Single-dose Preoperative Partial Breast Irradiation in Low-risk Breast Cancer Patients
ConditionBreast Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age40+
SponsorAmsterdam UMC, location VUmc
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
WHO performance scale ≤2.
Females at least 50 years of age with unifocal cT1N0 breast cancer on mammography, ultrasound and MRI.
Patients with an indication for chemotherapy or HER2-targeted therapy according to Dutch National Oncoline Guidelines or own hospital protocols are not eligible. Patients with an indication for endocrine therapy are eligible.
Tumor size as assessed on MRI.
Disqualifiers
Legal incapacity.
BRCA1, BRCA2 or CHEK2 gene mutation.
Distant metastasis.
Previous history of breast cancer or DCIS.
Trial design
Design model
Single group
Treatments tested in this trial
Single dose ablative radiotherapy
RadiationPatients 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
Treatment groups
100 Participants
are divided into 1 treatment groupGroup A: Pre-operative single dose partial breast irradiationExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Pathologic complete response
pCR is defined as the absence of residual invasive cancer on resected breast specimen
Time frame
12 months after radiotherapySecondary outcomes
1
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 radiotherapy2
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 radiotherapy3
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 radiotherapy4
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 radiotherapySponsors and contacts
Click on the lead sponsor to view all of their trials.
Amsterdam UMC, location VUmc
Lead sponsor
Dutch Cancer Society
Collaborator
Source ClinicalTrials.gov