Cryoablation Therapy in Treating Patients With Invasive Ductal Breast Cancer

Study Description

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Brief 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.

Condition or disease	Intervention/treatment	Phase
Breast Cancer	Procedure: cryosurgery; Procedure: therapeutic conventional surgery	Phase 2

Detailed Description:

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

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	99 participants
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	A Phase II Trial Exploring the Success of Cryoablation Therapy in the Treatment of Invasive Breast Carcinoma
Study Start Date :	September 2008
Actual Primary Completion Date :	September 2013

Arms and Interventions

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Arm

Intervention/treatment

Experimental: Treatment (cryoablation); 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.

Procedure: cryosurgery Procedure: therapeutic conventional surgery

Outcome Measures

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Primary Outcome Measures :

1. Rate of Complete Tumor Ablation [ Time Frame: Up to 14 days post surgery ]
   The primary endpoint for this study is the rate of complete ablation. Complete ablation is defined as no remaining invasive or in situ carcinoma present upon pathological examination of the targeted lesion. The rate (percentage) will be computed as the number of patient lesions with complete tumor ablation divided by the total number of eligible patient lesions. This rate will be estimated by the binomial point estimate (number of patients with no pathological evidence of residual disease in the targeted lesion after ablation divided by the number of eligible patients) and a one-sided 90% binomial confidence interval (interval with a lower bound).

Secondary Outcome Measures :

1. Negative Predictive Value of MRI [ Time Frame: Up to 14 days post cryoablation ]
   Negative predictive value of MRI: The negative predictive rate of MRI will be estimated as the number of patients with no residual disease upon pathologic review of the resected tissue AND with a MRI that indicated no residual disease divided by the number of patients who had an MRI that indicated no residual disease. Both a binomial point estimate and 90% two-sided confidence interval will be computed.
2. Adverse Events [ Time Frame: Up to 14 days post surgery ]
3. Pain Assessment [ Time Frame: Up to 14 days post surgery ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

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Locations

United States, California
Providence Saint Joseph Medical Center
Burbank, California, United States, 91505
United States, Connecticut
Bridgeport Hospital
Bridgeport, Connecticut, United States, 06610
United States, Florida
University of South Florida College of Medicine
Tampa, Florida, United States, 33612
United States, Illinois
Northwest Community Hospital
Arlington Heights, Illinois, United States, 60005
United States, Indiana
Indiana University Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, United States, 46202-5289
Indiana University Hospital/Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, United States, 46202
United States, Maryland
DeCesaris Cancer Institute at Anne Arundel Medical Center
Annapolis, Maryland, United States, 21401
United States, Michigan
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States, 48109-0942
Henry Ford Hospital
Detroit, Michigan, United States, 48202
William Beaumont Hospital-Royal Oak
Royal Oak, Michigan, United States, 48073
United States, New York
New York Weill Cornell Cancer Center at Cornell University
New York, New York, United States, 10021
United States, Ohio
Bethesda North Hospital
Cincinnati, Ohio, United States, 45242
United States, Pennsylvania
Penn State Hershey Cancer Institute at Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States, 17033-0850
Lankenau Cancer Center at Lankenau Hospital
Wynnewood, Pennsylvania, United States, 19096
United States, Texas
M. D. Anderson Cancer Center at University of Texas
Houston, Texas, United States, 77030-4009
United States, Washington
Bellingham Breast Center
Bellingham, Washington, United States, 98225

Sponsors and Collaborators

Alliance for Clinical Trials in Oncology

National Cancer Institute (NCI)

Investigators

Study Chair:	Rache M. Simmons, MD	Weill Medical College of Cornell University

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications of Results:

Simmons RM, Ballman KV, Cox C, Carp N, Sabol J, Hwang RF, Attai D, Sabel M, Nathanson D, Kenler A, Gold L, Kaufman C, Han L, Bleznak A, Stanley Smith J, Holmes D, Fornage B, Le-Petross C, Hoda S, McCall L, Hunt KK; ACOSOG investigators. A Phase II Trial Exploring the Success of Cryoablation Therapy in the Treatment of Invasive Breast Carcinoma: Results from ACOSOG (Alliance) Z1072. Ann Surg Oncol. 2016 Aug;23(8):2438-45. doi: 10.1245/s10434-016-5275-3. Epub 2016 May 24.

Responsible Party:	Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier:	NCT00723294 History of Changes
Other Study ID Numbers:	ACOSOG-Z1072; CDR0000600976
First Posted:	July 28, 2008
Results First Posted:	March 7, 2017
Last Update Posted:	August 14, 2017
Last Verified:	June 2017

Keywords provided by Alliance for Clinical Trials in Oncology:

invasive ductal breast carcinoma; male breast cancer; stage IA breast cancer; stage IB breast cancer; stage II breast cancer

Additional relevant MeSH terms:

Breast Neoplasms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases