficacy And Safety Of Pertuzumab In Combination With Trastuzumab And Chemotherapy In Patients With Her2-Positive Advanced Gastric Cancer NCT A Phase III Study of the Impact of a Physical Activity Program on Disease- Free Survival in Patients With High Risk Stage II or Stage III Colon Cancer: A Randomized Controlled Trial (CHALLENGE) NCT GI GI CRC.6 NEC.3 A Phase III Trial of 6 Versus 12 Treatments of Adjuvant FOLFOX Plus Celecoxib or Placebo for Patients With Resected Stage III Colon Cancer NCT Prospective Randomized Phase II Trial of Pazopanib (NSC # , IND 75648) Versus Placebo in Patients With Progressive Carcinoid Tumors NCT

3 GI PA.6 (PRODIGE) ACCORD GI RTOG 1112 AGS15E-13-1 Multicentric Randomized Phase III Trial Comparing Adjuvant Chemotherapy With Gemcitabine Versus 5-fluorouracil, Leucovorin, Irinotecan and Oxaliplatin (mfolfirinox) in Patients With Resected Pancreatic Adenocarcinoma NCT Sorafenib Tosylate With or Without Stereotactic Body Radiation Therapy in Treating Patients With Liver Cancer NCT A Phase 1 Study of the Safety and Pharmacokinetics of Escalating Doses of AGS15E Given as Monotherapy in Subjects with Metastatic Urothelial Cancer NCT BL.12 Trial Comparing Nab-Paclitaxel to Paclitaxel in Patients With Advance Urothelial Cancer Progressing on or After Platinum Containing Regimen. NCT IMRT_ISD_JARES Randomized Study of Quality of Life in Patients with High-Risk Prostate Cancer Undergoing Radiotherapy: Role of Pelvic Nodal IMRT IND.209 Reolysin Combined With Docetaxel and Prednisone or Docetaxel and Prednisone Alone in Metastatic Castration Resistant Prostate Cancer NCT

4 NCRN BAYER Radium223 in subjects with bone predominant metastatic CRPC OZM-042 OZM-053 PREVAIL Open Label Extension (OLE) A phase III randomized, double-blind, placebo-controlled trial of radium-223 dichloride in combination with abiraterone acetate and prednisone/prednisolone in the treatment of asymptomatic or mildly symptomatic chemotherapy-naïve subjects with bone predominant metastatic castration-resistant prostate cancer (CRPC) A Phase II, Multi-Centre, Study of the Efficacy and Safety of Sunitinib Given on an Individualized Schedule as First- Line Therapy for Metastatic Renal Cell Cancer. NCT A Phase II, Multi-Centre Study, of Stereotactic Radiotherapy for Oligo- Progression in Renal Cell Cancer Patients Receiving 1st Line Sunitinib Therapy NCT A Safety and Efficacy Study of Oral MDV3100 in Chemotherapy-Naive Patients With Progressive Metastatic Prostate Cancer (PREVAIL) - Open Label Extention (OLE) NCT RTOG 0534:Phase III PELVIC RTOG 0815 Prostate Radiation Therapy or Short- Term Androgen Deprivation Therapy and Pelvic Lymph Node Radiation Therapy With or Without Prostate Radiation Therapy in Treating Patients With a Rising PSA After Surgery for Prostate Cancer NCT Radiation Therapy With or Without Androgen-Deprivation Therapy in Treating Patients With Prostate Cancer NCT

5 GYNE SPARTAN (Selective Prostate AR Targeting with ARN-509) ARRAY :The MILO Study (MEK Inhibitor in Low-grade Serous Ovarian Cancer) SPARTAN MILO SPARTAN - A Multicenter, Randomized, Double-Blind, Placebo- Controlled, Phase III Study of ARN- 509 in Men with Non-Metastatic (M0) Castration-Resistant Prostate Cancer A Multinational, Randomized, Openlabel Phase 3 Study of MEK162 vs. Physician s Choice Chemotherapy in Patients with Recurrent or Persistent Low-grade Serous Carcinomas of the Ovary, Fallopian Tube or Primary Peritoneum NCT GYNE Brachytherapy-Rectal Retraction GYNE CO (ARIEL3) ARIEL 3 GYNE GYNE PHL-085:recurrent /metastatic HPV related PHL-086 PHL085 Dosimetric Comparison of Rectal Retraction Methods in Brachytherapy for Cervical Carcinoma A Multicenter, Randomized, Double- Blind, Placebo-Controlled Phase 3 Study of Rucaparib as witch Maintenance Therapy Following Platinum-Based Chemotherapy in Patients with Platinum-Sensitive, Relapsed High-Grade Serous Ovarian Cancer(ARIEL3) NCT A Phase 2 Study of Ipilimumab in women with metastatic or recurrent HPV-related cervical carcinoma of either squamous cell or adenocarcinoma histologies NCT A Study of XL184 (Cabozantinib) in Endometrial Cancer NCT GYNE PR C (NOVA) A Phase 3 Randomized Double-Blind Trial of Maintenance with Niraparib Versus Placebo in Patients with Platinum Sensitive Ovarian Cancer NCT

