Breast CancerDe-EscalationNCT07616258
Evaluating the De-Escalation of Surveillance for Patients Who Have Undergone Curative Treatment for Primary Breast Cancer
A study testing De-Escalation of Management in people with Breast Cancer, run by Royal College of Surgeons, Ireland at 1 site in Ireland.
Trial summary
Breast cancer is the most common cancer in women around the world. That means a lot of women are affected by it every year, and it's important that we always look for ways to improve their care, not just during treatment, but afterwards too. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- De-Escalation of Management
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 560 participants
- Where
- 1 siteIreland
- Study dates
- 2 Oct 2025to 30 Dec 2028
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants will be identified according to the eligibility criteria and will be approached and invited to participate in this study while attending the outpatient department at the breast centre in Beaumont Hospital. To be eligible to participate in this study, an individual must meet all of the following eligibility criteria:
- Female patients who are under cancer surveillance for a primary breast cancer which was treated with curative intent
- Aged 18 years or older at the time of 24-month surveillance
- Demonstrate no clinical or radiological evidence of disease recurrence or metastases at the time of recruitment (e.g.: palpable mass, skin or nipple changes, new indeterminant mass on mammography, etc)
- Fully fluent in English Language (Reading, Writing, and Speaking - has the ability to complete the EQ5D5L questionnaire in paper form and over the phone)
- Has a formal address in the Republic of Ireland and has the intention of undergoing further surveillance in this country
Who cannot join
- All individuals meeting any of the exclusion criteria at baseline or during screening will be excluded from study participation as per the following criteria: - An individual who fails to meet any of the aforementioned inclusion criteria will be excluded from participation in this study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Ireland1 site, 1 recruiting
- Recruiting
Beaumont RCSI Cancer Centre
Beaumont, Dublin, D09V2N0
Aisling Hegarty, PhD, 018093000, Aislinghegarty@rcsi.ie
About this study
Breast cancer is the most common cancer in women around the world. That means a lot of women are affected by it every year, and it's important that we always look for ways to improve their care, not just during treatment, but afterwards too. After treatment for early-stage breast cancer, patients usually come back to the hospital for regular check-ups for up to five years. These visits are based on old guidelines, and even though breast cancer treatment has improved a lot over the years, the follow-up schedule has stayed the same. This study is being done to see if we can safely reduce the number of hospital visits after treatment, while still keeping patients healthy and well looked after.
Right now, patients are asked to attend follow-up appointments at 6, 12, 18, 24, 36, 48 and 60 months (that's every 6 to 12 months for five years). These clinic visits often involve long waits and can cause stress or anxiety. At the same time, patients are also invited for a mammogram once a year. Recent research shows that most recurrences of breast cancer are found by patients themselves or during their annual mammograms, not necessarily at these clinic visits. That's why we're looking at whether we can safely reduce the number of hospital appointments, without affecting patient safety.
Read more
In this study, some patients will continue with the usual five-year clinic schedule. Others will only attend hospital clinics for the first two years (at 6, 12, 18 and 24 months), and after that, they will no longer need to come in for the extra follow-up visits, but they will still have their annual mammograms as normal.
Within this study all participants will complete a short questionnaire once a year. This will help us understand how the different follow-up plans affect quality of life, and how patients feel about their care. This research study is taking place to find out if fewer hospital check-ups, combined with continued mammogram screening, is just as safe and possibly better for patients' wellbeing.
Read the detailed description
This study began in 2025 at the Breast Centre in Beaumont RCSI Cancer Centre. We expect that around 600 people will take part. If you agree to join the study, you will be placed into one of two groups:
- One group will continue with the usual follow-up plan after breast cancer treatment. This includes regular hospital visits for up to five years.
- The other group will follow a new plan, where hospital visits will stop after two years, but yearly mammograms will continue as normal.
- Participants will continue to have access to the breast care team by the usual contact points such as your breast care nurse. All patients following treatment of breast cancer in Beaumont hospital are provided with a direct phone number to contact the breast care nurse should they have any concern.
Participants won't need to take any new medicines or treatments. Each year, we'll ask you to complete a short questionnaire (either in person or over the phone) to tell us how participants are feeling and how the follow-up process is working for them.
This will help the researchers understand whether the new follow-up plan is just as safe and possibly more convenient for patients.
Participants will be placed into one of two groups, this will be chosen at random (like flipping a coin). Both groups will be followed for a total of five years after their breast cancer treatment.
Group 1 - Current Follow-Up Plan (Usual Care):
- Continue with the current schedule of hospital clinic visits at: 6, 12, 18, 24, 36, 48 and 60 months after your treatment
- Be invited for your annual mammogram as normal
- Be asked to fill in a short questionnaire at your clinic visits at 24, 36, 48, and 60 months. This will help us understand how you're feeling and your experience with follow-up care
- All your appointments will take place in person at the Breast Centre in Beaumont Hospital.
