Cryoablation Therapy in Treating Patients With Invasive Ductal Breast Cancer
This study is currently recruiting participants.
Verified February 2013 by National Cancer Institute (NCI)
Sponsor:
American College of Surgeons
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00723294
First received: July 25, 2008
Last updated: February 12, 2013
Last verified: February 2013
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Primary Purpose: Treatment |
| Official Title: | A Phase II Trial Exploring the Success of Cryoablation Therapy in the Treatment of Invasive Breast Carcinoma |
Resource links provided by NLM:
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: | March 2013 (Final data collection date for primary outcome measure) |
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
- 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 with not contact or jeopardize the implant
No lobular carcinoma, multifocal and/or multicentric ipsilateral breast cancer, multifocal calcifications, ductal carcinoma in situ (DCIS) with microinvasion, or invasive breast carcinoma
- 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 en bloc open surgical biopsy and/or lumpectomy for diagnosis/treatment of the index breast cancer
- Prior rotational and/or vacuum-assisted core biopsies allowed provided that 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
- 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, 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, Indiana | |
| Indiana University Melvin and Bren Simon Cancer Center | Recruiting |
| Indianapolis, Indiana, United States, 46202-5289 | |
| Contact: Clinical Trials Office - Indiana University Cancer Center 317-274-2552 | |
| United States, Maryland | |
| DeCesaris Cancer Institute at Anne Arundel Medical Center | Recruiting |
| Annapolis, Maryland, United States, 21401 | |
| Contact: Lorraine Tafra, MD 443-481-5300 | |
| United States, Michigan | |
| 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, Ohio | |
| Bethesda North Hospital | Recruiting |
| Cincinnati, Ohio, United States, 45242 | |
| Contact: Susan Weinberg 513-745-1111 | |
| United States, Pennsylvania | |
| Penn State Hershey Cancer Institute at Milton S. Hershey Medical Center | Recruiting |
| Hershey, Pennsylvania, United States, 17033-0850 | |
| Contact: Clinical Trials Office - Penn State Hershey Cancer Institute a 717-531-3779 CTO@hmc.psu.edu | |
| Lankenau Cancer Center at Lankenau Hospital | Recruiting |
| Wynnewood, Pennsylvania, United States, 19096 | |
| Contact: Ned Z. Carp, MD 610-642-1908 | |
| United States, Texas | |
| M. D. Anderson Cancer Center at University of Texas | Recruiting |
| Houston, Texas, United States, 77030-4009 | |
| Contact: Clinical Trials Office - M. D. Anderson Cancer Center at the U 713-792-3245 | |
| United States, Washington | |
| Bellingham Breast Center | Recruiting |
| Bellingham, Washington, United States, 98225 | |
| Contact: Cary S. Kaufman 360-671-9877 | |
Sponsors and Collaborators
American College of Surgeons
Investigators
| Study Chair: | Rache M. Simmons, MD | Weill Medical College of Cornell University |
More Information
Additional Information:
No publications provided
| Responsible Party: | David M. Ota, American College of Surgeons Oncology Group |
| ClinicalTrials.gov Identifier: | NCT00723294 History of Changes |
| Other Study ID Numbers: | CDR0000600976, ACOSOG-Z1072 |
| Study First Received: | July 25, 2008 |
| Last Updated: | February 12, 2013 |
| Health Authority: | Unspecified |
Keywords provided by National Cancer Institute (NCI):
|
invasive ductal breast carcinoma male breast cancer stage IA breast cancer stage IB breast cancer stage II breast cancer |
Additional relevant MeSH terms:
|
Breast Neoplasms Carcinoma, Ductal, Breast Neoplasms by Site Neoplasms Breast Diseases Skin Diseases |
Carcinoma, Ductal Adenocarcinoma Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms, Ductal, Lobular, and Medullary |
ClinicalTrials.gov processed this record on June 17, 2013