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Clinical Information

ACOSOG Z1072

In 2016, the Annals of Surgical Oncology published the results of the National Cancer Institute (NCI) Sponsored study ACOSOG (Alliance) Z1072 Phase II, single arm non-randomized study in the treatment of invasive breast disease. This study evaluated the rate of complete tumor ablation. The Visica® 2 Treatment System was the exclusive device used in this landmark study.

Study Design

  • Patients were treated with cryoablation
  • Eligible patients included those with univocal invasive ductal breast cancer ≤2.0 cm, with <25% intraductal component and tumor enhancement on MRI
  • A total of 19 centers contributed 99 patients, of which 86 patients (87 breast cancers) were evaluable for data analysis

Results

  • 100% ablation in all tumors <1.0 cm in size, defined as no remaining invasive breast cancer (IBC) or ductal carcinoma in situ (DCIS) on pathological examination of the tumor
  • Cryoablation was effective in 92% of all targeted tumors
  • No cases were categorized as ineffective ablation within the cryoablation zone (all cancer cells within the treatment zone were killed)

To review the Z1072 abstract, please click here

Current Clinical Study: FROST

Sanarus Technologies is sponsoring a multi-center clinical study (FROST), A Study of Cryoablation in the Management of Early Stage Breast Cancer, for patients who prefer an alternative to surgery. This is a phase II clinical study of Z1072. To learn more about the FROST clinical study, please click here.

Where to learn more

For more information about clinical trials, visit: Understanding Clinical Trials

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