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This is a prospective, randomized, monocentric, non-inferiority interventional clinical study comparing an Accelerated Partial Breast Irradiation (APBI) for the surgical bed of early-stage breast cancer patients with favorable histological subtypes, using stereotactic radiotherapy in a single dose of 15.5 Gy with Simultaneous Integrated Boost (SIB) to 21 Gy (study treatment, delivered in a single fraction) versus multifractionated radiotherapy of 30 Gy in 5 fractions (standard treatment, delivered in 5 fractions).
The project refers to a study on patients with early-stage breast cancer with pathological Tumor stage (pT) from in situ (pTis) to pT2 up to 3 cm in diameter, and pathological/clinical nodal stage p/cN0, and favorable histology (Luminal A and Luminal B human epidermal growth factor receptor 2 (HER2)-negative subtypes), comparing an APBI treatment delivered with stereotactic radiotherapy to the Planning Target Volume (PTV) of the tumor bed of the breast with a total dose (TD) of 15.5 Gy in one fraction, with simultaneous integrated boost (SIB) to a TD of 21 Gy to the Gross Tumor Volume (GTV) represented by tumor bed, versus 30 Gy in 5 consecutive fractions to the PTV of the tumor bed, according to the standard APBI protocol of the department (Florence protocol).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1- Single-fraction APBI | Experimental | Patients in the study (randomized to arm 1) will be treated with a total dose (TD) of 15.5 Gy to the Planning Tumor Volume (PTV) with simultaneous integrated boost (SIB) to a TD of 21 Gy to the tumor bed. For each patient, a stereotactic radiotherapy treatment plan will be created to ensure adequate coverage of the treatment volumes and the tolerability of the Organs At Risk (OAR). Specific, already validated dose-volume constraints will be applied for the evaluation of OARs. The dose-volume histogram (DVH) for the Gross Tumor Volume (GTV), Clinical Target Volume (CTV), PTV, and OAR will be calculated in order to achieve the best optimization in terms of tolerability and efficacy. |
|
| Arm 2- Five-fractions APBI | Active Comparator | Patients randomized to arm 2 will be treated according to the standard APBI protocol of our department (Florence protocol), delivering a TD of 30 Gy in 5 fractions to the tumor bed. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Adjuvant single-fraction accelerated partial breast irradiation | Radiation | Experimental arm (arm 1-single-fraction APBI) patients will be treated to a total dose (TD) of 15.5 Gy to the PTV with a simultaneous integrated boost (SIB) to a TD of 21 Gy to the tumor bed, while arm 2-five-fractions APBI patients with 30 Gy/ 5 fractions to PTV. |
| Measure | Description | Time Frame |
|---|---|---|
| Ipsilateral Breast Tumor Recurrence (IBTR) | To demonstrate the non-inferiority of local control (ipsilateral breast tumor recurrence - IBTR) of the study treatment (delivered in a single-fraction APBI) compared to the department's standard APBI treatment (delivered in 5 fractions). | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Acute toxicity | Acute toxicity grade ≥3 as the maximum toxicity value within 1 month and 3 months after the completion of radiotherapy treatment evaluated with Radiation Therapy Oncology Group (RTOG) and the European Organization for Research and Treatment of Cancer (EORTC) scale with 4 grades, from 0 no change to 4, worst toxicity | 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Treatment-Emergent Adverse Events as assessed with breast tumor specific quality of life questionnaires | Survey with the questionnaire of European Organisation for Research and Treatment of Cancer (EORTC) Quality of life of brain tumor patients (EORTC QLQ BR42) which contains 42 questions on patients' quality of life with answers from 1, lowest grade, to 4, highest grade | 5 years |
Inclusion Criteria:
Exclusion Criteria:
Female patients aged ≥40 years, with early-stage breast cancer and favorable histology will be enrolled
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Andrei Fodor, MD | Contact | +390226437634 | fodor.andrei@hsr.it | |
| Nadia G Di Muzio, Prof | Contact | +390226437643 | dimuzio.nadia@hsr.it |
| Name | Affiliation | Role |
|---|---|---|
| Andrei Fodor, MD | IRCCS San Raffaele Scientific Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IRCCS San Raffaele Scientific Institute | Recruiting | Milan | 20132 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12393819 | Result | Veronesi U, Cascinelli N, Mariani L, Greco M, Saccozzi R, Luini A, Aguilar M, Marubini E. Twenty-year follow-up of a randomized study comparing breast-conserving surgery with radical mastectomy for early breast cancer. N Engl J Med. 2002 Oct 17;347(16):1227-32. doi: 10.1056/NEJMoa020989. | |
| 12393820 | Result | Fisher B, Anderson S, Bryant J, Margolese RG, Deutsch M, Fisher ER, Jeong JH, Wolmark N. Twenty-year follow-up of a randomized trial comparing total mastectomy, lumpectomy, and lumpectomy plus irradiation for the treatment of invasive breast cancer. N Engl J Med. 2002 Oct 17;347(16):1233-41. doi: 10.1056/NEJMoa022152. |
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The data that support the findings of this study (anonymized individual participant data) are available on request from the corresponding author to researchers who provide a methodologically sound proposal. Requests made to the corresponding author will be evaluated by the Lombardy Territorial Ethics Committee 1
for 5 years after the end of the study
request from the corresponding author approved by the Lombardy Territorial Ethics Committee
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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A total of 311 patients are expected to be enrolled in this prospective randomized study. For the sample size calculation, a 90% power and a significance level α = 5% are set. The hypothesis is that the proportion of patients free from Ipsilateral Breast Tumor Recurrence (IBTR) 5 years after the end of treatment will be no less than 97.8%, with a margin of 5%. A total of 148 patients per arm are required, with an additional 5% (15 patients) to compensate for drop-outs.
