Breast FibrosisSTARLINGSNCT05263362
An Integrated Optimization of Surgery and Radiotherapy Techniques to Improve Cosmetic Outcome and Quality of Life in Breast Conserving Therapy for Breast Cancer Patients (STARLINGS Study)
An observational study of Breast Fibrosis and Breast Cancer, run by Erasmus Medical Center at 4 sites in Netherlands.
Trial summary
To assess the role of different combinations of (oncoplastic) surgery and radiotherapy techniques as risk factors for moderate to severe fibrosis and for moderate to poor cosmetic outcome. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Fibrosis, Breast Cancer, Breast Cancer Female
- How many people
- 775 participants
- Where
- 4 sitesNetherlands
- Study dates
- 11 Apr 2022to 20 Sep 2024
- Phase
- Observational
- 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
Study population: The study population consists of breast cancer patients who were treated with breast conserving therapy (BCT) at one of the four participating hospitals (Erasmus MC, Albert Schweitzer hospital, Maasstad hospital and Franciscus hospital Gasthuis and Vlietland), for non-metastatic, histological proven invasive breast cancer or DCIS between 2016 and 2020 (at time of inclusion in 2022 respectively 6 to 2 years after treatment), and subsequently received adjuvant radiotherapy of the whole breast at the Erasmus MC as part of their BCT.
Who may be able to join
- Female patients aged ≥ 18 years
- History of BCT with adjuvant radiation therapy for non-metastatic, histologically proven invasive breast cancer or DCIS. In light of BCT adjuvant systemic treatment (i.e. endocrine therapy, chemotherapy and immune therapy) is allowed.
- Operated between 1st of January 2016 and 31th of December 2020
- Treated according to the currently applied dose fractionation schedules, i.e. whole breast radiotherapy (22, 23), with or without boost
- Adequate understanding of the Dutch language and written informed consent
Who cannot join
- Any breast surgery or re-irradiation on the breast area after BCT
- Progression of disease (and additional treatment) since BCT
- Patients who received partial breast irradiation
- Current pregnancy or breast feeding
Trial locations and contacts
4 sites in 1 country.
Netherlands4 sites
Albert Schweitzer hospital
Dordrecht
Erasmus Medical Center
Rotterdam
Maasstad hospital
Rotterdam
Franciscus Gasthuis & Vlietland
Schiedam
About this study
Official title: An Integrated Optimization of Surgery and Radiotherapy Techniques to Improve Cosmetic Outcome and Quality of Life in Breast Conserving Therapy for Breast Cancer Patients.
To assess the role of different combinations of (oncoplastic) surgery and radiotherapy techniques as risk factors for moderate to severe fibrosis and for moderate to poor cosmetic outcome.
Read the detailed description
The primary objectives of this study are to assess the role of different combinations of (oncoplastic) surgery and radiotherapy techniques as risk factors for moderate to severe fibrosis and for moderate to poor cosmetic outcome. Based on these insights predictive models for the development of moderate to severe fibrosis and moderate to poor cosmetic outcome will be developed. Second, the relation between the presence and severity of fibrosis, cosmetic outcome and different QoL domains and symptoms will be assessed.
- Conditions
- Breast Fibrosis, Breast Cancer, Breast Cancer Female, Breast Neoplasms, Breast Carcinoma in Situ, Breast Carcinoma
- Being tested
- no intervention
- Keywords
- Fibrosis, Cosmetic outcome, Quality of life, Oncoplastic breast surgery, Radiotherapy
- Medical subject headings
- Breast Neoplasms, Breast Carcinoma In Situ, Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no interventionOther
At one timepoint patients will get physical examination of the breasts, medical photographs will be taken, and they will fill in five questionnaires about satisfaction of the breasts, quality of life and general health.
| Study group | Role | What they receive |
|---|---|---|
| STARLINGS study population | The study population consists of breast cancer patients who were treated with breast conserving therapy (BCT) at one of the four participating hospitals (Erasmus MC, Albert Schweitzer hospital, Maasstad hospital and Franciscus hospital Gasthuis and Vlietland), for non-metastatic, histological proven invasive breast cancer or DCIS between 2016 and 2020 (at time of inclusion in 2022 respectively 6 to 2 years after treatment), and subsequently received adjuvant (whole breast) irradiation (WBI), with or without boost, at the Erasmus MC as part of their BCT. Receives: Other: no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fibrosis of the breast as measured by CTCAE v5 scale
Fibrosis will be graded by the researcher using the CTCAE v5 scale.
