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A Phase II Trial Exploring the Success of Cryoablation Therapy in the Treatment of Invasive Breast Carcinoma

Phase 2
Open (Enrolling)
Breast Cancer

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Trial Information

A Phase II Trial Exploring the Success of Cryoablation Therapy in the Treatment of Invasive Breast Carcinoma



- To determine the rate of complete tumor ablation in patients with invasive ductal
breast carcinoma treated with cryoablation.


- To evaluate the negative predictive value of MRI in the post-ablation setting in
detecting residual in situ or invasive breast carcinoma.

- To describe the adverse events associated with cryoablation in these patients.

- To prospectively gather pain assessment data before and after cryoablation and after
surgical resection in these patients.

- To explore technical variables that may affect the success of cryoablation in these

OUTLINE: This is a multicenter study.

A cryoprobe is inserted percutaneously under ultrasound guidance into the targeted lesion.
Patients undergo ablation using a freeze-thaw-freeze cycle lasting approximately 6-10-6 or
8-10-8 minutes, respectively. Patients undergo surgical resection and sentinel lymph node
biopsy and/or axillary dissection within 28 days after completion of cryoablation.

Patients complete the Brief Pain Inventory before and after cryoablation and after surgery.

After completion of study treatment, patients are followed within 14 days.

Inclusion Criteria


- Diagnosis of invasive ductal breast carcinoma by core needle biopsy, meeting the
following criteria:

- Unifocal primary disease

- Tumor size ≤ 2.0 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

- Tumor enhancement on baseline MRI

- Tumor with < 25% intraductal components in the aggregate

- Breast size adequate for safe cryoablation

- 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 with not contact or jeopardize the implant

- No lobular carcinoma, multifocal and/or multicentric ipsilateral breast cancer,
multifocal calcifications, ductal carcinoma in situ (DCIS) with microinvasion, or
invasive breast carcinoma

- Contralateral disease allowed

- HER2/neu status and Oncotype DX status (if needed) known

- Hormone receptor status:

- Estrogen receptor and progesterone receptor status known


- Menopausal status not specified

- Not pregnant or nursing

- Negative pregnancy test


- No prior en bloc open surgical biopsy and/or lumpectomy for diagnosis/treatment of
the index breast cancer

- Prior rotational and/or vacuum-assisted core biopsies allowed provided that 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

- No prior or concurrent neoadjuvant chemotherapy for breast cancer

Type of Study:


Study Design:

Allocation: Non-Randomized, Primary Purpose: Treatment

Outcome Measure:

Rate of complete tumor ablation

Safety Issue:


Principal Investigator

Rache M. Simmons, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Weill Medical College of Cornell University



Study ID:




Start Date:

September 2008

Completion Date:

Related Keywords:

  • Breast Cancer
  • invasive ductal breast carcinoma
  • male breast cancer
  • stage IA breast cancer
  • stage IB breast cancer
  • stage II breast cancer
  • Breast Neoplasms
  • Carcinoma, Ductal, Breast



University of Michigan Comprehensive Cancer Center Ann Arbor, Michigan  48109-0752
Bridgeport Hospital Bridgeport, Connecticut  06610
Northwest Community Hospital Arlington Heights, Illinois  60005
New York Weill Cornell Cancer Center at Cornell University New York, New York  10021
Indiana University Melvin and Bren Simon Cancer Center Indianapolis, Indiana  46202-5289
M. D. Anderson Cancer Center at University of Texas Houston, Texas  77030-4009
Lankenau Cancer Center at Lankenau Hospital Wynnewood, Pennsylvania  19096
DeCesaris Cancer Institute at Anne Arundel Medical Center Annapolis, Maryland  21401
Penn State Hershey Cancer Institute at Milton S. Hershey Medical Center Hershey, Pennsylvania  17033-0850
Bethesda North Hospital Cincinnati, Ohio  45242
Bellingham Breast Center Bellingham, Washington  98225