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

Sponsors and Collaborators:	American College of Surgeons 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:	Treatment, Non-Randomized
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 Surgery

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
Estimated Primary Completion Date:	September 2009 (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
No lobular carcinoma, multifocal and/or multicentric ipsilateral breast cancer, multifocal calcifications, or ductal carcinoma in situ (DCIS) with microinvasion
- 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 rotational vacuum assisted core biopsies, en bloc open surgical biopsy, and/or lumpectomy for diagnosis/treatment of the index breast cancer
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
Center for Breast Care, Incorporated	Recruiting
Glendale, California, United States, 91204
Contact: Deanna J. Attai, MD, FACS 818-243-5640
Providence Saint Joseph Medical Center - Burbank	Recruiting
Burbank, California, United States, 91505
Contact: Clinical Trials Office - Providence Saint Joseph Medical Cente 818-847-3220
United States, Connecticut
Bridgeport Hospital	Recruiting
Bridgeport, Connecticut, United States, 06610
Contact: Clinical Trials Office - Bridgeport Hospital 203-384-4869
United States, Illinois
Northwest Community Hospital	Recruiting
Arlington Heights, Illinois, United States, 60005
Contact: Michael R. Kinney 847-618-6660
United States, Michigan
Genesys Regional Medical Center	Recruiting
Grand Blanc, Michigan, United States, 48439
Contact: Linsey P. Gold 810-606-5000
University of Michigan Comprehensive Cancer Center	Recruiting
Ann Arbor, Michigan, United States, 48109-0942
Contact: Clinical Trials Office - University of Michigan Comprehensive 800-865-1125
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, Pennsylvania
Lankenau Cancer Center at Lankenau Hospital	Recruiting
Wynnewood, Pennsylvania, United States, 19096
Contact: Paul B. Gilman, MD 610-645-2000
Penn State Cancer Institute at Milton S. Hershey Medical Center	Recruiting
Hershey, Pennsylvania, United States, 17033-0850
Contact: Clinical Trials Office - Penn State Cancer Institute at Milton 717-531-3779 CTO@hmc.psu.edu

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:	American College of Surgeons Oncology Group ( David M. Ota )
Study ID Numbers:	CDR0000600976, ACOSOG-Z1072
Study First Received:	July 25, 2008
Last Updated:	July 25, 2009
ClinicalTrials.gov Identifier:	NCT00723294 History of Changes
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

invasive ductal breast carcinoma
male breast cancer
stage I breast cancer
stage II breast cancer

Study placed in the following topic categories:

Carcinoma, Ductal
Skin Diseases
Breast Neoplasms, Male
Breast Neoplasms
Carcinoma, Ductal, Breast

Breast Cancer, Male
Adenocarcinoma
Breast Diseases
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:

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

Carcinoma, Ductal, Breast
Neoplasms, Ductal, Lobular, and Medullary
Adenocarcinoma
Breast Diseases
Neoplasms, Glandular and Epithelial
Carcinoma

ClinicalTrials.gov processed this record on September 11, 2009