Clinical trial · Interventional
Accelerated Partial Breast Irradiation Versus Standard or Hypofractionated Whole-Breast Irradiation, in Early Breast Cancer, After Breast-conserving Surgery
Clinical Trial, Randomized, Open Label, With an Active Comparator to Assess the Efficacy and Safety of Using Accelerated Partial Irradiation Versus Standard or Hypofractionated Irradiation of the Entire Breast in Patients With Initial Breast Cancer After Conservative Surgery
NCT04669873CI-TRIAL-00050526LAPIDARYrecruitingN/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)
Radiotherapy has been confirmed as an important treatment breast-conserving surgery reducing the risk of any recurrence of breast cancer and breast cancer-related mortality in patients with early breast cancer. There are no comparative data on the ideal radiotherapy treatment regimen for patients with early stage breast cancer who underwent conservative surgery in the Brazilian population.
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 |
|---|---|---|---|
| Malignant Neoplasm of Breast | Malignant Breast Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Active Comparator: Standard | Radiation | — | UNRESOLVED |
| Experimental 1: Hypofractionated radiotherapy | Radiation | — | UNRESOLVED |
| Experimental 2: Accelerated Partial Breast Irradiation | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- ACTIVE_COMPARATOR
- label
- Active Comparator: Standard
- description
- Whole breast Radiotherapy, 40 Gray (40Gy) fractions
- interventionNames
- Radiation: Active Comparator: Standard
- type
- EXPERIMENTAL
- label
- Experimental 1: Hypofractionated radiotherapy
- description
- Whole breast Radiotherapy, 26 Gray (26Gy) in 5 fractions
- interventionNames
- Radiation: Experimental 1: Hypofractionated radiotherapy
- type
- EXPERIMENTAL
- label
- Experimental 2: Accelerated Partial Breast Irradiation
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 50 Years
- Maximum age
- 90 Years
Show eligibility criteria text
Inclusion Criteria: * Information to the patient and signed informed consent; * Women aged ≥50 years * Breast conserving surgery * Pathologic tumor size \< 3 cm (maximum microscopic diameter of the invasive component) * Invasive adenocarcinoma (except classic invasive lobular carcinoma) * Unifocal disease * Histopathologic grades I or II * Eastern Cooperative Oncology Group (ECOG) 0-1 * Lymphovascular invasion absent * Negative axillary lymph nodes * Minimum microscopic margins of non-cancerous tissue of 2mm (excluding deep margin when in deep fascia) * No prior breast or mediastinal radiotherapy * No hematogenous metastases Exclusion Criteria: * Previous malignancy (except non-melanomatous skin cancer) * Mastectomy * Classical-Type Invasive Lobular Carcinoma * Neoadjuvant chemotherapy * Human Epidermal growth factor Receptor-type 2 positive (HER2+) * Triple-negative breast cancers * Intravascular lymphoma present * Contraindications to radiotherapy. * No geographical, social or psychologic reasons that would prevent study follow
References
Publications (11)
- BACKGROUNDEarly Breast Cancer Trialists' Collaborative Group (EBCTCG); Darby S, McGale P, Correa C, Taylor C, Arriagada R, Clarke M, Cutter D, Davies C, Ewertz M, Godwin J, Gray R, Pierce L, Whelan T, Wang Y, Peto R. Effect of radiotherapy after breast-conserving surgery on 10-year recurrence and 15-year breast cancer death: meta-analysis of individual patient data for 10,801 women in 17 randomised trials. Lancet. 2011 Nov 12;378(9804):1707-16. doi: 10.1016/S0140-6736(11)61629-2. Epub 2011 Oct 19. PMID 22019144
- BACKGROUNDStrnad V, Ott OJ, Hildebrandt G, Kauer-Dorner D, Knauerhase H, Major T, Lyczek J, Guinot JL, Dunst J, Gutierrez Miguelez C, Slampa P, Allgauer M, Lossl K, Polat B, Kovacs G, Fischedick AR, Wendt TG, Fietkau R, Hindemith M, Resch A, Kulik A, Arribas L, Niehoff P, Guedea F, Schlamann A, Potter R, Gall C, Malzer M, Uter W, Polgar C; Groupe Europeen de Curietherapie of European Society for Radiotherapy and Oncology (GEC-ESTRO). 5-year results of accelerated partial breast irradiation using sole interstitial multicatheter brachytherapy versus whole-breast irradiation with boost after breast-conserving surgery for low-risk invasive and in-situ carcinoma of the female breast: a randomised, phase 3, non-inferiority trial. Lancet. 2016 Jan 16;387(10015):229-38. doi: 10.1016/S0140-6736(15)00471-7. Epub 2015 Oct 19. PMID 26494415
- BACKGROUNDPolgar C, Fodor J, Major T, Sulyok Z, Kasler M. Breast-conserving therapy with partial or whole breast irradiation: ten-year results of the Budapest randomized trial. Radiother Oncol. 2013 Aug;108(2):197-202. doi: 10.1016/j.radonc.2013.05.008. Epub 2013 Jun 3. PMID 23742961
- BACKGROUNDVeronesi U, Orecchia R, Maisonneuve P, Viale G, Rotmensz N, Sangalli C, Luini A, Veronesi P, Galimberti V, Zurrida S, Leonardi MC, Lazzari R, Cattani F, Gentilini O, Intra M, Caldarella P, Ballardini B. Intraoperative radiotherapy versus external radiotherapy for early breast cancer (ELIOT): a randomised controlled equivalence trial. Lancet Oncol. 2013 Dec;14(13):1269-77. doi: 10.1016/S1470-2045(13)70497-2. Epub 2013 Nov 11. PMID 24225155
- BACKGROUNDOlivotto IA, Whelan TJ, Parpia S, Kim DH, Berrang T, Truong PT, Kong I, Cochrane B, Nichol A, Roy I, Germain I, Akra M, Reed M, Fyles A, Trotter T, Perera F, Beckham W, Levine MN, Julian JA. Interim cosmetic and toxicity results from RAPID: a randomized trial of accelerated partial breast irradiation using three-dimensional conformal external beam radiation therapy. J Clin Oncol. 2013 Nov 10;31(32):4038-45. doi: 10.1200/JCO.2013.50.5511. Epub 2013 Jul 8.