Clinical trial · Interventional
Single Dose Ablative Radiation Treatment for Early-Stage Breast Cancer
Single Dose Ablative Preoperative Radiation Treatment for Early-Stage Breast Cancer in Elderly Patients
NCT02316561CI-TRIAL-00033874ABLATIVEcompletedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of the study is to investigate the feasibility of a preoperative, single dose, ablative partial breast radiation treatment in patients with early-stage breast cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Neoplasm | Breast Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Single dose ablative radiotherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Single dose ablative radiotherapy
- description
- Eligible patients for single dose ablative radiotherapy according to inclusion and exclusion criteria
- interventionNames
- Radiation: Single dose ablative radiotherapy
Primary outcomes (1)
- measure
- Pathological complete response
- timeFrame
- 6 months after radiotherapy
Secondary outcomes (11)
- measure
- Radiological tumor response on MRI according to the RECIST criteria
- timeFrame
- Within 1 week and 2, 4 and 6 months after radiotherapy
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 50 Years
Show eligibility criteria text
Inclusion Criteria: * WHO performance scale ≤2. * Females at least 50 years of age with unifocal cT1N0 breast cancer or females at least 70 years of age with an unifocal cT1-2(maximum 3 cm)N0 breast cancer: \- Tumor size as assessed on MRI * On tumor biopsy: * Non-lobular invasive histological type carcinoma. * LCIS is accepted. * ER positive tumor receptor. * Tumor negative sentinel node. * Adequate communication and understanding skills of the Dutch language. Exclusion Criteria: * Legal incapacity * Indication for chemotherapy or immunotherapy (i.e. patients with an indication for endocrine therapy are eligible) * BRCA gene mutation. * Previous history of breast cancer * Other type of malignancy within 5 years before breast cancer diagnosis. For adequately treated carcinoma in situ of the cervix or basal cell carcinoma of the skin no specific time span from breast cancer diagnosis is required for inclusion * Her2neu positive tumor. * Previous history of ipsilateral breast surgery and impaired cosmetic outcome, as assessed by the treating surgeon or radiation-oncologist. * Collagen synthesis disease. * Signs of extensive DCIS component on histological biopsy or mammogram. * Invasive lobular carcinoma. * MRI absolute contraindications as defined by the Radiology Department. * Nodal involvement with cytological or histological confirmation. * Treatment with neo-adjuvant systemic therapy.
References
Publications (3)
- DERIVEDCivil YA, Vasmel JE, Charaghvandi RK, Houweling AC, Vreuls CPH, van Diest PJ, Witkamp AJ, Doeksen A, van Dalen T, Felderhof J, van Dam I, Slotman BJ, Kirby AM, Verkooijen HM, van der Velde S, van der Leij F, van den Bongard HJGD. Preoperative Magnetic Resonance Guided Single-Dose Partial Breast Irradiation: 5-Year Results of the Prospective Single-Arm ABLATIVE Trial. Int J Radiat Oncol Biol Phys. 2025 Mar 1;121(3):613-622. doi: 10.1016/j.ijrobp.2024.07.2326. Epub 2024 Aug 2. PMID 39098432
- DERIVEDGroot Koerkamp ML, de Hond YJM, Maspero M, Kontaxis C, Mandija S, Vasmel JE, Charaghvandi RK, Philippens MEP, van Asselen B, van den Bongard HJGD, Hackett SS, Houweling AC. Synthetic CT for single-fraction neoadjuvant partial breast irradiation on an MRI-linac. Phys Med Biol. 2021 Apr 16;66(8). doi: 10.1088/1361-6560/abf1ba. PMID 33761491
- DERIVEDCharaghvandi RK, van Asselen B, Philippens ME, Verkooijen HM, van Gils CH, van Diest PJ, Pijnappel RM, Hobbelink MG, Witkamp AJ, van Dalen T, van der Wall E, van Heijst TC, Koelemij R, van Vulpen M, van den Bongard HJ. Redefining radiotherapy for early-stage breast cancer with single dose ablative treatment: a study protocol. BMC Cancer. 2017 Mar 9;17(1):181. doi: 10.1186/s12885-017-3144-5. PMID 28274211