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Breast CancerNCT07439432

Stereotactic Guided Biopsy and Cryoablation

A study testing Stereotactic Guided Biopsy and Cryoablation in people with Breast Cancer, run by Montefiore Medical Center.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

The purpose of this study is to evaluate a new strategy to treat small breast cancer called cryoablation, or cryosurgery, in combination with biopsy methods which are guided by certain imaging like mammography. Read more about this study

Who is it for?
Ages 60 years and older, women only
Conditions the study is for
Breast Cancer
What is being tested?
Stereotactic Guided Biopsy and Cryoablation
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
No sites listed yet
Study dates
Oct 2025to Jun 2027
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age 60 years or older, European Cooperative Oncology Group (ECOG) score 0-2
  • Lesion size 1.0 cm or smaller in greatest diameter. The largest diameter will be determined at the time of the diagnostic work up. For targets that are imaged in multiple modalities the largest diameter will prevail in determining eligibility. Note- 1.0 cm target size is chosen since extent may be underestimated upon initial diagnosis.
  • Biopsy proven DCIS, (including any lesion with DCIS +/- IDC)
  • Closest margin of target to the skin >15 mm
  • Compressed breast thickness to > 55mm
  • Unifocal primary disease (Patients with contralateral disease will remain eligible.)
  • Able to provide consent

Who cannot join

  • Multifocal or multicentric disease within the breast.
  • Prior surgical biopsy for diagnosis or treatment of index lesion.
  • Patients not suitable for stereotactic biopsy/cryoablation technique according to treating physician.
  • Patients receiving neoadjuvant therapy.
  • History of previously treated ipsilateral or contralateral breast carcinoma is not an exclusion criterion if the investigator is certain newly diagnosed carcinoma is a new unifocal primary tumor.
  • High-risk pathology (e.g., Grade 3, HER2+ status, Genomic high-risk score (if available)).

About this study

Official title: Stereotactic Guided Biopsy and Cryoablation of Breast Cancer

The purpose of this study is to evaluate a new strategy to treat small breast cancer called cryoablation, or cryosurgery, in combination with biopsy methods which are guided by certain imaging like mammography.

Read the detailed description

For participants who choose to enroll in this study, the doctor will perform an excisional biopsy to remove the tumor (a biopsy to attempt to remove the whole tumor), after which a clip will be placed. Using the clip as a guide, the doctor will then cryoablate the biopsy cavity. Cryoablation is a kind of treatment that uses a hollow, thin tube, called a cryoprobe, to kill any residual tumor by freezing it. By conducting this study, the research team will investigate whether biopsy followed by cryoablation guided by mammography will prove to be an effective and safe way of treating breast cancers. It is anticipated that participation in this research will last about 2 years.

Conditions
Breast Cancer
Being tested
Stereotactic Guided Biopsy and Cryoablation
Keywords
cryoablation
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Stereotactic Guided Biopsy and CryoablationDevice

    Treatment of the lesion through a three-step procedure: 1) Tomosynthesis-guided stereotactic biopsy of the target (minimum 12 cores) which would include the initial tissue marking clip placed at time of initial diagnostic biopsy, then biopsy of the surrounding tissue using the same fixed sheath (minimum 12 cores) to allow for a better pathologic evaluation of extent of the target Ductal Carcinoma In Situ (DCIS). 2) Immediate cryoablation of biopsy site/cavity performed through the same sheath. 3) four post cryoablation biopsies through the same sheath to evaluate for any residual disease.

Study groups in NCT07439432
Study groupRoleWhat they receive
CryoablationExperimentalNot described
Receives: Device: Stereotactic Guided Biopsy and Cryoablation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall feasibility

    Overall feasibility will be defined as study procedure completeness in more than 90% of enrolled patients AND data completeness in more than 90% of enrolled patients.

    Measured: Up to 5 Years

  2. Feasibility - Procedure Completeness

    Study procedure completeness feasibility will be defined as the patient's ability to tolerate the entire single procedure consisting of stereotactic biopsy of central target \& surrounding tissue + cryoablation of biopsy site/cavity + stereotactic biopsy (through the same sheath) of the post-cryoablation cavity. Study procedure completeness feasibility will be considered to have been met if > 90% of enrolled patients complete the procedure.

