Description:

CALGB: 40101 PRE-STUDY ELIGIBILITY CHECKLIST NCT00041119 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

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

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Versions (3) ▾
  1. 8/26/12
  2. 7/8/15
  3. 7/8/15
Uploaded on:

July 8, 2015

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License:
Creative Commons BY-NC 3.0 Legacy
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CALGB: 40101 PRE-STUDY ELIGIBILITY CHECKLIST NCT00041119

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

  1. StudyEvent: CALGB: 40101 PRE-STUDY ELIGIBILITY CHECKLIST
    1. INSTRUCTIONS: Complete all information on this form. Do not leave any entries blank.
Header module
Breast Cancer ELIGIBILITY
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
<= 84 days since last major breast surgery
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)
Meets ALL of the following laboratory criteria completed within 16 days before registration
ANC >= 1000/mcL
Platelets >= 100,000/mcL
Creatinine <= 2.0 mg/dL
Total Bilirubin < 1.5 x upper limits of normal of laboratory (mg/dL)
Ccrr Module For Calgb: 40101 Pre-study Eligibility Checklist

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