Cryoablation for Invasive Breast Carcinoma Following Neoadjuvant Therapy

Stopped early · Phase 2

Conditions studied: Breast Cancer

In brief

Cryoablation is a procedure that uses a hollow, thin tube called a cryoprobe to freeze and destroy cancer tissue. The goal of this clinical research study is to learn about the level of effectiveness of using ultrasound-guided cryoablation in patients with invasive breast cancer. The safety of this procedure will also be studied.

Key facts

Study ID

NCT01388777

Run by

M.D. Anderson Cancer Center

People needed

1

Starts

2012-01-24

Expected to finish

2017-06-14

Last updated by the study team

2018-07-17

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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 ductal carcinoma in situ (DCIS) with microinvasion are NOT eligible. Patients with contralateral disease will remain eligible.
• Neoadjuvant chemotherapy or hormonal therapy for the index tumor is required.
• Residual 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 mammogram, ultrasound or MRI will be used to determine eligibility.
• Tumor enhancement on pre-registration MRI.
• Tumor with <25% intraductal components in the aggregate.
• 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.
• 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.

You may not qualify if…

• History of open surgical biopsy and/or lumpectomy for diagnosis/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.
• Pregnant and/or 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.
• Patient has contra-indication to an MRI examination, such as clips/prostheses/implants that are not MRI compatible, or compromised renal function, with a measured or calculated glomerular filtration rate of 60ml/min/1.73m\^2
• Patients less than 18 years of age will not be included in this study.

Where it is running

• University of Texas MD Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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