Home Diseases and Conditions Breast Tumors 

Breast Tumors 

Last Updated:
Development Stage

Early Stage

Focused ultrasound research is in the laboratory phase and is not yet available for patients.

Clinical Trials

Focused ultrasound for this condition is being researched in clinical trials.

International Approval

Focused ultrasound is approved to treat this condition outside the US. Patients can seek commercial treatment at participating international sites.

FDA Approved

The US Food and Drug Administration has approved focus ultrasound for this condition. Patients can seek commercial treatment at participating sites.

Early Stage

Clinical Trials

International

FDA Approved

Focused ultrasound is approved to treat this condition outside the US. Patients can seek commercial treatment at participating international sites. There are also clinical trials that may be of interest to patients.

Focused Ultrasound Therapy

Breast Cancer
Focused ultrasound is a noninvasive, therapeutic technology with the potential to improve the quality of life and decrease the cost of care for patients with breast cancer. This novel technology focuses beams of ultrasound energy precisely and accurately on targets in the body without damaging surrounding normal tissue.

How it Works
Where the beams converge, focused ultrasound produces several therapeutic effects that are being evaluated. One mechanism is precise ablation (thermal destruction of tissue). The goal could be complete ablation of the cancer, or it can be done partially. Partial ablation may help awaken the immune system for a more generalized response. A second mechanism is to promote the targeted release of therapeutic treatments in the region of the tumor.

Advantages
Current treatment options for breast cancer include combinations of surgery, radiation, chemotherapy, hormone therapy or targeted drug therapies.

Focused ultrasound – used alone and in combination with other therapies – is being investigated to treat breast cancer.

Potential advantages as compared to current treatments:

  • Focused ultrasound is noninvasive and therefore has reduced risk for infection and blood clots, and potential for shorter recovery time.
  • Precise targeting minimizes damage to non-targeted healthy tissue.
  • No ionizing radiation, enabling repeat treatment if necessary.
  • Treatment can be a complement to drug therapy, enabling enhanced delivery of chemotherapy or immunotherapy to tumors.
  • May potentially induce an anti-tumor immune response.

Benign Breast Disease 
Focused ultrasound is a noninvasive, therapeutic technology with the potential to improve the quality of life and decrease the cost of care for patients with benign breast tumors. Most of the work done has been on breast fibroadenoma. This novel technology focuses beams of ultrasound energy precisely and accurately on targets deep in the body without damaging surrounding normal tissue. 

How it Works 
Where the beams converge, focused ultrasound produces precise ablation (thermal destruction of tissue) enabling breast fibroadenoma to be treated without surgery. 

Advantages 
The primary options for treatment of breast fibroadenoma include invasive surgery. 

For certain patients, focused ultrasound could provide a noninvasive alternative to surgery with less risk of complications – such as surgical wound healing or infection – at a lower cost. It can reach the desired target without damaging surrounding tissue and is repeatable, if necessary. There is also little to no scarring and minimal risk for breast deformation, and focused ultrasound therapy allows for a shorter recovery time.  

Clinical Trials

Breast Cancer
A clinical trial in Canada is combining the use of radiation therapy with focused ultrasound for patients with advanced breast cancer.

A clinical trial in New York is treating benign and stage 1 malignant breast tumors.

A clinical trial is evaluating the use of high-intensity focused ultrasound combined with gemcitabine in patients with stage I-III breast cancer at the University of Virginia. This is a treatment followed by surgical resection.

A clinical trial in Utah is recruiting patients with breast cancer for focused ultrasound treatment. This is a treatment followed by surgical resection.

A clinical trial for patients with breast cancer that has metastasized to their brain has begun enrolling patients in Canada. The team will use focused ultrasound to open the blood brain barrier to allow therapeutic medications to more effectively reach the tumor in their brain. This study is only open to Canadian citizens. A summary of the first four patients has been published.

A clinical trial in China is using high intensity focused ultrasound for treatment of breast cancer patients. 

The Foundation updates these pages regularly, but with the increasing number of clinical trials, we want to be sure that our audience has the latest information available. Therefore, we also added the website search information for the above trials. If you click here, it will take you to the latest information available from https://www.clinicaltrials.gov/.  

Benign Breast Disease
A clinical trial in New York is using focused ultrasound to treat breast fibroadenoma. 

A multi-site clinical trial is being conducted using focused ultrasound to treat breast fibroadenoma.  

The Foundation updates these pages regularly, but with the increasing number of clinical trials, we want to be sure that our audience has the latest information available. Therefore, we also added the website search information for the above trials. If you click here, it will take you to the latest information available from https://www.clinicaltrials.gov/.    

See a list of treatment sites >
See a list of laboratory research sites >

Regulatory Approval and Reimbursement

The Model JC system manufactured by Chongqing Haifu has been approved in Europe, Russia, and China treatment of breast cancer.

