Cryoablation of Low Risk Small Breast Cancer- Ice3 Trial

I

IceCure Medical

Status

Active, not recruiting

Conditions

Breast Cancer

Treatments

Device: Ice-Sense3TM/ ProSenseTM

Study type

Interventional

Funder types

Industry

Identifiers

NCT02200705
ICMBC-02

Details and patient eligibility

About

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

Enrollment

208 patients

Sex

Female

Ages

50+ years old

Volunteers

No Healthy Volunteers

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)
  • 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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

208 participants in 1 patient group

single arm, open label
Other group
Description:
Early stage Breast cancers up to 1.5cm
Treatment:
Device: Ice-Sense3TM/ ProSenseTM

Trial contacts and locations

19

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Data sourced from clinicaltrials.gov

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