Cryoablation Therapy in Treating Patients With Invasive Ductal Breast Cancer



Status:Recruiting
Conditions:Breast Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:11/23/2013
Start Date:September 2008
Contact:Rache Simmons, M.D.
Phone:212-821-0870

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


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.


This is a phase II non-randomized exploratory study. All fully eligible and registered
patients will undergo imaging by mammography, ultrasound, and breast MRI. Patients will then
undergo complete surgical resection of the primary tumor. The primary and secondary
objectives of the study are described below.

OBJECTIVES:

Primary

- To determine the rate of complete tumor ablation in patients treated with cryoablation,
with complete tumor ablation defined as no remaining invasive or in situ carcinoma
present upon pathological examination of the targeted lesion

Secondary

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

- To describe the adverse events associated with cryoablation

- To prospectively gather pain assessment data on cryoablation and surgical resection

- Explore technical variables that may affect the success of cryoablation

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.
We found this trial at
16
sites
100 E Lancaster Ave
Wynnewood, Pennsylvania 19096
(484) 476-2000
Lankenau Cancer Center at Lankenau Hospital At Lankenau we pride ourselves on the breadth of...
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Wynnewood, PA
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500 University Drive
Hershey, Pennsylvania 17033
(717) 531-8521
Penn State Hershey Cancer Institute at Milton S. Hershey Medical Center Penn State Milton S....
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Hershey, PA
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1300 York Avenue # A421
New York, New York 10065
New York Weill Cornell Cancer Center at Cornell University Welcome to the Division of Hematology...
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New York, NY
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Tampa, FL
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1500 East Medical Center Drive
Ann Arbor, Michigan 48109
800-865-1125
University of Michigan Comprehensive Cancer Center The U-M Comprehensive Cancer Center's mission is the conquest...
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Ann Arbor, MI
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Annapolis, MD
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Arlington Heights, Illinois 60005
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Arlington Heights, IL
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Bellingham, Washington 98225
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Bellingham, WA
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Bridgeport, Connecticut 06610
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Bridgeport, CT
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501 S Buena Vista St
Burbank, California 91505
(818) 843-5111
Providence Saint-Joseph Medical Center Located just north of Los Angeles, Providence Saint Joseph Medical Center...
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Burbank, CA
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Cincinnati, Ohio 45242
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Cincinnati, OH
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2799 W Grand Blvd
Detroit, Michigan 48202
(313) 916-2600
Henry Ford Hospital Founded in 1915 by auto pioneer Henry Ford and now one of...
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Detroit, MI
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1515 Holcombe Blvd
Houston, Texas 77030
 713-792-2121
University of Texas M.D. Anderson Cancer Center The mission of The University of Texas MD...
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Houston, TX
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535 Barnhill Dr
Indianapolis, Indiana 46202
(888) 600-4822
Indiana University Melvin and Bren Simon Cancer Center At the IU Simon Cancer Center, more...
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Indianapolis, IN
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Indianapolis, IN
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3601 W 13 Mile Rd
Royal Oak, Michigan 48073
(248) 898-5000
William Beaumont Hospital-Royal Oak The largest Beaumont Hospital is located at 3601 W Thirteen Mile...
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Royal Oak, MI
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