Focused ultrasound treatment for patients with breast disease is not universally reimbursed by medical insurers.

Preclinical Laboratory Studies

Preclinical studies are underway to investigate the use of non-ablation mechanisms of focused ultrasound in the treatment of breast disease. Examples of these studies include:

  • Focused ultrasound to induce an immune response that could be combined with immunotherapeutics (e.g., checkpoint inhibitors) to treat both local and systemic disease.
  • Focused ultrasound to enable targeted delivery and/or activation of drugs via carrier vehicles (e.g., microbubbles, nanoparticles, liposomes) to enable delivery of high concentrations in the tumor with minimal systemic side effects.

Additional Resources

American Cancer Society
National Cancer Institute
Blog: Beating Breast Cancer – My Hope for Focused Ultrasound

Help us revolutionize treatment for breast cancer by funding studies that will develop strategies for both early-and later-stage disease.
See the case statement >

Notable Papers

Liu Y, Hu S, Munot S, Konofagou EE. 3-D Handheld Harmonic Motion Imaging System for Breast Tumor Assessment: A Clinical Feasibility Study. Ultrasound Med Biol. 2026 Jan 27:S0301-5629(26)00001-3. doi: 10.1016/j.ultrasmedbio.2026.01.001. PMID: 41605726 

Wu X, Pan F, Xiao Y, Chen M, Yin H, Mu D, Yang L, Yang H, Chen W, Zhang C. Factors influencing the volume reduction rate of ultrasound-guided high-intensity focused ultrasound for breast fibroadenoma. Int J Hyperthermia. 2026 Dec;43(1):2610775. doi: 10.1080/02656736.2025.2610775. Epub 2026 Jan 8. PMID: 41506619 

Feng J, Tong Y, Zhang Z, He Y. Case Report: Pathological complete response yet early brain relapse in HER2-positive breast cancer: a case-based review. Front Immunol. 2026 Jan 5;16:1668995. doi: 10.3389/fimmu.2025.1668995. eCollection 2025. PMID: 41562063 

Zhou Y, Huang X, Su T, Su K, Peng S, Li H. Hypoxia-specific metal-organic frameworks combined with lactate immunometabolism regulation augment anti-tumor immunity of HIFU. Mater Today Bio. 2025 Dec 15;36:102695. doi: 10.1016/j.mtbio.2025.102695. eCollection 2026 Feb. PMID: 41509979 

Hu S, Liu Y, Wang R, Li X, Konofagou EE. A Multimodal Ultrasound-Driven Approach for Automated Tumor Assessment With B-Mode and Multi-Frequency Harmonic Motion Images. IEEE Trans Biomed Eng. 2026 Feb;73(2):498-509. doi: 10.1109/TBME.2025.3586250. PMID: 40614147 

Yang T, Lou Y, Ying Z. Nanoparticle-ultrasound synergy: an emerging theranostic paradigm for breast and gynecologic cancers. Front Oncol. 2025 Dec 4;15:1617939. doi: 10.3389/fonc.2025.1617939. eCollection 2025. PMID: 41426324 

Su X, Wang Y, Qin X, Xiao Y, Ouyang B, Hu L, Kang L, Xu R, Xu C, Sun Z, Sun C, Guo H, Pang Z, Shen S. HIFU-Driven Targeted Pyroptosis Therapy in Basal-Like Breast Cancer. Adv Sci (Weinh). 2025 Nov;12(44):e03830. doi: 10.1002/advs.202503830. Epub 2025 Sep 14. PMID: 40946176 

Lee SN, Choi JH, Moon H, Kim D, Hong J, Lee HJ, Lim YT. Focused ultrasound-triggered doxorubicin liposomes reshape tumor microenvironment to boost checkpoint depletion in triple-negative breast cancer model. J Control Release. 2025 Dec 10;388(Pt 2):114389. doi: 10.1016/j.jconrel.2025.114389. Epub 2025 Nov 4. PMID: 41197832 

Zhou D, Mu D, Lin Z, Ren Y, Zhou Y, Liu H, Zhu L, Luo J, Li M, Li C, Li F. Ultrasound radiomics-based nomogram to predict the non-perfused volume ratio of breast fibroadenomas treated with ultrasound-guided high-intensity focused ultrasound: a multicenter study. Int J Hyperthermia. 2025 Dec;42(1):2568624. doi: 10.1080/02656736.2025.2568624. Epub 2025 Oct 9. PMID: 41069014 

Sengupta S, Bhattacharjee A, Basu B, Kar S, Moulik S. Ultrasound-Mediated Nanocarrier-Based Drug Delivery in Breast Cancer Therapy: Innovations and Outlook. J Ultrasound Med. 2025 Nov 17. doi: 10.1002/jum.70117. PMID: 41247034 

