Single-dose preoperative radiation for low-risk breast cancer
Single-dose Preoperative Partial Breast Irradiation in Low-risk Breast Cancer Patients
This study is testing if a single dose of MRI-guided radiation before surgery can help people with low-risk breast cancer and improve their treatment results.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 50 Years and up |
| Sex | Female |
| Sponsor | Amsterdam UMC, location VUmc Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 7 sites (Sydney and 6 other locations) |
| Trial ID | NCT05350722 on ClinicalTrials.gov |
What this trial studies
This trial investigates the effectiveness of MRI-guided single-dose preoperative partial breast radiotherapy in patients with low-risk breast cancer. Participants will receive this treatment followed by breast conserving surgery, with the timing of surgery dependent on the radiologic response observed through MRI scans. The study aims to monitor tumor response using MRI and biological markers over a follow-up period of up to 10 years to evaluate oncological outcomes and quality of life.
Who should consider this trial
Good fit: Ideal candidates are females aged 50 and older with unifocal cT1N0 breast cancer who meet specific histological and receptor criteria.
Not a fit: Patients with BRCA mutations, distant metastasis, or a history of breast cancer are unlikely to benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a less invasive treatment option for low-risk breast cancer patients, potentially improving their quality of life.
How similar studies have performed: Other studies have shown promise with similar preoperative radiotherapy approaches, indicating potential for success in this trial.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Sydney and 6 other locations
- GenesisCare — Sydney, Australia (Not_yet_recruiting)
- Flevoziekenhuis — Almere Stad, Netherlands (Recruiting)
- Ziekenhuis Amstelland — Amstelveen, Netherlands (Recruiting)
- Amsterdam UMC — Amsterdam, Netherlands (Recruiting)
- Canisius Wilhelmina Ziekenhuis — Nijmegen, Netherlands (Recruiting)
- Radboud UMC — Nijmegen, Netherlands (Recruiting)
- Zaans Medisch Centrum — Zaandam, Netherlands (Recruiting)
Study contacts
- Principal investigator: Desirée van den Bongard, MD, PhD — Amsterdam UMC, location VUmc
- Study coordinator: Yasmin Civil, MD
- Email: y.civil@amsterdamumc.nl
- Phone: 020 4441484
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.