Description:

Z1031 Registration Worksheet Form Exemestane, Letrozole, or Anastrozole in Treating Postmenopausal Women Who Are Undergoing Surgery for Stage II or Stage III Breast Cancer Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=02F0FC02-607A-58B8-E044-0003BA3F9857

Link:

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=02F0FC02-607A-58B8-E044-0003BA3F9857

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Versions (3) ▾
  1. 9/19/12
  2. 1/9/15
  3. 9/17/21
Uploaded on:

September 17, 2021

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License:
Creative Commons BY-NC 3.0 Legacy
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Endometrial Cancer NCT00265759 Registration - Z1031 Registration Worksheet Form - 2417050v1.0

No Instruction available.

  1. StudyEvent: Z1031 Registration Worksheet Form
    1. No Instruction available.
Header Module
Visit
Header
Has patient previously been registered to an ACOSOG study
Patient Information
Gender
Race (Mark all that apply)
Ethnicity (Mark only one)
Method of payment (Mark all that apply)
Kg
cm
HIPAA Authorization form
Unnamed 4
Consent for correlative studies and specimen banking signed
Inclusion Criteria
Patient must have an ECOG performance status of <= 2 (Zubrod)
Patient must have T2-T4c, any N, M0 breast cancer, by clinical staging (NOTE: Primary tumor must be palpable and measure > 2 cm by tape, ruler or caliper measurements in at least one dimension)
Patient must be postmenopausal, verified by bilateral surgical oophorectomy, no spontaneous menses >= 1 year, or no menses for < 1 year with FSH and estradiol levels in postmenopausal range, according to institutional standards
Patient, as documented by the treating physician, is clinically staged as one of the following: T4 a-c for whom modified radical mastectomy with negative margins is the goal T2 or T3 for whom conversion from needing mastectomy to breast conservation is the goal T2 for whom lumpectomy at first attempt is the goal
Patient has ER+ tumor with an Allred score of 6, 7, or 8 (NOTE: patients with > 66.6% two-thirds of cells staining positive have a minimum Allred score of 6 and are eligible)
Patient must have mammogram and ultrasound within 42 days prior to registration
If patient is a cancer survivor, all of the following criteria must be met Patient has undergone potentially curative therapy for all prior malignancies, No evidence of any prior malignancies for at least 5 years with no evidence of recurrence (except for successfully treated cervical carcinoma in situ, lobular carcinoma in situ of the breast, contralateral DCIS treated with mastectomy or lumpectomy and radiation but without tamoxifen treatment, or non-melanoma skin cancer with no evidence of recurrence), and Patient is deemed by their treating physician to be at low risk for recurrence from prior malignancies
Exclusion Criteria
Patient has inflammatory breast cancer defined as clinically significant erythema of the breast and/or documented dermal lymphatic invasion (not direct skin invasion by tumor or peau d'orange without erythema NOTE: Patient with T4d disease are ineligible)
Patient has received prior treatment for breast cancer, including radiation, endocrine therapy, chemotherapy or investigational agent. Patients whose diagnosis was established by incisional biopsy are not eligible
Patient has received hormone replacement therapy of any type, megestrol acetate, or raloxifene within one week prior to registration
Patient has distant metastasis (M1), excluding isolated ipsilateral supraclavicular node involvement
Patient does not agree to undergo mastectomy or lumpectomy after neoadjuvant aromatose inhibitor therapy
Patient is enrolled in another neoadjuvant clinical trial for treatment of the existing breast cancer
Patient has undergone prior sentinel lymph node biopsy (Cohort B only)
Unnamed Module 3
In the opinion of the investigator, is the patient eligible?
Baseline Performace Status (ECOG/Zubrod scale Note: Document patient's performance status in the medical record.)
Clinical Stage
Clinical T Stage (mark one)
Clinical N Stage (mark one)
cm
cm
Primary Tumor Biopsy
Receptor Status, ER
Marker Test Method (Mark one. If both were performed, mark confirmatory test)
HER-2/neu status
Histologic Grade (mark one)
Histologic Type (mark one)
Was FNA done on the axillary nodes prior to study initiation
FNA Results (biopsy)
Method of Evaluation (imaging within 42 days prior to registration)
Postmenopausal verification (mark one)
Surgery status according to investigator (mark one)
Treatment Arm (Please indicate which aromatase inhibitor the patient will receive)
Did the Investigator sign the CRF indicating review of all data and certifying data are accurate and complete to the best of their knowledge

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