Single-dose Preoperative Partial Breast Irradiation in Low-risk Breast Cancer Patients
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
| Condition(s) | Breast Cancer |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| Summary | 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. |
| Who can participate | Inclusion Criteria: * 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. * On tumor biopsy: * Bloom-Richardson grade 1 or 2. * Non-lobular invasive histological type carcinoma. * LCIS or (non-extensive) DCIS is accepted. * ER positive tumor receptor. * HER2 negative tumor. * Tumor-negative sentinel node (excluding isolated tumor cells). * Adequate communication and understanding skills of the Dutch language. Exclusion Criteria: * Legal incapacity. * BRCA1 |
| Ages | 50 Years |
| Sex | Female |
| Lead sponsor | Amsterdam UMC, location VUmc |
| Locations | Sydney, Australia; Almere Stad, Netherlands; Amstelveen, Netherlands; Amsterdam, Netherlands; Nijmegen, Netherlands; Nijmegen, Netherlands (+1 more sites) |
| Start date | 2022-08-24 |
| NCT ID | NCT05350722 |
| Official listing | https://clinicaltrials.gov/study/NCT05350722 |