Breast TumorNCT04626986
Comparison of Microwave Ablation With Breast Conserving Surgery for Breast Tumor
A study testing microwave ablation and breast conserving surgery in people with Breast Tumor and Microwave Ablation, run by Chinese PLA General Hospital at 1 site in China.
Trial summary
The investigators will perform this study to prospectively compare the clinical outcome after percutaneous microwave ablation(MWA) and breast conserving surgery of benign and malignant breast lesion under ultrasound (US) guidance. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Breast Tumor, Microwave Ablation, Breast Conserving Surgery
- What is being tested?
- microwave ablation and breast conserving surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 18 Sep 2020to 30 May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- women,
- with invasive ductal carcinoma of the breast according to core-needle
- tumor measuring 50mm or smaller, no axillary lymph node metastasis or Ipsilateral grade I and II axillary lymph node metastasis, movable(pT0-2N0-1M0 )
- located at least 10 mm from the skin surface and chest wall.
Who cannot join
- men
- women who were pregnant or breastfeeding
- radiologic suspicion of multifocality or extensive intraductal carcinoma
- histologic diagnosis of lobular carcinoma
- neoadjuvant therapy
- previous surgery or radiation therapy of the ipsilateral breast.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Chinese PLA General Hospital
Beijing, Beijing Municipality, 100853
Jie Yu, Doctor, 8601066939530, jiemi301@163.com
About this study
Official title: Comparison of Ultrasound Guided Percutaneous Microwave Ablation With Breast Conserving Surgery for Breast Tumor
The investigators will perform this study to prospectively compare the clinical outcome after percutaneous microwave ablation(MWA) and breast conserving surgery of benign and malignant breast lesion under ultrasound (US) guidance.
Read the detailed description
A total of more than 300 patients diagnosed with breast tumor in multiple centers will be recruited in this study and underwent US-guided percutaneous MWA and breast conserving surgery treatment. Information for each patient includes demographics; longest diameters of tumors; tumor numbers; tumor pathological type; location of tumor according to whether adjacent to skin, pectoralis, areola and papilla. Ablation variables including session, puncture, time, and power; complete ablation, complications; reduction in volume, palpability, pain and cosmetic satisfying outcomes,recurrence,survival will be compared and analyzed.
- Conditions
- Breast Tumor, Microwave Ablation, Breast Conserving Surgery
- Being tested
- microwave ablation, breast conserving surgery
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
microwave ablationProcedure or surgery
Microwave ablation has the advantages of aesthetics, precise positioning, minimally invasive and painless for patients with early breast cancer.The tumor can be completely killed without injurying adjacent tissue. Some studies have suggested MWA is a safe and effective therapy for the treatment of breast cancer.
breast conserving surgeryProcedure or surgery
The treatment of early-stage breast cancer tends to be less-invasive including less morbidity, shorter hospitalization, and improved cosmetic results. Many reports have concluded that there was no difference between breast-conserving surgery and the traditional radical mastectomy for early stage breast cancer in time to distant metastases or overall survival, so breast-conserving surgery is becoming an alternative treatment for early-stage breast cancer.
| Study group | Role | What they receive |
|---|---|---|
| microwave ablation | Experimental | Microwave ablation（MWA）refers to all electromagnetic methods of inducing tumor destruction by using devices with frequencies greater than or equal to 900MHz. The rotation of dipole molecules accounts for most of the heat generated during MWA. Water molecules as dipoles attempt to continuously reorient at the same rate in microwave's oscillating electric field. As a result of microwave transmission, the water molecules flip back and forth billions of times a second. The vigorous movement of water molecules produce friction and heat, thus inducing cellular death via coagulation necrosis. The microwave unit (KY-2000, Kangyou Medical, Nanjing, China) is capable of producing 100 Watts of power at 2450 MHz.The needle antenna has a diameter of 1.6 mm (16G) and a length of 10 cm. The active tip length is 3mm and 5mm. Receives: Procedure: microwave ablation |
| breast conserving surgery | Active comparator | Breast-conserving surgery refers to the removal of the primary tumor and adjacent breast tissue, supplemented by postoperative radiotherapy.Its principle is to remove the primary tumor completely while meet patient's cosmetic satisfaction.The combined treatment of early breast cancer with radiotherapy and chemotherapy is the same as radical surgery or modified radical surgery in terms of local and regional control rate and long-term survival rate. Breast conserving surgery and postoperative comprehensive treatment have become one of the main methods for the treatment of early breast cancer. Receives: Procedure: breast conserving surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
overall survival：Defined as the length of time from the beginning of treatment to death or the last follow-up (if no death)
Defined as the length of time from the beginning of treatment to death or the last follow-up (if no death)
Measured: 5 years
cosmetic satisfaction：Patients are rated whether they are satisfied with the surgical scars（bad / moderate /good / very good）
Patients are rated whether they are satisfied with the surgical scars（bad / moderate /good / very good）
Measured: 3 years
Secondary outcomes (3)
local tumor progress：Defined as the proportion of patients with active tumor at the edge of the treatment ：Defined as the proportion of patients with active tumor at the edge of the treatment
Defined as the proportion of patients with active tumor at the edge of the treatment area during follow-up after the tumor was completely treated
Measured: 5 years
metastasis：Defined as the proportion of cases with metastasis from the beginning of the study to the end of the study or the death of the patient
Defined as the proportion of cases with metastasis from the beginning of the study to the end of the study or the death of the patient
Measured: 5 years
complication：Defined as numbers of participants with side effect and major complications to the end of the study or the death of the patient
Defined as numbers of participants with side effect and major complications to the end of the study or the death of the patient
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2020
- Study start18 Sep 2020
- Primary completion30 May 2023 (estimated)
- Study completion30 May 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast TumorStudies of the same condition, open and under way.
