Description:

ACOSOG-Z1031 OPEN Registration Worksheet 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=8036B060-D675-EB4B-E040-BB89AD434531

Link:

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=8036B060-D675-EB4B-E040-BB89AD434531

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Versions (4) ▾
  1. 9/19/12
  2. 1/9/15
  3. 1/9/15
  4. 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 - ACOSOG-Z1031 OPEN Registration Worksheet - 3014513v1.0

No Instruction available.

  1. StudyEvent: ACOSOG-Z1031 OPEN Registration Worksheet
    1. No Instruction available.
Header Module
Patient Information
Gender of a Person
Ethnicity
Race
Method of Payment
General Information
Has patient previously been registered to an ACOSOG study
Was HIPAA Authorization included in Study Informed Consent (mark one)
Inclusion Criteria
Patient must have an ECOG performance status of <= 2 (Zubrod)
ECOG Performance Status (Zubrod 0, 1, 2)
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 an 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
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)
Prior treatment for invasive 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)
Randomization
Treatment Arm

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