Search results - Portal of Medical Data Models (MDM-Portal)

On-Study - Metastatic Brain Cancer - On-Study Form - 2287553v3.0 - Metastatic Brain Cancer - On-Study Form

- 1/9/15 - 1 form, 10 itemgroups, 64 items, 1 language

Itemgroups: CRF Header, Brain: Form Administration, Non-CNS: Initial Disease Description, Brain: Current Disease Description, Brain: Concomitant Medications, Metastatic Brain: Prior Health History, Metastatic Brain: Prior Treatment, Brain: Prior Treatment - Systemic Regimens, Brain: Prior Treatment - CNS RT, Brain: Prior Treatment - CNS Surgery

Metastatic Brain Cancer - On-Study Form Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=EF3A8ACE-5457-4C56-E034-0003BA3F9857

Cognitive/Functional Effects NCT01372774 Eligibility - N107C Pre-Registration (Step 1) Form and Eligibility Checklist - 3226376v1.0 - N107C Pre-Registration (Step 1) Form and Eligibility Checklist

- 9/20/21 - 1 form, 4 itemgroups, 45 items, 1 language

Itemgroups: Pre-Registration Inclusion Criteria - All responses in this section below must be "Yes.", Pre-Registration Exclusion Criteria, Registration Check, Randomization Check (continued) - All responses in section below may be "Yes" or "No."

N107C Pre-Registration (Step 1) Form and Eligibility Checklist Stereotactic Radiosurgery or Whole-Brain Radiation Therapy in Treating Patients With Brain Metastases That Have Been Removed By Surgery Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=A06D80B4-4143-B9BC-E040-BB89AD437EB8

Cognitive/Functional Effects NCT01279681 Eligibility - N0949 Registration Form and Eligibility Checklist - 3143440v1.0 - N0949 Registration Form and Eligibility Checklist

- 9/20/21 - 1 form, 5 itemgroups, 80 items, 1 language

Itemgroups: Inclusion Criteria - All responses in this section below must be "Yes.", Exclusion Criteria - All responses in section below must be "No.", Randomization Check, Randomized Check (continued) - All responses in section below may be "Yes" or "No"., Stratification Factors (used fo randomization to Arms A-B)

N0949 Registration Form and Eligibility Checklist Combination Chemotherapy Plus Bevacizumab With or Without Oxaliplatin in Treating Older Patients With Metastatic Colorectal Cancer Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=9156A820-0337-BDA0-E040-BB89AD435144

Lapatinib + Topotecan or + Capecitabine in Recurrent Brain Metastases from Breast Cancer; NCT00437073 - Log

- 4/26/21 - 1 form, 9 itemgroups, 117 items, 1 language

Itemgroups: Date of visit, Assessment Date, Event Log, Status, Non-serious Adverse Event, Serious Adverse Event, Concomitant Agent, Concomitant Agent, Adrenal Cortex Hormones, Blood product; Supportive care, Collection of blood specimen for laboratory procedure, Pharmacogenetic Test, Informed Consent, Pharmacogenetic Test, Informed Consent, Withdraw (activity)

Study ID: 107671 Clinical Study ID: 107671 Study Title: EGF107671 – A Phase II Study of Lapatinib plus Topotecan or Lapatinib plus Capecitabine in the Treatment of Recurrent Brain Metastases from ErbB2-Positive Breast Cancer Following Cranial Radiotherapy Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00437073 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: N/A Trade Name: capecitabine, topotecan, lapatinib Study Indication: Neoplasms, Breast; Recurrent Brain Metastases

Lapatinib + Topotecan or + Capecitabine in Recurrent Brain Metastases from Breast Cancer; NCT00437073 - Cycle 1 - Day 15

