Comparing cryoablation and lumpectomy for early-stage breast cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This trial evaluates the safety and effectiveness of cryoablation, a technique that freezes tumors, in treating low-risk, early-stage breast cancer compared to the standard lumpectomy procedure. It focuses on patients diagnosed with invasive ductal carcinoma of the breast, specifically Luminal type A, and aims to assess disease control, complication rates, and quality of life outcomes. The study will initially review the safety of cryoablation before making direct comparisons with lumpectomy outcomes.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Diagnosis of invasive ductal carcinoma of the breast (ER , Her-2 negative) that is grade 1 or 2 with intraductal component \<25%. Must be T1N0M0 (2 cm or less).
* If DCIS is present in the biopsy specimen it should be \<25% of the tumor and should be contiguous with the IDC. (i.e. DCIS should not be a separate tumor from the IDC).
* Oncotyping will be performed on T1b+Allred\<6/8 and T1c tumors. Oncotype score in this subset of patients must be \<26 to be included in the trial.
* At least 50 years of age.
* Negative ipsilateral axillary assessment as determined either by (1) negative axillary ultrasound (2) negative sentinel lymph node biopsy or (3) negative percutaneous axillary node biopsy with no further clinical or imaging concern for nodal metastatic disease.
* Able to understand and willing to sign an IRB-approved written informed consent document.

Exclusion Criteria:

* Indication for neoadjuvant chemotherapy.
* Prior history of breast cancer.
* Breast augmentation.
* Allergy to local anesthetics.
* Pregnant or lactating. Women of childbearing potential must have a negative pregnancy test within 14 days of study entry.
* Tumoral involvement of skin or chest wall.

Where it's running

• Washington University School of Medicine
  St Louis, Missouri, United States Recruiting

Study contacts

• Principal investigator: Heather Garrett, M.D. — Washington University School of Medicine
• Study coordinator: Heather Garrett, M.D.
• Email: hvgarrett@wustl.edu
• Phone: 636-916-9662

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• AI-powered mobile app to support chemotherapy for breast cancer

  A mobile app in Arabic uses AI to help women undergoing chemotherapy see if it can improve symptom control and medication adherence compared with standard care.

  Recruiting University of Baghdad · Baghdad · NCT07273812

• Cryoablation for small breast tumors (SIX)

  This study will test whether cryoablation works as well as standard breast surgery for people with small (≤2.0 cm), unifocal early-stage breast cancer and will compare direct costs over one year.

  Recruiting Phase 3 Hospital do Coracao · São Paulo, São Paulo and 1 other locations · NCT06839001

• Predicting outcomes for advanced breast cancer patients treated with CDK4/6 inhibitors and endocrine therapy

  This study is trying to see how well different CDK4/6 inhibitors combined with hormone therapy work for people with advanced breast cancer and how safe they are.

  Recruiting at 24 sites Fondazione IRCCS Istituto Nazionale dei Tumori, Milano · Aviano and 23 other locations · NCT06805812

• Using tart cherry juice to prevent nerve damage from chemotherapy in breast cancer patients

  This study is testing if drinking tart cherry juice can help prevent nerve damage in breast cancer patients receiving chemotherapy.

  Recruiting Phase 2 University of California, Davis · Sacramento, California · NCT06268665

• Oral MBQ-167 treatment for advanced breast cancer

  This study is testing a new oral medication called MBQ-167 to see if it can help people with advanced breast cancer who haven't had success with other treatments.

  Recruiting at 3 sites Phase 1 MBQ Pharma · Beverly Hills, California and 3 other locations · NCT06075810

• Evaluating Bria-IMT with Checkpoint Inhibitor for Advanced Metastatic Breast Cancer

  This study is testing if a new treatment combining Bria-IMT with a checkpoint inhibitor can help people with advanced metastatic breast cancer live longer compared to other treatments their doctors might choose.

  Recruiting at 79 sites Phase 3 BriaCell Therapeutics Corporation · Phoenix, Arizona and 78 other locations · NCT06072612

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.