Bates JG, Dillon CR, Jones MR, Tencer JT. Multifidelity Uncertainty Quantification for Focused Ultrasound Breast Cancer Therapies Using Reduced Order Models. ASME J Heat Mass Transf. 2025 Dec 1;147(12):121201. doi: 10.1115/1.4069124. Epub 2025 Aug 19. PMID: 41256765 

Alikarami S, Harandi H, Jahanshahi A, Zakavi SS, Frounchi N, Ghavam M, Momtazmanesh S. High-Intensity Focused Ultrasound in Treatment of Primary Breast Cancer: A Systematic Review and Meta-Analysis. J Clin Ultrasound. 2025 Nov 24. doi: 10.1002/jcu.70143. PMID: 41287177 

Wang H, Wang H, Ning W, Zhang G, Guo Q, Li K. Retrospective cohort study on the effects of corticosteroid combined with focused ultrasound therapy on lesion size and inflammatory markers in patients with granulomatous mastitis. Pak J Pharm Sci. 2025;38(6):2229-2237. doi: 10.36721/PJPS.2025.38.6.REG.13937.1. PMID: 41139272 

Filippou A, Evripidou N, Spanoudes K, Damianou C. Veterinary pilot study on focused ultrasound treatment of spontaneous canine and feline tumours: technical and feasibility assessment. J U 

Fu Q, Zhou H, Xu X, Wan Y, Li Y, Huang K, Gong J, Tang J, Wang Q, Zhong Y, Wang N, Yuan J, Li F. High-Intensity Focused Ultrasound Elevates Il-2rb on CD8+ T Cells: Enhancing JAK-STAT and IL-2 Efficacy in Triple-Negative Breast Cancer. J Proteome Res. 2025 Sep 17. doi: 10.1021/acs.jproteome.5c00583. PMID: 40960236 

Guzmán-Lorite M, Muñoz-Moreno L, Marina ML, Carmena MJ, García MC. In vitro and in vivo approaches demonstrating the antiproliferative activity of pomegranate seed proteins and peptides on breast cancer. PLoS One. 2025 Sep 18;20(9):e0330895. doi: 10.1371/journal.pone.0330895. eCollection 2025. PMID: 40966212 

Li J, Yang S, Zhu L, Jiang L, Zhou Y, Deng L. The Added Value of Low-Intensity Focused Ultrasound Treatment on Breast Recovery Following Aspiration of Breast Abscesses in Lactating Women. Breastfeed Med. 2025 Sep 26. doi: 10.1177/15568253251382576. PMID: 41003489

Huang X, Li H, Wang Q, Liao Y, Xie X, Zhou Y, Wu D, Li H. Hypoxia-responsive albumin nanoparticles co-delivering banoxantrone and STING agonist enhance immunotherapy of high-intensity focused ultrasound. J Control Release. 2025 Jul 10;383:113789. doi: 10.1016/j.jconrel.2025.113789. Epub 2025 May 1. PMID: 40318808 

Xu R, Su X, Qin X, Liu Y, Wu J, Li X, Wang T, Gong X, Ouyang B, Liu H, Yang W, Zhang J, Zhang B, Pang Z. An omics-based drug-HIFU combination therapy discovery for ferroptosis treatment of TNBC. Biomaterials. 2026 Jan;324:123535. doi: 10.1016/j.biomaterials.2025.123535. Epub 2025 Jul 3. PMID: 40627961 

Liang M, Liu Y, Huang Y, Ma G, Han X, Li S, Hang J, Xie H, Chen L, Liu X, Wang S, Xia T. Predicting the sonication energy for focused ultrasound surgery treatment of breast fibroadenomas using machine learning algorithms. Int J Hyperthermia. 2025 Dec;42(1):2497824. doi: 10.1080/02656736.2025.2497824. Epub 2025 Jul 9. PMID: 40635307 

Singh A, Adams-Tew S, Johnson S, Odeen H, Shea J, Johnson A, Day L, Pessin A, Payne A, Joshi S. Treatment efficacy prediction of focused ultrasound therapies using multi-parametric magnetic resonance imaging. Cancer Prev Detect Interv (2024). 2025;15199:190-199. doi: 10.1007/978-3-031-73376-5_18. Epub 2024 Oct 9. PMID: 39802501 

Nelson CK, Kline M, Payne A, Dillon CR. Computational predictions of magnetic resonance acoustic radiation force imaging for breast cancer focused ultrasound therapy. Int J Hyperthermia. 2025 Dec;42(1):2452927. doi: 10.1080/02656736.2025.2452927. Epub 2025 Jan 22. PMID: 39842813 

