Info
Dialog
Download

Rating Ratings

Description:

NSABP Protocol B-42 - Protocol Entry Form Worksheet Letrozole in Treating Postmenopausal Women Who Have Received Hormone Therapy for Hormone Receptor-Positive Breast Cancer Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=17AF2627-D64B-3BA6-E044-0003BA3F9857

Link:

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=17AF2627-D64B-3BA6-E044-0003BA3F9857

Keywords:

Clinical Trial

Registration

Breast Neoplasms

Versions (3)

12/18/14 12/18/14 - Martin Dugas
1/9/15 1/9/15 - Martin Dugas
1/9/15 1/9/15 - Martin Dugas

Uploaded on:

January 9, 2015

DOI:

To request one please log in.

License :

Creative Commons BY-NC 3.0 Legacy

Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Back to model comments

Itemgroup comments for :

Item comments for :

In order to download data models you must be logged in. Please log in or register for free.

Breast Cancer NCT00382070 Registration - NSABP Protocol B-42 - Protocol Entry Form Worksheet - 2494107v1.0

English 1

English

Details

Submit every 6 months from date of randomization for the first 5 years; yearly thereafter, and when a protocol event occurs. Fax Form F to 412-622-2111

1 forms

StudyEvent: NSABP Protocol B-42 - Protocol Entry Form Worksheet
1. Submit every 6 months from date of randomization for the first 5 years; yearly thereafter, and when a protocol event occurs. Fax Form F to 412-622-2111

Header

Last

First

Middle

Site Name

Patient Birth Date

Treating physician

Patient Social Security Number (USA Only)

Unnamed2

Eligibility Criteria

Postmenopausal (Postmenopausal)

Disease-free From Initial Breast Cancer Diagnosis (Disease-free from initial breast cancer diagnosis)

Histologically-confirmed Invasive Breast Carcinoma By Diagnostic Core Needle Biopsy Or Final Pathologic Evaluation Of Surgical Specimen (Histologically-confirmed invasive breast carcinoma by diagnostic core needle biopsy or final pathologic evaluation of surgical specimen)

Primary Tumor Was Er-positive And/or Pgr-positive (Primary tumor was ER-positive and/or PgR-positive)

5 more items in the detailed view.

Race

A Person Having Origins In Any Of The Original Peoples Of Europe, The Middle East, Or North Africa. (White)

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)

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 Original Peoples Of North And South America (including Central America), And Who Maintains Tribal Affiliation Or Community Attachment. (American Indian or Alaska Native)

Could Not Be Determined Or Unsure (Unknown)

Person Completing Form, Last Name

Method of Payment (mark primary method only)

Private Insurance (Private Insurance)

Medicare (Medicare)

Medicare And Private Insurance (Medicare and Private Insurance)

Medicaid (Medicaid)

8 more items in the detailed view.

Ethnicity

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)

Country of residence

Usa (US)

Puerto Rico (PR)

Canada (CA)

Other (Other)

Country of Residence (Other)

Patient Zip Code (USA)

Consent

Patient consents to

Future Cancer Research (Future Cancer Research)

Future Contact (Future Contact)

Future Other Research (Future Other Research)

Unnamed4

Date Informed Consent Signed

Planned Date of Treatment Initiation (Should begin within 30 days following randomization. Allow 7+ days after randomization for drug distribution.)

Has the patient authorized the release of Protected Health Information to the NSABP?

Yes

Date of Pre-entry History & Physical Exam (must be within 3 months prior to randomization)

Date of Most Recent Mammogram (must be within 12 months prior to randomization)

Did the patient have a bilateral mastectomy

Yes

Date of Most Recent Bone Mineral Density Test (BMDmust be within 12 months prior to randomization)

Lumbar-Sacral Spine

Total Hip

Femoral Neck

Date of Protocol-Qualifying Lipid Profile

Date of Initial Breast Cancer Diagnosis

Date of Prior Primary Surgery

Type of surgery

Lumpectomy + Axillary Staging + Rt (Lumpectomy + Axillary Staging + RT)

Total Mastectomy + Axillary Staging (Total Mastectomy + Axillary Staging)

Pathologic Lymph Node Assessment

Negative (negative)

Positive (positive)

Receptor Status, ER

Positive (Positive)

Negative (Negative)

Unknown (Unknown)

Receptor Status, PgR

Positive (Positive)

Negative (Negative)

Unknown (Unknown)

Was HER2 testing performed

Yes

HER-2/neu status

Positive (Positive)

Negative (Negative)

Unknown (Unknown)

Therapy Status

Did this patient receive any tamoxifen?

Yes

Total Duration (Must be =< 36 months)

Tamoxifen Treatment End Date

Cumulative Duration of AIs (# months)

Which aromatase inhibitor was most recently being taken

Is the patient currently receiving an AI

Yes

Aromatase inhibitor treatment end date

Was the patient on the B-42 Letrozole Registration Program

Yes

Registration number (If Yes,)

Unnamed4

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

Yes

Has the patient participated in any other NSABP trial

Yes

Patient ID#

Patient Characteristics

Height (cm)

Weight (kg)

Cardiac History

Medical Condition

Hypertension (hypertension)

Ischemic Heart Disease (Ischemic Heart Disease)

Congestive Heart Failure (Congestive Heart Failure)

Atrial Fibrillation: C50466 (Atrial Arrhythmia)

3 more items in the detailed view.

Medications (in the 12 months prior to study entry)

Yes

Comments (Optional)

Cardiac History - Other

Has the patient smoked daily for at least 3 months at any time since her breast cancer diagnosis

Yes

Does the patient have any first degree relatives who died from heart disease before the age of 55 ("First degree relatives" include parent, children, brothers, and sisters)

Yes

Concomitant Medications

Agent Category

Bisphosphonate (Bisphosphonate)

Calcium (Calcium)

Other Medication For Bone Density (Other Medication for Bone Density)

Lipid Lowering Drug (Lipid Lowering Drug)

3 more items in the detailed view.

Agent Name

Taking at time of randomization?

Yes

Continuing after Randomization

Yes

Footer Module

Completed by

Date

Back to the top of the page

Similar models

Show recommended models

Description:

Link:

Keywords:

Versions (3)

Uploaded on:

DOI:

License :

Model comments :

Itemgroup comments for :

Item comments for :

Breast Cancer NCT00382070 Registration - NSABP Protocol B-42 - Protocol Entry Form Worksheet - 2494107v1.0

Submit every 6 months from date of randomization for the first 5 years; yearly thereafter, and when a protocol event occurs. Fax Form F to 412-622-2111

Similar models

Contact

Help