NCT05350722 Single-dose Preoperative Partial Breast Irradiation in Low-risk Breast Cancer Patients
| NCT ID | NCT05350722 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Amsterdam UMC, location VUmc |
| Condition | Breast Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2022-08-24 |
| Primary Completion | 2027-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 100 participants in total. It began in 2022-08-24 with a primary completion date of 2027-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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, BRCA2 or CHEK2 gene mutation. * Distant metastasis. * Previous history of breast cancer or DCIS. * Other type of malignancy within 5 years before breast cancer diagnosis. Patients with adequately treated malignancy longer than 5 years before breast cancer diagnosis are eligible for inclusion. * For adequately treated carcinoma in situ of the cervix or basal cell carcinoma of the skin no specific time span to breast cancer diagnosis is required for inclusion. * Collagen synthesis disease. * Signs of extensive DCIS component on histological biopsy or on imaging (e.g. no extensive calcifications on mammography). * Invasive lobular carcinoma. * MRI absolute contraindications as defined by the Department of Radiology. * Nodal involvement with cytological or histological confirmation. * Indication for treatment with (neo-)adjuvant chemotherapy. * Non-feasible dosimetric RT plan.
Contact & Investigator
Desirée van den Bongard, MD, PhD
PRINCIPAL INVESTIGATOR
Amsterdam UMC, location VUmc
Frequently Asked Questions
Who can join the NCT05350722 clinical trial?
This trial is open to female participants only, aged 50 Years or older, studying Breast Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05350722 currently recruiting?
Yes, NCT05350722 is actively recruiting participants. Contact the research team at y.civil@amsterdamumc.nl for enrollment information.
Where is the NCT05350722 trial being conducted?
This trial is being conducted at Sydney, Australia, Almere Stad, Netherlands, Amstelveen, Netherlands, Amsterdam, Netherlands and 3 additional locations.
Who is sponsoring the NCT05350722 clinical trial?
NCT05350722 is sponsored by Amsterdam UMC, location VUmc. The principal investigator is Desirée van den Bongard, MD, PhD at Amsterdam UMC, location VUmc. The trial plans to enroll 100 participants.
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