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)

NCT05263362 | Completed

• 1 other identifier: MEC-2021-0829
• Study Type: observational
• Target: 775
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

Breast Fibrosis; Breast Cancer; Breast Cancer Female; Breast Neoplasms; Breast Carcinoma; Breast Carcinoma in Situ

Keywords

Fibrosis; Cosmetic outcome; Quality of life; Oncoplastic breast surgery; Radiotherapy

Outcome Measures

Primary Outcomes (3)

• 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).

  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).

  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.

  2-6 years after breast conserving treatment. 1 point of measurement.

Secondary Outcomes (5)

• Quality of life, as measured by BREAST-Q

  2-6 years after breast conserving treatment. 1 point of measurement.

• Quality of life, as measured by EORTC Quality of Life Questionnaires-C30

  2-6 years after breast conserving treatment. 1 point of measurement.

• Quality of life, as measured by EORTC Quality of Life Questionnaires-B23

  2-6 years after breast conserving treatment. 1 point of measurement.

• Quality of life, as measured by EQ-5D-5L - five dimensions

  2-6 years after breast conserving treatment. 1 point of measurement.

• Quality of life, as measured by EQ-5D-5L - VAS

  2-6 years after breast conserving treatment. 1 point of measurement.

Study Arms (1)

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.

Other: no intervention

Interventions

no intervention OTHER

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.

STARLINGS study population

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Erasmus Medical Center: lead
• Albert Schweitzer Ziekenhuis, Netherlands: collaborator

Study Sites (4)

Albert Schweitzer hospital

Dordrecht, Netherlands

Location

Erasmus Medical Center

Rotterdam, Netherlands

Location

Maasstad hospital

Rotterdam, Netherlands

Location

Franciscus Gasthuis & Vlietland

Schiedam, Netherlands

Location

Related Publications (1)

• 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.

  PMID: 40774221 DERIVED

MeSH Terms

Conditions

Breast Neoplasms; Breast Carcinoma In Situ; Fibrosis

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Carcinoma in Situ; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• R.A. Nout, Professor

  Erasmus Medical Center

  STUDY DIRECTOR

• E.A.M. Froklage, MD, PhD

  Erasmus Medical Center

  PRINCIPAL INVESTIGATOR

• M.B.E. Menke-Pluijmers, MD, PhD

  Albert Schweitzer Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD, Principal Investigator

Study Record Dates

• First Submitted: January 12, 2022
• First Posted: March 2, 2022
• Study Start: April 11, 2022
• Primary Completion: February 1, 2024
• Study Completion: September 20, 2024
• Last Updated: April 13, 2026

Record last verified: 2026-04

Locations

NL (4)