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
Qualifiers
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
Treatments tested in this trial
- Single dose ablative radiotherapy
Treatment groups
100 Participants
are divided into 1 treatment groupSponsors and collaborators
Amsterdam UMC, location VUmc
Lead sponsor
Dutch Cancer Society
Collaborator
Source ClinicalTrials.gov