Tang S, McGinnis R, Cao Z, Baker JR Jr, Xu Z, Wang S. Ultrasound-Guided Histotripsy Triggers the Release of Tumor-Associated Antigens from Breast Cancers. Cancers (Basel). 2025 Jan 8;17(2):183. doi: 10.3390/cancers17020183. PMID: 39857965 

Liu Y, Hossain MM, Li XJ, Konofagou EE. Amplitude-Modulation Frequency Optimization for Enhancing Harmonic Motion Imaging Performance of Breast Tumors in the Clinic. Ultrasound Med Biol. 2025 Jan;51(1):169-179. doi: 10.1016/j.ultrasmedbio.2024.09.021. Epub 2024 Oct 19. PMID: 39428259 

Murad HY, Sabol RA, Nyiramana J, Twizeyimana A, Bortz EP, Matossian MD, Hong S, Kelly CA, Burow ME, Bunnell BA, Khismatullin DB. Mechanical Disruption by Focused Ultrasound Re-sensitizes ER+ Breast Cancer Cells to Hormone Therapy. Ultrasound Med Biol. 2024 Dec;50(12):1885-1892. doi: 10.1016/j.ultrasmedbio.2024.08.015. Epub 2024 Sep 14. PMID: 39277462 

DeWitt M, Demir ZEF, Sherlock T, Brenin DR, Sheybani ND. MR Imaging-Guided Focused Ultrasound for Breast Tumors. Magn Reson Imaging Clin N Am. 2024 Nov;32(4):593-613. doi: 10.1016/j.mric.2024.04.004. Epub 2024 May 16. PMID: 39322350 

Rahpeima R, Lin CA. A comprehensive numerical procedure for high-intensity focused ultrasound ablation of breast tumour on an anatomically realistic breast phantom. PLoS One. 2024 Oct 1;19(10):e0310899. doi: 10.1371/journal.pone.0310899. eCollection 2024. PMID: 39352893 

Murad HY, Sabol RA, Nyiramana J, Twizeyimana A, Bortz EP, Matossian MD, Hong S, Kelly CA, Burow ME, Bunnell BA, Khismatullin DB. Mechanical Disruption by Focused Ultrasound Re-sensitizes ER+ Breast Cancer Cells to Hormone Therapy. Ultrasound Med Biol. 2024 Sep 13:S0301-5629(24)00323-5. doi: 10.1016/j.ultrasmedbio.2024.08.015. PMID: 39277462 

DeWitt M, Demir ZEF, Sherlock T, Brenin DR, Sheybani ND. MR Imaging-Guided Focused Ultrasound for Breast Tumors. Magn Reson Imaging Clin N Am. 2024 Nov;32(4):593-613. doi: 10.1016/j.mric.2024.04.004. Epub 2024 May 16. PMID: 39322350 

Kaplińska-Kłosiewicz PM, Fura Ł, Kujawska T, Andrzejewski K, Kaczyńska K, Strzemecki D, Sulejczak M, Chrapusta SJ, Macias M, Sulejczak D. Study of Biological Effects Induced in Solid Tumors by Shortened-Duration Thermal Ablation Using High-Intensity Focused Ultrasound. Cancers (Basel). 2024 Aug 14;16(16):2846. doi: 10.3390/cancers16162846. PMID: 39199617 

Liu Y, Tang R, Cao Y, Wu N, Qin Q, Chen Y, Wei X, Ren J, Sun Y, Zhou H, Zhou Y, Li P. LIFU/MMP-2 dual-responsive release of repurposed drug disulfiram from nanodroplets for inhibiting vasculogenic mimicry and lung metastasis in triple-negative breast cancer. J Nanobiotechnology. 2024 Apr 25;22(1):209. doi: 10.1186/s12951-024-02492-7. PMID: 38664830 

Li Z, Yue X, Pan F, Yang L, Xiao Y, Mu D, Liu H, Chen M, Yin H, Huang H, Wang Z, Zhang C. A Comparison of Quality of Life, Cosmesis and Cost-Utility of Open Surgery, Vacuum-Assisted Breast Biopsy and High Intensity Focused Ultrasound for Breast Fibroadenoma. Acad Radiol. 2024 Apr 17:S1076-6332(24)00201-0. doi: 10.1016/j.acra.2024.03.036. PMID: 38637238  

Yu X, Li X, Chen Q, Wang S, Xu R, He Y, Qin X, Zhang J, Yang W, Shi L, Lu L, Zheng Y, Pang Z, Peng S. High Intensity Focused Ultrasound-Driven Nanomotor for Effective Ferroptosis-Immunotherapy of TNBC. Adv Sci (Weinh). 2024 Feb 11:e2305546. doi: 10.1002/advs.202305546. PMID: 38342612 

Click here for additional references from PubMed.  

Video courtesy of Insightec