6 GYNE RTOG 1174 (OUTBACK) OUTBACK GYNE RTOG 1203 A Phase III Trial of Adjuvant Chemotherapy Following Chemoradiation as Primary Treatment for Locally Advanced Cervical Cancer Compared to Chemoradiation Alone: The OUTBACK Trial NCT Standard Versus Intensity-Modulated Pelvic Radiation Therapy in Treating Patients With Endometrial or Cervical Cancer NCT Head&Neck Head&Neck Head&Neck CBKM120H2201:Study of Efficacy and Safety of Buparlisib (BKM120) MU ALTENS for Dysphagia: A Pilot Study of ALTENS in Improving Dysphagia Induced by IMRT for Head and Neck Cancers PHL-088:Cisplatin With or Without MK-1775 in Squamous Cell Cancer of the Head and Neck PHL 088 Double Blind, Placebo Controlled Study Assessing the Efficacy of Buparlisib (BKM120) Plus Paclitaxel Versus Placebo Plus Paclitaxel in Patients With Platinum Pre-treated Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (HNSCC) NCT Effectiveness of Acupuncture-like Transcutaneous Nerve Stimulation (ALTENS) in Improving Dysphagla and Associated Symptoms of Current Chemotherapy and IMRT for Head and Neck Cancers: A Pilot Study NCT A Randomized Phase II Trial of Cisplatin with or without Wee1 kinase inhibitor MK-1775 for First-line Treatment of Recurrent or Metastatic Squamous Cell Cancer of the Head and Neck (RM-SCCHN) NCT Head&Neck VOICE Voice Quality Assessment Following External Beam Radiotherapy for T1 Laryngeal Cancer

7 Hematology B A Study To Evaluate PF With Chemotherapy In Patients With Acute Myeloid Leukemia or Myelodysplastic Syndrome NCT Hematology C16014(Millenium ) Hematology CICL670A2421:Combinati on Study of Deferasirox and Erythropoietin in Patients With Low- and Int- 1-risk Myelodysplastic Syndrome. KALLISTO A Phase 3, Randomized, Double- Blind, Multicenter Study Comparing Oral MLN9708 Plus Lenalidomide and Dexamethasone Versus Placebo Plus Lenalidomide and Dexamethasone in Adult Patients With Newly Diagnosed Multiple Myeloma NCT An open-label, phase II, randomized, pilot study to assess the effect in term of erythroid improvement of deferasirox combined with erythropoietin compared to erythropoietin alone in patients with low- and int-1-risk myelodysplastic syndrome. NCT Hematology Hematology Hematology A Phase 3, Randomized Study To Evaluate the Efficacy of Momelotinib Versus Best Available Therapy in Anemic or Thrombocytopenic Subjects with Primary Myelofibrosis, Postpolycythemia Vera Myelofibrosis, or Post-essential Thrombocythemia Myelofibrosis who were Treated with Ruxolitinib NCT GS-US MEDICATE - Cardiac Troponin Study MEDICATE - Cardiac Troponin Study NCRN GDC-0199 in CLL (GO28667) - MURANO A multicentre, phase III, open label randomised study in relapsed/refractory patients with chronic lymphocytic leukaemia to evaluate the benefit of GDC-0199 (ABT-199) plus rituximab compared with bendamustine plus rituximab NCT

8 Hematology Hematology NCRN525 (AZACITIDINE + BSC v PLACEBO + BSC) NCRN529 SHINE: Ibrutinib + BR in newly diagnosed mantle cell AZA-MDS-003 A phase 3, multicentre, randomized, double-blind study to compare with efficacy and safety of oral azacitidine plus best supportive care versus placebo plus best supportive care in subjects with red blood cell transfusiondependent anemia and thrombocytopenia due to IPSS lowerrisk myelodysplatic syndromes NCT lymphoma SHINE NCT A Phase III Prospective Double Blind Placebo Controlled Randomized Study of Adjuvant MEDI4736 In Completely Resected Non-Small Cell BR.31 Cancer. NCT C14018 A Randomized, Double-blind, Placebocontrolled, Phase 2 Clinical Trial of Alisertib (MLN8237) in Combination With Paclitaxel Versus Placebo in Combination With Paclitaxel as Second Line Therapy for Small Cell Cancer (SCLC) NCT IND.211 IND.215:Study of Selumetinib in Patients With Previously Treated or Untreated Advanced/Metastatic NSCLC IND.215 A Randomized Phase II Study Of Reolysin In Patients With Previously Treated Advanced Or Metastatic, Non Small Cell Cancer Receiving Standard Salvage Therapy NCT A Phase Ib Study of Selumetinib in Patients With Previously Treated or Untreated Advanced/Metastatic NSCLC Who Are Receiving Standard Chemotherapy Regimens. NCT

