Breast Tumors, Malignant 

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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.

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 >

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

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.

clinical trial of patients with breast cancer is recruiting patients in France. This study is treating patients with breast cancer prior to surgical removal.

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.

clinical trial for patients with breast cancer that is locally advanced or includes the chest wall has begun in Canada. This study uses a combination of focused ultrasound and radiation. This study is only open to Canadian citizens.

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.
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Notable Papers

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.  

Dai Y, Liang P, Yu J. Percutaneous Management of Breast Cancer: a Systematic Review. Curr Oncol Rep. 2022 Nov;24(11):1443-1459. doi: 10.1007/s11912-022-01290-4. Epub 2022 Jun 14.  

Novoselova MV, Shramova EI, Sergeeva OV, Shcherbinina EY, Perevoschikov SV, Melnikov P, Griaznova OY, Sergeev IS, Konovalova EV, Schulga AA, Proshkina GM, Zatsepin TS, Deyev SM, Gorin DA. Polymer/magnetite carriers functionalized by HER2-DARPin: Avoiding lysosomes during internalization and controlled toxicity of doxorubicin by focused ultrasound induced release. Nanomedicine. 2022 Oct 13;47:102612. doi: 10.1016/j.nano.2022.102612.  

Pattyn A, Kratkiewicz K, Alijabbari N, Carson PL, Littrup P, Fowlkes JB, Duric N, Mehrmohammadi M. Feasibility of ultrasound tomography-guided localized mild hyperthermia using a ring transducer: Ex vivo and in silico studies. Med Phys. 2022 Sep;49(9):6120-6136. doi: 10.1002/mp.15829. Epub 2022 Jul 10.  

Zhang M, Narumi R, Azuma T, Okita K, Takagi S. Numerical study on a focus-control method using breast model with intentionally assigned High-Absorbing Layer near skin for High-Intensity Focused Ultrasound treatment. IEEE Trans Ultrason Ferroelectr Freq Control. 2022 Sep 12;PP. doi: 10.1109/TUFFC.2022.3205620.  

Dahan M, Cortet M, Lafon C, Padilla F. Combination of Focused Ultrasound, Immunotherapy, and Chemotherapy: New Perspectives in Breast Cancer Therapy. J Ultrasound Med. 2022 Jul 23. doi: 10.1002/jum.16053.  

Humphries BA, Aliabouzar M, Quesada C, Bevoor A, Ho KKY, Farfel A, Buschhaus JM, Rajendran S, Fabiilli ML, Luker GD. Ultrasound-Induced Mechanical Compaction in Acoustically Responsive Scaffolds Promotes Spatiotemporally Modulated Signaling in Triple Negative Breast Cancer. Adv Healthc Mater. 2022 May;11(10):e2101672. doi: 10.1002/adhm.202101672. Epub 2022 Feb 17.  

Kang Z, Yang M, Feng X, Liao H, Zhang Z, Du Y. Multifunctional Theranostic Nanoparticles for Enhanced Tumor Targeted Imaging and Synergistic FUS/Chemotherapy on Murine 4T1 Breast Cancer Cell. Int J Nanomedicine. 2022 May 13;17:2165-2187. doi: 10.2147/IJN.S360161. eCollection 2022.  

Huang C, Xu Y, Wang D, Chen Z, Fang W, Shi C, Xiao Z, Luo L. Interference With Redox Homeostasis Through a G6PD-Targeting Self-Assembled Hydrogel for the Enhancement of Sonodynamic Therapy in Breast Cancer. Front Chem. 2022 May 4;10:908892. doi: 10.3389/fchem.2022.908892. eCollection 2022.  

Ngamcherdtrakul W, Bejan DS, Cruz-Muñoz W, Reda M, Zaidan HY, Siriwon N, Marshall S, Wang R, Nelson MA, Rehwaldt JPC, Gray JW, Hynynen K, Yantasee W. Targeted Nanoparticle for Co-delivery of HER2 siRNA and a Taxane to Mirror the Standard Treatment of HER2+ Breast Cancer: Efficacy in Breast Tumor and Brain Metastasis. Small. 2022 Mar;18(11):e2107550. doi: 10.1002/smll.202107550. Epub 2022 Jan 27.  

Bose RJ, Kumar US, Garcia-Marques F, Zeng Y, Habte F, McCarthy JR, Pitteri S, Massoud TF, Paulmurugan R. Engineered Cell-Derived Vesicles Displaying Targeting Peptide and Functionalized with Nanocarriers for Therapeutic microRNA Delivery to Triple-Negative Breast Cancer in Mice. Adv Healthc Mater. 2021 Dec 8:e2101387. doi: 10.1002/adhm.202101387.  

van de Voort EMF, Struik GM, Birnie E, Moelker A, Verhoef C, Klem TMAL. Thermal Ablation as an Alternative for Surgical Resection of Small ( 2 cm) Breast Cancers: A Meta-Analysis. Clin Breast Cancer. 2021 Dec;21(6):e715-e730. doi: 10.1016/j.clbc.2021.03.004. Epub 2021 Mar 17.  

Zhu XQ, Lu P, Xu ZL, Zhou Q, Zhang J, Wang ZB, Wu F. Alterations in Immune Response Profile of Tumor-Draining Lymph Nodes after High-Intensity Focused Ultrasound Ablation of Breast Cancer Patients. Cells. 2021 Nov 29;10(12):3346. doi: 10.3390/cells10123346.  

