Breast Cancer (Early Breast Cancer)NCT07071402
A Study on the Treatment of Early Small Breast Cancer With Ultrasound-guided Vacuum-assisted Excision Combined With Surgery
A study testing Ultrasound-guided vacuum-assisted excision combined with surgical treatment in people with Breast Cancer (Early Breast Cancer), run by Xijing Hospital at 1 site in China.
Trial summary
The aim of this clinical trial is to assess the feasibility and safety of ultrasound-guided vacuum-assisted excision (VAE) in the treatment of early breast cancer with Tis (carcinoma in situ) or T1 (maximum tumor diameter ≤2cm) and negative axillary lymph nodes on imaging. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Breast Cancer (Early Breast Cancer)
- What is being tested?
- Ultrasound-guided vacuum-assisted excision combined with surgical treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 18 Jul 2025to 1 Jun 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects must meet all of the following inclusion criteria to be enrolled in this trial:
- Age: 18 - 70 years old;
- Female patients;
- Patients diagnosed with suspected breast cancer through imaging (such as breast ultrasound, mammography, etc.) with BI - RADS Category 4C and Category 5;
- Clinical stage T1: Mass ≤2cm;
- No previous treatment related to breast cancer;
- Be willing to undergo ultrasound - guided vacuum - assisted resection, biopsy and surgical treatment; 7) The subjects voluntarily join this study and sign the informed consent form.
Who cannot join
- Those with any of the following circumstances will not be selected as subjects:
- Imaging suggests that the lesion is greater than 2cm;
- Suspected positive axillary lymph nodes in imaging (Bedi 4, Bedi 5, Bedi 6);
- The tumor invades the nipples, areolas and subcutaneous tissues;
- Breast cancer during pregnancy;
- Abnormal functions of vital organs such as the heart, lungs, liver and kidneys, and poorly controlled diabetes, etc., cannot tolerate surgery;
- Any other circumstances in which the researcher deems the patient unsuitable to participate in this study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single-center, Single-arm, Open Study on the Treatment of Early Small Breast Cancer With Ultrasound-guided Vacuum-assisted Excision Combined With Surgery
The aim of this clinical trial is to assess the feasibility and safety of ultrasound-guided vacuum-assisted excision (VAE) in the treatment of early breast cancer with Tis (carcinoma in situ) or T1 (maximum tumor diameter ≤2cm) and negative axillary lymph nodes on imaging. The main question it aims to answer is:
- After VAE, when undergoing routine breast cancer surgery again, what is the complete resection rate of the lesion in the surgically removed tissue (pathologically confirmed), that is, the false negative rate of VAE?
- Which type of breast cancer lesion has the highest complete resection rate?
- Is it clear whether VAE can be applied in the treatment of early breast cancer with Tis or T1 and negative axillary lymph nodes on imaging?
- Do patients with benign breast nodules who undergo VAE or are recommended for Vacuum-assisted breast biopsy (VABB) due to limited puncture and are diagnosed with breast cancer need to undergo surgery again?
- The incidence of complications of VAE.
Read more
Participants will:
- Single early breast cancer subjects with Tis or T1 and negative axillary lymph nodes on imaging, after being fully informed and signing the informed consent form, enter the trial period after screening and being qualified.
- After the subjects are confirmed to be enrolled, VAE biopsy resection is performed first.
- Patients clearly diagnosed with breast cancer receive traditional radical mastectomy for breast cancer: Breast-conserving surgery or total mastectomy, sentinel lymph node biopsy or dissection in the axilla, assessment of whether the lesion has been completely removed based on postoperative pathology, and follow-up is conducted.
Read the detailed description
This is a single-arm and single-center clinical study. The specific implementation steps of the study are as follows:
- Patient recruitment and screening Recruit eligible patients through channels such as the breast surgery outpatient department of the hospital. Conduct a preliminary assessment of potential patients, including medical history inquiry, physical examination, and imaging examinations (breast ultrasound, mammography, etc.), to determine whether they meet the inclusion criteria. Adopt the Common Decision Questionnaire (SDM-Q-9). Evaluate the patients and select those with better compliance and a standardized total score of the scale ≥80. Introduce in detail the research purpose, methods, risks and benefits, etc. to the patients who meet the inclusion criteria and the assessment, and obtain the written informed consent forms of the patients.
