Cryoablation Therapy in Treating Patients With Invasive Ductal Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: cryosurgery; therapeutic conventional surgery
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 99.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: invasive ductal breast carcinoma; male breast cancer; stage IA breast cancer; stage IB breast cancer; stage II breast cancer

Summary:

      This phase II trial is studying how well cryoablation therapy works in treating patients with
      invasive ductal breast cancer. Cryoablation kills tumor cells by freezing them. This may be
      an effective treatment for patients with invasive ductal breast cancer.
    

Eligibility criteria:

        1. Unifocal primary invasive ductal breast carcinoma diagnosed by core needle biopsy.
             NOTE: Patients with lobular carcinoma, multifocal and/or multicentric ipsilateral
             breast cancer, multifocal calcifications, or DCIS with microinvasion are NOT eligible.
             Patients with contralateral disease will remain eligible.

          2. No history of en bloc open surgical biopsy and/or lumpectomy for diagnostic/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.

          3. 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.

          4. Tumor enhancement on pre-study MRI.

          5. Tumor with < 25% intraductal components in the aggregate. NOTE: The percent
             intraductal component from the patient's diagnostic biopsy must be available prior to
             registration. If the biopsy pathology report does not contain the percent intraductal
             component, then re-review of pathology slides and creation of a report addendum or
             note-to-file by the reviewing pathologist will be required.

          6. No prior or planned neoadjuvant chemotherapy for breast cancer.

          7. Non-pregnant and non-lactating. Patients of childbearing potential must have a
             negative serum or urine pregnancy test. NOTE: Peri-menopausal women must be
             amenorrheic for > 12 months to be considered not of childbearing potential.

          8. 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. NOTE: 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.

          9. 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.