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Breast Cancer NCT01242800 On-Study - E2108 Step 2 On-Study Form - 3130597v1.0 - E2108 Step 2 On-Study Form

- 9/20/21 - 1 form, 8 itemgroups, 40 items, 1 language
Itemgroups: Header Module, Header, Amended Data, Patient Characteristics, Disease Description, Treatment Plan, Circulating Tumor Cell (CTC) Enumeration, Comments
E2108 Step 2 On-Study Form Early Surgery or Standard Palliative Therapy in Treating Patients With Stage IV Breast Cancer Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=8E2EE15D-B7A5-69C7-E040-BB89AD431929

Breast Cancer NCT01242800 Follow-Up - E2108 Step 2 Follow-up Form - 3130846v1.0 - E2108 Step 2 Follow-up Form

- 9/20/21 - 1 form, 12 itemgroups, 67 items, 1 language
Itemgroups: Header Module, Header, Amended Data, Report Period, Section I - Vital Status, Section II - Reporting Period, Status of Local-Regional Disease, CHEST WALL, Breast Involvement, Section IV - Status of Distant Disease, Circulating Tumor Cell (CTC) Enumeration, Comments
E2108 Step 2 Follow-up Form Early Surgery or Standard Palliative Therapy in Treating Patients With Stage IV Breast Cancer Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=8E30083E-7422-9EAD-E040-BB89AD430E1D

Breast Cancer NCT01242800 On-Study - E2108 Step 1 On-Study Form - ARM S - 3130381v1.0 - E2108 Step 1 On-Study Form - ARM S

- 9/20/21 - 1 form, 9 itemgroups, 59 items, 1 language
Itemgroups: Header Module, Header, Amended Data, Pre-Registration Evaluation, Disease Description, Metastatic Site(s) of Involvement (At Study Entry), STATUS OF LOCAL-REGIONAL DISEASE - Prior to initiation of Optimal Systemic Therapy, Breast Involvement, Comments
E2108 Step 1 On-Study Form - ARM S Early Surgery or Standard Palliative Therapy in Treating Patients With Stage IV Breast Cancer Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=8E2ED499-121B-8389-E040-BB89AD4330F7

Breast Cancer NCT01242800 Follow-Up - E2108 Surgical Resection Form - 3145725v1.0 - E2108 Surgical Resection Form

- 1/9/15 - 1 form, 3 itemgroups, 27 items, 1 language
Itemgroups: General information, Surgery, Footer Module
E2108 Surgical Resection Form Early Surgery or Standard Palliative Therapy in Treating Patients With Stage IV Breast Cancer Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=91CE8B54-1649-B633-E040-BB89AD433125

Breast Cancer NCT01242800 Off Treatment - E2108 End-of-Study Form - 3128917v1.0 - E2108 End-of-Study Form

- 1/9/15 - 1 form, 6 itemgroups, 21 items, 1 language
Itemgroups: Header Module, Header, Amended Data, Vital Status, Section I, Comments
E2108 End-of-Study Form Early Surgery or Standard Palliative Therapy in Treating Patients With Stage IV Breast Cancer Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=8DF34112-9349-8BCA-E040-BB89AD4347FD

Breast Cancer NCT01242800 Quality of Life - E2108 Assessment Compliance Form - 3128759v1.0 - E2108 Assessment Compliance Form

- 1/9/15 - 1 form, 12 itemgroups, 49 items, 1 language
Itemgroups: Header Module, Header, Report Period, Amended Data , Section I, Section II - Assessment Not Completed, Indicate reason(s) why form was not completed, Section III Assessment Completed, How was the patient assisted, What was the reason for assistance, Who assisted or completed the assessment, Comments
E2108 Assessment Compliance Form Early Surgery or Standard Palliative Therapy in Treating Patients With Stage IV Breast Cancer Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=8DF2D222-1D4F-10F8-E040-BB89AD432CF6

E2108 Vital Status Form NCT01242800

- 6/8/15 - 1 form, 6 itemgroups, 22 items, 1 language
Itemgroups: ECOG clinical trial administrative data, Data amendment, Report Period, Section II - Reporting Period, Section 1 - Vital Status, Footer Module
E2108 Vital Status Form NCT01242800 Early Surgery or Standard Palliative Therapy in Treating Patients With Stage IV Breast Cancer Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=918F7A63-0F65-C218-E040-BB89AD43477E

E2108 Step 2 Treatment Form NCT01242800

- 6/3/15 - 1 form, 5 itemgroups, 27 items, 1 language
Itemgroups: Header module, Report Period (since randomization), Section II - Reporting Period, Therapies Recieved, Footer Module
E2108 Step 2 Treatment Form NCT01242800 Early Surgery or Standard Palliative Therapy in Treating Patients With Stage IV Breast Cancer Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=8E317E27-15FB-BDB6-E040-BB89AD4354FA

Breast Cancer NCT01242800 Quality of Life - E2108 FACT-B + Local Symptoms-9 - 3129088v1.0 - E2108 FACT-B + Local Symptoms-9

- 1/9/15 - 1 form, 8 itemgroups, 59 items, 1 language
Itemgroups: Header Module, Reporting Period, Header, PHYSICAL WELL-BEING, FUNCTIONAL WELL-BEING, SOCIAL/FAMILY WELL-BEING, EMOTIONAL WELL-BEING, ADDITIONAL CONCERNS
E2108 FACT-B + Local Symptoms-9 Early Surgery or Standard Palliative Therapy in Treating Patients With Stage IV Breast Cancer Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=8E06DE1E-7AF1-0A7A-E040-BB89AD43472D

E2108 Optimal Systemic Therapy Summary Form NCT01242800

- 6/16/15 - 1 form, 9 itemgroups, 31 items, 1 language
Itemgroups: ECOG clinical trial administrative data, Report Period, Data amendment, Section II - Reporting Period, Section 1 - Vital Status, Therapy Administered - Chemotherapy, Therapy Administered - Hormone therapy, Therapy Administered - New Progression, Footer Module
E2108 Optimal Systemic Therapy Summary Form NCT01242800 Early Surgery or Standard Palliative Therapy in Treating Patients With Stage IV Breast Cancer Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=91E1D8B2-2FF5-DD0A-E040-BB89AD434391

ECOG-E2108 Source Document Tracking Coversheet NCT01242800

- 6/16/15 - 1 form, 3 itemgroups, 13 items, 1 language
Itemgroups: Header, Patient demographics, Footer module
ECOG-E2108 Source Document Tracking Coversheet NCT01242800 Early Surgery or Standard Palliative Therapy in Treating Patients With Stage IV Breast Cancer Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=91E2AAB8-28DA-A87B-E040-BB89AD43631D

E2108 Optimal Systemic Therapy Summary Form NCT01242800

- 6/8/15 - 1 form, 5 itemgroups, 18 items, 1 language
Itemgroups: ECOG clinical trial administrative data, Data amendment, Section II - Reporting Period, Section 1 - Vital Status, Footer Module
E2108 Optimal Systemic Therapy Summary Form NCT01242800 Early Surgery or Standard Palliative Therapy in Treating Patients With Stage IV Breast Cancer Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=9192F0DC-00AE-56AC-E040-BB89AD431CAF

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