Group 2 - New Follow-Up Plan (Study Group):
- Attend clinic visits at: 6, 12, 18, and 24 months after treatment
- Be discharged from hospital clinics after 2 years
- Continue to have your annual mammogram as normal
- Fill in the same questionnaire at 24 months in person, and then by telephone at 36, 48 and 60 months
- If you are in this group and ever feel you would prefer to return to hospital clinic visits, you will be supported to do so.
No extra hospital visits, medical tests, or blood samples are required for this study. The questionnaire may ask about your health, daily activities, and how you feel about the follow-up care you are receiving. Some people may find questions about quality of life or cancer follow-up a little emotional or upsetting, but you can skip any question you don't want to answer. Researchers may look at medical records to check information about diagnosis, treatment, and follow-up care. This will be done confidentially, and only by members of the research team who are trained to handle personal health information safely.
- Conditions
- Breast Cancer
- Being tested
- De-Escalation of Management, Control
- Keywords
- Breast Cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
De-Escalation of ManagementOther
Reduction in hospital based appointments to 2 years only and discharge to primary care for follow up post same.
ControlOther
Standard of care
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Intervention group:
* Hospital-based outpatient clinic appointments for two years
* Annual mammogram
* Patient satisfaction questionnaire, EQ5D5L Receives: Other: De-Escalation of Management |
| Control | Active comparator | Control Group:
* Hospital-based outpatient clinic appointments for five years
* Annual mammogram
* Patient satisfaction questionnaire, EQ5D5L Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Health-Related Quality of Life Measured by the EuroQol 5-Dimension 5-Level Questionnaire (EQ-5D-5L)
Health-related quality of life measured using the EuroQol 5-Dimension 5-Level questionnaire (EQ-5D-5L). The EQ-5D-5L evaluates five dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression), each scored on five response levels. Responses will be converted to an EQ-5D-5L index score using validated scoring methods. Higher index scores indicate better health-related quality of life.
Measured: Measured at months 24, 36, 48 and 60 post randomisation.
Secondary outcomes (1)
Breast Cancer Recurrence During Follow-Up
Number of participants with breast cancer recurrence identified during follow-up through annual mammography, clinical assessment, patient-reported symptoms, or medical record review.
Measured: Measured with annual mammogram and clinical outcomes at months 12, 24, 36, 48 and 60 post randomisation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2026
- Study start2 Oct 2025
- Primary completion30 Dec 2027 (estimated)
- Study completion30 Dec 2028 (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.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Single centre, prospective, non-blinded, randomised trial to be performed at one centre (Beaumont Hospital) over a 24-month period.
- Masking
- None (open label)
- Enrolment
- 560 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Royal College of Surgeons, Ireland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07616258
- Sponsor's protocol ID
- REC: 25-52
- Acronym
- De-Escalation
- Status last verified
- Feb 2026
- First submitted
- 16 Feb 2026
- Last updated
- 1 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the De-Escalation of Surveillance for Patients Who Have Undergone Curative Treatment for Primary Breast Cancer
- ClinicalTrials.gov ID
- NCT07616258
- Acronym / sponsor ID
- De-Escalation / REC: 25-52
- Conditions
- Breast Cancer
- Keywords
- Breast Cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 560 participants (estimated)
- Lead sponsor
- Royal College of Surgeons, IrelandUniversity, hospital or other
- Study start
- 2 Oct 2025 (actual)
- Primary completion
- 30 Dec 2027 (estimated)
- Study completion
- 30 Dec 2028 (estimated)
- First posted
- 1 Jun 2026 (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.
Breast cancer is the most common cancer in women around the world. That means a lot of women are affected by it every year, and it's important that we always look for ways to improve their care, not just during treatment, but afterwards too. After treatment for early-stage breast cancer, patients usually come back to the hospital for regular check-ups for up to five years. These visits are based on old guidelines, and even though breast cancer treatment has improved a lot over the years, the follow-up schedule has stayed the same. This study is being done to see if we can safely reduce the number of hospital visits after treatment, while still keeping patients healthy and well looked after.
Right now, patients are asked to attend follow-up appointments at 6, 12, 18, 24, 36, 48 and 60 months (that's every 6 to 12 months for five years). These clinic visits often involve long waits and can cause stress or anxiety. At the same time, patients are also invited for a mammogram once a year. Recent research shows that most recurrences of breast cancer are found by patients themselves or during their annual mammograms, not necessarily at these clinic visits. That's why we're looking at whether we can safely reduce the number of hospital appointments, without affecting patient safety.
In this study, some patients will continue with the usual five-year clinic schedule. Others will only attend hospital clinics for the first two years (at 6, 12, 18 and 24 months), and after that, they will no longer need to come in for the extra follow-up visits, but they will still have their annual mammograms as normal.
Within this study all participants will complete a short questionnaire once a year. This will help us understand how the different follow-up plans affect quality of life, and how patients feel about their care. This research study is taking place to find out if fewer hospital check-ups, combined with continued mammogram screening, is just as safe and possibly better for patients' wellbeing.
Detailed description
This study began in 2025 at the Breast Centre in Beaumont RCSI Cancer Centre. We expect that around 600 people will take part. If you agree to join the study, you will be placed into one of two groups:
- One group will continue with the usual follow-up plan after breast cancer treatment. This includes regular hospital visits for up to five years.
