Focused ultrasound-guided targeted drug delivery with neoadjuvant therapy for HER2-positive 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 interventional study examines whether using focused ultrasound to enhance targeted drug delivery, in combination with standard neoadjuvant therapy, can be safely implemented in HER2-positive breast cancer patients. The trial compares observed pathological complete response rates to a historical cohort treated at the same center. Primary attention is on feasibility and safety, with early efficacy signals as a secondary consideration. Eligible participants are women aged 18–70 with confirmed HER2-positive disease eligible for the T(P)CbHP neoadjuvant regimen and meeting organ function criteria. Exclusion criteria include prior systemic therapy for breast cancer, pregnancy, metastasis, bilateral disease, or other safety concerns.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Female patients aged 18-70 years.
2. Histologically confirmed HER2 positive breast cancer, with indication for neoadjuvant chemotherapy, and scheduled to receive the T(P)CbHP neoadjuvant regimen.
3. TNM stage T2N0-2M0.
4. Adequate bone marrow reserve (ANC \>1.5×10⁹/L, platelets \>100×10⁹/L).
5. Normal liver function (ALAT, ASAT, and bilirubin \<2.5× upper limit of normal).
6. Adequate renal function (creatinine clearance \>50 mL/min).
7. Left ventricular ejection fraction (LVEF) ≥50% measured by echocardiography or MUGA.
8. No psychological, family, social, or geographical conditions that would compromise compliance with the study protocol and follow-up schedule.
9. No medical conditions that would place the subject at undue risk.
10. Written informed consent signed by the subject.

Exclusion Criteria:

1. Prior history of radiotherapy or chemotherapy.
2. Pregnant or lactating patients.
3. Presence of distant metastasis.
4. Bilateral invasive breast cancer.
5. Concurrent administration of other anticancer therapies or another investigational agent.
6. inadequate physical tolerance, including significant cardiovascular, hepatic, or renal dysfunction, massive ascites, intestinal obstruction, severe infection, high fever, as well as water-electrolyte and acid-base imbalance.
7. Patients with known hyper sensitivity to SonoVue®.

Where it's running

• The Second Affiliated Hospital Zhejiang University School of Medicine (SAHZU)
  Hangzhou, Zhejiang, China Recruiting

Study contacts

• Principal investigator: Yiding Chen — The Second Affiliated Hospital Zhejiang University School of Medicine (SAHZU)
• Study coordinator: Yong Shen
• Email: shenyong@zju.edu.cn
• Phone: +86-13616555799

Similar studies

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

• Can we skip radiation after lumpectomy for low-risk HER2-positive breast cancer?

  This study tests whether patients who had breast-conserving surgery and low-risk HER2-positive breast cancer can safely skip radiation therapy while receiving HER2-targeted treatment.

  Recruiting at 7 sites Memorial Sloan Kettering Cancer Center · Basking Ridge, New Jersey and 6 other locations · NCT07895511

• Breast cancer subtypes and outcomes in Colombian women

  This study looks back at medical records of women with breast cancer to see how different molecular subtypes relate to survival and recurrence in a single Colombian hospital.

  Recruiting Fundación Santa Fe de Bogota · Bogotá, Bogota D.C. · NCT07856225

• SMP-656 in HER2-positive advanced breast cancer after ADC therapy

  This trial tests whether SMP-656 given by IV every 3 weeks can help people with HER2-positive locally advanced or metastatic breast cancer who progressed after a HER2-targeted antibody-drug conjugate.

  Recruiting Phase 2 Chengdu SciMount Pharmatech Co., Ltd. · Hefei, Anhui and 14 other locations · NCT07726342

• Entinostat with Pyrotinib and Endocrine Therapy in HER2-positive, HR-positive Advanced Breast Cancer after Trastuzumab Failure

  This study tests whether adding entinostat to pyrotinib and hormone therapy is safe and helps patients with advanced HR+/HER2+ breast cancer who progressed after trastuzumab.

  Recruiting Phase 1/2 Tianjin Medical University Cancer Institute and Hospital · Tianjin, Tianjin Municipality · NCT07708194

• GQ1005 versus T-DM1 in HER2-positive unresectable or metastatic breast cancer

  This trial tests whether GQ1005 works as well as T-DM1 for adults with HER2-positive unresectable or metastatic breast cancer who have already had trastuzumab and taxane.

  Recruiting at 70 sites Phase 3 GeneQuantum Healthcare (Suzhou) Co., Ltd. · Bengbu, Anhui and 69 other locations · NCT07673029

• Trastuzumab Rezetecan Neoadjuvant Therapy for HER2-Positive Breast Cancer

  This trial tests whether adding trastuzumab rezetecan after an initial THP treatment helps patients with HER2-positive breast cancer decide if they should switch therapies based on response.

  Recruiting Phase 2 The First Affiliated Hospital of Soochow University · Suzhou, Jiangsu · NCT07647263

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.