Breast CancerNCT06288620
Microwave Ablation in the Treatment of Early-stage Unifocal Invasive Breast Cancer
A study testing Microwave Ablation in people with Breast Cancer, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
Trial summary
Microwave Ablative (MWA) therapy, as a minimally invasive thermal therapy, has been attempted to treat breast cancer of small lesions . However, the optimal indications for MWA in the treatment of breast cancer is unknown. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Microwave Ablation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 77 participants
- Where
- 1 siteChina
- Study dates
- 25 Feb 2024to 30 May 2025
- 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 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- female patients aged 18-70 years;
- patients with newly diagnosed invasive breast cancer confirmed by core needle biopsy;
- the tumor smaller than 2cm in greatest diameter confirmed by US (ultrasonography), breast X-ray and breast MRI (contrast-enhanced magnetic resonance image ) were performed at the same time, and the difference of the largest diameter between breast US and MRI was less than 0.5 cm;
- the single tumor without other suspicious lesions (BI-RADS (the Breast Imaging Recording and Data System) score ≥4) evaluated by breast US, X-ray and MRI;
- the tumor without adhesion to chest wall, nipple or skin;
- patients without distant metastasis;
- Karnofsky performance status greater than 70%.
Who cannot join
- multicentric or multifocal breast tumor;
- the tumor located on nipple and areola area;
- signs of extensive intraductal carcinoma on imaging examination (diffuse malignant calcification on breast X-ray or segmental distribution, non-mass enhancement, ductal or linear enhancement > 2.5 cm on MRI);
- extensive intraductal component in invasive cancer (more than 50% of the tumor volume) confirmed by pathology;
- invasive lobular carcinoma, metaplastic carcinoma or carcinoma with sclerosing adenosis;
- patients who were pregnant or breastfeeding;
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- patients with evidence of coagulopathy, chronic liver diseases or renal failure;
- patients with previous treatment including chemotherapy, targeted drug therapy, or local radiation therapy, etc;
- patients with substance abuse, or mental or psychological disorders that may interfere with study compliance;
- any condition that is unstable or likely to compromise the patient's safety and compliance;
- patients enrolled in other clinical trials;
- diseases or symptoms that other investigators consider unsuitable for participation.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
the First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu
Wenbin Zhou, Professor
About this study
Official title: A Prospective, Open-label, Single-arm Phase II Clinical Study to Evaluate the Efficacy and Safety of Microwave Ablation in the Treatment of Early-stage Unifocal Invasive Breast Cancer
Microwave Ablative (MWA) therapy, as a minimally invasive thermal therapy, has been attempted to treat breast cancer of small lesions . However, the optimal indications for MWA in the treatment of breast cancer is unknown. This prospective, open-label, single-arm phase II clinical study was conducted to evaluate the efficacy and safety of MWA in the treatment of early-stage unifocal invasive breast cancer, and to explore the immune activating effect.
- Conditions
- Breast Cancer
- Being tested
- Microwave Ablation
- Keywords
- Ablation
- 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
Preoperative US-guided microwave ablation of breast cancer
| Study group | Role | What they receive |
|---|---|---|
| Microwave Ablation | Experimental | Preoperative US-guided microwave ablation of breast cancer Receives: Procedure: Microwave Ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete ablation rate
The proportion of patients with complete ablation was calculated for all patients. Complete ablation was defined as: tissue section at the ablation margin that was negative by histochemical staining.
Measured: 1 day
Secondary outcomes (1)
Safety of microwave ablation
Safety measured by occurrence of study related adverse effects defined by NCI CTCAE 5.0
Measured: 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2024
- Study start25 Feb 2024
- Primary completion10 May 2025 (estimated)
- Study completion30 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital with Nanjing Medical UniversityThe 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
- 77 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06288620
- Sponsor's protocol ID
- MA-EBC-II-024
- Status last verified
- Feb 2024
- First submitted
- 25 Feb 2024
- Last updated
- 1 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Available from the corresponding author upon reasonable request
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Open-label, Single-arm Phase II Clinical Study to Evaluate the Efficacy and Safety of Microwave Ablation in the Treatment of Early-stage Unifocal Invasive Breast Cancer
- ClinicalTrials.gov ID
- NCT06288620
- Acronym / sponsor ID
- MA-EBC-II-024
- Conditions
- Breast Cancer
- Keywords
- Ablation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 77 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 25 Feb 2024 (actual)
- Primary completion
- 10 May 2025 (estimated)
- Study completion
- 30 May 2025 (estimated)
- First posted
- 1 Mar 2024 (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.
Microwave Ablative (MWA) therapy, as a minimally invasive thermal therapy, has been attempted to treat breast cancer of small lesions . However, the optimal indications for MWA in the treatment of breast cancer is unknown. This prospective, open-label, single-arm phase II clinical study was conducted to evaluate the efficacy and safety of MWA in the treatment of early-stage unifocal invasive breast cancer, and to explore the immune activating effect.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Microwave Ablation | Experimental | Procedure: Microwave AblationPreoperative US-guided microwave ablation of breast cancer |
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)
- female patients aged 18-70 years;
- patients with newly diagnosed invasive breast cancer confirmed by core needle biopsy;
- the tumor smaller than 2cm in greatest diameter confirmed by US (ultrasonography), breast X-ray and breast MRI (contrast-enhanced magnetic resonance image ) were performed at the same time, and the difference of the largest diameter between breast US and MRI was less than 0.5 cm;
- the single tumor without other suspicious lesions (BI-RADS (the Breast Imaging Recording and Data System) score ≥4) evaluated by breast US, X-ray and MRI;
- the tumor without adhesion to chest wall, nipple or skin;
Key exclusion criteria (12 listed)
- multicentric or multifocal breast tumor;
- the tumor located on nipple and areola area;
- signs of extensive intraductal carcinoma on imaging examination (diffuse malignant calcification on breast X-ray or segmental distribution, non-mass enhancement, ductal or linear enhancement > 2.5 cm on MRI);
- extensive intraductal component in invasive cancer (more than 50% of the tumor volume) confirmed by pathology;
- invasive lobular carcinoma, metaplastic carcinoma or carcinoma with sclerosing adenosis;
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 AblationPreoperative US-guided microwave ablation of breast cancer | Procedure or surgery | Microwave Ablation |
Primary outcome
Complete ablation rate
Time frame: 1 day
The proportion of patients with complete ablation was calculated for all patients. Complete ablation was defined as: tissue section at the ablation margin that was negative by histochemical staining.
1 secondary outcome
Safety of microwave ablation
Time frame: 10 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2024.
- Individual participant dataSharing planned: Yes. Available from the corresponding author upon reasonable request
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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 in people with Breast Cancer, run by The First Affiliated Hospital with Nanjing Medical University 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 12 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 1 Mar 2024. 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 Wenbin Zhou,, Professor (025-68308162, zhouwenbin@njmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete ablation rate (time frame: 1 day). 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 1 Mar 2024.