- VAE surgery Ultrasound-guided vacuum-assisted resection: Place the patient in an appropriate position, and use a routine disinfection towel. Locate the tumor location by ultrasound. After local anesthesia, percutaneously puncture a vacuum-assisted rotary cutting needle beneath the tumor. Under ultrasound guidance, gradually remove the tumor tissue until the ultrasound shows that the tumor is completely resected. Send the resected tissue for pathological examination.
- Follow-up surgery After the patient is confirmed to have breast cancer through VAE resection biopsy, according to the specific condition of the patient, perform radical mastectomy for breast cancer in the hospital. The surgical methods can be breast-conserving surgery or mastectomy. At the same time, perform sentinel lymph node biopsy, and send the resected tissue for pathological examination. The surgical process follows the procedures for breast cancer surgical treatment norms.
- Postoperative assessment Pathological assessment: Conduct a detailed pathological examination on the specimens removed by vacuum-assisted resection and subsequent surgical resection, including tumor size, histological grade, molecular typing, resection margin conditions, and tumor residue conditions, etc. Complication assessment: Observe whether complications such as bleeding, infection, breast tissue injury, poor incision healing, and lymphatic leakage occur in patients during vacuum-assisted resection and subsequent surgeries. Record the occurrence time, severity, and treatment measures of complications. Evaluation of surgical satisfaction, treatment satisfaction and quality of life satisfaction: After the operation, give chemotherapy, targeted therapy or endocrine therapy according to the diagnosis and treatment routine. The treatment plan follows the recommendations of guidelines such as NCCN. If local radiotherapy is required, carry it out according to the clinical routine. At 1 week, 1 month, 3 months and 6 months after the operation at time points such as months, evaluate the surgical satisfaction, treatment satisfaction and quality of life satisfaction of the patients.
- Establish a database for follow-up Utilize the existing breast cancer database of the department to establish individual information data for patients, recording their general information, diagnosis and treatment processes, and other data.
- Conditions
- Breast Cancer (Early Breast Cancer)
- Being tested
- Ultrasound-guided vacuum-assisted excision combined with surgical treatment
- Keywords
- vacuum-assisted excision
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound-guided vacuum-assisted excision combined with surgical treatmentProcedure or surgery
Patients undergoing VAE surgery （EnCor® vacuum-assisted minimally invasive rotary system）are placed in an appropriate position, undergo routine disinfection and blanching, and the tumor location is located by ultrasound. After local anesthesia, a vacuum-assisted rotary cutting needle is percutaneous punctured beneath the tumor. Under ultrasound guidance, the tumor tissue is gradually resected until the ultrasound shows complete tumor resection. The resected tissue is sent for pathological examination. After the patient is confirmed to have breast cancer through VAE resection biopsy, depending on the patient's specific condition, they are hospitalized for radical mastectomy. The surgical methods can be breast-conserving surgery or mastectomy. At the same time, sentinel lymph node biopsy is performed, and the resected tissue is sent for pathological examination. The surgical process follows the surgical treatment norms for breast cancer.
| Study group | Role | What they receive |
|---|---|---|
| Ultrasound-guided VAE combined with surgery for the treatment of early small breast cancer | Experimental | Single early breast cancer subjects with Tis (carcinoma in situ) or T1 (maximum tumor diameter ≤2cm) and negative axillary lymph nodes on imaging, after being fully informed and signing the informed consent form, and passing the screening, enter the trial period. After the subjects are confirmed to be enrolled, VAE is performed first. Patients with a clear diagnosis of breast cancer receive traditional radical mastectomy for breast cancer: Breast-conserving surgery or total mastectomy, and sentinel lymph node biopsy or dissection in the axilla. The complete resection of the lesion is evaluated based on the postoperative pathology, and follow-up is conducted. Receives: Procedure: Ultrasound-guided vacuum-assisted excision combined with surgical treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
The complete resection rate of the lesion in the surgically resected tissue after vacuum-assisted excision under ultrasound guidance
The proportion of patients whose tumor tissues are completely resected by VAE confirmed through postoperative pathological examination, that is, the false negative rate of VAE
Measured: Two weeks after the operation
Secondary outcomes (3)
Incidence of surgery-related complications
The occurrence of complications such as bleeding, infection, breast tissue injury, poor incision healing and lymphatic leakage during VAE and subsequent surgical procedures
Measured: During the operation, 3 days after the operation, 2 weeks after the operation, 1 month after the operation
The local recurrence rate of the breast and axilla
The patients are followed up to evaluate whether there is recurrence of breast and axillary lesions
Measured: Two years after the operation
Patient satisfaction
The BREAST Q2 questionnaire is used for the investigation
Measured: Three months after the operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2025
- Study start18 Jul 2025
- Primary completion1 Jun 2028 (estimated)
- Study completion1 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer (Early Breast Cancer)Studies of the same condition, open and under way.
