Cryoablation of Low Risk Small Breast Cancer- Ice3 Trial

Status: Closed to Accrual

Description

To evaluate the efficacy of cryoablation without lumpectomy and its impact on local and distant recurrence of early stage breast cancer .

Eligibility Criteria

Inclusion Criteria

  • 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
  • Age>= 50
  • 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.

Exclusion Criteria

  • 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) 4. Presence of multifocal and/or multicentric in breast cancer 5. Presence of multifocal calcifications 6. Presence of prior or concurrent neoadjuvant chemotherapy for breast cancer

Locations & Contacts

New York

Bronx
Montefiore Medical Center-Einstein Campus
Status: Active
Name Not Available

Trial Phase & Type

Trial Phase

No phase specified

Trial Type

Treatment

Lead Organization

Lead Organization
IceCure Medical Limited

Trial IDs

Primary ID ICMBC-02
Secondary IDs NCI-2015-00716
Clinicaltrials.gov ID NCT02200705