Breast Cancer
Conditions
Keywords
breast cancer
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.
Interventions
DEVICEa high-intensity focused ultrasound tumor treatment system (Super Knife)
All participants will be randomly divided into groups A and B. Participants in group A will receive a high-intensity focused ultrasound tumor treatment (Super Knife) once, and participants in group B will receive treatment twice (4 weeks, one cycle).. Breast cancer surgery was performed at 3 months ± 1 week after the Super Knife treatment.
Sponsors
Shengjing Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pathological complete response (pCR) | 1 month after surgery | pCR is defined as the absence of residual invasive cancer in the breast and the lymph nodes. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Disease control rate | In the first month, the second month, the third month | The percentage of patients whose therapeutic intervention has led to a complete response, partial response, or stable disease. |
| Objective response rate | In the first month, the second month, the third month | The percentage of patients whose therapeutic intervention has led to a complete response, partial response. |
| Adverse events | 1 month after surgery | Adverse events during and after the treatment |
Countries
China
Contacts
Primary ContactNan Niu, Phd
Outcome results
None listed