Clinical trial · Interventional
Accelerated Partial Breast Irradiation for Early Breast Cancer
A Multicentre Feasibility Study of Accelerated Partial Breast Irradiation Using Three-dimensional Conformal Radiation Therapy for Early Breast Cancer.
- 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)
Hypothesis: In selected women with node-negative invasive breast cancer treated with breast conserving surgery, postoperative accelerated partial breast irradiation (APBI) limited to the region of the tumour bed delivered by 3-dimensional conformal radiation therapy (3D CRT) is technically feasible and reproducible with acceptable treatment toxicity, cosmetic outcome, and local control rate in a multicentre trial.
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 |
|---|---|---|---|
| Accelerated partial breast irradiation (APBI) to region of tumour bed using 3D conformal radiation therapy (3D CRT) | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Accelerated partial breast irradiation
- description
- Accelerated partial breast irradiation (APBI) to region of tumour bed using 3D conformal radiation therapy (3D CRT)
- interventionNames
- Radiation: Accelerated partial breast irradiation (APBI) to region of tumour bed using 3D conformal radiation therapy (3D CRT)
Primary outcomes (1)
- measure
- Feasibility rate of APBI using 3D conformal radiation therapy
- timeFrame
- First analysis will occur 6 months after accrual of all patients (approximately 1.5 years after start of trial)
Secondary outcomes (6)
- measure
- Radiation toxicity
- timeFrame
- First analysis will occur 6 months after accrual of all patients (approximately 1.5 years after start of trial). A final analysis will occur when all patients have been followed up for 5 years.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 50 Years
Show eligibility criteria text
Inclusion Criteria: Patients must fulfill all of the following criteria for admission to study: * Women aged \>= 50 years. * Histologically confirmed diagnosis of invasive breast carcinoma of non-lobular histology. * Bilateral mammograms performed within 6 months prior to registration. * Treated with breast conserving surgery (primary excision or re-excision) with negative radial resection margins of \>= 2 mm\* for both the invasive and if present, associated intraductal tumour. \*Patients with superficial or deep resection margin of \< 2 mm are eligible if surgery has removed all of the intervening breast tissue from the subcutaneous tissue to the pectoralis fascia. * Unifocal tumour measuring ≤ 20 mm in maximum microscopic dimension. * Negative nodal status determined by sentinel node biopsy, axillary dissection, or for women \> 70 years of age, clinical examination. * No evidence of distant metastasis. * Assessed by surgeon and radiation oncologist to be suitable for breast conserving therapy. * Ability to tolerate protocol therapy. * Protocol therapy must commence no later than 12 weeks from the last surgical procedure or 8 weeks from the last dose of chemotherapy. * Availability for long-term follow-up. * Women of child-bearing potential must use adequate contraception during RT. * Written informed consent. Exclusion Criteria: Patients who fulfill any of the following criteria are not eligible for admission to study: * Multifocal or multicentric tumours. * Clinical or pathologic evidence of any of the following tumour features: extension to chest wall (excluding pectoralis muscle); oedema (including peau d'orange) or ulceration of skin; satellite skin nodules confined to the same breast; and inflammatory carcinoma. * Presence of extensive intraductal component (ductal carcinoma in situ occupying \> 25% of the primary invasive tumour and present adjacent to the primary tumour). * Node-positive breast cancer determined by sentinel node biopsy, axillary dissection, or in women \> 70 years of age, clinical examination. * Inability to localise surgical cavity on CT scans with no evidence of a surgical cavity, seroma or surgical clips delineating the tumour bed. * Treatment target volume estimated to occupy \> 25% of the ipsilateral whole breast volume. * Synchronous or metachronous bilateral invasive or intraductal breast cancer. * Locally recurrent breast cancer. * Ipsilateral breast implant. * Serious non-malignant disease that precludes definitive surgical or radiation treatment (e.g. scleroderma, systemic lupus erythematosus, cardiovascular/pulmonary/renal disease). * Previous or concomitant malignancies except non-melanoma skin cancer, carcinoma in situ of the cervix, and invasive carcinoma of the colon, thyroid, cervix, or endometrium treated five years prior to study entry. * Women who are pregnant or lactating. * Psychiatric or addictive disorders that preclude obtaining informed consent or adherence to protocol
References
Publications (3)
- BACKGROUNDKron T, Willis D, Miller J, Hubbard P, Oliver M, Chua B. A spreadsheet to determine the volume ratio for target and breast in partial breast irradiation. Australas Phys Eng Sci Med. 2009 Jun;32(2):98-104. doi: 10.1007/BF03178635. PMID 19623861
- RESULTKron T, Willis D, Bignell F, Martland J, Donnell S, May S, Chua BH. Centre credentialing for Trans Tasman Radiation Oncology Group trial 06.02: multicentre feasibility study of accelerated partial breast irradiation. J Med Imaging Radiat Oncol. 2009 Aug;53(4):412-8. doi: 10.1111/j.1754-9485.2009.02097.x. PMID 19695049
- DERIVEDKron T, Willis D, Link E, Lehman M, Campbell G, O'Brien P, Chua B. Can we predict plan quality for external beam partial breast irradiation: results of a multicenter feasibility study (Trans Tasman Radiation Oncology Group Study 06.02). Int J Radiat Oncol Biol Phys. 2013 Nov 15;87(4):817-24. doi: 10.1016/j.ijrobp.2013.07.036. Epub 2013 Sep 21. PMID 24064318