    Measured: Within 1 month post procedure (+/- 7 days)

  3. Feasibility - Data Completeness

    Data completeness feasibility will be defined as the ability to complete data collection from patients on study procedure, adverse events, follow-up imaging assessment, and tumor recurrence assessment elements. Data completeness feasibility will be considered to be met if these elements are collected in > 90% of enrolled patients.

    Measured: Up to 5 Years

  4. Study Safety

    Study safety will be defined as ≤ 10% of patients having experienced serious adverse events that are either possibly or definitely related to the 3-step procedure (i.e., ≤ 2 patients in the entire study) AND ≤ 15% of patients experiencing moderate or severe adverse events (i.e., the Common Terminology Criteria for Adverse Events v 5.0) (CTCAE) Grades 3-5 that are either possibly or probably related to the 3-step procedure (i.e., ≤ 3 patients in the entire study). For purposes of this study, cancer recurrence will be identified as a serious adverse event due to its life-threatening nature. All patients that begin the 3-step procedure will be included in the safety analysis.

    Measured: Day of procedure and within 1-month post-procedure (+/- 7 days)

Secondary outcomes (8)

  1. Feasibility Outcomes - Removal of biopsy clip

    Removal of the cryoablation biopsy clip from the central target lesion will be analyzed as the proportion of patients who had clip removed relative to all patients who participated in the study. Successful targeting and removal of the cryoablation biopsy clip in ≥ 90% of patients who participated in the study is the threshold for this feasibility outcome.

    Measured: Within 1 month post procedure (+/- 7 days)

  2. Feasibility Outcomes - Negative margins

    Negative (clean) margins will be defined as no tumor seen in the surrounding tissue by pathological evaluation following the procedure. Negative margins will be analyzed as the proportion of patients with negative margins relative to all patients who participated in the study. Negative margins (as determined by biopsies of surrounding tissue upon pathological assessment) observed in ≥ 90% of patients who participate in the study is the threshold for this feasibility outcome.

    Measured: Within 1 month post procedure (+/- 7 days)

  3. Feasibility Outcomes - Local recurrence

    Local recurrence will be defined as evidence of invasive or in situ breast cancer in the ipsilateral breast or chest wall. Patients who develop clinical evidence of tumor recurrence in the remainder of the breast or chest wall will be recommended to have a biopsy of the suspicious lesion to confirm the diagnosis. If a biopsy is not performed for any reason, an imaging designation of BIRADS 4 and 5 will be considered evidence of disease recurrence. Given the challenges of reliably defining local recurrence vs. new primary, all recurrences in the ipsilateral breast will be considered in the analysis of local recurrence. Local recurrence will be evaluated in patients for 5 years after study procedure using Kaplan-Meier methods.

    Measured: 6 months, 12 months, 18 months, 24 months, 36 months, 48 months, and 60 months

  4. Patient satisfaction questionnaire - time

    Patient satisfaction related to the time necessary to complete the procedure will be evaluated via administration of a questionnaire. Patients will be asked to rate satisfaction of the time needed based on a 5-point scale ranging from 1 ("Very Dissatisfied") to 5 ("Very Satisfied"), such that higher scores are indicative of better satisfaction with the time needed to complete the procedure.

    Measured: Within 7 days of procedure

  5. Procedural Pain - questionnaire

    Pain associated with the procedure will be evaluated via administration of a questionnaire. Patients will be asked to rate pain associated with the procedure based on a 6-point scale ranging from 1 ("No pain") to 5 ("Worst pain possible"), such that lower scores are indicative of less pain severity in association with the procedure.

    Measured: Within 7 days of procedure

  6. Procedural symptoms - questionnaire

    Symptom severity associated with the procedure will be evaluated via administration of a questionnaire. Patients will be asked to rate the severity of their symptoms using a 4-point scale ranging from 1 ("Mild") to 4 ("Very Severe"), such that lower scores are indicative of less symptom severity associated with the procedure.

    Measured: Within 7 days of procedure

  7. Patient satisfaction with breasts - preoperatively

    Patient satisfaction with breasts prior to treatment will be evaluated using Version 2.0 of the Breast-Q 'Satisfaction with Breasts' module. The preoperative Breast-Q module consists of 4 questions which asks patients to describe how satisfied/dissatisfied they have been over the past week with their breasts. The 4 responses are rated using a 4-point scale ranging from 1 ("Very Dissatisfied") to 4 ("Very Satisfied"), yielding a raw sum score of 4-16. Raw Breast-Q sum scores are then converted using a validated "Equivalent Rasch Transformed Score" table ranging from 0-100 such that higher Rasch scores are indicative of a better outcome. If missing data comprises <50% of the scale's items, the mean of the missing items is inserted into the table.