- The other group will follow a new plan, where hospital visits will stop after two years, but yearly mammograms will continue as normal.
- Participants will continue to have access to the breast care team by the usual contact points such as your breast care nurse. All patients following treatment of breast cancer in Beaumont hospital are provided with a direct phone number to contact the breast care nurse should they have any concern.
Participants won't need to take any new medicines or treatments. Each year, we'll ask you to complete a short questionnaire (either in person or over the phone) to tell us how participants are feeling and how the follow-up process is working for them.
This will help the researchers understand whether the new follow-up plan is just as safe and possibly more convenient for patients.
Participants will be placed into one of two groups, this will be chosen at random (like flipping a coin). Both groups will be followed for a total of five years after their breast cancer treatment.
Group 1 - Current Follow-Up Plan (Usual Care):
- Continue with the current schedule of hospital clinic visits at: 6, 12, 18, 24, 36, 48 and 60 months after your treatment
- Be invited for your annual mammogram as normal
- Be asked to fill in a short questionnaire at your clinic visits at 24, 36, 48, and 60 months. This will help us understand how you're feeling and your experience with follow-up care
- All your appointments will take place in person at the Breast Centre in Beaumont Hospital.
Group 2 - New Follow-Up Plan (Study Group):
- Attend clinic visits at: 6, 12, 18, and 24 months after treatment
- Be discharged from hospital clinics after 2 years
- Continue to have your annual mammogram as normal
- Fill in the same questionnaire at 24 months in person, and then by telephone at 36, 48 and 60 months
- If you are in this group and ever feel you would prefer to return to hospital clinic visits, you will be supported to do so.
No extra hospital visits, medical tests, or blood samples are required for this study. The questionnaire may ask about your health, daily activities, and how you feel about the follow-up care you are receiving. Some people may find questions about quality of life or cancer follow-up a little emotional or upsetting, but you can skip any question you don't want to answer. Researchers may look at medical records to check information about diagnosis, treatment, and follow-up care. This will be done confidentially, and only by members of the research team who are trained to handle personal health information safely.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Single centre, prospective, non-blinded, randomised trial to be performed at one centre (Beaumont Hospital) over a 24-month period.
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: De-Escalation of ManagementIntervention group: * Hospital-based outpatient clinic appointments for two years * Annual mammogram * Patient satisfaction questionnaire, EQ5D5L |
| Control | Active comparator | Other: ControlControl Group: * Hospital-based outpatient clinic appointments for five years * Annual mammogram * Patient satisfaction questionnaire, EQ5D5L |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Participants will be identified according to the eligibility criteria and will be approached and invited to participate in this study while attending the outpatient department at the breast centre in Beaumont Hospital. To be eligible to participate in this study, an individual must meet all of the following eligibility criteria:
- Female patients who are under cancer surveillance for a primary breast cancer which was treated with curative intent
- Aged 18 years or older at the time of 24-month surveillance
- Demonstrate no clinical or radiological evidence of disease recurrence or metastases at the time of recruitment (e.g.: palpable mass, skin or nipple changes, new indeterminant mass on mammography, etc)
- Fully fluent in English Language (Reading, Writing, and Speaking - has the ability to complete the EQ5D5L questionnaire in paper form and over the phone)
Key exclusion criteria (1 listed)
- All individuals meeting any of the exclusion criteria at baseline or during screening will be excluded from study participation as per the following criteria: - An individual who fails to meet any of the aforementioned inclusion criteria will be excluded from participation in this study.
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 |
|---|---|---|
| De-Escalation of ManagementReduction in hospital based appointments to 2 years only and discharge to primary care for follow up post same. | Other | Intervention |
| ControlStandard of care | Other | Control |
Primary outcome
Health-Related Quality of Life Measured by the EuroQol 5-Dimension 5-Level Questionnaire (EQ-5D-5L)
Time frame: Measured at months 24, 36, 48 and 60 post randomisation.
Health-related quality of life measured using the EuroQol 5-Dimension 5-Level questionnaire (EQ-5D-5L). The EQ-5D-5L evaluates five dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression), each scored on five response levels. Responses will be converted to an EQ-5D-5L index score using validated scoring methods. Higher index scores indicate better health-related quality of life.
1 secondary outcome
Breast Cancer Recurrence During Follow-Up
Time frame: Measured with annual mammogram and clinical outcomes at months 12, 24, 36, 48 and 60 post randomisation.
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 1 Jun 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing De-Escalation of Management in people with Breast Cancer, run by Royal College of Surgeons, Ireland at 1 site in Ireland.
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 6 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 1 Jun 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 Ireland. 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?
Contact Prof Arnold Hill, MB, BCh, BAO, MCh, FRCSI (+35318093000, adkhill@rcsi.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Health-Related Quality of Life Measured by the EuroQol 5-Dimension 5-Level Questionnaire (EQ-5D-5L) (time frame: Measured at months 24, 36, 48 and 60 post randomisation.). 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 Jun 2026.