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Eligibility DRKS00007744 NCT01026142 Breast Cancer - Eligibility

- 2021-09-27 - 1 Formulär, 2 Item-grupper, 17 Dataelement, 2 Språk
Item-grupper: Inclusion Criteria, Exclusion Criteria
ODM derived from http://clinicaltrials.gov/show/NCT01026142

Eligibility Metastatic Breast Cancer NCT01288092

- 2021-09-20 - 1 Formulär, 2 Item-grupper, 18 Dataelement, 1 Språk
Item-grupper: Inclusion Criteria, Exclusion Criteria
BEZ235 Trial in Patients With HER2-(Human Epidermal Growth Factor Receptor 2 Negative) /HR+ (Hormonal Receptor Positive) Metastatic Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT01288092

Eligibility Metastatic Breast Cancer NCT00907959

- 2021-09-20 - 1 Formulär, 2 Item-grupper, 18 Dataelement, 1 Språk
Item-grupper: Inclusion Criteria, Exclusion Criteria
A Clinical Trial Assessing Safety and Efficacy of BZL101 for Metastatic Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00907959

Eligibility Metastatic Breast Cancer NCT00214864

- 2016-07-25 - 1 Formulär, 2 Item-grupper, 12 Dataelement, 1 Språk
Item-grupper: Inclusion Criteria, Exclusion Criteria
A Study of Weekly Taxotere and Xeloda in Metastatic Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00214864

Eligibility Metastatic Breast Cancer NCT01392586

- 2016-03-13 - 1 Formulär, 2 Item-grupper, 14 Dataelement, 1 Språk
Item-grupper: Inclusion Criteria, Exclusion Criteria
Systemic Therapy With or Without Upfront Surgery in Metastatic Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT01392586

Breast Cancer Swedish National Quality Registry - Surgery

- 2018-01-18 - 1 Formulär, 5 Item-grupper, 60 Dataelement, 2 Språk
Item-grupper: National Quality Register for Breast Cancer, Surgery, Surgery, Pathology, Postoperative Assessment, Responsible Hospital / deparment for treatment and Follow-up
Description of registry: The aim of the National Quality Registry for Breast Cancer is to: -in an objective and standardised manner, monitor the continuum of care from diagnosis to any recurrence and death -enable the identification of regional differences -collectively relate to current guidelines and quality targets set by specialist associations and the National Board of Health and Welfare -facilitate research and developments in breast cancer. Surgery Source: http://www.cancercentrum.se/samverkan/cancerdiagnoser/brost/kvalitetsregister/dokument/ Facts Owner: Kerstin Sandelin surgeon, Karolinska University Hospital, Solna kerstin.sandelin@sll.se

Breast Cancer Swedish National Quality Registry - Local Recurrence post surgery / remote metastasis

- 2018-01-12 - 1 Formulär, 2 Item-grupper, 18 Dataelement, 2 Språk
Item-grupper: National Quality Register for Breast Cancer, Local Recurrence post surgery / remote metastasis, Local Recurrence post surgery / remote metastasis
Description of registry: The aim of the National Quality Registry for Breast Cancer is to: -in an objective and standardised manner, monitor the continuum of care from diagnosis to any recurrence and death -enable the identification of regional differences -collectively relate to current guidelines and quality targets set by specialist associations and the National Board of Health and Welfare -facilitate research and developments in breast cancer. Local Recurrence post surgery / remote metastasis Source: http://www.cancercentrum.se/samverkan/cancerdiagnoser/brost/kvalitetsregister/dokument/ Facts Owner: Kerstin Sandelin surgeon, Karolinska University Hospital, Solna kerstin.sandelin@sll.se

dbGaP phs001043 GWAS of Breast Events with Adjuvant Aromatase Inhibitors - pht005313.v1.p1

- 2023-08-07 - 5 Formulär, 1 Item-grupp, 2 Dataelement, 1 Språk
Item-grupp: pht005313
Principal Investigator: James N. Ingle, M.D., Mayo Clinic, Rochester, MN, USA MeSH: Neoplasm,Breast Neoplasms,Neoplasm Metastasis https://www.ncbi.nlm.nih.gov/projects/gap/cgi-bin/study.cgi?study_id=phs001043 *Source of patients*:The source of the patients for this genome-wide case-control study was MA.27, which was conducted as a multi-cooperative group effort under the auspices of the NCI Breast Cancer Intergroup of North America. The NCIC Clinical Trials Group (CTG) serves as the coordinating group, with participation by the NCI-sponsored North Central Cancer Treatment Group, Eastern Cooperative Oncology Group (ECOG), Southwest Oncology Group, and Cancer and Leukemia Group B (CALGB). MA.27 involved postmenopausal women with histologically confirmed and completely resected invasive breast cancer with surgical margins clear of invasive carcinoma in the following TMN categories (AJCC Version 6): pT1, pT2, pT3; pNx, pN0, pN1, pN2, pN3 (only when the sole basis is presence of 10 or more involved axillary nodes); MO. The primary tumor must have been estrogen receptor (ER) and/or progesterone receptor positive. Patients were stratified by lymph node status at diagnosis, prior adjuvant chemotherapy, and trastuzumab use and were randomized to 5 years of adjuvant therapy with anastrozole or exemestane. The trial was activated on May 26, 2003, and reached its accrual objectives on July 31, 2008, after the randomization of 6827 North American patients, with the majority (79%) providing DNA and consent for genetic testing. Non-North American patients were also entered by the International Breast Cancer Study Group but they did not contribute DNA. From 2003 to December 21, 2004, patients also underwent a second randomization to celecoxib 400 mg twice daily or placebo but, after the entry of 1,622 patients, this treatment was discontinued because of reports of increased cardiovascular risk associated with celecoxib. The final results of this study have been published, see Goss et al., 2013 (23358971). The patients in this analysis came from three cohorts: Cohort 1 consisted of 870 patients genotyped on the Illumina Human610-Quad BeadChip studied in a GWAS with the phenotype of musculoskeletal adverse event, see Ingle et al., 2010 (20876420), Cohort 2 consisted of 882 patients genotyped on the Illumina OmniExpress platform studied in a GWAS with the phenotype of fragility fractures, see Liu et al., 2014 (25148458), and the remaining 2913 patients were genotyped with the Illumina OmniExpressExome platform.

pht005314.v1.p1

1 Item-grupp 3 Dataelement

pht005315.v1.p1

1 Item-grupp 28 Dataelement

pht005316.v1.p1

1 Item-grupp 6 Dataelement

Eligibility

1 Item-grupp 3 Dataelement

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

- 2021-04-26 - 1 Formulär, 9 Item-grupper, 117 Dataelement, 1 Språk
Item-grupper: 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

- 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

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