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RADIOTHERAPY TREATMENT WHILE ON STUDY Roche H0650g Breast Cancer - RADIOTHERAPY TREATMENT WHILE ON STUDY

- 15/03/2021 - 1 Formulaire, 1 Groupe Item, 8 Eléments de données, 1 Langue
Groupe Item: RADIOTHERAPY
Study part: Radiotherapy treatment while on study. 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"

DIAGNOSIS Roche H0650g Breast Cancer - DIAGNOSIS

- 29/05/2017 - 1 Formulaire, 3 Groupes Item, 45 Eléments de données, 1 Langue
Groupes Item: PRIMARY DIAGNOSIS, Diagnosis Metastasis, method of assessment
Study part: Diagnosis. 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"

STUDY TERMINATION TUMOR ASSESSMENT Roche H0650g Breast Cancer - STUDY TERMINATION TUMOR ASSESSMENT

- 29/05/2017 - 1 Formulaire, 1 Groupe Item, 23 Eléments de données, 1 Langue
Groupe Item: Tumor assessment
Study part: Study Termination Tumor Assessment. 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"

UNSCHEDULED TUMOR ASSESSMENT Roche H0650g Breast Cancer - UNSCHEDULED TUMOR ASSESSMENT

- 29/05/2017 - 1 Formulaire, 1 Groupe Item, 23 Eléments de données, 1 Langue
Groupe Item: Tumor assessment
Study part: Unscheduled Tumor Assessment. 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"

4 WEEK CONFIRMATION OF RESPONSE WORKSHEET Roche H0650g Breast Cancer - 4 WEEK CONFIRMATION OF RESPONSE WORKSHEET

- 29/05/2017 - 1 Formulaire, 1 Groupe Item, 23 Eléments de données, 1 Langue
Groupe Item: Tumor assessment
Study part: 4 Week Confirmation of Response Worksheet. 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"

TUMOR ASSESSMENT WORKSHEET & TUMOR ASSESSMENT Roche H0650g Breast Cancer - TUMOR ASSESSMENT WORKSHEET & TUMOR ASSESSMENT

- 29/05/2017 - 1 Formulaire, 4 Groupes Item, 39 Eléments de données, 1 Langue
Groupes Item: tumor location, Tumor assessment, tumor location, worksheet tumor assessment
Study part: Tumor Assessment Worksheet & Tumor Assessment. 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"

STUDY TERMINATION CHEST X-RAY (AP AND LATERAL) Roche H0650g Breast Cancer - STUDY TERMINATION CHEST X-RAY (AP AND LATERAL)

- 20/05/2017 - 1 Formulaire, 1 Groupe Item, 5 Eléments de données, 1 Langue
Groupe Item: Chest X-Ray
Study part: Study Termination Chest X- ray. 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"

CHEST X-RAY (AP AND LATERAL) Roche H0650g Breast Cancer - CHEST X-RAY (AP AND LATERAL)

- 16/05/2017 - 1 Formulaire, 1 Groupe Item, 5 Eléments de données, 1 Langue
Groupe Item: Chest X-Ray
Study part: Chest X- ray. 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 - Liver imaging

- 26/01/2021 - 1 Formulaire, 11 Groupes Item, 60 Eléments de données, 1 Langue
Groupes Item: Date of hepatic or liver imaging test, method used for imaging test, images technically adequate, liver size, liver texture, diffuse and/or geographic fatty infiltrate of the liver, Ascites present, Focal Hepatic Lesions characterisable, Gallstones or gallbladder lesions, Biliary ductal lesions, Portal/Hepatic vein abnormalities
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 documents any liver imaging, if taken during the study.

Preoperative MRI of Prostate Cancer NCT01347320 - Eligibility

- 29/05/2019 - 1 Formulaire, 2 Groupes Item, 9 Eléments de données, 1 Langue
Groupes Item: Inclusion Criteria, Exclusion Criteria
Preoperative Magnetic Resonance (MR) Imaging of Prostate Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT01347320

Prostate Cancer Localization With Multiparametric MR (PCa-MAP) NCT01138527 - Eligibility Criteria

- 27/05/2019 - 1 Formulaire, 2 Groupes Item, 9 Eléments de données, 1 Langue
Groupes Item: Inclusion Criteria, Exclusion Criteria
Prostate Cancer Localization With a Multiparametric Magnetic Resonance (MR) Approach; ODM derived from: https://clinicaltrials.gov/show/NCT01138527

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