Cryoablation Therapy in Treating Patients With Invasive Ductal Breast Cancer

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00723294
• Other study ID #: ACOSOG-Z1072
• Secondary ID: CDR0000600976
• Status: Active, not recruiting
• Phase: Phase 2
• First received: July 25, 2008
• Last updated: June 6, 2016
• Start date: September 2008

Study information

• Verified date: June 2016
• Source: Alliance for Clinical Trials in Oncology
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Central Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 99
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Carcinoma, Ductal, Breast

Intervention

Procedure:
• cryosurgery

• therapeutic conventional surgery

Locations

Country	Name	City	State
United States	University of Michigan Comprehensive Cancer Center	Ann Arbor	Michigan
United States	DeCesaris Cancer Institute at Anne Arundel Medical Center	Annapolis	Maryland
United States	Northwest Community Hospital	Arlington Heights	Illinois
United States	Bellingham Breast Center	Bellingham	Washington
United States	Bridgeport Hospital	Bridgeport	Connecticut
United States	Providence Saint Joseph Medical Center	Burbank	California
United States	Bethesda North Hospital	Cincinnati	Ohio
United States	Henry Ford Hospital	Detroit	Michigan
United States	Penn State Hershey Cancer Institute at Milton S. Hershey Medical Center	Hershey	Pennsylvania
United States	M. D. Anderson Cancer Center at University of Texas	Houston	Texas
United States	Indiana University Hospital/Melvin and Bren Simon Cancer Center	Indianapolis	Indiana
United States	Indiana University Melvin and Bren Simon Cancer Center	Indianapolis	Indiana
United States	New York Weill Cornell Cancer Center at Cornell University	New York	New York
United States	William Beaumont Hospital-Royal Oak	Royal Oak	Michigan
United States	University of South Florida College of Medicine	Tampa	Florida
United States	Lankenau Cancer Center at Lankenau Hospital	Wynnewood	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Alliance for Clinical Trials in Oncology	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of complete tumor ablation		Up to 14 days post surgery	No
Secondary	Negative predictive value of MRI		Up to 14 days post cryoablation	No
Secondary	Adverse Events		Up to 14 days post surgery	Yes
Secondary	Pain assessment		Up to 14 days post surgery	No