- More trials run by Chinese PLA General 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese PLA General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ping Liang, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04626986
- Sponsor's protocol ID
- S2020-09
- Status last verified
- Oct 2021
- First submitted
- 27 Sep 2020
- Last updated
- 26 Oct 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Ultrasound Guided Percutaneous Microwave Ablation With Breast Conserving Surgery for Breast Tumor
- ClinicalTrials.gov ID
- NCT04626986
- Acronym / sponsor ID
- S2020-09
- Conditions
- Breast Tumor, Microwave Ablation, Breast Conserving Surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Chinese PLA General HospitalUniversity, hospital or other
- Study start
- 18 Sep 2020 (actual)
- Primary completion
- 30 May 2023 (estimated)
- Study completion
- 30 May 2023 (estimated)
- First posted
- 13 Nov 2020 (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 investigators will perform this study to prospectively compare the clinical outcome after percutaneous microwave ablation(MWA) and breast conserving surgery of benign and malignant breast lesion under ultrasound (US) guidance.
Detailed description
A total of more than 300 patients diagnosed with breast tumor in multiple centers will be recruited in this study and underwent US-guided percutaneous MWA and breast conserving surgery treatment. Information for each patient includes demographics; longest diameters of tumors; tumor numbers; tumor pathological type; location of tumor according to whether adjacent to skin, pectoralis, areola and papilla. Ablation variables including session, puncture, time, and power; complete ablation, complications; reduction in volume, palpability, pain and cosmetic satisfying outcomes,recurrence,survival will be compared and analyzed.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| microwave ablation | Experimental | Procedure: microwave ablationMicrowave ablation（MWA）refers to all electromagnetic methods of inducing tumor destruction by using devices with frequencies greater than or equal to 900MHz. The rotation of dipole molecules accounts for most of the heat generated during MWA. Water molecules as dipoles attempt to continuously reorient at the same rate in microwave's oscillating electric field. As a result of microwave transmission, the water molecules flip back and forth billions of times a second. The vigorous movement of water molecules produce friction and heat, thus inducing cellular death via coagulation necrosis. The microwave unit (KY-2000, Kangyou Medical, Nanjing, China) is capable of producing 100 Watts of power at 2450 MHz.The needle antenna has a diameter of 1.6 mm (16G) and a length of 10 cm. The active tip length is 3mm and 5mm. |
| breast conserving surgery | Active comparator | Procedure: breast conserving surgeryBreast-conserving surgery refers to the removal of the primary tumor and adjacent breast tissue, supplemented by postoperative radiotherapy.Its principle is to remove the primary tumor completely while meet patient's cosmetic satisfaction.The combined treatment of early breast cancer with radiotherapy and chemotherapy is the same as radical surgery or modified radical surgery in terms of local and regional control rate and long-term survival rate. Breast conserving surgery and postoperative comprehensive treatment have become one of the main methods for the treatment of early breast cancer. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- women,
- with invasive ductal carcinoma of the breast according to core-needle
- tumor measuring 50mm or smaller, no axillary lymph node metastasis or Ipsilateral grade I and II axillary lymph node metastasis, movable(pT0-2N0-1M0 )
- located at least 10 mm from the skin surface and chest wall.
Key exclusion criteria (6 listed)
- men
- women who were pregnant or breastfeeding
- radiologic suspicion of multifocality or extensive intraductal carcinoma
- histologic diagnosis of lobular carcinoma
- neoadjuvant therapy
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 |
|---|---|---|
| microwave ablationMicrowave ablation has the advantages of aesthetics, precise positioning, minimally invasive and painless for patients with early breast cancer.The tumor can be completely killed without injurying adjacent tissue. Some studies have suggested MWA is a safe and effective therapy for the treatment of breast cancer. | Procedure or surgery | microwave ablation |
| breast conserving surgeryThe treatment of early-stage breast cancer tends to be less-invasive including less morbidity, shorter hospitalization, and improved cosmetic results. Many reports have concluded that there was no difference between breast-conserving surgery and the traditional radical mastectomy for early stage breast cancer in time to distant metastases or overall survival, so breast-conserving surgery is becoming an alternative treatment for early-stage breast cancer. | Procedure or surgery | breast conserving surgery |
Primary outcome
overall survival：Defined as the length of time from the beginning of treatment to death or the last follow-up (if no death)
Time frame: 5 years
Defined as the length of time from the beginning of treatment to death or the last follow-up (if no death)
cosmetic satisfaction：Patients are rated whether they are satisfied with the surgical scars（bad / moderate /good / very good）
Time frame: 3 years
Patients are rated whether they are satisfied with the surgical scars（bad / moderate /good / very good）
3 secondary outcomes
local tumor progress：Defined as the proportion of patients with active tumor at the edge of the treatment ：Defined as the proportion of patients with active tumor at the edge of the treatment
Time frame: 5 years
metastasis：Defined as the proportion of cases with metastasis from the beginning of the study to the end of the study or the death of the patient
Time frame: 5 years
complication：Defined as numbers of participants with side effect and major complications to the end of the study or the death of the patient
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2021.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing microwave ablation and breast conserving surgery in people with Breast Tumor and Microwave Ablation, run by Chinese PLA General 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 4 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 26 Oct 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jie Yu, Dr. (66937981, jiemi301@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
overall survival：Defined as the length of time from the beginning of treatment to death or the last follow-up (if no death) (time frame: 5 years). The study lists 2 primary outcomes in all. 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 26 Oct 2021.