Late Toxicity in Breast Cancer Patients Treated With Breast-conserving Surgical Procedures and Radiotherapy Using the Simultaneous Integrated Boost Technique

Study Overview
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Brief Summary
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In summary, breast conserving therapy (BCT) is an effective, save and widely used treatment technique for early breast cancer. Radiotherapy has shown to give better local control and survival benefit and is an integrated part of BCT. The simultaneous integrated boost (SIB) technique is a new treatment technique in breast irradiation. In this technique the whole breast is irradiated simultaneous with boosting the tumour bed, as part of BCT. Late radiation-induced toxicity has not been investigated in patients treated with radiotherapy using this technique. Proposed study will study the late radiation-induced toxicity, describe patients-rated complaints, quality of life, survival and local control curves in patients treated for early breast cancer with breast-conserving surgery in combination with radiotherapy with the SIB technique as compared to sequential radiotherapy treatment.

Conditions
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Breast Cancer

Intervention / Treatment
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* Radiation: Simultaneous Integrated Boost Technique


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: WHO performance status 0-2. Invasive breast cancer or ductal carcinoma in situ (DCIS). Stage I-III breast cancer or DCIS. Treated with curative radiotherapy of the breast (as part of breast conserving therapy) with simultaneous integrated boost technique, with or without irradiation of the regional (including internal mammary) lymph nodes. Exclusion Criteria: Previous thoracic radiotherapy. Previous history of malignancy, except adequately treated carcinoma in situ of the cervix or basal cell carcinoma of the skin. Bilateral (synchrone) invasive breast cancer. Treatment prior to surgery (i.e. neoadjuvant chemotherapy, neoadjuvant hormonal therapy, pre-operative radiotherapy). Distant metastases at diagnosis (M1). Unsufficient knowledge of Dutch language.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Radiation: Simultaneous Integrated Boost Technique|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Late radiation-induced toxicity (grade 2 or higher) | Toxicity score using Common Terminology for Adverse Events (CTCAE) | At 1 year after completion of radiation therapy | 
| Late radiation-induced toxicity (grade 2 or higher) | Toxicity score using Common Terminology for Adverse Events (CTCAE) | At 2 years after completion of radiation therapy | 
| Late radiation-induced toxicity (grade 2 or higher) | Toxicity score using Common Terminology for Adverse Events (CTCAE) | At 3 years after completion of radiation therapy | 
| Late radiation-induced toxicity (grade 2 or higher) | Toxicity score using Common Terminology for Adverse Events (CTCAE) | At 4 years after completion of radiation therapy | 
| Late radiation-induced toxicity (grade 2 or higher) | Toxicity score using Common Terminology for Adverse Events (CTCAE) | At 5 years after completion of radiation therapy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival |  | At 1,2,3,4 and 5 years after completion of radiation therapy | 
| Patient-rated symptoms | Questionnaire: BCSCQ | At 1,2,3,4 and 5 years after completion of radiation therapy | 
| Quality of life in breast cancer patients treated with radiotherapy after breast conserving surgery | Questionnaires: European Organization for Research and Treatment of Cancer Quality of Life - Core Questionnaire (EORTC QLQ-C30), Quality of Life Questionnaire - Breast Cancer Module (QLQ-BR23) and Adult Comorbidity Evaluation (ACE-27) | At 1,2,3,4 and 5 years after completion of radiation therapy | 
| Recurrence (local) | Assessed by Mammography, MRI (optional). If indicated: chest X-ray, bone scan, ultrasound | At 1,2,3,4 and 5 years after completion of radiation therapy | 
| Recurrence (regional) | Assessed by Mammography, MRI (optional). If indicated: chest X-ray, bone scan, ultrasound | At 1,2,3,4 and 5 years after completion of radiation therapy | 
| Recurrence (distant metastasis) | Assessed by Mammography, MRI (optional). If indicated: chest X-ray, bone scan, ultrasound | At 1,2,3,4 and 5 years after completion of radiation therapy | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Late toxicity, Simultaneous integrated boost (SIB), Radiotherapy