ACOSOG-Z1072 OPEN Registration Worksheet NCT00723294 Cryoablation Therapy in Treating Patients With Invasive Ductal Breast Cancer Source Form: NCI FormBuilder:


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September 20, 2021

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ACOSOG-Z1072 OPEN Registration Worksheet NCT00723294

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  1. StudyEvent: ACOSOG-Z1072 OPEN Registration Worksheet
    1. No Instruction available.
Patient demographics
Gender of a Person
Method of Payment
General Information
Has patient previously been registered to an ACOSOG study
Was HIPAA Authorization included in Study Informed Consent
Eligibility Criteria
Unifocal primary invasive ductal breast carcinoma diagnosed by core needle biopsy (NOTE: Patients with multifocal and/or multicentric ipsilateral breast cancer, multifocal calcifications, or DCIS with microinvasion are NOT eligible. Patients with contralateral disease will remain eligible.)
No history of en bloc open surgical biopsy and/or lumpectomy for diagnosis/treatment of the index breast cancer (Note: Prior rotational and/or vacuum-assisted core biopsies are permitted if no significant distortion is seen on imaging that could obscure visualization and detection of residual disease on MRI, or visualization of cancer on ultrasound for cryoablation procedure.)
Tumor size <= 2.0 cm in greatest diameter (Specifically, the tumor must measure <=2.0 cm in the axis parallel to the treatment probe and <=1.5 cm in the axis anti-parallel to the treatment probe. Largest size measured by required scans mammogram, ultrasound and MRI will be used to determine eligibility.)
Tumor enhancement on pre-study MRI
Tumor with < 25% intraductal components in the aggregate
No prior or planned neoadjuvant chemotherapy for breast cancer
Non-pregnant and non-lactating (Patients of childbearing potential must have a negative serum or urine pregnancy test. Note: Peri-menopausal women must be mernorrheic for >12 months to be considered not of childbearing potential. If not a woman of childbearing potential or male mark NA)
Adequate breast size for safe cryoablation (Male breast cancer patients and female breast cancer patients with breasts too small to allow safe cryoablation are not eligible as the minimal thickness of the breast tissue does not lend itself to cryoablation. For patients with breast implants, the treating physician must document that adequate distance exists between the lesion and the implant to ensure that the ablated lesion will not contact or jeopardize the implant.)
Patients with prior in-situ or invasive breast carcinomas are eligible if the prior carcinomas occurred in the contralateral breast. Patients with prior in-situ or invasive carcinomas of the ipsilateral breast are not eligible

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