Clinical trial NCT00723294: 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
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Breast Cancer
Keywords: invasive ductal breast carcinoma
male breast cancer
stage IA breast cancer
stage IB breast cancer
stage II breast cancer
Lead sponsor: Alliance for Clinical Trials in Oncology
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2008-07-28
Enrollment: 99
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

Eligibility criteria: 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.

Primary outcomes:
measure: Rate of Complete Tumor Ablation
timeFrame: Up to 14 days post surgery
Secondary outcomes:
measure: Negative Predictive Value of MRI
timeFrame: Up to 14 days post cryoablation
measure: Adverse Events
timeFrame: Up to 14 days post surgery
measure: Pain Assessment
timeFrame: Up to 14 days post surgery
Other outcomes:
Locations:
city: Burbank
country: United States
facility: Providence Saint Joseph Medical Center
state: California
city: Bridgeport
country: United States
facility: Bridgeport Hospital
state: Connecticut
city: Tampa
country: United States
facility: University of South Florida College of Medicine
state: Florida
city: Arlington Heights
country: United States
facility: Northwest Community Hospital
state: Illinois
city: Indianapolis
country: United States
facility: Indiana University Melvin and Bren Simon Cancer Center
state: Indiana
city: Indianapolis
country: United States
facility: Indiana University Hospital/Melvin and Bren Simon Cancer Center
state: Indiana
city: Annapolis
country: United States
facility: DeCesaris Cancer Institute at Anne Arundel Medical Center
state: Maryland
city: Ann Arbor
country: United States
facility: University of Michigan Comprehensive Cancer Center
state: Michigan
city: Detroit
country: United States
facility: Henry Ford Hospital
state: Michigan
city: Royal Oak
country: United States
facility: William Beaumont Hospital-Royal Oak
state: Michigan
city: New York
country: United States
facility: New York Weill Cornell Cancer Center at Cornell University
state: New York
city: Cincinnati
country: United States
facility: Bethesda North Hospital
state: Ohio
city: Hershey
country: United States
facility: Penn State Hershey Cancer Institute at Milton S. Hershey Medical Center
state: Pennsylvania
city: Wynnewood
country: United States
facility: Lankenau Cancer Center at Lankenau Hospital
state: Pennsylvania
city: Houston
country: United States
facility: M. D. Anderson Cancer Center at University of Texas
state: Texas
city: Bellingham
country: United States
facility: Bellingham Breast Center
state: Washington
Study officials:
affiliation: Weill Medical College of Cornell University
name: Rache M. Simmons, MD
role: STUDY_CHAIR
References:
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.