ID

775

Description

CALGB: 40101 PRE-STUDY ELIGIBILITY CHECKLIST Four Versus Six Cycles of Cyclophosphamide/Doxorubicin or Paclitaxel in Adjuvant Breast Cancer Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=A4CFBF75-6AD3-69D3-E034-080020C9C0E0

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=A4CFBF75-6AD3-69D3-E034-080020C9C0E0

Keywords

Clinical Trial

Eligibility Determination

Breast Neoplasms

8/26/12 8/26/12 -
7/8/15 7/8/15 -
7/8/15 7/8/15 -

Uploaded on

August 26, 2012

DOI

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License

Creative Commons BY-NC 3.0 Legacy

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Breast Cancer NCT00041119 Eligibility - CALGB: 40101 PRE-STUDY ELIGIBILITY CHECKLIST - 2039130v3.0

Details

INSTRUCTIONS: Complete all information on this form. Do not leave any entries blank.

1 forms

StudyEvent: CALGB: 40101 PRE-STUDY ELIGIBILITY CHECKLIST
1. INSTRUCTIONS: Complete all information on this form. Do not leave any entries blank.

Unnamed1

CALGB Study No.

CALGB Patient ID

Unnamed2

Patient's Name

Participating Group

Patient Hospital Number

Participating Group Protocol No.

Main Member Institution/Adjunct

Participating Group Patient No.

Unnamed3

Histologically confirmed invasive carcinoma of the breast

Undergone either modified radical mastectomy or lumpectomy

Negative tumor margins for invasive cancer and DCIS in case of mastectomy or lumpectomy

No locally advanced breast cancer, inflammatory breast cancer or metastatic breast cancer

No involvement of dermal lymphatics on pathology

"High-risk" node-negative breast cancer (guidelines are ER/PgR positive primary tumor >= 1 cm in greatest diameter, or ER/PgR negative tumor of any size; physician discretion is allowed)

Negative sentinel node biopsy, and/or an axillary dissection where at least 6 lymph nodes are removed and found to be negative

No previous chemotherapy or hormonal therapy (except for tamoxifen as described in the protocol) for this malignancy

Age >= 18 years

CTC Performance status 0-1

Non-pregnant and non-nursing

No active congestive heart failure nor myocardial infarction within 6 months prior to registration

Disease-free of prior invasive malignancies for >5 years except for curatively treated basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix

Willing to stop exogenous hormone therapy, including oral contraceptives, post-menopausal hormone replacement therapy, and raloxifene

Discontinued tamoxifen at time of enrollment to study if tamoxifen has been received as breast cancer preventive agent, or as treatment for this malignancy for <= 4 weeks. (If latter, indicate dates below)

Date tamoxifen started

Date tamoxifen discontinued

Meets ALL of the following laboratory criteria completed within 16 days before registration

ANC >= 1000/mcL

Date obtained (ANC)

Platelets >= 100,000/mcL

Date obtained (Platelets)

Creatinine <= 2.0 mg/dL

Date obtained (Creatinine)

Total Bilirubin < 1.5 x upper limits of normal of laboratory (mg/dL)

Date obtained (Total Bilirubin)

ULN (Total Bilirubin)

<= 84 days since last major breast surgery

Ccrr Module For Calgb: 40101 Pre-study Eligibility Checklist

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