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PROGNOSTIC FACTORS Roche H0650g Breast Cancer - PROGNOSTIC FACTORS

- 20-09-21 - 1 Formulier, 1 Itemgroep, 26 Data-elementen, 1 Taal
Itemgroep: Prognostic factors
Study part: Prognostic factors. 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

- 29-05-17 - 1 Formulier, 1 Itemgroep, 1 Data-element, 1 Taal
Itemgroep: Concomitant medication
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"

MEDICAL HISTORY Roche H0650g Breast Cancer - MEDICAL HISTORY

- 14-05-17 - 1 Formulier, 3 Itemgroepen, 10 Data-elementen, 1 Taal
Itemgroepen: MEDICAL HISTORY, Active diseases, history of prior surgery; disease Previous
Study part: Medical History. 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"

Intravenous Topotecan and Gemcitabine as Second-line Treatment in Patients With Ovarian Cancer NCT00061308 - Screening - Significant Medical/ Surgical History and Physical Examination; History of Ovarian Cancer; Tumor Marker

- 23-08-19 - 1 Formulier, 6 Itemgroepen, 18 Data-elementen, 1 Taal
Itemgroepen: Administrative, Significant Medical/ Surgical History and Physical Examination, Significant Medical/ Surgical History and Physical Examination , History of Ovarian Cancer, Metastatic, Tumor Marker (CA-125) (7 days prior to Day 1)
Study ID: 104864/627 Clinical Study ID: 104864/627 Study Title: An Open-label, Multicenter, Non-Comparative Phase II Study of the Combination of Intravenous Topotecan and Gemcitabine Administered Once Weekly for Three Weeks Every 28 Days as Second-line Treatment in Patients With Recurrent Platinum Sensitive Ovarian Cancer Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00061308 Sponsor: GlaxoSmithKline Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Topotecan, Gemcitabine Study Indication: Peritoneal Cancer, Ovarian Cancer, Neoplasms, Ovarian, Fallopian Tube Cancer

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

- 17-03-20 - 1 Formulier, 3 Itemgroepen, 9 Data-elementen, 1 Taal
Itemgroepen: Administrative Data, Medical conditions, Medical conditions entry
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 medical conditions of the patient. It has to be filled in for screening.

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