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

- 3/15/21 - 1 form, 2 itemgroups, 10 items, 1 language
Itemgroups: 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)

- 3/15/21 - 1 form, 3 itemgroups, 18 items, 1 language
Itemgroups: 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

- 3/15/21 - 1 form, 1 itemgroup, 11 items, 1 language
Itemgroup: 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"

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

- 3/15/21 - 1 form, 1 itemgroup, 10 items, 1 language
Itemgroup: 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"

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

- 3/15/21 - 1 form, 1 itemgroup, 11 items, 1 language
Itemgroup: 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"

Intravenous Topotecan and Gemcitabine as Second-line Treatment in Patients With Ovarian Cancer NCT00061308 - Screening - Prior Ovarian Cancer Treatment; Laboratory Tests; Lesion Assessment Record

- 8/23/19 - 1 form, 13 itemgroups, 48 items, 1 language
Itemgroups: Administrative, Prior Ovarian Cancer Treatment - Chemotherapy, Has the patient received radiotherapy?, Prior Ovarian Cancer Treatment - Radiotherapy , Has the patient received prior cancer-related surgery?, Prior Ovarian Cancer Treatment - Surgical Treatment , Has the patient received other cancer-related treatments?, Other Cancer Related Treatments, Laboratory Tests (within 7 days prior to Day 1) - Haematology, Laboratory Tests (within 7 days prior to Day 1) - Haematology , Laboratory Tests (within 7 days prior to Day 1) - Chemistry, Laboratory Tests (within 7 days prior to Day 1) - Chemistry , Lesion Assessment Record
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

Treatment - Gynecologic Cancer - Treatment Summary Form - 2019337v2.31 - Gynecologic Cancer - Treatment Summary Form

- 1/8/15 - 1 form, 12 itemgroups, 76 items, 1 language
Itemgroups: CRF Header, GYN: FORM ADMINISTRATION, GYN: SURGICAL TREATMENT, GYN: TREATMENT MODIFICATIONS (SURGICAL TREATMENT), GYN: TREATMENT SCHEDULE - RADIATION THERAPY, GYN: TREATMENT MODIFICATIONS (RADIATION THERAPY), GYN: TREATMENT SCHEDULE - SYSTEMIC THERAPY, GYN: TREATMENT MODIFICATIONS (SYSTEMIC THERAPY), GYN: OFF-TREATMENT REASON, GYN: TREATMENT SCHEDULE - OPTIONAL THERAPY, GYN: TREATMENT SCHEDULE - NON-PROTOCOL THERAPY, Comments
Gynecologic Cancer - Treatment Summary Form Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=99CD59C5-A96A-3FA4-E034-080020C9C0E0

Treatment - Gynecologic Cancer - Treatment by Cycle Form - 2019338v2.31 - Gynecologic Cancer - Treatment by Cycle Form

- 1/8/15 - 1 form, 9 itemgroups, 59 items, 1 language
Itemgroups: CRF Header, GYN: FORM ADMINISTRATION, GYN: SURGICAL TREATMENT, GYN: TREATMENT MODIFICATIONS (SURGICAL TREATMENT), GYN: RADIATION THERAPY-TREATMENT CYCLE INFORMATION, GYN: TREATMENT MODIFICATIONS (RADIATION THERAPY), GYN: SYSTEMIC THERAPY-TREATMENT CYCLE INFORMATION, GYN: TREATMENT MODIFICATIONS (SYSTEMIC THERAPY), Comments
Gynecologic Cancer - Treatment by Cycle Form Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=99CD59C5-A96C-3FA4-E034-080020C9C0E0

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

- 3/26/20 - 1 form, 4 itemgroups, 28 items, 1 language
Itemgroups: 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.

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

- 7/20/20 - 1 form, 3 itemgroups, 9 items, 1 language
Itemgroups: Administrative Data, Lapatinib Dosing, Treatment confirmation
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 Lapatinib Dosing information. It has to be filled in once for each week 1, week 2 and week 3.

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

- 7/4/20 - 1 form, 7 itemgroups, 10 items, 1 language
Itemgroups: Administrative Data, Week number and study day, Predose Overnight Fast, Lapatinib Dosage, Count of entities, Postdose Fasting, Post-dose Vomiting, Therapeutic procedure, Confirmation
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 Lapatinib diary. This form is for dosing and meal data from the diary only. Go to visits Week 1 to Week 3 for Lapatinib and Meal data from clinic visits. This form has to be filled in for each week and each study day of the trial.

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