Breast Cancer Stage IMASTERNCT05887154
Non Surgical Treatment (Microwave Ablation) of Breast Cancer
A study testing Microwave ablation in people with Breast Cancer Stage I, run by University Medical Center Groningen.
Trial summary
In the Netherlands approximately one out of seven women will develop breast cancer during her life. Most of these breast cancers are early stage, 40% of the women have stage 1. Stage 1 breast cancer means that the cancer is small (size <2cm) and only in the breast tissue or it might be found in lymph nodes close to… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer Stage I
- What is being tested?
- Microwave ablation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2023to 1 Jun 2024
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age should be 18 years and older
- a solid non-lobular invasive breast tumor with a size <2cm based upon ultrasound and MRI measurements
- without mammographic or MRI evidence of extensive disease
- no involved lymph nodes on ultrasound and MRI scan.
Who cannot join
- more than one breast tumor,
- (lymph node) metastases
- breast implants
- indication for neoadjuvant chemotherapy.
- pacemaker,
- pregnant
- breastfeeding
About this study
Official title: Minimal Invasive Microwave Ablation in Early Stage breaST cancER, a Feasibility Study
In the Netherlands approximately one out of seven women will develop breast cancer during her life. Most of these breast cancers are early stage, 40% of the women have stage 1. Stage 1 breast cancer means that the cancer is small (size <2cm) and only in the breast tissue or it might be found in lymph nodes close to the breast. The standard treatment for stage 1 breast cancer is breast conserving surgery (BCS), sentinel lymph node procedure (SLNP) and additional radiotherapy. This standard treatment protocol results in a10 years survival rate of 95% for stage 1 disease. However, nowadays there is a discussion whether these early stage breast cancer could be treated less invasively. To reduce the invasiveness of breast cancer treatment, without compromising breast cancer specific survival, minimally invasive ablation procedure of the breast tumor can be an option for small breast lesions.
Patients with a tumor size<2 cm will undergo ultra guided microwave ablation (MWA) with local anesthesia. After a small incision 2-3 millimeters, an MWA electrode is placed at the end of the tumor with ultrasound guidance. The microwaves in MWA create heat around the needle and destroy the cancer cells. There are several advantages of ablation procedures: it is a minimal invasive technique, with a small or absent cutaneous scar and thereby potentially improving patient quality of life. Furthermore, ablative treatment can be done under local anesthesia and/or conscious sedation instead of general anesthesia and in daycare setting, which can reduce treatment cost. A post procedural MRI (after ablation) can determine whether the ablation procedure of the tumor volume is complete. The purpose of this study is to assess whether minimally invasive microwave ablation (MWA) followed by postprocedural MRI scan can be an alternative treatment for breast surgery in early stage breast cancer. Is the quality of life, the cosmetic outcome, fear of breast cancer recurrence, and costs in patient treated with MWA comparable or better compared to patients treated with breast surgery?
- Conditions
- Breast Cancer Stage I
- Being tested
- Microwave ablation
- Keywords
- breast cancer, microwave ablation, MRI
- 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 ablationDevice
microwave ablation
| Study group | Role | What they receive |
|---|---|---|
| Microwave ablation | Other | Each patient will undergo Microwave ablation of breast tumor before the standard clinical care (surgery) Receives: Device: Microwave ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
MWA followed by MRI in breast tumors
MWA will be succesfull if less than 20% of the patients has residual disease
Measured: 1 year
Secondary outcomes (3)
Cosmetic outcome
Breast Q questionaire
Measured: Timepoints 4 days and 2 weeks after MWA and timepoints 4 days, 2 weeks and 2 months after surgery
breast cancer recurrence fear
Lerman Breast Cancer Worry scal
Measured: Timepoints 4 days and 2 weeks after MWA and timepoints 4 days, 2 weeks and 2 months after surgery
Quality of life
EuroQol 5D5L
Measured: Timepoints 4 days and 2 weeks after MWA and timepoints 4 days, 2 weeks and 2 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2023
- Study start1 Jul 2023 (estimated)
- Primary completion1 Jun 2024 (estimated)
- Study completion1 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer Stage IStudies of the same condition, open and under way.