- More trials run by Xijing HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xijing Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07071402
- Sponsor's protocol ID
- KY-20252227-F-1
- Status last verified
- Oct 2026
- First submitted
- 29 Jun 2025
- Last updated
- 13 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-center, Single-arm, Open Study on the Treatment of Early Small Breast Cancer With Ultrasound-guided Vacuum-assisted Excision Combined With Surgery
- ClinicalTrials.gov ID
- NCT07071402
- Acronym / sponsor ID
- KY-20252227-F-1
- Conditions
- Breast Cancer (Early Breast Cancer)
- Keywords
- vacuum-assisted excision
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Xijing HospitalUniversity, hospital or other
- Study start
- 18 Jul 2025 (actual)
- Primary completion
- 1 Jun 2028 (estimated)
- Study completion
- 1 Jun 2029 (estimated)
- First posted
- 17 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this clinical trial is to assess the feasibility and safety of ultrasound-guided vacuum-assisted excision (VAE) in the treatment of early breast cancer with Tis (carcinoma in situ) or T1 (maximum tumor diameter ≤2cm) and negative axillary lymph nodes on imaging. The main question it aims to answer is:
- After VAE, when undergoing routine breast cancer surgery again, what is the complete resection rate of the lesion in the surgically removed tissue (pathologically confirmed), that is, the false negative rate of VAE?
- Which type of breast cancer lesion has the highest complete resection rate?
- Is it clear whether VAE can be applied in the treatment of early breast cancer with Tis or T1 and negative axillary lymph nodes on imaging?
- Do patients with benign breast nodules who undergo VAE or are recommended for Vacuum-assisted breast biopsy (VABB) due to limited puncture and are diagnosed with breast cancer need to undergo surgery again?
- The incidence of complications of VAE.
Participants will:
- Single early breast cancer subjects with Tis or T1 and negative axillary lymph nodes on imaging, after being fully informed and signing the informed consent form, enter the trial period after screening and being qualified.
- After the subjects are confirmed to be enrolled, VAE biopsy resection is performed first.
- Patients clearly diagnosed with breast cancer receive traditional radical mastectomy for breast cancer: Breast-conserving surgery or total mastectomy, sentinel lymph node biopsy or dissection in the axilla, assessment of whether the lesion has been completely removed based on postoperative pathology, and follow-up is conducted.
Detailed description
This is a single-arm and single-center clinical study. The specific implementation steps of the study are as follows:
- Patient recruitment and screening Recruit eligible patients through channels such as the breast surgery outpatient department of the hospital. Conduct a preliminary assessment of potential patients, including medical history inquiry, physical examination, and imaging examinations (breast ultrasound, mammography, etc.), to determine whether they meet the inclusion criteria. Adopt the Common Decision Questionnaire (SDM-Q-9). Evaluate the patients and select those with better compliance and a standardized total score of the scale ≥80. Introduce in detail the research purpose, methods, risks and benefits, etc. to the patients who meet the inclusion criteria and the assessment, and obtain the written informed consent forms of the patients.
- VAE surgery Ultrasound-guided vacuum-assisted resection: Place the patient in an appropriate position, and use a routine disinfection towel. Locate the tumor location by ultrasound. After local anesthesia, percutaneously puncture a vacuum-assisted rotary cutting needle beneath the tumor. Under ultrasound guidance, gradually remove the tumor tissue until the ultrasound shows that the tumor is completely resected. Send the resected tissue for pathological examination.
- Follow-up surgery After the patient is confirmed to have breast cancer through VAE resection biopsy, according to the specific condition of the patient, perform radical mastectomy for breast cancer in the hospital. The surgical methods can be breast-conserving surgery or mastectomy. At the same time, perform sentinel lymph node biopsy, and send the resected tissue for pathological examination. The surgical process follows the procedures for breast cancer surgical treatment norms.