- 10/13/20 - 1 form, 11 itemgroups, 157 items, 1 language

Itemgroups: Date of visit, Assessment Date, Laboratory Procedures, Central Laboratory; Laboratory Procedures, Local, Laboratory Procedures, Chemistry, Clinical, Laboratory Procedures, Hematology finding, Central Laboratory, Data, Disease, Operative Surgical Procedures, Vital signs, Experimental drug, Topotecan, Dosage, Therapeutic procedure, Confirmation, Lapatinib, Compliance behavior, Continuation status, Study

Study ID: 107671 Clinical Study ID: 107671 Study Title: EGF107671 – A Phase II Study of Lapatinib plus Topotecan or Lapatinib plus Capecitabine in the Treatment of Recurrent Brain Metastases from ErbB2-Positive Breast Cancer Following Cranial Radiotherapy Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00437073 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: N/A Trade Name: capecitabine, topotecan, lapatinib Study Indication: Neoplasms, Breast; Recurrent Brain Metastases

Lapatinib + Topotecan or + Capecitabine in Recurrent Brain Metastases from Breast Cancer; NCT00437073 - Cycle 1 - Day 8

- 10/13/20 - 1 form, 10 itemgroups, 154 items, 1 language

Itemgroups: Date of visit, Assessment Date, Laboratory Procedures, Central Laboratory; Laboratory Procedures, Local, Laboratory Procedures, Chemistry, Clinical, Laboratory Procedures, Hematology finding, Central Laboratory, Data, Vital signs, Experimental drug, Topotecan, Dosage, Therapeutic procedure, Confirmation, Lapatinib, Compliance behavior, Continuation status, Study

Study ID: 107671 Clinical Study ID: 107671 Study Title: EGF107671 – A Phase II Study of Lapatinib plus Topotecan or Lapatinib plus Capecitabine in the Treatment of Recurrent Brain Metastases from ErbB2-Positive Breast Cancer Following Cranial Radiotherapy Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00437073 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: N/A Trade Name: capecitabine, topotecan, lapatinib Study Indication: Neoplasms, Breast; Recurrent Brain Metastases

Lapatinib + Topotecan or + Capecitabine in Recurrent Brain Metastases from Breast Cancer; NCT00437073 - Cycle 1 - Day 1

- 10/13/20 - 1 form, 12 itemgroups, 168 items, 1 language

Itemgroups: Date of visit, Assessment Date, Visit, Previous, Laboratory Procedures, Central Laboratory; Laboratory Procedures, Local, Laboratory Procedures, Chemistry, Clinical, Laboratory Procedures, Hematology finding, Central Laboratory, Data, Vital signs, Experimental drug, Lapatinib, Experimental drug, Topotecan, Dosage, Therapeutic procedure, Confirmation, Lapatinib, Compliance behavior, Continuation status, Study

Study ID: 107671 Clinical Study ID: 107671 Study Title: EGF107671 – A Phase II Study of Lapatinib plus Topotecan or Lapatinib plus Capecitabine in the Treatment of Recurrent Brain Metastases from ErbB2-Positive Breast Cancer Following Cranial Radiotherapy Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00437073 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: N/A Trade Name: capecitabine, topotecan, lapatinib Study Indication: Neoplasms, Breast; Recurrent Brain Metastases

Lapatinib + Topotecan or + Capecitabine in Recurrent Brain Metastases from Breast Cancer; NCT00437073 - Local Laboratories

- 8/13/20 - 1 form, 3 itemgroups, 7 items, 1 language

Itemgroups: Date of visit, Assessment Date, Laboratory, Local, Laboratory, Local

Study ID: 107671 Clinical Study ID: 107671 Study Title: EGF107671 – A Phase II Study of Lapatinib plus Topotecan or Lapatinib plus Capecitabine in the Treatment of Recurrent Brain Metastases from ErbB2-Positive Breast Cancer Following Cranial Radiotherapy Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00437073 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: N/A Trade Name: capecitabine, topotecan, lapatinib Study Indication: Neoplasms, Breast; Recurrent Brain Metastases

dbGaP phs001063 Genomic Characterization of PDX Models for Breast Cancer Brain Metastases - pht005289.v1.p1

- 6/23/23 - 5 forms, 1 itemgroup, 2 items, 1 language

Itemgroup: pht005289

Principal Investigator: Jean J. Zhao, PhD, Dana-Farber Cancer Institute, Harvard Medical School, Boston, MA, USA MeSH: Breast Neoplasms,Neoplasm Metastasis,Brain Neoplasms,Neoplasm Transplantation,Molecular Targeted Therapy https://www.ncbi.nlm.nih.gov/projects/gap/cgi-bin/study.cgi?study_id=phs001063 We have developed orthotopic patient-derived xenograft models of HER2 positive breast cancer metastasized into the brain of patients to test novel therapeutic strategies. In this study, we identified a novel combinatorial therapeutic strategy that has resulted in a durable remission and markedly increased overall survival in majority of patient-derived xenograft (PDX) models tested. We performed whole exome sequencing analysis of these PDX tumors and their matched blood and patient samples to investigate drug sensitive and resistance mechanisms. Our sequencing data revealed an interesting association of genotyping and phenotyping with tumors responses to drug treatment.

pht005290.v1.p1

1 itemgroup 3 items

pht005291.v1.p1

1 itemgroup 3 items

pht005292.v1.p1

1 itemgroup 12 items

Eligibility

1 itemgroup 1 item

Lapatinib + Topotecan or + Capecitabine in Recurrent Brain Metastases from Breast Cancer; NCT00437073 - Survival Follow-Up

- 10/13/20 - 1 form, 2 itemgroups, 5 items, 1 language

Itemgroups: Date of visit, Assessment Date, follow-up, Continuance of life

Study ID: 107671 Clinical Study ID: 107671 Study Title: EGF107671 – A Phase II Study of Lapatinib plus Topotecan or Lapatinib plus Capecitabine in the Treatment of Recurrent Brain Metastases from ErbB2-Positive Breast Cancer Following Cranial Radiotherapy Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00437073 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: N/A Trade Name: capecitabine, topotecan, lapatinib Study Indication: Neoplasms, Breast; Recurrent Brain Metastases

Lapatinib + Topotecan or + Capecitabine in Recurrent Brain Metastases from Breast Cancer; NCT00437073 - Cycle 1 - Week 4

- 10/13/20 - 1 form, 9 itemgroups, 163 items, 1 language

Itemgroups: Date of visit, Assessment Date, Neurologic Examination, Neurologic Symptoms, Associated with, Neoplasms, Laboratory Procedures, Central Laboratory; Laboratory Procedures, Local, Laboratory Procedures, Chemistry, Clinical, Laboratory Procedures, Hematology finding, Central Laboratory, Data, Vital signs, Continuation status, Study

Study ID: 107671 Clinical Study ID: 107671 Study Title: EGF107671 – A Phase II Study of Lapatinib plus Topotecan or Lapatinib plus Capecitabine in the Treatment of Recurrent Brain Metastases from ErbB2-Positive Breast Cancer Following Cranial Radiotherapy Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00437073 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: N/A Trade Name: capecitabine, topotecan, lapatinib Study Indication: Neoplasms, Breast; Recurrent Brain Metastases

Lapatinib + Topotecan or + Capecitabine in Recurrent Brain Metastases from Breast Cancer; NCT00437073 - Conclusion

- 10/13/20 - 1 form, 4 itemgroups, 9 items, 1 language

Itemgroups: Date of visit, Assessment Date, Cessation of life, Pregnancy, Information, Conclusion, Clinical Research

Study ID: 107671 Clinical Study ID: 107671 Study Title: EGF107671 – A Phase II Study of Lapatinib plus Topotecan or Lapatinib plus Capecitabine in the Treatment of Recurrent Brain Metastases from ErbB2-Positive Breast Cancer Following Cranial Radiotherapy Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00437073 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: N/A Trade Name: capecitabine, topotecan, lapatinib Study Indication: Neoplasms, Breast; Recurrent Brain Metastases

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