Cryoablation Therapy in Treating Patients With Invasive Ductal Breast Cancer
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT00723294 |
|
Recruitment Status :
Active, not recruiting
First Posted : July 28, 2008
Results First Posted : March 7, 2017
Last Update Posted : August 14, 2017
|
Sponsor:
Alliance for Clinical Trials in Oncology
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Breast Cancer | Procedure: cryosurgery Procedure: therapeutic conventional surgery | Phase 2 |
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 (Clinical Trial) |
| Actual Enrollment : | 99 participants |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | A Phase II Trial Exploring the Success of Cryoablation Therapy in the Treatment of Invasive Breast Carcinoma |
| Study Start Date : | September 2008 |
| Actual Primary Completion Date : | September 2013 |
Resource links provided by the National Library of Medicine
Genetics Home Reference related topics:
Breast cancer
MedlinePlus related topics:
Breast Cancer
| 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: cryosurgery Procedure: therapeutic conventional surgery |
Primary Outcome Measures :
- Rate of Complete Tumor Ablation [ Time Frame: Up to 14 days post surgery ]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 [ Time Frame: Up to 14 days post cryoablation ]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 [ Time Frame: Up to 14 days post surgery ]
- Pain Assessment [ Time Frame: Up to 14 days post surgery ]
Information from the National Library of Medicine
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00723294
Locations
| United States, California | |
| Providence Saint Joseph Medical Center | |
| Burbank, California, United States, 91505 | |
| United States, Connecticut | |
| Bridgeport Hospital | |
| Bridgeport, Connecticut, United States, 06610 | |
| United States, Florida | |
| University of South Florida College of Medicine | |
| Tampa, Florida, United States, 33612 | |
| United States, Illinois | |
| Northwest Community Hospital | |
| Arlington Heights, Illinois, United States, 60005 | |
| United States, Indiana | |
| Indiana University Melvin and Bren Simon Cancer Center | |
| Indianapolis, Indiana, United States, 46202-5289 | |
| Indiana University Hospital/Melvin and Bren Simon Cancer Center | |
| Indianapolis, Indiana, United States, 46202 | |
| United States, Maryland | |
| DeCesaris Cancer Institute at Anne Arundel Medical Center | |
| Annapolis, Maryland, United States, 21401 | |
| United States, Michigan | |
| University of Michigan Comprehensive Cancer Center | |
| Ann Arbor, Michigan, United States, 48109-0942 | |
| Henry Ford Hospital | |
| Detroit, Michigan, United States, 48202 | |
| William Beaumont Hospital-Royal Oak | |
| Royal Oak, Michigan, United States, 48073 | |
| United States, New York | |
| New York Weill Cornell Cancer Center at Cornell University | |
| New York, New York, United States, 10021 | |
| United States, Ohio | |
| Bethesda North Hospital | |
| Cincinnati, Ohio, United States, 45242 | |
| United States, Pennsylvania | |
| Penn State Hershey Cancer Institute at Milton S. Hershey Medical Center | |
| Hershey, Pennsylvania, United States, 17033-0850 | |
| Lankenau Cancer Center at Lankenau Hospital | |
| Wynnewood, Pennsylvania, United States, 19096 | |
| United States, Texas | |
| M. D. Anderson Cancer Center at University of Texas | |
| Houston, Texas, United States, 77030-4009 | |
| United States, Washington | |
| Bellingham Breast Center | |
| Bellingham, Washington, United States, 98225 | |
Sponsors and Collaborators
Alliance for Clinical Trials in Oncology
National Cancer Institute (NCI)
Investigators
| Study Chair: | Rache M. Simmons, MD | Weill Medical College of Cornell University |
Publications of Results:
| Responsible Party: | Alliance for Clinical Trials in Oncology |
| ClinicalTrials.gov Identifier: | NCT00723294 History of Changes |
| Other Study ID Numbers: |
ACOSOG-Z1072 CDR0000600976 |
| First Posted: | July 28, 2008 Key Record Dates |
| Results First Posted: | March 7, 2017 |
| Last Update Posted: | August 14, 2017 |
| Last Verified: | June 2017 |
Keywords provided by Alliance for Clinical Trials in Oncology:
|
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 Neoplasms by Site Neoplasms Breast Diseases Skin Diseases |