Cryoablation Therapy in Treating Patients With Invasive Ductal Breast Cancer - Full Text View

Sponsor:	American College of Surgeons
Collaborator:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00723294

Purpose

RATIONALE: Cryoablation kills tumor cells by freezing them. This may be an effective treatment for patients with invasive ductal breast cancer.

PURPOSE: This phase II trial is studying how well cryoablation therapy works in treating patients with invasive ductal breast cancer.

Condition	Intervention	Phase
Breast Cancer	Procedure: cryosurgery Procedure: therapeutic conventional surgery	Phase II

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Primary Purpose: Treatment
Official Title:	A Phase II Trial Exploring the Success of Cryoablation Therapy in the Treatment of Invasive Breast Carcinoma

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Rate of complete tumor ablation [ Designated as safety issue: No ]

Secondary Outcome Measures:

Negative predictive value of MRI [ Designated as safety issue: No ]
Adverse events [ Designated as safety issue: Yes ]
Pain assessment [ Designated as safety issue: No ]

Estimated Enrollment:	99
Study Start Date:	September 2008
Primary Completion Date:	August 2010 (Final data collection date for primary outcome measure)

Detailed Description:

OBJECTIVES:

Primary

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

Secondary

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 patients.

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.

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

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

PATIENT CHARACTERISTICS:

Menopausal status not specified
Not pregnant or nursing
Negative pregnancy test

PRIOR CONCURRENT THERAPY:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00723294

Locations

United States, California
Roy and Patricia Disney Family Cancer Center at Providence Saint Joseph Medical Center	Recruiting
Burbank, California, United States, 91505
Contact: Clinical Trials Office - Providence Saint Joseph Medical Cente 818-847-3220
USC/Norris Comprehensive Cancer Center and Hospital	Recruiting
Los Angeles, California, United States, 90089-9181
Contact: Clinical Trials Office - USC/Norris Comprehensive Cancer Cente 323-865-0451
United States, Connecticut
Bridgeport Hospital	Recruiting
Bridgeport, Connecticut, United States, 06610
Contact: Clinical Trials Office - Bridgeport Hospital 203-384-4869
United States, Florida
Bethesda Comprehensive Cancer Care Center at Bethesda Memorial Hospital	Recruiting
Boynton Beach, Florida, United States, 33435
Contact: Clinical Trials Office - Bethesda Comprehensive Cancer Care Ce 561-374-5020
University of South Florida	Recruiting
Tampa, Florida, United States, 33612
Contact: Charles E. Cox, MD, FACS 813-745-8480
United States, Illinois
Northwest Community Hospital	Recruiting
Arlington Heights, Illinois, United States, 60005
Contact: Michael R. Kinney 847-618-6660
United States, Maryland
DeCesaris Cancer Institute at Anne Arundel Medical Center	Recruiting
Annapolis, Maryland, United States, 21401
Contact: Lorraine Tafra, MD 443-481-5300
United States, Michigan
Josephine Ford Cancer Center at Henry Ford Hospital	Recruiting
Detroit, Michigan, United States, 48202
Contact: S. David Nathanson, MD 313-916-2917
William Beaumont Hospital - Royal Oak Campus	Recruiting
Royal Oak, Michigan, United States, 48073
Contact: Clinical Trials Office - William Beaumont Hospital - Royal Oak 248-551-7695
United States, New York
New York Weill Cornell Cancer Center at Cornell University	Recruiting
New York, New York, United States, 10021
Contact: Clinical Trials Office - New York Weill Cornell Cancer Center 212-746-1848
United States, Ohio
Bethesda North Hospital	Recruiting
Cincinnati, Ohio, United States, 45242
Contact: Susan Weinberg 513-745-1111
United States, Pennsylvania
Penn State Hershey Cancer Institute at Milton S. Hershey Medical Center	Recruiting
Hershey, Pennsylvania, United States, 17033-0850
Contact: Clinical Trials Office - Penn State Hershey Cancer Institute a 717-531-3779 CTO@hmc.psu.edu
Lankenau Cancer Center at Lankenau Hospital	Recruiting
Wynnewood, Pennsylvania, United States, 19096
Contact: Ned Z. Carp, MD 610-642-1908
United States, Texas
M. D. Anderson Cancer Center at University of Texas	Recruiting
Houston, Texas, United States, 77030-4009
Contact: Clinical Trials Office - M. D. Anderson Cancer Center at the U 713-792-3245
United States, Virginia
Bon Secours Cancer Institute - Virginia Breast Center	Recruiting
Midlothian, Virginia, United States, 23114
Contact: James V. Pellicane, Jr. 804-594-3130

Sponsors and Collaborators

American College of Surgeons

National Cancer Institute (NCI)

Investigators

Study Chair:

Rache M. Simmons, MD

Weill Medical College of Cornell University

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	David M. Ota, American College of Surgeons Oncology Group
ClinicalTrials.gov Identifier:	NCT00723294 History of Changes
Other Study ID Numbers:	CDR0000600976, ACOSOG-Z1072
Study First Received:	July 25, 2008
Last Updated:	January 24, 2012
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

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
Carcinoma, Ductal, Breast
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

Carcinoma, Ductal
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Ductal, Lobular, and Medullary

ClinicalTrials.gov processed this record on February 09, 2012