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Table of contents
  1. 1. Clinical Trial
  2. 2. Routine Documentation
  3. 3. Registry/Cohort Study
  4. 4. Quality Assurance
  5. 5. Data Standard
  6. 6. Patient-Reported Outcome
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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 - 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

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