On the CTCAE scale of superficial soft tissue fibrosis:
Grade 0 = no fibrosis, Grade 1 = mild induration, able to move skin parallel to plane (sliding) and perpendicular to skin (pinching up), Grade 2 = Moderate induration, able to slide skin, unable to pinch skin; limiting instrumental ADL, Grade 3 = Severe induration; unable to slide or pinch skin; limiting joint or orifice movement (e.g., mouth, anus); limiting self care ADL, Grade 4 = Generalized; associated with signs or symptoms of impaired breathing or feeding, Grade 5 = Death.
We are planning to score fibrosis of the breast as none/mild (grade 0-1) or moderate/severe (grade 2-3).
Measured: 2-6 years after breast conserving treatment. 1 point of measurement.
Cosmetic outcome as measured by 9-item questionnaire
Cosmetic outcome will be evaluated by means of a 9-item cosmetic patient questionnaire filled out by the patient with scoring on a four point scale (range from 'excellent' to 'poor' per item).
Measured: 2-6 years after breast conserving treatment. 1 point of measurement.
Cosmetic outcome as measured by BCCT.core software
Patients' photographs of the breasts will be taken. With the use of BCCT.core software from The Breast Research group (INESC TEC, the Faculdade de Medicina da Universidade do Porto) cosmetic outcome will be assessed.
Measured: 2-6 years after breast conserving treatment. 1 point of measurement.
Secondary outcomes (5)
Quality of life, as measured by BREAST-Q
Which includes the following domains: psychosocial well being, sexual well being, satisfaction with the breasts, physical well being, adverse effects of radiation.
All domains are scored 0 to 100 points, higher points means a better outcome.
Measured: 2-6 years after breast conserving treatment. 1 point of measurement.
Quality of life, as measured by EORTC Quality of Life Questionnaires-C30
Which include functional domains, global health status and symptom scales.
For functional domains and global health status, scores range from 0 to 100. Higher scores means a better level of functioning. For symptoms scales, scores range from 0 to 100. Higher scores represent a greater degree of symptoms.
Measured: 2-6 years after breast conserving treatment. 1 point of measurement.
Quality of life, as measured by EORTC Quality of Life Questionnaires-B23
Which include functional domains, global health status and symptom scales.
For functional domains and global health status, scores range from 0 to 100. Higher scores means a better level of functioning. For symptoms scales, scores range from 0 to 100. Higher scores represent a greater degree of symptoms.
Measured: 2-6 years after breast conserving treatment. 1 point of measurement.
Quality of life, as measured by EQ-5D-5L - five dimensions
The EQ-5D-5L include five questions about five dimensions: mobility, self-care, daily activities, pain/discomfort and anxiety/depression.
For each dimension, participants choose one of five levels that best fits their health on that day (from 'no problem'= 1 to 'unable/extreme'= 5). The numbers chosen for the five dimensions are combined to give a 5 digit score (minimum score = 11111 maximum score = 55555).
Measured: 2-6 years after breast conserving treatment. 1 point of measurement.
Quality of life, as measured by EQ-5D-5L - VAS
The EQ-5D-5L include, apart from the five questions about five dimensions (see above), a visual analogue scale (VAS).
The VAS provides rating of the participant's health on a scale from 0 ('the worst health you can imagine') to 100 ('the best health you can imagine').
Measured: 2-6 years after breast conserving treatment. 1 point of measurement.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2022
- Study start11 Apr 2022
- Primary completion1 Feb 2024
- Study completion20 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast FibrosisStudies of the same condition, open and under way.
