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PRIOR TREATMENT FOR METASTATIC BREAST CANCER Roche H0650g Breast Cancer - PRIOR TREATMENT FOR METASTATIC BREAST CANCER

- 15.03.21 - 1 Formular, 2 Itemgruppen, 10 Datenelemente, 1 Sprache
Itemgruppen: RADIOTHERAPY, HORMONAL THERAPY, METASTASE
Study part: Prior treatment for metastatic breast cancer. A phase III multinational, randomized, single-blind study of recombinant humanized anti-p185HER2 monoclonal antibody (rhuMAb HER2) in patients with HER2/neu overexpression who have not received prior cytotoxic chemotherapy for metastatic breast cancer. "Terms of use: You may not use this document or the information contained herein to a regulatory authority in connection with an application for a marketing authorization or any other regulatory submission without the express written consent of Roche"

PRIOR TREATMENT FOR BREAST CANCER (ADJUVANT SETTING) Roche H0650g Breast Cancer - PRIOR TREATMENT FOR BREAST CANCER (ADJUVANT SETTING)

- 15.03.21 - 1 Formular, 3 Itemgruppen, 18 Datenelemente, 1 Sprache
Itemgruppen: Chemotherapy, Therapeutic regimen, ADJUVANT THERAPY
Study part: Prior treatment for breast cancer (Adjuvant setting). A phase III multinational, randomized, single-blind study of recombinant humanized anti-p185HER2 monoclonal antibody (rhuMAb HER2) in patients with HER2/neu overexpression who have not received prior cytotoxic chemotherapy for metastatic breast cancer. "Terms of use: You may not use this document or the information contained herein to a regulatory authority in connection with an application for a marketing authorization or any other regulatory submission without the express written consent of Roche"

CONCOMITANT MEDICATIONS Roche H0650g Breast Cancer - CONCOMITANT MEDICATIONS

- 15.03.21 - 1 Formular, 1 Itemgruppe, 11 Datenelemente, 1 Sprache
Itemgruppe: CONCOMITANT MEDICATIONS
Study part: Concomitant medications. A phase III multinational, randomized, single-blind study of recombinant humanized anti-p185HER2 monoclonal antibody (rhuMAb HER2) in patients with HER2/neu overexpression who have not received prior cytotoxic chemotherapy for metastatic breast cancer. "Terms of use: You may not use this document or the information contained herein to a regulatory authority in connection with an application for a marketing authorization or any other regulatory submission without the express written consent of Roche"

Lung cancer (clinical) DSS Metadata Online Registry (METeOR)

- 07.09.16 - 1 Formular, 6 Itemgruppen, 47 Datenelemente, 1 Sprache
Itemgruppen: Cancer treatment, Health service event, Patient, Person (address), Person with cancer, Person
Health sector data set specifications from METeOR, Australia's repository for national metadata standards, developed by the Australian Institute of Health and Welfare (http://meteor.aihw.gov.au/content/index.phtml/itemId/345165) Lung cancer (clinical) DSS: The purpose of the Lung cancer (clinical) data set specification (LCCDSS) is to define data standards for the national collection of lung cancer clinical data so that data collected is consistent and reliable. Collection of this data set specification is not mandated but it is recommended as best practice if clinical cancer data are to be collected. It will facilitate more consistent data collection while enabling individual treatment centres or health service areas to develop data extraction and collection processes and policies that are appropriate for their service settings. The Lung cancer (clinical) data set specification is used in conjunction with the Cancer (clinical) data set specification (CCDSS). Mandatory reporting regulations have enabled population-based cancer registries in Australia to collect standard information on all incident cases of cancer apart from non-melanoma skin cancers, from which incidence, mortality and overall survival have been determined and trends monitored. The CCDSS provides a framework for the collection of more detailed and comprehensive clinical data such as stage of cancer at diagnosis, other prognostic characteristics, cancer treatment and patient outcomes. The Lung cancer (clinical) data set specification will support prospective data collection from the time a person with cancer symptoms is referred or first presents to a hospital or specialist through the entire duration of their illness. The definitions used in this data set specification are designed to capture the provision of cancer care on a day-to-day level. They relate to the cancer care pathway and the need to optimise care by correctly diagnosing, evaluating and managing patients with cancer. In addition, end-points and patterns of care can be monitored to understand both the appropriateness and effectiveness of cancer care. The data elements specified provide a framework for: • promoting the delivery of evidence-based care to patients with cancer • facilitating the ongoing improvement in the quality and safety of cancer management in treatment settings • improving the epidemiological and public health understanding of cancer • informing treatment guidelines and professional education • guiding resource planning and the evaluation of cancer control activities They will facilitate the aggregation of data across different treatment centres. The underlying long-term goal is to provide data support to improve outcomes for patients by increasing the quality and length of life. For example, a comparison of the actual management of patients with best practice guidelines may identify shortfalls in treatment and limitations in access to treatment modalities for some patients. Metadata and Classifications Unit Australian Institute of Health and Welfare GPO Box 570 Canberra ACT 2601