- More trials run by University Medical Center GroningenThe 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
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Medical Center Groningen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Monique Dorrius, University Medical Center Groningen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05887154
- Sponsor's protocol ID
- NL76030.042.21
- Other IDs
- 4901216
- Acronym
- MASTER
- Status last verified
- May 2023
- First submitted
- 15 Dec 2022
- Last updated
- 2 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Minimal Invasive Microwave Ablation in Early Stage breaST cancER, a Feasibility Study
- ClinicalTrials.gov ID
- NCT05887154
- Acronym / sponsor ID
- MASTER / NL76030.042.21
- Conditions
- Breast Cancer Stage I
- Keywords
- breast cancer, microwave ablation, MRI
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- University Medical Center GroningenUniversity, hospital or other
- Study start
- 1 Jul 2023 (estimated)
- Primary completion
- 1 Jun 2024 (estimated)
- Study completion
- 1 Jun 2024 (estimated)
- First posted
- 2 Jun 2023 (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.
In the Netherlands approximately one out of seven women will develop breast cancer during her life. Most of these breast cancers are early stage, 40% of the women have stage 1. Stage 1 breast cancer means that the cancer is small (size <2cm) and only in the breast tissue or it might be found in lymph nodes close to the breast. The standard treatment for stage 1 breast cancer is breast conserving surgery (BCS), sentinel lymph node procedure (SLNP) and additional radiotherapy. This standard treatment protocol results in a10 years survival rate of 95% for stage 1 disease. However, nowadays there is a discussion whether these early stage breast cancer could be treated less invasively. To reduce the invasiveness of breast cancer treatment, without compromising breast cancer specific survival, minimally invasive ablation procedure of the breast tumor can be an option for small breast lesions.
Patients with a tumor size<2 cm will undergo ultra guided microwave ablation (MWA) with local anesthesia. After a small incision 2-3 millimeters, an MWA electrode is placed at the end of the tumor with ultrasound guidance. The microwaves in MWA create heat around the needle and destroy the cancer cells. There are several advantages of ablation procedures: it is a minimal invasive technique, with a small or absent cutaneous scar and thereby potentially improving patient quality of life. Furthermore, ablative treatment can be done under local anesthesia and/or conscious sedation instead of general anesthesia and in daycare setting, which can reduce treatment cost. A post procedural MRI (after ablation) can determine whether the ablation procedure of the tumor volume is complete. The purpose of this study is to assess whether minimally invasive microwave ablation (MWA) followed by postprocedural MRI scan can be an alternative treatment for breast surgery in early stage breast cancer. Is the quality of life, the cosmetic outcome, fear of breast cancer recurrence, and costs in patient treated with MWA comparable or better compared to patients treated with breast surgery?
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 | Other | Device: Microwave ablationEach patient will undergo Microwave ablation of breast tumor before the standard clinical care (surgery) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- age should be 18 years and older
- a solid non-lobular invasive breast tumor with a size <2cm based upon ultrasound and MRI measurements
- without mammographic or MRI evidence of extensive disease
- no involved lymph nodes on ultrasound and MRI scan.
Key exclusion criteria (7 listed)
- more than one breast tumor,
- (lymph node) metastases
- breast implants
- indication for neoadjuvant chemotherapy.
- pacemaker,
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 | Device | Microwave ablation |
Primary outcome
MWA followed by MRI in breast tumors
Time frame: 1 year
MWA will be succesfull if less than 20% of the patients has residual disease
3 secondary outcomes
Cosmetic outcome
Time frame: Timepoints 4 days and 2 weeks after MWA and timepoints 4 days, 2 weeks and 2 months after surgery
breast cancer recurrence fear
Time frame: Timepoints 4 days and 2 weeks after MWA and timepoints 4 days, 2 weeks and 2 months after surgery
Quality of life
Time frame: Timepoints 4 days and 2 weeks after MWA and timepoints 4 days, 2 weeks and 2 months after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2023.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Microwave ablation in people with Breast Cancer Stage I, run by University Medical Center Groningen.
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 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: status not confirmed, as of the sponsor's last update on 2 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
MWA followed by MRI in breast tumors (time frame: 1 year). 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 2 Jun 2023.