Clinical trial · Interventional
Single-dose Preoperative Partial Breast Irradiation in Low-risk Breast Cancer Patients
NCT05350722CI-TRIAL-00118189ABLATIVE-2recruitingN/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)
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.
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 Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Single dose ablative radiotherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Pre-operative single dose partial breast irradiation
- interventionNames
- Radiation: Single dose ablative radiotherapy
Primary outcomes (1)
- measure
- Pathologic complete response
- timeFrame
- 12 months after radiotherapy
- description
- pCR is defined as the absence of residual invasive cancer on resected breast specimen
Secondary outcomes (12)
- measure
- Radiologic complete response
- timeFrame
- at baseline, 2 weeks, 3, 6, 9, and 12 months after radiotherapy
- description
- Radiologic complete response (rCR) is defined as complete absence of pathologic contrast enhancement in the original tumor bed and complete absence of pathologic ADC (apparent diffusion coefficient) reduction in the original tumor bed. rCR is reported according to the Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 guidelines.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 40 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDCivil YA, Oei AL, Duvivier KM, Bijker N, Meijnen P, Donkers L, Verheijen S, van Kesteren Z, Palacios MA, Schijf LJ, Barbe E, Konings IRHM, -van der Houven van Oordt CWM, Westhoff PG, Meijer HJM, Diepenhorst GMP, Thijssen V, Mouliere F, Slotman BJ, van der Velde S, van den Bongard HJGD. Prediction of pathologic complete response after single-dose MR-guided partial breast irradiation in low-risk breast cancer patients: the ABLATIVE-2 trial-a study protocol. BMC Cancer. 2023 May 9;23(1):419. doi: 10.1186/s12885-023-10910-6. PMID 37161377