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|
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| Acute toxicity |
Acute toxicity grade ≥3 as the maximum toxicity value within 1 month and 3 months after the completion of radiotherapy treatment evaluated with RTOG/EORTC scale with 4 grades, from 0 no change to 4, worst toxicity |
| 3 months |
| Late toxicity | Late toxicity evaluated with RTOG/EORTC and Common Terminology Criteria for Adverse Events (CTCAE) v5.0 scale, with 5 grades, from 0 = no change, to 5 = death for toxicity | 5 years |
| Local Control | Local control of the treated site expressed in terms of local recurrence rate | 5 years |
| Local Relapse-Free Survival (LRFS) | Time to local recurrence | From the date of radiotherapy end until the date of local relapse, assessed up to 5 years |
| Regional Relapse-Free Survival (RRFS) | Time to regional (nodal) recurrence | From the date of radiotherapy end until the date of regional relapse, assessed up to 5 years |
| Distant Metastasis-Free Survival (DMFS) | Time to distant (metastatic) relapse | From the date of radiotherapy end until the date of distant metasis diagnosis, assessed up to 5 years |
| Disease-Free Survival (DFS) | Time to first any relapse: local, regional or distant | From the date of radiotherapy end until the date of first, any ( local, regional, distant) relapse, assessed up to 5 years |
| Breast Cancer Specific Survival (BCSS) | Time until death from breast cancer | From the date of radiotherapy end until the date of death from breast cancer, assessed up to 5 years |
| Overall Survival (OS) | Time until death from any cause | From the date of radiotherapy end until the date of death from any cause, assessed up to 5 years |
| Cosmesis | Cosmetic results evaluated with Harvard scale. It assesses the global esthetic appearance of the breast, categorized as Excellent, Good, Fair, or Poor | 5 years |
| Acute toxicity interim analysis | An interim analysis of acute toxicity (with RTOG/EORTC andf CTCAE v5.0 scales) will be performed for the first 120 patients | 3 months |
| Late toxicity interim analysis | An interim analysis of late toxicity (with RTOG/EORTC andf CTCAE v5.0 scales) will be performed for the first 120 patients | 42 months |
| Local relapse interim analysis | An interim analysis of local relapse rate will be performed for the first 120 patients | 42 months |
| Modeling of organ movement | Modeling of organ movement during treatment | 5 days |
| Radiomics | Evaluation of radiomic characteristics: Mathematical extraction of the spatial distribution of signal intensities and pixel interrelationships of medical images of the patients, to quantify textural information resampled according to International Biomarker Standardization Initiative (IBSI). | 5 years |
| Predictive factors for toxicity, disease progression and death | Identification of clinical, imaging, and laboratory prognostic factors for an aggressive phenotype of Luminal A and Luminal B HER2-negative breast cancer and for toxicity | 5 years |
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| 17577015 | Result | Bartelink H, Horiot JC, Poortmans PM, Struikmans H, Van den Bogaert W, Fourquet A, Jager JJ, Hoogenraad WJ, Oei SB, Warlam-Rodenhuis CC, Pierart M, Collette L. Impact of a higher radiation dose on local control and survival in breast-conserving therapy of early breast cancer: 10-year results of the randomized boost versus no boost EORTC 22881-10882 trial. J Clin Oncol. 2007 Aug 1;25(22):3259-65. doi: 10.1200/JCO.2007.11.4991. Epub 2007 Jun 18. |
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| 18355913 | Result | START Trialists' Group; Bentzen SM, Agrawal RK, Aird EG, Barrett JM, Barrett-Lee PJ, Bentzen SM, Bliss JM, Brown J, Dewar JA, Dobbs HJ, Haviland JS, Hoskin PJ, Hopwood P, Lawton PA, Magee BJ, Mills J, Morgan DA, Owen JR, Simmons S, Sumo G, Sydenham MA, Venables K, Yarnold JR. The UK Standardisation of Breast Radiotherapy (START) Trial B of radiotherapy hypofractionation for treatment of early breast cancer: a randomised trial. Lancet. 2008 Mar 29;371(9618):1098-107. doi: 10.1016/S0140-6736(08)60348-7. Epub 2008 Mar 19. |