    Measured: Within 7 days of procedure

  8. Patient satisfaction with breasts - postoperatively

    Patient satisfaction with breasts and breast cancer treatment prior following the procedure will be evaluated using Version 2.0 of the Breast-Q breast cancer treatment (BCT) module. This Breast-Q module consists of 11 questions which ask patients to describe how satisfied/dissatisfied they have been over the past week with respect to their breasts and breast cancer treatment. The 11 responses are rated using a 4-point scale ranging from 1 ("Very Dissatisfied") to 4 ("Very Satisfied"), yielding an overall sum score of 11-44. Raw Breast-Q sum scores are then converted using a validated "Equivalent Rasch Transformed Score" table ranging from 0-100 such that higher Rasch scores are indicative of a better outcome. If missing data comprises <50% of the scale's items, the mean of the missing items is inserted into the table.

    Measured: Within 7 days of procedure and within 1 year (+/- 1 month) post procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Feb 2026
  2. Study startOct 2025 (estimated)
  3. Primary completionJun 2027 (estimated)
  4. Study completionJun 2027 (estimated)

Why it stopped: Study never approved by the Albert Einstein College of Medicine IRB.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07439432
Sponsor's protocol ID
2025-17267
Other IDs
2025
Status last verified
Feb 2026
First submitted
16 Sep 2025
Last updated
27 Feb 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Publications

  • Farante G, Toesca A, Magnoni F, Lissidini G, Vila J, Mastropasqua M, Viale G, Penco S, Cassano E, Lazzeroni M, Bonanni B, Leonardi MC, Ripoll-Orts F, Curigliano G, Orecchia R, Galimberti V, Veronesi P. Advances and controversies in management of breast ductal carcinoma in situ (DCIS). Eur J Surg Oncol. 2022 Apr;48(4):736-741. doi: 10.1016/j.ejso.2021.10.030. Epub 2021 Nov 9.

    PubMed 34772587

  • Cowell CF, Weigelt B, Sakr RA, Ng CK, Hicks J, King TA, Reis-Filho JS. Progression from ductal carcinoma in situ to invasive breast cancer: revisited. Mol Oncol. 2013 Oct;7(5):859-69. doi: 10.1016/j.molonc.2013.07.005. Epub 2013 Jul 12.

    PubMed 23890733

  • Sheaffer WW, Gray RJ, Wasif N, Stucky CC, Cronin PA, Kosiorek HE, Basu A, Pizzitola VJ, Patel B, Giurescu ME, Lorans R, McCullough AE, Ocal IT, Pockaj BA. Predictive factors of upstaging DCIS to invasive carcinoma in BCT vs mastectomy. Am J Surg. 2019 Jun;217(6):1025-1029. doi: 10.1016/j.amjsurg.2018.12.069. Epub 2019 Feb 23.

    PubMed 30879795

  • Wapnir IL, Dignam JJ, Fisher B, Mamounas EP, Anderson SJ, Julian TB, Land SR, Margolese RG, Swain SM, Costantino JP, Wolmark N. Long-term outcomes of invasive ipsilateral breast tumor recurrences after lumpectomy in NSABP B-17 and B-24 randomized clinical trials for DCIS. J Natl Cancer Inst. 2011 Mar 16;103(6):478-88. doi: 10.1093/jnci/djr027. Epub 2011 Mar 11.

    PubMed 21398619

  • Sabel MS, Kaufman CS, Whitworth P, Chang H, Stocks LH, Simmons R, Schultz M. Cryoablation of early-stage breast cancer: work-in-progress report of a multi-institutional trial. Ann Surg Oncol. 2004 May;11(5):542-9. doi: 10.1245/ASO.2004.08.003.

    PubMed 15123465

  • Erinjeri JP, Clark TW. Cryoablation: mechanism of action and devices. J Vasc Interv Radiol. 2010 Aug;21(8 Suppl):S187-91. doi: 10.1016/j.jvir.2009.12.403.