Meng Y, Reilly R, Pezo R, Trudeau M, Sahgal A, Singnurkar A, Perry J, Myrehaug S, Pople C, Davidson B, Llinas M, Hyen C, Huang Y, Hamani C, Suppiah S, Hynynen K, and Lipsman N. MR-guided focused ultrasound enhances delivery of trastuzumab to Her2-positive brain metastases. Science Translational Medicine 13 Oct 2021 Vol 13, Issue 615 DOI: 10.1126/scitranslmed.abj4011  

Dhamija E, Singh R, Mishra S, Hari S. Image-Guided Breast Interventions: Biopsy and Beyond. Indian J Radiol Imaging. 2021 Apr;31(2):391-399. doi: 10.1055/s-0041-1734223. Epub 2021 Jul 28.  

Fant C, Granzotto A, Mestas JL, Ngo J, Lafond M, Lafon C, Foray N, Padilla F. DNA Double-Strand Breaks in Murine Mammary Tumor Cells Induced by Combined Treatment with Doxorubicin and Controlled Stable Cavitation. Ultrasound Med Biol. 2021 Jul 24:S0301-5629(21)00258-1. doi: 10.1016/j.ultrasmedbio.2021.05.028.  

Sanchez M, Barrere V, Treilleux I, Chopin N, Melodelima D. Development of a noninvasive HIFU treatment for breast adenocarcinomas using a toroidal transducer based on preliminary attenuation measurements. Ultrasonics. 2021 May 9;115:106459. doi: 10.1016/j.ultras.2021.106459.  

Zhang Q, Wang W, Shen H, Tao H, Wu Y, Ma L, Yang G, Chang R, Wang J, Zhang H, Wang C, Zhang F, Qi J, Mi C. Low-Intensity Focused Ultrasound-Augmented Multifunctional Nanoparticles for Integrating Ultrasound Imaging and Synergistic Therapy of Metastatic Breast Cancer. Nanoscale Res Lett. 2021 Apr 29;16(1):73. doi: 10.1186/s11671-021-03532-z.  

Tolba MF, Elghazaly H, Bousoik E, Elmazar MMA, Tolaney SM. Novel combinatorial strategies for boosting the efficacy of immune checkpoint inhibitors in advanced breast cancers. Clin Transl Oncol. 2021 Apr 19. doi: 10.1007/s12094-021-02613-w.  

van de Voort EMF, Struik GM, Birnie E, Moelker A, Verhoef C, Klem TMAL. Thermal Ablation as an Alternative for Surgical Resection of Small ( 2 cm) Breast Cancers: A Meta-Analysis. Clin Breast Cancer. 2021 Mar 17:S1526-8209(21)00059-8. doi: 10.1016/j.clbc.2021.03.004.  

Cohen G, Chandran P, Lorsung RM, Aydin O, Tomlinson LE, Rosenblatt RB, Burks SR, Frank JA. Pulsed-Focused Ultrasound Slows B16 Melanoma and 4T1 Breast Tumor Growth through Differential Tumor Microenvironmental Changes. Cancers (Basel). 2021 Mar 27;13(7):1546. doi: 10.3390/cancers13071546.  

Cressey P, Amrahli M, So PW, Gedroyc W, Wright M, Thanou M. Image-guided thermosensitive liposomes for focused ultrasound enhanced co-delivery of carboplatin and SN-38 against triple negative breast cancer in mice. Biomaterials. 2021 Mar 16;271:120758. doi: 10.1016/j.biomaterials.2021.120758.  

Si Y, Yue J, Liu Z, Li M, Du F, Wang X, Dai Z, Hu N, Ju J, Gao S, Wang X, Yuan P. Phase-Transformation Nanoparticle-Mediated Sonodynamic Therapy: An Effective Modality to Enhance Anti-Tumor Immune Response by Inducing Immunogenic Cell Death in Breast Cancer. Int J Nanomedicine. 2021 Mar 5;16:1913-1926. doi: 10.2147/IJN.S297933. eCollection 2021.  

Amrahli M, Centelles M, Cressey P, Prusevicius M, Gedroyc W, Xu XY, So PW, Wright M, Thanou M. MR-labelled liposomes and focused ultrasound for spatiotemporally controlled drug release in triple negative breast cancers in mice. Nanotheranostics. 2021 Jan 1;5(2):125-142. doi: 10.7150/ntno.52168. eCollection 2021.  

Feril LB, Fernan RL, Tachibana K. High-Intensity Focused Ultrasound in the Treatment of Breast Cancer. Curr Med Chem. 2020 Nov 11. doi: 10.2174/0929867327666201111143206.  

Sheybani ND, Witter AR, Thim EA, Yagita H, Bullock TNJ, Price RJ. Combination of thermally ablative focused ultrasound with gemcitabine controls breast cancer via adaptive immunity. J Immunother Cancer. 2020 Aug;8(2):e001008. doi: 10.1136/jitc-2020-001008.  
Payne A, Merrill R, Minalga E, Hadley R, Odeen H, Hofstetter L, Johnson S, Tunon de Lara C, Auriol S, Recco S, Dumont E, Parker DL, Palussiere J. A breast-specific MR guided focused ultrasound platform and treatment protocol: first-in-human technical evaluation. IEEE Trans Biomed Eng. 2020 Aug 12;PP. doi: 10.1109/TBME.2020.3016206.

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