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CALGB 40601 REGISTRATION WORKSHEET 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=39E131B2-F4E4-13F1-E044-0003BA3F9857

Link:

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=39E131B2-F4E4-13F1-E044-0003BA3F9857

Keywords:

Clinical Trial

Registration

Breast Neoplasms

Versions (4)

8/27/12 8/27/12 -
1/9/15 1/9/15 - Martin Dugas
1/9/15 1/9/15 - Martin Dugas
9/17/21 9/17/21 -

Uploaded on:

September 17, 2021

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Creative Commons BY-NC 3.0 Legacy

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Breast Cancer NCT00770809 Registration - CALGB 40601 REGISTRATION WORKSHEET - 2680365v1.0

English 1

English

Details

Endocrine Therapy in Combination with Anti-VEGF Therapy: A Randomized, Double-Blind, Placebo-Controlled Phase III Trial of Endocrine Therapy Alone or Endocrine Therapy plus for Women with Hormone Receptor-Positive Advanced Breast Cancer

1 forms

StudyEvent: CALGB 40601 REGISTRATION WORKSHEET
1. Endocrine Therapy in Combination with Anti-VEGF Therapy: A Randomized, Double-Blind, Placebo-Controlled Phase III Trial of Endocrine Therapy Alone or Endocrine Therapy plus for Women with Hormone Receptor-Positive Advanced Breast Cancer

Header Module

Lead Institution

Institution/Affiliate

CALGB Patient ID (Assigned)

Physician of Record

Principal Investigator No.

Participating Group Name

Protocol Administration

IRB Approval Date

Date Informed Consent Signed

Projected Start Date of Treatment

HIPAA Authorization Date

Contact Person at Institution

Phone

Fax

Patient Demographics/pre-treatment Characteristics

Patient Initials (Last, First Middle)

Date of Birth (MM DD YYYY)

Patient Social Security Number

Patient Hospital No.

Gender

Female (FEMALE)

Male (MALE)

Race (Mark all that apply)

A Person Having Origins In Any Of The Original Peoples Of North And South America (including Central America), And Who Maintains Tribal Affiliation Or Community Attachment. (American Indian or Alaska Native)

A Person Having Origins In Any Of The Original Peoples Of The Far East, Southeast Asia, Or The Indian Subcontinent Including, For Example, Cambodia, China, India, Japan, Korea, Malaysia, Pakistan, The Philippine Islands, Thailand, And Vietnam. (Asian)

A Person Having Origins In Any Of The Black Racial Groups Of Africa. Terms Such As "haitian" Or "negro" Can Be Used In Addition To "black Or African American." (Black or African American)

A Person Having Origins In Any Of The Original Peoples Of Hawaii, Guam, Samoa, Or Other Pacific Islands. (Native Hawaiian or other Pacific Islander)

3 more items in the detailed view.

Ethnicity (Mark one)

A Person Of Mexican, Puerto Rican, Cuban, Central Or South American Or Other Spanish Culture Or Origin, Regardless Of Race. (Hispanic or Latino)

A Person Not Meeting The Definition For Hispanic Or Latino. (Not Hispanic or Latino)

Could Not Be Determined Or Unsure (Unknown)

Patient Demographics/pre-treatment Characteristics2

Performance Status (ECOG/Zubrod scale)

Fully Active, Able To Carry On All Pre-disease Performance Without Restriction. (0)

Restricted In Physically Strenuous Activity But Ambulatory And Able To Carry Out Work Of A Light Or Sedentary Nature, E.g., Light Housework, Office Work. (1)

Ambulatory And Capable Of All Selfcare But Unable To Carry Out Any Work Activities. Up And About More Than 50% Of Waking Hours. (2)

Capable Of Only Limited Selfcare, Confined To Bed Or Chair More Than 50% Of Waking Hours. (3)

Completely Disabled. Cannot Carry On Any Selfcare. Totally Confined To Bed Or Chair. (4)

Dead (5)

Height (cm)

Weight (kg)

Body Surface Area (m^2)

Method of Payment (USA only Mark one)

Medicaid (Medicaid)

Medicaid And Medicare (Medicaid and Medicare)

Medicare (Medicare)

Medicare And Private Insurance (Medicare and Private Insurance)

7 more items in the detailed view.

Disease

Stage

T0, N1, M0 Or T1*, N1, M0 Or T2, N0, M0 Or T2, N1, M0 Or T3, N0, M0 (II)

T0, N2, M0 Or T1*, N2, M0 Or T2, N2, M0 Or T3, N1, M0 Or T3, N2, M0 Or T4, N0, M0 Or T4, N1, M0 Or T4, N2, M0 Or Any T, N3, M0 (III)

Pathologic type

Patient Zip Code

Country of Residence (if not USA)

Certification Of Eligibility And Protocol Design

In the opinion of the investigator, is the patient eligible?

Yes

Protocol Design

Stratification factors

Stage Ii Breast Cancer (Stage II)

Stage Iii Breast Cancer (Stage III)

Er And Pgr Negative (ER and PGR negative)

Er And/or Pgr Positive (ER and/or PGR positive)

Assigned Treatment Arm

Arm 1: Paclitaxel + Trastuzumab + Lapatinib (Arm 1: Paclitaxel + Trastuzumab + Lapatinib)

Arm 2: Paclitaxel + Trastuzumab (Arm 2: Paclitaxel + Trastuzumab)

Initial Patient Consent For Specimen Use

Patient's Initial Consent given for specimen use for research on the patient's cancer?

Yes

Patient's initial consent given for specimen use for genetic research relating to the study treatment

Yes

Patient's Initial Consent given for specimen kept for future use in research to learn about, prevent, or treat cancer

Yes

Patient's initial consent given for specimen(s) may be kept for use in research to learn about, prevent, or treat other health problems (for example: diabetes, Alzheimer's disease, or heart disease)

Yes

Patient's initial consent given for further contact regarding specimen?

Yes

Tissue Procurement Kit

Name

Institution

Shipping Address

Phone

FAX

Registration Information

Registration Date

CALGB Patient ID (Assigned)

Participating Group Patient ID (Assigned)

Registrar's Signature

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