Recurrent Breast CarcinomaRAY-no-BANNCT06704659
Study on Recurrent Breast Cancer and Repeated Radiation Therapy
A study testing Breast conserving surgey and radiotherapy and Mastectomy in people with Recurrent Breast Carcinoma, run by Turku University Hospital at 2 sites in Finland.
Trial summary
This study explores whether recurrent breast cancer can be safely treated with breast-conserving surgery and repeated radiation therapy in cases where patients have previously undergone radiation. Traditionally, recurrent breast cancer has been treated by removing the entire breast. Read more about this study
- Who is it for?
- Ages 55 years and older, women only
- Conditions the study is for
- Recurrent Breast Carcinoma
- What is being tested?
- Breast conserving surgey and radiotherapy and Mastectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesFinland
- Study dates
- 1 Dec 2024to 31 Dec 2030
- 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 55 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The patient has a diagnosed breast cancer or tumor area in the breast with a maximum diameter of 3 cm, where a previous breast-conserving surgery has been performed (either invasive breast cancer or carcinoma in situ, DCIS).
- The patient has only a local recurrence, and imaging studies show no suspicion of metastases outside the breast (preoperative staging N0M0).
- At least 3 years have passed since the completion of prior radiation therapy. The new breast cancer can be technically treated with another breast-conserving surgery using a technique that does not require tissue transfer from areas opposite the removed tumor to restore the shape of the breast.
- The patient is at least 55 years old at the time of surgery. The patient is willing to participate in the study. The patient is capable of providing informed consent.
Who cannot join
- A booster dose, also known as a "boost," was administered during prior radiation therapy.
- Preoperative assessments suggest multifocal breast cancer, with the tumor area to be removed exceeding 3 cm.
- The planned radiation therapy per the study protocol cannot be administered due to factors such as shoulder joint stiffness, a pacemaker located in the radiation field, or a skin condition (e.g., scleroderma).
- The patient is unable to provide informed consent or is unwilling to participate in the study.
- Metastases outside the breast (e.g., axillary or distant metastases) are present.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Finland2 sites, 2 recruiting
- Recruiting
Helsinki University Hospital
Helsinki
Tuomo Meretoja, MD, PhD, +358504272 877, tuomo.meretoja@hus.fi
- Recruiting
Turku University Hospital
Turku
Anselm Tamminen, MD, PhD, jlatam@utu.fi
About this study
This study explores whether recurrent breast cancer can be safely treated with breast-conserving surgery and repeated radiation therapy in cases where patients have previously undergone radiation. Traditionally, recurrent breast cancer has been treated by removing the entire breast. However, recent research has shown that in certain situations, it may be possible to preserve the breast.
The study will collect data on the safety of this treatment approach and its effects on patients. The treatment follows standard breast cancer care practices, involving 30 patients from Helsinki and Turku University Hospitals. Patients are carefully selected based on specific criteria, such as tumor size, localization, and prior treatment history. Special attention is given to the planning of radiation therapy and surgical techniques.
The goal is to develop new treatment strategies that allow breast preservation even in cases of recurrent breast cancer, providing patients with high-quality and individualized care.
- Conditions
- Recurrent Breast Carcinoma
- Being tested
- Breast conserving surgey and radiotherapy, Mastectomy
- Keywords
- Breast cancer, Recurrence, Repeat radiation therapy, Radiation therapy
- Medical subject headings
- Breast Neoplasms, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breast conserving surgey and radiotherapyRadiation
The patients will undergo repeat Breast Conserving Surgery and Radiotherapy
MastectomyProcedure or surgery
The patients will undergo mastectomy
| Study group | Role | What they receive |
|---|---|---|
| Repeat breast conserving surgery and radiotherapy Arm | Experimental | The patients in this arm undergo repeat breast conserving surgery and partial breast radiotherapy Receives: Radiation: Breast conserving surgey and radiotherapy |
| Mastectomy Arm | Active comparator | The patients in this arm undergo mastectomy Receives: Procedure: Mastectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
A treatment-limiting radiation therapy complication.
Any complication related to radiation therapy, that would limit completing the radiotherapy
Measured: From the beginning of the radiotherapy until 30 days after finishing the therapy
Secondary outcomes (4)
Quality of life (Breast-Q scale)
Patients are asked to complete a quality of life questionnaire (Breast-Q) before the surgery and at 3 months, 1 year, 3 years, and 5 years after the surgery.
Measured: 5 years from surgery
Second Breast Cancer Recurrence
The patients are surveilled for second breast cancer recurrence
Measured: 5 years from surgery
Secondary malignancies
The patients are surveilled for any other secondary malignancy than breast cancer
Measured: 5 years
Quality of life (EORTC QLQ-C30)
Patients are asked to complete a quality of life questionnaire (EORTC QLQ-C30) before the surgery and at 3 months, 1 year, 3 years, and 5 years after the surgery
Measured: 5 years from the operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2024
- Study start1 Dec 2024
- Primary completion31 May 2026 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent Breast CarcinomaStudies of the same condition, open and under way.
