Breast Cancer Clinical Trial
Cryoablation of Low Risk Small Breast Cancer- Ice3 Trial
To evaluate the efficacy of cryoablation without lumpectomy and its impact on local and distant recurrence of early stage breast cancer .
Competent to sign informed consent
Diagnosis of invasive ductal breast carcinoma by core needle biopsy, meeting the following criteria:
Unifocal primary disease NOTE: Patients with multifocal and/or multicentric in breast cancer, or evidence of EIC are NOT eligible. Patients with contralateral disease will remain eligible.
Tumor size ≤1.5 cm in greatest diameter in the axis parallel to the treatment probe AND ≤1.5 cm in the axis anti-parallel to the treatment probe AND ≤1.5 cm in Anterior/ Posterior dimension. Tumor size ≤1.5 cm in greatest diameter as measured by breast ultrasound, mammogram and/or MRI. The largest dimension measured will be used to determine eligibility.
Nottingham grade 1-2. Specifically, nuclear and mitotic scores must be less than or equal to 2.
Estrogen receptor-positive, progesterone receptor-positive, HER2 negative
Breast size adequate for safe cryoablation
Lesion must be sonographically visible at the time of treatment.
History of previously treated ipsilateral or contralateral breast carcinoma is not an exclusion criteria if the investigator is certain newly diagnosed carcinoma is new unifocal primary tumor.
Presence of lobular carcinoma
Presence of luminal B pathology
Nottingham score of 3 (specially nuclear and mitotic score>2)
Presence of microinvasion, or invasive breast carcinoma with extensive intraductal component (EIC)
Presence of multifocal and/or multicentric in breast cancer
Presence of multifocal calcifications
Presence of prior or concurrent neoadjuvant chemotherapy for breast cancer
Presence of prior en bloc open surgical biopsy and/or lumpectomy for diagnosis/treatment of the index breast cancer
Patient that is not suitable to cryoablation procedure according to the physician opinion
ER AND PR negative, or Her2 positive noted on pre-cryo biopsy
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There are 19 Locations for this study
Glendale Arizona, 85306, United States
Santa Ana California, 92705, United States
Trumbull Connecticut, 06611, United States
Dalton Georgia, 30720, United States
Indianapolis Indiana, 46202, United States
Detroit Michigan, 48201, United States
Flint Michigan, 48507, United States
Troy Michigan, 48085, United States
Freehold New Jersey, 07728, United States
Albuquerque New Mexico, 87114, United States
New York New York, 10011, United States
New York New York, 10032, United States
New York New York, 10065, United States
New York New York, 10467, United States
Cincinnati Ohio, 45227, United States
Cleveland Ohio, 44106, United States
Philadelphia Pennsylvania, 19107, United States
Germantown Tennessee, 38138, United States
Plano Texas, 75075, United States
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