Single Dose Ablative Radiation Treatment for Early-Stage Breast Cancer

Study Overview
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Brief Summary
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The purpose of the study is to investigate the feasibility of a preoperative, single dose, ablative partial breast radiation treatment in patients with early-stage breast cancer.

Detailed Description
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A total of twenty-five patients will be treated with a single dose preoperative ablative radiation treatment. After a vigilant follow-up with MRI, breast conserving surgery will be performed 6 months after the ablative radiation treatment. The total follow-up time is 10 years. This study aims to present an ablative radiotherapy treatment approach that could resolve to some extent the disadvantages of current breast conserving treatment in elderly low-risk breast cancer patients who are currently not treated according to guidelines due to co-morbidity.

Official Title
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Single Dose Ablative Preoperative Radiation Treatment for Early-Stage Breast Cancer in Elderly Patients

Conditions
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Breast Neoplasm

Intervention / Treatment
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* Radiation: Single dose ablative radiotherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: WHO performance scale ≤2. Females at least 50 years of age with unifocal cT1N0 breast cancer or females at least 70 years of age with an unifocal cT1-2(maximum 3 cm)N0 breast cancer: - Tumor size as assessed on MRI On tumor biopsy: Non-lobular invasive histological type carcinoma. LCIS is accepted. ER positive tumor receptor. Tumor negative sentinel node. Adequate communication and understanding skills of the Dutch language. Exclusion Criteria: Legal incapacity Indication for chemotherapy or immunotherapy (i.e. patients with an indication for endocrine therapy are eligible) BRCA gene mutation. Previous history of breast cancer Other type of malignancy within 5 years before breast cancer diagnosis. For adequately treated carcinoma in situ of the cervix or basal cell carcinoma of the skin no specific time span from breast cancer diagnosis is required for inclusion Her2neu positive tumor. Previous history of ipsilateral breast surgery and impaired cosmetic outcome, as assessed by the treating surgeon or radiation-oncologist. Collagen synthesis disease. Signs of extensive DCIS component on histological biopsy or mammogram. Invasive lobular carcinoma. MRI absolute contraindications as defined by the Radiology Department. Nodal involvement with cytological or histological confirmation. Treatment with neo-adjuvant systemic therapy.

Ages Eligible for Study
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Minimum Age: 50 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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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Single dose ablative radiotherapy<br>Eligible patients for single dose ablative radiotherapy according to inclusion and exclusion criteria | Radiation: Single dose ablative radiotherapy<br>* A single dose ablative radiotherapy will be delivered prior to surgery<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pathological complete response |  | 6 months after radiotherapy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Radiological tumor response on MRI according to the RECIST criteria |  | Within 1 week and 2, 4 and 6 months after radiotherapy | 
| Radiological tumor response on FDG-PET-CT according to the PERCIST criteria |  | At 6 months after radiotherapy | 
| Quality of life according to EORTC QLQ-BR23 and EORTC QLQ-C30 questionnaires |  | Until 10 years after radiotherapy | 
| Cosmetic results as assessed by patient questionnaire, radiation oncologist evaluation and BCCT.core software |  | Until 10 years after radiotherapy | 
| Frailty assessment according to the Groningen Frailty Indicator |  | Until 10 years after radiotherapy | 
| Functionality assessment using patient questionnaires on physical activity and the Hospital Anxiety and Depression Scale questionnaire. |  | Until 10 years after radiotherapy | 
| Local relapse rates |  | Until 10 years after radiotherapy | 
| Regional relapse rates |  | Until 10 years after radiotherapy | 
| Distant relapse rates |  | Until 10 years after radiotherapy | 
| Disease free survival |  | Until 10 years after radiotherapy | 
| Overall survival |  | Until 10 years after radiotherapy |