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Cryoablation Therapy in Treating Patients With Invasive Ductal Breast Cancer

Primary Purpose

Breast Cancer

Status

Unknown status

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

cryosurgery

therapeutic conventional surgery

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring invasive ductal breast carcinoma, male breast cancer, stage IA breast cancer, stage IB breast cancer, stage II breast cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.
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.
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.
Tumor enhancement on pre-study MRI.
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.
No prior or planned neoadjuvant chemotherapy for breast cancer.
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.
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.
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.

Sites / Locations

Providence Saint Joseph Medical Center
Bridgeport Hospital
University of South Florida College of Medicine
Northwest Community Hospital
Indiana University Melvin and Bren Simon Cancer Center
Indiana University Hospital/Melvin and Bren Simon Cancer Center
DeCesaris Cancer Institute at Anne Arundel Medical Center
University of Michigan Comprehensive Cancer Center
Henry Ford Hospital
William Beaumont Hospital-Royal Oak
New York Weill Cornell Cancer Center at Cornell University
Bethesda North Hospital
Penn State Hershey Cancer Institute at Milton S. Hershey Medical Center
Lankenau Cancer Center at Lankenau Hospital
M. D. Anderson Cancer Center at University of Texas
Bellingham Breast Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment (cryoablation)

Arm Description

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.

Outcomes

Primary Outcome Measures

Rate of Complete Tumor Ablation

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

Negative Predictive Value of MRI

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.

Adverse Events

Pain Assessment

Full Information

NCT ID

NCT00723294

First Posted

July 25, 2008

Last Updated

June 30, 2017

Sponsor

Alliance for Clinical Trials in Oncology

Collaborators

National Cancer Institute (NCI)

1. Study Identification

Unique Protocol Identification Number

NCT00723294

Brief Title

Cryoablation Therapy in Treating Patients With Invasive Ductal Breast Cancer

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2017

Overall Recruitment Status

Unknown status

Study Start Date

September 2008 (undefined)

Primary Completion Date

September 2013 (Actual)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Alliance for Clinical Trials in Oncology

Collaborators

National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Breast Cancer

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

99 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Treatment (cryoablation)

Arm Type

Experimental

Arm Description

Intervention Type

Procedure

Intervention Name(s)

cryosurgery

Intervention Type

Procedure

Intervention Name(s)

therapeutic conventional surgery

Primary Outcome Measure Information:

Title

Rate of Complete Tumor Ablation

Description

Time Frame

Up to 14 days post surgery

Secondary Outcome Measure Information:

Title

Negative Predictive Value of MRI

Description

Time Frame

Up to 14 days post cryoablation

Title

Adverse Events

Time Frame

Up to 14 days post surgery

Title

Pain Assessment

Time Frame

Up to 14 days post surgery

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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. 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. 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. Tumor enhancement on pre-study MRI. 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. No prior or planned neoadjuvant chemotherapy for breast cancer. 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. 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. 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Rache M. Simmons, MD

Organizational Affiliation

Weill Medical College of Cornell University

Official's Role

Study Chair

Facility Information:

Facility Name

Providence Saint Joseph Medical Center

City

Burbank

State/Province

California

ZIP/Postal Code

91505

Country

United States

Facility Name

Bridgeport Hospital

City

Bridgeport

State/Province

Connecticut

ZIP/Postal Code

06610

Country

United States

Facility Name

University of South Florida College of Medicine

City

Tampa

State/Province

Florida

ZIP/Postal Code

33612

Country

United States

Facility Name

Northwest Community Hospital

City

Arlington Heights

State/Province

Illinois

ZIP/Postal Code

60005

Country

United States

Facility Name

Indiana University Melvin and Bren Simon Cancer Center

City

Indianapolis

State/Province

Indiana

ZIP/Postal Code

46202-5289

Country

United States

Facility Name

Indiana University Hospital/Melvin and Bren Simon Cancer Center

City

Indianapolis

State/Province

Indiana

ZIP/Postal Code

46202

Country

United States

Facility Name

DeCesaris Cancer Institute at Anne Arundel Medical Center

City

Annapolis

State/Province

Maryland

ZIP/Postal Code

21401

Country

United States

Facility Name

University of Michigan Comprehensive Cancer Center

City

Ann Arbor

State/Province

Michigan

ZIP/Postal Code

48109-0942

Country

United States

Facility Name

Henry Ford Hospital

City

Detroit

State/Province

Michigan

ZIP/Postal Code

48202

Country

United States

Facility Name

William Beaumont Hospital-Royal Oak

City

Royal Oak

State/Province

Michigan

ZIP/Postal Code

48073

Country

United States

Facility Name

New York Weill Cornell Cancer Center at Cornell University

City

New York

State/Province

New York

ZIP/Postal Code

10021

Country

United States

Facility Name

Bethesda North Hospital

City

Cincinnati

State/Province

Ohio

ZIP/Postal Code

45242

Country

United States

Facility Name

Penn State Hershey Cancer Institute at Milton S. Hershey Medical Center

City

Hershey

State/Province

Pennsylvania

ZIP/Postal Code

17033-0850

Country

United States

Facility Name

Lankenau Cancer Center at Lankenau Hospital

City

Wynnewood

State/Province

Pennsylvania

ZIP/Postal Code

19096

Country

United States

Facility Name

M. D. Anderson Cancer Center at University of Texas

City

Houston

State/Province

Texas

ZIP/Postal Code

77030-4009

Country

United States

Facility Name

Bellingham Breast Center

City

Bellingham

State/Province

Washington

ZIP/Postal Code

98225

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

27221361

Citation

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.

Results Reference

result

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Cryoablation Therapy in Treating Patients With Invasive Ductal Breast Cancer

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