- More trials run by Erasmus Medical CenterThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 775 participants (actual)
Sponsor and investigators
- Lead sponsor
- Erasmus Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Albert Schweitzer Ziekenhuis, Netherlands
- Responsible party
- Principal investigator, E. (Euphemia) A.M. Froklage, Erasmus Medical Center
- Investigators
- R.A. Nout, Professor, Study director, Erasmus Medical CenterE.A.M. Froklage, MD, PhD, Principal investigator, Erasmus Medical CenterM.B.E. Menke-Pluijmers, MD, PhD, Principal investigator, Albert Schweitzer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05263362
- Sponsor's protocol ID
- MEC-2021-0829
- Acronym
- STARLINGS
- Status last verified
- Apr 2026
- First submitted
- 12 Jan 2022
- Last updated
- 13 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Notenboom MCAW, Klem TMAL, Contant CME, Ribbe SP, Franckena M, Penninkhof JJ, Koppert LB, Plaisier PW, Mureau MAM, van Werkhoven ED, van der Veen FJC, de Kraker M, Nout RA, Menke-Pluijmers MBE, Froklage FE. The association between breast fibrosis, cosmetic outcomes, and long-term health-related quality of life after breast-conserving therapy: a multicenter cross-sectional observational cohort study. Breast. 2025 Oct;83:104541. doi: 10.1016/j.breast.2025.104541. Epub 2025 Jul 14.
PubMed 40774221
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Integrated Optimization of Surgery and Radiotherapy Techniques to Improve Cosmetic Outcome and Quality of Life in Breast Conserving Therapy for Breast Cancer Patients.
- ClinicalTrials.gov ID
- NCT05263362
- Acronym / sponsor ID
- STARLINGS / MEC-2021-0829
- Conditions
- Breast Fibrosis, Breast Cancer, Breast Cancer Female, Breast Neoplasms, Breast Carcinoma in Situ, Breast Carcinoma
- Keywords
- Fibrosis, Cosmetic outcome, Quality of life, Oncoplastic breast surgery, Radiotherapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 775 participants (actual)
- Lead sponsor
- Erasmus Medical CenterUniversity, hospital or other
- Collaborators
- Albert Schweitzer Ziekenhuis, Netherlands
- Study start
- 11 Apr 2022 (actual)
- Primary completion
- 1 Feb 2024 (actual)
- Study completion
- 20 Sep 2024 (actual)
- First posted
- 2 Mar 2022 (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.
To assess the role of different combinations of (oncoplastic) surgery and radiotherapy techniques as risk factors for moderate to severe fibrosis and for moderate to poor cosmetic outcome.
Detailed description
The primary objectives of this study are to assess the role of different combinations of (oncoplastic) surgery and radiotherapy techniques as risk factors for moderate to severe fibrosis and for moderate to poor cosmetic outcome. Based on these insights predictive models for the development of moderate to severe fibrosis and moderate to poor cosmetic outcome will be developed. Second, the relation between the presence and severity of fibrosis, cosmetic outcome and different QoL domains and symptoms will be assessed.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| STARLINGS study population | – | Other: no interventionThe study population consists of breast cancer patients who were treated with breast conserving therapy (BCT) at one of the four participating hospitals (Erasmus MC, Albert Schweitzer hospital, Maasstad hospital and Franciscus hospital Gasthuis and Vlietland), for non-metastatic, histological proven invasive breast cancer or DCIS between 2016 and 2020 (at time of inclusion in 2022 respectively 6 to 2 years after treatment), and subsequently received adjuvant (whole breast) irradiation (WBI), with or without boost, at the Erasmus MC as part of their BCT. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consists of breast cancer patients who were treated with breast conserving therapy (BCT) at one of the four participating hospitals (Erasmus MC, Albert Schweitzer hospital, Maasstad hospital and Franciscus hospital Gasthuis and Vlietland), for non-metastatic, histological proven invasive breast cancer or DCIS between 2016 and 2020 (at time of inclusion in 2022 respectively 6 to 2 years after treatment), and subsequently received adjuvant radiotherapy of the whole breast at the Erasmus MC as part of their BCT.
Key inclusion criteria (5 listed)
- Female patients aged ≥ 18 years
- History of BCT with adjuvant radiation therapy for non-metastatic, histologically proven invasive breast cancer or DCIS. In light of BCT adjuvant systemic treatment (i.e. endocrine therapy, chemotherapy and immune therapy) is allowed.
