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Breast Cancer NCT00433589 Treatment - Endocrine therapy - 2498727v1.0 - Endocrine therapy

- 09.01.15 - 1 Formular, 3 Itemgruppen, 14 Datenelemente, 1 Sprache
Itemgruppen: Header, Endocrine therapy, Footer Module
Endocrine therapy Genetic Testing or Clinical Assessment in Determining the Need for Chemotherapy in Women With Breast Cancer That Involves No More Than 3 Lymph Nodes Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=19677A9A-FFBD-2E6F-E044-0003BA3F9857

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"

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"

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"

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"

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"

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.

Treatment - Breast Cancer - Adjuvant Radiotherapy Report Form - 2280049v3.0 - Breast Cancer - Adjuvant Radiotherapy Report Form

- 09.01.15 - 1 Formular, 3 Itemgruppen, 14 Datenelemente, 1 Sprache
Itemgruppen: CRF Header, Breast: Form Administration, Breast: Radiation Treatment
Breast Cancer - Adjuvant Radiotherapy Report Form Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=DA18A97F-D17C-0637-E034-0003BA12F5E7

CALGB: 40601 POST SURGERY HISTOPATHOLOGY REVIEW FORM NCT00770809

- 20.09.21 - 1 Formular, 10 Itemgruppen, 58 Datenelemente, 1 Sprache
Itemgruppen: Header, Patient demographics, SPECIMEN DETAILS, GROSS FINDINGS, HISTOLOGIC FINDINGS, MARGINS, DCIS, LYMPH NODES, DISEASE STAGING, COMMENTS
CALGB: 40601 POST SURGERY HISTOPATHOLOGY REVIEW FORM NCT00770809 Paclitaxel and Trastuzumab With or Without Lapatinib in Treating Patients With Stage II or Stage III Breast Cancer That Can Be Removed by Surgery Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=3A58BBD2-8485-72B0-E044-0003BA3F9857

Breast Cancer NCT00769379 Treatment - NSABP Protocol B-43 Worksheet Protocol Treatment Form (Radiation Therapy and Trastuzumab) - 2675912v1.0 - NSABP Protocol B-43 Worksheet Protocol Treatment Form (Radiation Therapy and Trastuzumab)

- 20.09.21 - 1 Formular, 5 Itemgruppen, 28 Datenelemente, 1 Sprache
Itemgruppen: Header, SECTION A - Radiation Therapy (RT) -- All Patients, SECTION B Trastuzumab Administration -- Group 2 Patients Only, Adverse Events/Side Effects/Complications, Footer
NSABP Protocol B-43 Worksheet Protocol Treatment Form (Radiation Therapy and Trastuzumab) Radiation Therapy With or Without Trastuzumab in Treating Women With Ductal Carcinoma In Situ Who Have Undergone Lumpectomy Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=38EE2EF6-D07E-1323-E044-0003BA3F9857

Breast Cancer NCT00310180 Treatment - PACCT-1 TAILORx Radiation Therapy Form - 2431830v1.0 - PACCT-1 TAILORx Radiation Therapy Form

- 20.09.21 - 1 Formular, 4 Itemgruppen, 24 Datenelemente, 1 Sprache
Itemgruppen: Header, Header, Whole Breast Irradiation, Partial Breast Irradiation
PACCT-1 TAILORx Radiation Therapy Form Hormone Therapy With or Without Combination Chemotherapy in Treating Women Who Have Undergone Surgery for Node-Negative Breast Cancer (The TAILORx Trial) Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=05DDE05E-BAB7-050B-E044-0003BA3F9857

North Central Cancer Treatment Group Evaluation/Observation Form NCT00377156

- 20.09.21 - 1 Formular, 8 Itemgruppen, 29 Datenelemente, 1 Sprache
Itemgruppen: Header, Patient status assessment, Neurologic Examination, Observation, Systemic Disease Follow-up Status, Notice of First Recurrence, Treatment of Any Recurrence, Notice of New Primary
North Central Cancer Treatment Group Evaluation/Observation Form NCT00377156 Stereotactic Radiation Therapy With or Without Whole-Brain Radiation Therapy in Treating Patients With Brain Metastases Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=109FB871-880B-538E-E044-0003BA3F9857

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