Cryoablation Therapy in Treating Patients With Invasive Ductal Breast Cancer

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

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.

Study Overview

• Status: Unknown
• Conditions: Breast Cancer
• Intervention / Treatment: Procedure: therapeutic conventional surgery; Procedure: cryosurgery

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

• Study Type: Interventional
• Enrollment (Actual): 99
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • Burbank, California, United States, 91505
      • Providence Saint Joseph Medical Center
  • Connecticut
    • Bridgeport, Connecticut, United States, 06610
      • Bridgeport Hospital
  • Florida
    • Tampa, Florida, United States, 33612
      • University of South Florida College of Medicine
  • Illinois
    • Arlington Heights, Illinois, United States, 60005
      • Northwest Community Hospital
  • Indiana
    • Indianapolis, Indiana, United States, 46202-5289
      • Indiana University Melvin and Bren Simon Cancer Center
    • Indianapolis, Indiana, United States, 46202
      • Indiana University Hospital/Melvin and Bren Simon Cancer Center
  • Maryland
    • Annapolis, Maryland, United States, 21401
      • DeCesaris Cancer Institute at Anne Arundel Medical Center
  • Michigan
    • Ann Arbor, Michigan, United States, 48109-0942
      • University of Michigan Comprehensive Cancer Center
    • Detroit, Michigan, United States, 48202
      • Henry Ford Hospital
    • Royal Oak, Michigan, United States, 48073
      • William Beaumont Hospital-Royal Oak
  • New York
    • New York, New York, United States, 10021
      • New York Weill Cornell Cancer Center at Cornell University
  • Ohio
    • Cincinnati, Ohio, United States, 45242
      • Bethesda North Hospital
  • Pennsylvania
    • Hershey, Pennsylvania, United States, 17033-0850
      • Penn State Hershey Cancer Institute at Milton S. Hershey Medical Center
    • Wynnewood, Pennsylvania, United States, 19096
      • Lankenau Cancer Center at Lankenau Hospital
  • Texas
    • Houston, Texas, United States, 77030-4009
      • M. D. Anderson Cancer Center at University of Texas
  • Washington
    • Bellingham, Washington, United States, 98225
      • Bellingham Breast Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Treatment (cryoablation); 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.

Procedure: therapeutic conventional surgery; Procedure: cryosurgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	Up to 14 days post surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Up to 14 days post cryoablation
Adverse Events		Up to 14 days post surgery
Pain Assessment		Up to 14 days post surgery

Collaborators and Investigators

• Sponsor: Alliance for Clinical Trials in Oncology
• Collaborators: National Cancer Institute (NCI)
• Investigators: Study Chair: Rache M. Simmons, MD, Weill Medical College of Cornell University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: September 1, 2008
• Primary Completion (Actual): September 1, 2013

Study Registration Dates

• First Submitted: July 25, 2008
• First Submitted That Met QC Criteria: July 25, 2008
• First Posted (Estimate): July 28, 2008

Study Record Updates

• Last Update Posted (Actual): August 14, 2017
• Last Update Submitted That Met QC Criteria: June 30, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Keywords: male breast cancer; stage II breast cancer; stage IA breast cancer; stage IB breast cancer; invasive ductal breast carcinoma
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: ACOSOG-Z1072; CDR0000600976