- Operated between 1st of January 2016 and 31th of December 2020
- Treated according to the currently applied dose fractionation schedules, i.e. whole breast radiotherapy (22, 23), with or without boost
- Adequate understanding of the Dutch language and written informed consent
Key exclusion criteria (4 listed)
- Any breast surgery or re-irradiation on the breast area after BCT
- Progression of disease (and additional treatment) since BCT
- Patients who received partial breast irradiation
- Current pregnancy or breast feeding
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 |
|---|---|---|
| no interventionAt one timepoint patients will get physical examination of the breasts, medical photographs will be taken, and they will fill in five questionnaires about satisfaction of the breasts, quality of life and general health. | Other | STARLINGS study population |
Primary outcome
Fibrosis of the breast as measured by CTCAE v5 scale
Time frame: 2-6 years after breast conserving treatment. 1 point of measurement.
Fibrosis will be graded by the researcher using the CTCAE v5 scale. On the CTCAE scale of superficial soft tissue fibrosis: Grade 0 = no fibrosis, Grade 1 = mild induration, able to move skin parallel to plane (sliding) and perpendicular to skin (pinching up), Grade 2 = Moderate induration, able to slide skin, unable to pinch skin; limiting instrumental ADL, Grade 3 = Severe induration; unable to slide or pinch skin; limiting joint or orifice movement (e.g., mouth, anus); limiting self care ADL, Grade 4 = Generalized; associated with signs or symptoms of impaired breathing or feeding, Grade 5 = Death. We are planning to score fibrosis of the breast as none/mild (grade 0-1) or moderate/severe (grade 2-3).
Cosmetic outcome as measured by 9-item questionnaire
Time frame: 2-6 years after breast conserving treatment. 1 point of measurement.
Cosmetic outcome will be evaluated by means of a 9-item cosmetic patient questionnaire filled out by the patient with scoring on a four point scale (range from 'excellent' to 'poor' per item).
Cosmetic outcome as measured by BCCT.core software
Time frame: 2-6 years after breast conserving treatment. 1 point of measurement.
Patients' photographs of the breasts will be taken. With the use of BCCT.core software from The Breast Research group (INESC TEC, the Faculdade de Medicina da Universidade do Porto) cosmetic outcome will be assessed.
5 secondary outcomes
Quality of life, as measured by BREAST-Q
Time frame: 2-6 years after breast conserving treatment. 1 point of measurement.
Quality of life, as measured by EORTC Quality of Life Questionnaires-C30
Time frame: 2-6 years after breast conserving treatment. 1 point of measurement.
Quality of life, as measured by EORTC Quality of Life Questionnaires-B23
Time frame: 2-6 years after breast conserving treatment. 1 point of measurement.
Quality of life, as measured by EQ-5D-5L - five dimensions
Time frame: 2-6 years after breast conserving treatment. 1 point of measurement.
Quality of life, as measured by EQ-5D-5L - VAS
Time frame: 2-6 years after breast conserving treatment. 1 point of measurement.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
- Derived from this study: PubMed 40774221Notenboom MCAW, Klem TMAL, Contant CME, Ribbe SP, Franckena M, Penninkhof JJ, Koppert LB, Plaisier PW, Mureau MAM, van Werkhoven ED, van der Veen FJC, de Kraker M, Nout RA, Menke-Pluijmers MBE, Froklage FE. The association between breast fibrosis, cosmetic outcomes, and long-term health-related quality of life after breast-conserving therapy: a multicenter cross-sectional observational cohort study. Breast. 2025 Oct;83:104541. doi: 10.1016/j.breast.2025.104541. Epub 2025 Jul 14.
- 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. This study is not recruiting at the moment.
R.A. Nout, Professor study director
Erasmus Medical Center
E.A.M. Froklage, MD, PhD principal investigator
Erasmus Medical Center
M.B.E. Menke-Pluijmers, MD, PhD principal investigator
Albert Schweitzer Hospital
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Fibrosis and Breast Cancer, run by Erasmus Medical Center at 4 sites in Netherlands.
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 5 inclusion and 4 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: finished, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Netherlands. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Fibrosis of the breast as measured by CTCAE v5 scale (time frame: 2-6 years after breast conserving treatment. 1 point of measurement.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05263362, which also lists 1 linked publication.
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 13 Apr 2026.