- More trials run by Turku University 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
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Turku University Hospital
- Sponsor type
- Other government
- Collaborators
- Helsinki University Central Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06704659
- Sponsor's protocol ID
- T1641/2024
- Acronym
- RAY-no-BAN
- Status last verified
- Nov 2025
- First submitted
- 21 Nov 2024
- Last updated
- 9 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 9 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on Recurrent Breast Cancer and Repeated Radiation Therapy
- ClinicalTrials.gov ID
- NCT06704659
- Acronym / sponsor ID
- RAY-no-BAN / T1641/2024
- Conditions
- Recurrent Breast Carcinoma
- Keywords
- Breast cancer, Recurrence, Repeat radiation therapy, Radiation therapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Turku University HospitalOther government
- Collaborators
- Helsinki University Central Hospital
- Study start
- 1 Dec 2024 (actual)
- Primary completion
- 31 May 2026 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 26 Nov 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.
This study explores whether recurrent breast cancer can be safely treated with breast-conserving surgery and repeated radiation therapy in cases where patients have previously undergone radiation. Traditionally, recurrent breast cancer has been treated by removing the entire breast. However, recent research has shown that in certain situations, it may be possible to preserve the breast.
The study will collect data on the safety of this treatment approach and its effects on patients. The treatment follows standard breast cancer care practices, involving 30 patients from Helsinki and Turku University Hospitals. Patients are carefully selected based on specific criteria, such as tumor size, localization, and prior treatment history. Special attention is given to the planning of radiation therapy and surgical techniques.
The goal is to develop new treatment strategies that allow breast preservation even in cases of recurrent breast cancer, providing patients with high-quality and individualized care.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Repeat breast conserving surgery and radiotherapy Arm | Experimental | Radiation: Breast conserving surgey and radiotherapyThe patients in this arm undergo repeat breast conserving surgery and partial breast radiotherapy |
| Mastectomy Arm | Active comparator | Procedure: MastectomyThe patients in this arm undergo mastectomy |
Who may qualify
- Ages
- 55 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- The patient has a diagnosed breast cancer or tumor area in the breast with a maximum diameter of 3 cm, where a previous breast-conserving surgery has been performed (either invasive breast cancer or carcinoma in situ, DCIS).
- The patient has only a local recurrence, and imaging studies show no suspicion of metastases outside the breast (preoperative staging N0M0).
- At least 3 years have passed since the completion of prior radiation therapy. The new breast cancer can be technically treated with another breast-conserving surgery using a technique that does not require tissue transfer from areas opposite the removed tumor to restore the shape of the breast.
- The patient is at least 55 years old at the time of surgery. The patient is willing to participate in the study. The patient is capable of providing informed consent.
Key exclusion criteria (5 listed)
- A booster dose, also known as a "boost," was administered during prior radiation therapy.
- Preoperative assessments suggest multifocal breast cancer, with the tumor area to be removed exceeding 3 cm.
- The planned radiation therapy per the study protocol cannot be administered due to factors such as shoulder joint stiffness, a pacemaker located in the radiation field, or a skin condition (e.g., scleroderma).
- The patient is unable to provide informed consent or is unwilling to participate in the study.
- Metastases outside the breast (e.g., axillary or distant metastases) are present.
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 |
|---|---|---|
| Breast conserving surgey and radiotherapyThe patients will undergo repeat Breast Conserving Surgery and Radiotherapy | Radiation | Repeat breast conserving surgery and radiotherapy Arm |
| MastectomyThe patients will undergo mastectomy | Procedure or surgery | Mastectomy Arm |
Primary outcome
A treatment-limiting radiation therapy complication.
Time frame: From the beginning of the radiotherapy until 30 days after finishing the therapy
Any complication related to radiation therapy, that would limit completing the radiotherapy
4 secondary outcomes
Quality of life (Breast-Q scale)
Time frame: 5 years from surgery
Second Breast Cancer Recurrence
Time frame: 5 years from surgery
Secondary malignancies
Time frame: 5 years
Quality of life (EORTC QLQ-C30)
Time frame: 5 years from 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 9 Mar 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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Breast conserving surgey and radiotherapy and Mastectomy in people with Recurrent Breast Carcinoma, run by Turku University Hospital at 2 sites in Finland.
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 5 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 9 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Finland. 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 Anselm Tamminen, MD, PhD (+3583130000, jlatam@utu.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
A treatment-limiting radiation therapy complication. (time frame: From the beginning of the radiotherapy until 30 days after finishing the therapy). 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 9 Mar 2026.