9 NCRN VESTA: Veliparib, carboplatin & paclitaxel in NSCLC M OCOG-2011-BRACHY Brachy OCOG-2013-LUSTRE OCOG-2014-ALMERA ALMERA NSCLC M11089 A Phase 3 Veliparib plus Chemotherapy Study in Adv/Met squamous NSCLC A Trial to Evaluate the Improvement in Cancer Patients Receiving Radiation With or Without Brachytherapy (BRACHY) NCT A Randomized Trial of Medically- Inoperable Stage I Non-Small Cell Cancer Patients Comparing Stereotactic Body Radiotherapy Versus Conventional Radiotherapy (LUSTRE) NCT A Phase II Study to Investigate a Combination of Metformin with Chemo- Radiotherapy in Patients with Locally Advanced Non-Small Cell Cancer Advanced Cancer TIDAL Study of a Tiotropium Inhaler For Shortness of Breath in Advanced Non- Small Cell Cancer (TIDAL) NCT Melanoma BRF COMBI-MB Melanoma Neuro Neuro OZM-049/TH-CR-413 CEC.1 (RTOG 0834; EORTC ) CEC.3/N107C BRF117277: A Phase II, Open-Label, Multicentre Study of Dabrafenib plus Trametinib in Subjects with BRAF Mutation-Positive Melanoma that has Metastasized to the Brain NCT A Phase 2 Biomarker-Enriched Study of TH-302 in Subjects with Advanced Melanoma NCT Radiation Therapy With or Without Temozolomide in Treating Patients With Anaplastic Glioma. NCT A Phase III Trial of Post-Surgical Stereotactic Radiosurgery (SRS) Compared with Whole Brain Radiotherapy (WBRT) for Resected Metastatic Brain Disease NCT

10 Neuro EF-14:Effect of NovoTTF- 100A Together With Temozolomide in Newly Diagnosed Glioblastoma Multiforme (GBM) EF-14 Neuro SABR-COMET SABR-COMET Other PHL-072 PHL072 A Prospective, Multi-center Trial of NovoTTF-100A Together With Temozolomide Compared to Temozolomide Alone in Patients with Newly Diagnosed GBM NCT Stereotactic Ablative Radiotherapy for Comprehensive Treatment of Oligometastatic Tumors (SABR- COMET): A Randomized Phase II Trial NCT A Phase II Trial of Temsirolimus and Bevacizumab in Patients With Endometrial, Ovarian, Hepatocellular Carcinoma, Carcinoid and Islet Cell Cancer NCT Other Other PROUD Study (PAL- ABST-401) RTOG 0631:Phase II/III Radiosurg for spine METs PROUD/Abstral Program Abstral Drug Utilization Study - Observational Study Evaluating "Real World" Utilization of Abstral in Canada Image-Guided Radiosurgery or Stereotactic Body Radiation Therapy in Treating Patients With Localized Spine Metastasis NCT Phase I BAY /16653 A Phase I, multi-center, nonrandomized, open label, parallel-group study evaluating the pharmacokinetics and safety of regorafenib (BAY ) in cancer subjects with severe renal impairment compared to a control group NCT Phase I BAY / An open-label, non-randomized, Phase I study to evaluate the effect of itraconazole on the pharmacokinetics of a single intravenous dose of copanlisib in patients with advanced solid tumors

11 Phase I BI An open label phase I dose finding study of BI administered orally in a continuous dosing schedule in patients with various advanced or metastatic non-hematologic malignancies NCT Phase I Phase I Sarcoma Sarcoma CPD-1028 IND.214 AB04030 AB11002 A Phase 1a, multi-centre, open-label, non-randomized study to assess the safety, biodistribution and tumour uptake of [I-124]-CPD-1028 Injection NCT A Phase I/II Study of MG1 Maraba/MAGE-A3 (MG1MA3), With and Without Adenovirus Vaccine, With Transgenic MAGE-A3 Insertion (AdMA3) in Patients With Incurable Advanced/Metastatic MAGE-A3- Expressing Solid Tumours NCT A prospective, multicenter, randomized, open-label, activecontrolled, 2-parallel group, phase III study to compare efficacy and safety of masitinib at 7.5 mg/kg/day to imatinib at 400 or 600 mg in treatment of patients with gastro-intestinal stromal tumour in first line medical treatment NCT A Phase 3 Study to Evaluate Efficacy and Safety of Masitinib in Comparison to Sunitinib in Patients With Gastrointestinal Stromal Tumour After Progression With Imatinib NCT

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