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

- 2020-10-13 - 1 Formulär, 24 Item-grupper, 273 Dataelement, 1 Språk
Item-grupper: Date of visit, Assessment Date, Trial Screening, Enrollment, Clinical Trial Subject Unique Identifier, Demography, Eligibility Determination, Inclusion, Exclusion Criteria, disease characteristic, disease characteristic, Neoplasm Metastasis, Electrocardiography, Echocardiography; Multiple gated acquisition scanning, Laboratory Procedures, Central Laboratory; Laboratory Procedures, Local, Laboratory Procedures, Chemistry, Clinical, Laboratory Procedures, Hematology finding, Central Laboratory, Data, Disease, Operative Surgical Procedures, Disease, Relationships, Disease, Clinical Trials, Therapeutic procedures, Relationships, Disease, Cancer treatment, Prior Therapy, Neurologic Examination, Vital signs, Prior Radiation Therapy, Prior Radiation Therapy, Central Nervous System
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

- 2020-10-13 - 1 Formulär, 9 Item-grupper, 163 Dataelement, 1 Språk
Item-grupper: 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

- 2020-10-13 - 1 Formulär, 11 Item-grupper, 157 Dataelement, 1 Språk
Item-grupper: 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

- 2020-10-13 - 1 Formulär, 10 Item-grupper, 154 Dataelement, 1 Språk
Item-grupper: 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

- 2020-10-13 - 1 Formulär, 12 Item-grupper, 168 Dataelement, 1 Språk
Item-grupper: 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

- 2020-08-13 - 1 Formulär, 3 Item-grupper, 7 Dataelement, 1 Språk
Item-grupper: 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

Ganetespib in Breast Cancer NCT01677455 - Eligibility Criteria

- 2019-06-15 - 1 Formulär, 2 Item-grupper, 18 Dataelement, 1 Språk
Item-grupper: Inclusion Criteria, Exclusion Criteria
An Open-Label Multicenter Phase 2 Window of Opportunity Study Evaluating Ganetespib in Women With Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT01677455 The purpose of this study is to determine if ganetespib (STA-9090) is effective in the treatment of patients with HER2+ or triple negative breast cancer who have not received prior systemic treatment in the metastatic setting.

Eligibility Breast Cancer NCT01196455

- 2017-02-22 - 1 Formulär, 2 Item-grupper, 17 Dataelement, 1 Språk
Item-grupper: Inclusion Criteria, Exclusion Criteria
Capecitabine and Mitomycin C in Treatment of Patients With Metastatic Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT01196455

Effects of Esomeprazole on Lapatinib in Subjects with Breast Cancer; 109275 - Unscheduled/Repeat Labs

- 2020-08-09 - 1 Formulär, 6 Item-grupper, 261 Dataelement, 1 Språk
Item-grupper: Date of visit, Laboratory Procedures, Laboratory Procedures, Chemistry, Clinical, Laboratory Procedures, Hematology finding, Laboratory Procedures, Serologic tests, Laboratory Procedures, Creatine kinase measurement, Lactate dehydrogenase measurement
Study ID: 109275 Clinical Study ID: 109275 Study Title: An Open-Label, Single Sequence Study to Examine the Effects of Esomeprazole on the Pharmacokinetics of Orally Administered Lapatinib in Subjects with Metastatic ErbB2 Positive Breast Cancer Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: Lapatinib, Esomeprazole Trade Name: lapatinib plus esomeprazole Study Indication: Neoplasms, Breast

Effects of Esomeprazole on Lapatinib in Subjects with Breast Cancer; 109275 - Liver Events

- 2020-08-05 - 1 Formulär, 11 Item-grupper, 100 Dataelement, 1 Språk
Item-grupper: Date of visit, Liver, Adverse event, Evaluation, Liver, Adverse Event, Liver, Adverse Event, Experimental drug, Liver, Adverse event, Pharmacokinetic aspects, Liver, Adverse Event, Disease, Liver, Adverse Event, Drug-related disorder, Liver, Adverse Event, Disease, Other, Liver, Adverse Event, Alcohol consumption, Liver, Adverse Event, Imaging of liver, Liver, Adverse Event, Biopsy of liver
Study ID: 109275 Clinical Study ID: 109275 Study Title: An Open-Label, Single Sequence Study to Examine the Effects of Esomeprazole on the Pharmacokinetics of Orally Administered Lapatinib in Subjects with Metastatic ErbB2 Positive Breast Cancer Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: Lapatinib, Esomeprazole Trade Name: lapatinib plus esomeprazole Study Indication: Neoplasms, Breast

Effects of Esomeprazole on Lapatinib in Subjects with Breast Cancer; 109275 - PGx

- 2020-06-25 - 1 Formulär, 3 Item-grupper, 11 Dataelement, 1 Språk
Item-grupper: Date of visit, Pharmacogenetic Test, Informed Consent, Pharmacogenetic Test, Informed Consent, Withdraw
Study ID: 109275 Clinical Study ID: 109275 Study Title: An Open-Label, Single Sequence Study to Examine the Effects of Esomeprazole on the Pharmacokinetics of Orally Administered Lapatinib in Subjects with Metastatic ErbB2 Positive Breast Cancer Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: Lapatinib, Esomeprazole Trade Name: lapatinib plus esomeprazole Study Indication: Neoplasms, Breastn

Effects of Esomeprazole on Lapatinib in Subjects with Breast Cancer; 109275 - Eve of Period 2 Visit

- 2020-06-25 - 1 Formulär, 2 Item-grupper, 5 Dataelement, 1 Språk
Item-grupper: Date of visit, Vital signs
Study ID: 109275 Clinical Study ID: 109275 Study Title: An Open-Label, Single Sequence Study to Examine the Effects of Esomeprazole on the Pharmacokinetics of Orally Administered Lapatinib in Subjects with Metastatic ErbB2 Positive Breast Cancer Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: Lapatinib, Esomeprazole Trade Name: lapatinib plus esomeprazole Study Indication: Neoplasms, Breast

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