    PubMed 20656228

  • Ward RC, Lourenco AP, Mainiero MB. Ultrasound-Guided Breast Cancer Cryoablation. AJR Am J Roentgenol. 2019 Sep;213(3):716-722. doi: 10.2214/AJR.19.21329. Epub 2019 May 23.

    PubMed 31120790

  • Truesdale MD, Mues AC, Sartori S, Casazza CN, Hruby GW, Harik LR, O'Toole KM, Badani KK, Perez-Lanzac A, Landman J. Comparison of two core biopsy techniques before and after laparoscopic cryoablation of small renal cortical neoplasms. JSLS. 2011 Oct-Dec;15(4):509-16. doi: 10.4293/108680811X13176785204157.

    PubMed 22643507

  • Fine RE, Gilmore RC, Dietz JR, Boolbol SK, Berry MP, Han LK, Kenler AS, Sabel M, Tomkovich KR, VanderWalde NA, Chen M, Columbus KS, Curcio LD, Feldman SM, Gold L, Hernandez L, Manahan ER, Seedman SA, Vaidya RP, Sevrukov AB, Aoun HD, Hicks RD, Simmons RM. Cryoablation Without Excision for Low-Risk Early-Stage Breast Cancer: 3-Year Interim Analysis of Ipsilateral Breast Tumor Recurrence in the ICE3 Trial. Ann Surg Oncol. 2021 Oct;28(10):5525-5534. doi: 10.1245/s10434-021-10501-4. Epub 2021 Aug 15.

    PubMed 34392462

  • Hughes KS, Schnaper LA, Berry D, Cirrincione C, McCormick B, Shank B, Wheeler J, Champion LA, Smith TJ, Smith BL, Shapiro C, Muss HB, Winer E, Hudis C, Wood W, Sugarbaker D, Henderson IC, Norton L; Cancer and Leukemia Group B; Radiation Therapy Oncology Group; Eastern Cooperative Oncology Group. Lumpectomy plus tamoxifen with or without irradiation in women 70 years of age or older with early breast cancer. N Engl J Med. 2004 Sep 2;351(10):971-7. doi: 10.1056/NEJMoa040587.

    PubMed 15342805

  • Kunkler IH, Williams LJ, Jack WJ, Cameron DA, Dixon JM; PRIME II investigators. Breast-conserving surgery with or without irradiation in women aged 65 years or older with early breast cancer (PRIME II): a randomised controlled trial. Lancet Oncol. 2015 Mar;16(3):266-73. doi: 10.1016/S1470-2045(14)71221-5. Epub 2015 Jan 28.

    PubMed 25637340

  • Grimm LJ, Rahbar H, Abdelmalak M, Hall AH, Ryser MD. Ductal Carcinoma in Situ: State-of-the-Art Review. Radiology. 2022 Feb;302(2):246-255. doi: 10.1148/radiol.211839. Epub 2021 Dec 21.

    PubMed 34931856

  • Strom C, Rasmussen LS, Sieber FE. Should general anaesthesia be avoided in the elderly? Anaesthesia. 2014 Jan;69 Suppl 1(Suppl 1):35-44. doi: 10.1111/anae.12493.

    PubMed 24303859

  • Poullain F, Mattei JC, Rochwerger A, Bouvier C, Chagnaud C, Champsaur P, Le Corroller T. Percutaneous cryoablation of osteoblastoma in the proximal femur. Skeletal Radiol. 2020 Sep;49(9):1467-1471. doi: 10.1007/s00256-020-03413-z. Epub 2020 Mar 12.

    PubMed 32166366

  • Ushijima Y, Nishie A, Fujita N, Kubo Y, Ishimatsu K, Ishigami K. Diagnostic accuracy of percutaneous core biopsy before cryoablation for small-sized renal cell carcinoma. Diagn Interv Radiol. 2023 Nov 7;29(6):800-804. doi: 10.4274/dir.2022.221152. Epub 2022 Dec 12.

    PubMed 36994482

Questions about this trial

What is this clinical trial studying?

A study testing Stereotactic Guided Biopsy and Cryoablation in people with Breast Cancer, run by Montefiore Medical Center.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall feasibility (time frame: Up to 5 Years). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07439432, which also lists 18 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2026; AzTrials last refreshed its copy on 3 Nov 2026.

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