An interventional study of Single dose ablative radiotherapy in Breast Cancer, sponsored by Amsterdam UMC, location VUmc. Recruiting at 7 sites in 2 countries. Open to female participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2026-07-16.
Sponsored by Amsterdam UMC, location VUmc · Not applicable, Interventional, and Treatment
In this ABLATIVE-2 trial, low-risk breast cancer patients will be treated with MRI-guided single dose preoperative partial breast radiotherapy to assess the rate of pathologic complete response after an interval of six to twelve months between radiotherapy and surgery. Response monitoring will be assessed using MRI and markers in blood and tumor tissue to enable prediction of pathologic response.
Patients will receive single-dose preoperative radiotherapy followed by breast conserving surgery (BCS) at 12 months after radiotherapy, as long as follow-up MRI scans show a complete radiologic response. In case of incomplete radiologic response, BCS will be performed at 6 months after radiotherapy. BCS is performed earlier when progressive disease is found on MRI. In the follow-up period between radiotherapy and surgery, tumor response will be monitored using MRI every 3 months. After surgery, patients will be followed up until 10 years after radiotherapy treatment to assess oncological outcomes, toxicity, cosmetic outcome and quality of life.
Females at least 50 years of age with unifocal cT1N0 breast cancer on mammography, ultrasound and MRI.
On tumor biopsy:
Exclusion Criteria:
Radiation: Single dose ablative radiotherapy
Patients will receive a single dose of 20Gy/15Gy on the gross tumor volume and clinical tumor volume respectively, in the context of pre-operative partial breast irradiation
Pathologic complete response
pCR is defined as the absence of residual invasive cancer on resected breast specimen
Time frame: 12 months after radiotherapy
Radiologic complete response
Radiologic complete response (rCR) is defined as complete absence of pathologic contrast enhancement in the original tumor bed and complete absence of pathologic ADC (apparent diffusion coefficient) reduction in the original tumor bed. rCR is reported according to the Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 guidelines.
Time frame: at baseline, 2 weeks, 3, 6, 9, and 12 months after radiotherapy
Treatment-related adverse events
Number of participants with treatment-related adverse events as assessed by the Common Terminology Criteria Adverse Events version 5.0
Time frame: at baseline, 2 weeks, 3, 6, 9, 12 months, 2, 3, 4, 5, 6, 8 and 10 years after radiotherapy
Patient quality of life
PROMs are assessed using the European Organization for Research and Treatment of Cancer core-30 quality of life questionnaire (EORTC QLQ-C30)
Time frame: at baseline, 2 weeks, 3, 6, 9, 12 months, 2, 3, 4, 5, 6, 8 and 10 years after radiotherapy
Breast cancer specific quality of life
PROMs are assessed using the European Organization for Research and Treatment of Cancer breast cancer-specific quality of life questionnaire (EORTC QLQ-BR23)
Time frame: at baseline, 2 weeks, 3, 6, 9, 12 months, 2, 3, 4, 5, 6, 8 and 10 years after radiotherapy
Patient distress
PROMs are assessed using the Hospital Anxiety and Depression Scale (HADS) questionnaire
Time frame: at baseline, 2 weeks, 3, 6, 9, 12 months, 2, 3, 4, 5, 6, 8 and 10 years after radiotherapy
Physician reported cosmetic outcome
Cosmetic outcome is assessed by the physician using a questionnaire
Time frame: at baseline, 2 weeks, 3, 6, 9, 12 months, 2, 3, 4, 5, 6, 8 and 10 years after radiotherapy
Patient reported cosmetic outcome
Cosmetic outcome is assessed by the patient using the BREAST-Q questionnaire. .
Time frame: at baseline, 2 weeks, 3, 6, 9, 12 months, 2, 3, 4, 5, 6, 8 and 10 years after radiotherapy
Objective cosmetic outcome
Cosmetic outcome is assessed objectively using images captured using the VECTRA XT 3D-imaging system. This three-dimensional surface-imaging system uses stereophotogrammetry to estimate x, y, z coordinates of the imaged surface. These coordinates will be used to calculate the volume-shape-symmetry measure.
Time frame: at baseline, 2 weeks, 3, 6, 9, 12 months, 2, 3, 4, 5, 6, 8 and 10 years after radiotherapy
Local, regional and distant relapse rates
A local recurrence is defined as disease occurrence in the ipsilateral breast. A regional recurrence is defined as nodal occurrence in the ipsilateral axilla, internal mammary, infraclavicular or supraclavicular region. A distant metastasis defined as disease occurrence in the contralateral breast or contralateral breast nodal region or another organ than breast involvement.
Time frame: Day of radiotherapy till end of follow-up of 10 years
Overall survival
Overall survival will be calculated from the date of the radiotherapy treatment until the time of breast-cancer related death or breast-cancer unrelated death.
Time frame: Day of radiotherapy till end of follow-up of 10 years
Radiotherapy-associated immune response markers
Immune response markers as CD3, CD4, CD8 and FOXP3 will be assessed in tumor tissue after surgery.
Time frame: 12 months after radiotherapy
Radiotherapy-associated biomarkers
ctDNA will be assessed in blood samples taken between radiotherapy and surgery.
Time frame: at baseline, 2 weeks, 3, 6, 9, and 12 months after radiotherapy
Plan to share: No
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Amsterdam UMC, location VUmc