- Postoperative assessment Pathological assessment: Conduct a detailed pathological examination on the specimens removed by vacuum-assisted resection and subsequent surgical resection, including tumor size, histological grade, molecular typing, resection margin conditions, and tumor residue conditions, etc. Complication assessment: Observe whether complications such as bleeding, infection, breast tissue injury, poor incision healing, and lymphatic leakage occur in patients during vacuum-assisted resection and subsequent surgeries. Record the occurrence time, severity, and treatment measures of complications. Evaluation of surgical satisfaction, treatment satisfaction and quality of life satisfaction: After the operation, give chemotherapy, targeted therapy or endocrine therapy according to the diagnosis and treatment routine. The treatment plan follows the recommendations of guidelines such as NCCN. If local radiotherapy is required, carry it out according to the clinical routine. At 1 week, 1 month, 3 months and 6 months after the operation at time points such as months, evaluate the surgical satisfaction, treatment satisfaction and quality of life satisfaction of the patients.
- Establish a database for follow-up Utilize the existing breast cancer database of the department to establish individual information data for patients, recording their general information, diagnosis and treatment processes, and other data.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ultrasound-guided VAE combined with surgery for the treatment of early small breast cancer | Experimental | Procedure: Ultrasound-guided vacuum-assisted excision combined with surgical treatmentSingle early breast cancer subjects with Tis (carcinoma in situ) or T1 (maximum tumor diameter ≤2cm) and negative axillary lymph nodes on imaging, after being fully informed and signing the informed consent form, and passing the screening, enter the trial period. After the subjects are confirmed to be enrolled, VAE is performed first. Patients with a clear diagnosis of breast cancer receive traditional radical mastectomy for breast cancer: Breast-conserving surgery or total mastectomy, and sentinel lymph node biopsy or dissection in the axilla. The complete resection of the lesion is evaluated based on the postoperative pathology, and follow-up is conducted. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age: 18 - 70 years old;
- Female patients;
- Patients diagnosed with suspected breast cancer through imaging (such as breast ultrasound, mammography, etc.) with BI - RADS Category 4C and Category 5;
- Clinical stage T1: Mass ≤2cm;
- No previous treatment related to breast cancer;
Key exclusion criteria (7 listed)
- Imaging suggests that the lesion is greater than 2cm;
- Suspected positive axillary lymph nodes in imaging (Bedi 4, Bedi 5, Bedi 6);
- The tumor invades the nipples, areolas and subcutaneous tissues;
- Breast cancer during pregnancy;
- Abnormal functions of vital organs such as the heart, lungs, liver and kidneys, and poorly controlled diabetes, etc., cannot tolerate surgery;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ultrasound-guided vacuum-assisted excision combined with surgical treatmentPatients undergoing VAE surgery （EnCor® vacuum-assisted minimally invasive rotary system）are placed in an appropriate position, undergo routine disinfection and blanching, and the tumor location is located by ultrasound. After local anesthesia, a vacuum-assisted rotary cutting needle is percutaneous punctured beneath the tumor. Under ultrasound guidance, the tumor tissue is gradually resected until the ultrasound shows complete tumor resection. The resected tissue is sent for pathological examination. After the patient is confirmed to have breast cancer through VAE resection biopsy, depending on the patient's specific condition, they are hospitalized for radical mastectomy. The surgical methods can be breast-conserving surgery or mastectomy. At the same time, sentinel lymph node biopsy is performed, and the resected tissue is sent for pathological examination. The surgical process follows the surgical treatment norms for breast cancer. | Procedure or surgery | Ultrasound-guided VAE combined with surgery for the treatment of early small breast cancer |
Primary outcome
The complete resection rate of the lesion in the surgically resected tissue after vacuum-assisted excision under ultrasound guidance
Time frame: Two weeks after the operation
The proportion of patients whose tumor tissues are completely resected by VAE confirmed through postoperative pathological examination, that is, the false negative rate of VAE
3 secondary outcomes
Incidence of surgery-related complications
Time frame: During the operation, 3 days after the operation, 2 weeks after the operation, 1 month after the operation
The local recurrence rate of the breast and axilla
Time frame: Two years after the operation
Patient satisfaction
Time frame: Three months after the operation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound-guided vacuum-assisted excision combined with surgical treatment in people with Breast Cancer (Early Breast Cancer), run by Xijing Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The complete resection rate of the lesion in the surgically resected tissue after vacuum-assisted excision under ultrasound guidance (time frame: Two weeks after the operation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026.