| 12165639 | Result | Whelan T, MacKenzie R, Julian J, Levine M, Shelley W, Grimard L, Lada B, Lukka H, Perera F, Fyles A, Laukkanen E, Gulavita S, Benk V, Szechtman B. Randomized trial of breast irradiation schedules after lumpectomy for women with lymph node-negative breast cancer. J Natl Cancer Inst. 2002 Aug 7;94(15):1143-50. doi: 10.1093/jnci/94.15.1143. |
| 26494415 | Result | Strnad 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. |
| 31813636 | Result | Vicini FA, Cecchini RS, White JR, Arthur DW, Julian TB, Rabinovitch RA, Kuske RR, Ganz PA, Parda DS, Scheier MF, Winter KA, Paik S, Kuerer HM, Vallow LA, Pierce LJ, Mamounas EP, McCormick B, Costantino JP, Bear HD, Germain I, Gustafson G, Grossheim L, Petersen IA, Hudes RS, Curran WJ Jr, Bryant JL, Wolmark N. Long-term primary results of accelerated partial breast irradiation after breast-conserving surgery for early-stage breast cancer: a randomised, phase 3, equivalence trial. Lancet. 2019 Dec 14;394(10215):2155-2164. doi: 10.1016/S0140-6736(19)32514-0. Epub 2019 Dec 5. |
| 31813635 | Result | Whelan TJ, Julian JA, Berrang TS, Kim DH, Germain I, Nichol AM, Akra M, Lavertu S, Germain F, Fyles A, Trotter T, Perera FE, Balkwill S, Chafe S, McGowan T, Muanza T, Beckham WA, Chua BH, Gu CS, Levine MN, Olivotto IA; RAPID Trial Investigators. External beam accelerated partial breast irradiation versus whole breast irradiation after breast conserving surgery in women with ductal carcinoma in situ and node-negative breast cancer (RAPID): a randomised controlled trial. Lancet. 2019 Dec 14;394(10215):2165-2172. doi: 10.1016/S0140-6736(19)32515-2. Epub 2019 Dec 5. |
| 28779963 | Result | Coles CE, Griffin CL, Kirby AM, Titley J, Agrawal RK, Alhasso A, Bhattacharya IS, Brunt AM, Ciurlionis L, Chan C, Donovan EM, Emson MA, Harnett AN, Haviland JS, Hopwood P, Jefford ML, Kaggwa R, Sawyer EJ, Syndikus I, Tsang YM, Wheatley DA, Wilcox M, Yarnold JR, Bliss JM; IMPORT Trialists. Partial-breast radiotherapy after breast conservation surgery for patients with early breast cancer (UK IMPORT LOW trial): 5-year results from a multicentre, randomised, controlled, phase 3, non-inferiority trial. Lancet. 2017 Sep 9;390(10099):1048-1060. doi: 10.1016/S0140-6736(17)31145-5. Epub 2017 Aug 2. |
| 32840419 | Result | Meattini 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. |
| 36623246 | Result | Meduri B, Baldissera A, Iotti C, Scheijmans LJEE, Stam MR, Parisi S, Boersma LJ, Ammendolia I, Koiter E, Valli M, Scandolaro L, Busz D, Stenfert Kroese MC, Ciabatti S, Giacobazzi P, Ruggieri MP, Engelen A, Munafo T, Westenberg AH, Verhoeven K, Vicini R, D'Amico R, Lohr F, Bertoni F, Poortmans P, Frezza GP. Cosmetic Results and Side Effects of Accelerated Partial-Breast Irradiation Versus Whole-Breast Irradiation for Low-Risk Invasive Carcinoma of the Breast: The Randomized Phase III IRMA Trial. J Clin Oncol. 2023 Apr 20;41(12):2201-2210. doi: 10.1200/JCO.22.01485. Epub 2023 Jan 9. |
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| 24225155 | Result | Veronesi 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. |
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| 23484825 | Result | Darby SC, Ewertz M, McGale P, Bennet AM, Blom-Goldman U, Bronnum D, Correa C, Cutter D, Gagliardi G, Gigante B, Jensen MB, Nisbet A, Peto R, Rahimi K, Taylor C, Hall P. Risk of ischemic heart disease in women after radiotherapy for breast cancer. N Engl J Med. 2013 Mar 14;368(11):987-98. doi: 10.1056/NEJMoa1209825. |
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| 16360786 | Result | Clarke M, Collins R, Darby S, Davies C, Elphinstone P, Evans V, Godwin J, Gray R, Hicks C, James S, MacKinnon E, McGale P, McHugh T, Peto R, Taylor C, Wang Y; Early Breast Cancer Trialists' Collaborative Group (EBCTCG). Effects of radiotherapy and of differences in the extent of surgery for early breast cancer on local recurrence and 15-year survival: an overview of the randomised trials. Lancet. 2005 Dec 17;366(9503):2087-106. doi: 10.1016/S0140-6736(05)67887-7. |
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| 39098432 | Result | Civil 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. |
| 31987957 | Result | Bosma SCJ, Leij F, Vreeswijk S, Maaker M, Wesseling J, Vijver MV, Scholten A, Rivera S, Bourgier C, Auzac G, Foukakis T, Lekberg T, Bongard D, Loo C, