Clinical trial · Interventional
Accelerated Partial Breast Irradiation Using Intensity Modulated Radiotherapy Versus Whole Breast Irradiation
Randomised Phase 3 Trial Of Accelerated Partial Breast Irradiation Using Intensity Modulated Radiotherapy Versus Whole Breast Irradiation
NCT02104895CI-TRIAL-00023441completedPhase 3Results postedClinicalTrials.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 aim of this Phase 3 randomised trial is to compare the efficacy and safety of whole breast radiotherapy to accelerated partial breast irradiation using intensity-modulated radiotherapy technique in selected early breast cancer patients after breast conserving surgery.
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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Accelerated partial breast irradiation (APBI) | Radiation | — | UNRESOLVED |
| Whole breast irradiation (WBI) | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Whole breast irradiation (WBI)
- description
- Conventional whole breast irradiation (WBI)
- interventionNames
- Radiation: Whole breast irradiation (WBI)
- type
- EXPERIMENTAL
- label
- Partial breast irradiation (APBI)
- description
- Accelerated partial breast irradiation (APBI)
- interventionNames
- Radiation: Accelerated partial breast irradiation (APBI)
Primary outcomes (1)
- measure
- Ipsilateral Breast Tumor Recurrence
- timeFrame
- 5-year
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 40 Years
Show eligibility criteria text
Inclusion Criteria: * Age at presentation \>40 y * Tumor size \<25 mm * Wide excision or quadrantectomy with clear margins (\>5 mm) * Clips placed in tumor bed * Full informed consent from patient Exclusion Criteria: * Cardiac dysfunction * Forced expiratory volume in 1 second (FEV1) \<1 L/m * Extensive intraductal carcinoma * Multifocal cancer * Psychiatric problems * Recurrent breast cancer
References
Publications (6)
- RESULTLivi L, Buonamici FB, Simontacchi G, Scotti V, Fambrini M, Compagnucci A, Paiar F, Scoccianti S, Pallotta S, Detti B, Agresti B, Talamonti C, Mangoni M, Bianchi S, Cataliotti L, Marrazzo L, Bucciolini M, Biti G. Accelerated partial breast irradiation with IMRT: new technical approach and interim analysis of acute toxicity in a phase III randomized clinical trial. Int J Radiat Oncol Biol Phys. 2010 Jun 1;77(2):509-15. doi: 10.1016/j.ijrobp.2009.04.070. Epub 2009 Aug 21. PMID 19700248
- RESULTLivi L, Meattini I, Marrazzo L, Simontacchi G, Pallotta S, Saieva C, Paiar F, Scotti V, De Luca Cardillo C, Bastiani P, Orzalesi L, Casella D, Sanchez L, Nori J, Fambrini M, Bianchi S. Accelerated partial breast irradiation using intensity-modulated radiotherapy versus whole breast irradiation: 5-year survival analysis of a phase 3 randomised controlled trial. Eur J Cancer. 2015 Mar;51(4):451-463. doi: 10.1016/j.ejca.2014.12.013. Epub 2015 Jan 17. PMID 25605582
- RESULTMeattini I, Saieva C, Marrazzo L, Di Brina L, Pallotta S, Mangoni M, Meacci F, Bendinelli B, Francolini G, Desideri I, De Luca Cardillo C, Scotti V, Furfaro IF, Rossi F, Greto D, Bonomo P, Casella D, Bernini M, Sanchez L, Orzalesi L, Simoncini R, Nori J, Bianchi S, Livi L. Accelerated partial breast irradiation using intensity-modulated radiotherapy technique compared to whole breast irradiation for patients aged 70 years or older: subgroup analysis from a randomized phase 3 trial. Breast Cancer Res Treat. 2015 Oct;153(3):539-47. doi: 10.1007/s10549-015-3565-2. Epub 2015 Sep 9. PMID 26350524
- DERIVEDMeattini I, Marrazzo L, Saieva C, Desideri I, Scotti V, Simontacchi G, Bonomo P, Greto D, Mangoni M, Scoccianti S, Lucidi S, Paoletti L, Fambrini M, Bernini M, Sanchez L, Orzalesi L, Nori J, Bianchi S, Pallotta S, Livi L. Accelerated Partial-Breast Irradiation Compared With Whole-Breast Irradiation for Early Breast Cancer: Long-Term Results of the Randomized Phase III APBI-IMRT-Florence Trial. J Clin Oncol. 2020 Dec 10;38(35):4175-4183. doi: 10.1200/JCO.20.00650. Epub 2020 Aug 24. PMID 32840419
- DERIVEDBecherini C, Meattini I, Livi L, Garlatti P, Desideri I, Scotti V, Orzalesi L, Sanchez LJ, Bernini M, Casella D, Nesi S, Nori J, Bianchi S, Pallotta S, Marrazzo L. External accelerated partial breast irradiation for ductal carcinoma in situ: long-term follow-up from a phase 3 randomized trial. Tumori. 2019 Jun;105(3):205-209. doi: 10.1177/0300891618811278. Epub 2018 Nov 26.