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

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

Genetics Home Reference related topics:

breast cancer

MedlinePlus related topics:

Breast Cancer Cancer

U.S. FDA Resources

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

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:	January 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 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

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

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

Study ID Numbers:	CDR0000600976, ACOSOG-Z1072
First Received:	July 25, 2008
Last Updated:	October 22, 2008
ClinicalTrials.gov Identifier:	NCT00723294
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

Adenocarcinoma

Breast Diseases

Neoplasms, Glandular and Epithelial

Carcinoma

Additional relevant MeSH terms:

Neoplasms

Neoplasms by Histologic Type

Neoplasms by Site

Neoplasms, Ductal, Lobular, and Medullary

ClinicalTrials.gov processed this record on October 24, 2008

Sponsors and Collaborators:	American College of Surgeons National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00723294