NCT06210529
Recruiting
Not Applicable
A Single-center, Prospective Clinical Study of High-intensity Focused Ultrasound Tumor Treatment System(Super Knife) in the Treatment of Breast Cancer
ConditionsBreast Cancer
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Breast Cancer
- Sponsor
- Shengjing Hospital
- Enrollment
- 12
- Locations
- 1
- Primary Endpoint
- Pathological complete response (pCR)
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
Breast cancer is the most common cancer diagnosed among women and is the second leading cause of cancer death among women after lung cancer. The treatment methods of breast cancer include surgery, chemotherapy, radiotherapy and so on. The investigators discover a High-intensity focused ultrasound therapy to treat breast tumor, which is a non-invasive method.
Investigators
Caigang Liu
Professor
Shengjing Hospital
Eligibility Criteria
Inclusion Criteria
- •ECOG Performance Status of 0-1; Histological confirmed invasive breast cancer; Breast cancer tumor measuring ≥2 cm in maximal diameter and a single lesion as measured by mammogram, breast ultrasound, or breast MRI; Breast tumor's borders from the skin are greater than 1 cm; No lymph node or distant metastasis; Absolute neutrophil count (ANC) ≥ 1.5 × 109/L, Platelets ≥ 50 × 109/L, Hemoglobin ≥ 9.0 g/dl iv; Serum creatinine ≤1.5 x upper limit of normal (ULN); AST ≤ 2.5 x ULN, ALT ≤ 2.5 x ULN; Left ventricular ejection fraction ≥ 50%.
Exclusion Criteria
- •Inflammatory breast cancer, bilateral breast cancer, or occult breast cancer; Any kind of prior treatment for breast cancer, including chemotherapy, radiotherapy, endocrine therapy and so on; Pregnant and lactating women; Patients who have participated in other clinical trials.
Outcomes
Primary Outcomes
Pathological complete response (pCR)
Time Frame: 1 month after surgery
pCR is defined as the absence of residual invasive cancer in the breast and the lymph nodes.
Secondary Outcomes
- Objective response rate(In the first month, the second month, the third month)
- Disease control rate(In the first month, the second month, the third month)
- Adverse events(1 month after surgery)
Study Sites (1)
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