Home Diseases and Conditions Breast Tumors, Malignant 

Breast Tumors, Malignant 

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

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.

Clinical Trials

See a list of clinical trials assessing focused ultrasound for treatment of 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.  

See a list of treatment sites >
See a list of clinical trial 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 cancer 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 cancer. 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, 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 

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 

Thim EA, Fox T, Deering T, Vass LR, Sheybani ND, Kester M, Price RJ. Solid tumor treatment via augmentation of bioactive C6 ceramide levels with thermally ablative focused ultrasound. Drug Deliv Transl Res. 2023 Dec;13(12):3145-3153. doi: 10.1007/s13346-023-01377-w. Epub 2023 Jun 19. PMID: 37335416 

Qi T, Jing Y, Deng J, Chang J, Sun W, Yang R, Liu X, Zhang Q, Wan M, Lu M. Boiling Histotripsy Using Dual-Frequency Protocol on Murine Breast Tumor Model and Promotes Immune Activation. IEEE Trans Ultrason Ferroelectr Freq Control. 2023 Dec;70(12):1773-1785. doi: 10.1109/TUFFC.2023.3326561. Epub 2023 Dec 14. PMID: 37871099 

Thim EA, Fox T, Deering T, Vass LR, Sheybani ND, Kester M, Price RJ. Solid tumor treatment via augmentation of bioactive C6 ceramide levels with thermally ablative focused ultrasound. Drug Deliv Transl Res. 2023 Dec;13(12):3145-3153. doi: 10.1007/s13346-023-01377-w. Epub 2023 Jun 19. PMID: 37335416 

Qi T, Jing Y, Deng J, Chang J, Sun W, Yang R, Liu X, Zhang Q, Wan M, Lu M. Boiling histotripsy using dual-frequency protocol on murine breast tumor model and promotes immune activation. IEEE Trans Ultrason Ferroelectr Freq Control. 2023 Oct 23;PP. doi: 10.1109/TUFFC.2023.3326561. PMID: 37871099 

Tang N, Zhu Y, Lu Z, Deng J, Guo J, Ding X, Wang J, Cao R, Chen A, Huang Z, Lu H, Wang Z. pH-Responsive doxorubicin-loaded magnetosomes for magnetic resonance-guided focused ultrasound real-time monitoring and ablation of breast cancer. Biomater Sci. 2023 Sep 18. doi: 10.1039/d3bm00789h. PMID: 37718624 

Spatarelu CP, Jandhyala S, Luke GP. Dual-drug loaded ultrasound-responsive nanodroplets for on-demand combination chemotherapy. Ultrasonics. 2023 Aug;133:107056. doi: 10.1016/j.ultras.2023.107056. Epub 2023 May 26. PMID: 37269682 

Dasgupta A, Saifuddin M, McNabb E, Ho L, Lu L, Vesprini D, Karam I, Soliman H, Chow E, Gandhi S, Trudeau M, Tran W, Curpen B, Stanisz G, Sahgal A, Kolios M, Czarnota GJ. Novel MRI-guided focussed ultrasound stimulated microbubble radiation enhancement treatment for breast cancer. Sci Rep. 2023 Aug 21;13(1):13566. doi: 10.1038/s41598-023-40551-5. PMID: 37604988 

Zulkifli D, Manan HA, Yahya N, Hamid HA. The Applications of High-Intensity Focused Ultrasound (HIFU) Ablative Therapy in the Treatment of Primary Breast Cancer: A Systematic Review. Diagnostics (Basel). 2023 Aug 4;13(15):2595. doi: 10.3390/diagnostics13152595. PMID: 37568958 

Margolis R, Basavarajappa L, Li J, Obaid G, Hoyt K. Image-guided focused ultrasound-mediated molecular delivery to breast cancer in an animal model. Phys Med Biol. 2023 Jun 27. doi: 10.1088/1361-6560/ace23d. PMID: 37369225  

Saharkhiz N, Kamimura HAS, Konofagou EE. An Efficient and Multi-Focal Focused Ultrasound Technique for Harmonic Motion Imaging. IEEE Trans Biomed Eng. 2023 Apr;70(4):1150-1161. doi: 10.1109/TBME.2022.3211465. Epub 2023 Mar 21.  

Antoniou A, Spanoudes K, Damianou C. Treatment of mammary cancer with focused ultrasound: A pilot study in canine and feline patients. Ultrasonics. 2023 Mar 10;132:106974. doi: 10.1016/j.ultras.2023.106974.  

Shibamoto Y, Takano S. Non-Surgical Definitive Treatment for Operable Breast Cancer: Current Status and Future Prospects. Cancers (Basel). 2023 Mar 20;15(6):1864. doi: 10.3390/cancers15061864.   

Adams-Tew SI, Johnson S, Odéen H, Parker DL, Payne A. Validation of a drift-corrected 3D MR temperature imaging sequence for breast MR-guided focused ultrasound treatments. Magn Reson Imaging. 2023 Feb;96:126-134. doi: 10.1016/j.mri.2022.12.006. Epub 2022 Dec 7.  

Arsiwala TA, Blethen KE, Wolford CP, Panchal DM, Sprowls SA, Fladeland RA, Kielkowski BN, Pritt TA, Wang P, Wilson O, Carpenter JS, Finomore V, Rezai A, Lockman PR. Blood-tumor barrier opening by MRI-guided transcranial focused ultrasound in a preclinical breast cancer brain metastasis model improves efficacy of combinatorial chemotherapy. Front Oncol. 2023 Feb 10;13:1104594. doi: 10.3389/fonc.2023.1104594. eCollection 2023.  

Click here for additional references from PubMed.  

Video courtesy of Insightec