PREVIOUS/ CONCOMITANT MEDICATIONS Roche H0650g Breast Cancer - PREVIOUS/ CONCOMITANT MEDICATIONS

- 15.03.21 - 1 Formular, 1 Itemgruppe, 10 Datenelemente, 1 Sprache
Itemgruppe: CONCOMITANT MEDICATIONS
Study part: Previous/ Concomitant medications. A phase III multinational, randomized, single-blind study of recombinant humanized anti-p185HER2 monoclonal antibody (rhuMAb HER2) in patients with HER2/neu overexpression who have not received prior cytotoxic chemotherapy for metastatic breast cancer. "Terms of use: You may not use this document or the information contained herein to a regulatory authority in connection with an application for a marketing authorization or any other regulatory submission without the express written consent of Roche"

Eligibility Non-Small Cell Lung Cancer NCT02013206

- 04.06.17 - 1 Formular, 2 Itemgruppen, 9 Datenelemente, 1 Sprache
Itemgruppen: Inclusion Criteria, Exclusion Criteria
A Study of Tarceva (Erlotinib) in Patients With Advanced Non-Small Cell Lung Cancer Naive to Chemotherapy; ODM derived from: https://clinicaltrials.gov/show/NCT02013206

Eligibility Non-Small Cell Lung Cancer NCT00678964

- 04.06.17 - 1 Formular, 2 Itemgruppen, 21 Datenelemente, 1 Sprache
Itemgruppen: Inclusion Criteria, Exclusion Criteria
Erlotinib Versus Carboplatin/Vinorelbine in Elderly Patients With Advanced Non-Small Cell Lung Cancer (NSCLC); ODM derived from: https://clinicaltrials.gov/show/NCT00678964

Eligibility Non-small Cell Lung Cancer NCT00533429

- 04.06.17 - 1 Formular, 2 Itemgruppen, 10 Datenelemente, 1 Sprache
Itemgruppen: Inclusion Criteria, Exclusion Criteria
Study of Pemetrexed + Carboplatin + Bevacizumab + Enzastaurin Versus Pemetrexed + Carboplatin + Bevacizumab + Placebo in Patients With Non-Small Cell Lung Cancer Who Have Not Been Previously Treated With Chemotherapy; ODM derived from: https://clinicaltrials.gov/show/NCT00533429

Eligibility Non Small Cell Lung Cancer NCT00614965

- 02.06.17 - 1 Formular, 2 Itemgruppen, 11 Datenelemente, 1 Sprache
Itemgruppen: Inclusion Criteria, Exclusion Criteria
Irinotecan Plus Cisplatin vs Pemetrexed Plus Cisplatin as 2nd Line in NSCLC Stage IIIB/IV; ODM derived from: https://clinicaltrials.gov/show/NCT00614965

60 DAYS POST-TREATMENT CONCOMITANT MEDICATIONS Roche H0650g Breast Cancer - 60 DAYS POST-TREATMENT CONCOMITANT MEDICATIONS

- 15.03.21 - 1 Formular, 1 Itemgruppe, 11 Datenelemente, 1 Sprache
Itemgruppe: CONCOMITANT MEDICATIONS
Study part: 60 Days Post- Treatment Concomitant medications. A phase III multinational, randomized, single-blind study of recombinant humanized anti-p185HER2 monoclonal antibody (rhuMAb HER2) in patients with HER2/neu overexpression who have not received prior cytotoxic chemotherapy for metastatic breast cancer. "Terms of use: You may not use this document or the information contained herein to a regulatory authority in connection with an application for a marketing authorization or any other regulatory submission without the express written consent of Roche"

Effects of Low-fat and high-fat meals on the Pharmacokinetics of Lapatinib in ErB2+ Breast Cancer patients, NCT00821054 - Prior Anti-Cancer procedures

- 26.03.20 - 1 Formular, 4 Itemgruppen, 28 Datenelemente, 1 Sprache
Itemgruppen: Administrative Data, Prior Anti-Cancer Therapy: Chemotherapy, Hormonal, Immunotherapy, Biological Therapy, Prior Anti-Cancer Therapy: Radiotherapy, Prior anti-cancer medical/surgical procedures
Study ID: 111582 Clinical Study ID: 111582 Study Title: An Open Label Study to Examine the Effects of Low-fat and High-fat Meals on the Pharmacokinetics of Orally Administered Lapatinib in Metastatic ErbB2 Positive Breast Cancer Patients. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00821054 https://clinicaltrials.gov/ct2/show/NCT00821054 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: Lapatinib Trade Name: N/A Study Indication: Neoplasms, Breast The study consists of a screening, four study visits at day-1, week 1, 2 and 3 and a follow-up visit. This document contains the prior Anti-Cancer procedures. It has to be filled in for screening.

Concomitant Medication SirTac NCT02936388 - Concomitant Medication

- 03.12.17 - 1 Formular, 1 Itemgruppe, 12 Datenelemente, 1 Sprache
Itemgruppe: Concomitant Medication
Study part: Concomitant Medication. A Randomized Phase II Trial of Transarterial Radioembolisation With Yttrium-90 (SIRT) in Comparison to Transarterial Chemoembolisation With Cisplatin (TACE) in Patients With Liver Metastases From Uveal Melanoma. Provided by Prof. Dr. Ulrich Keilholz, Charité – University of medicine Berlin. EudraCT-Nummer: 2014-002439-32. NCT02936388.

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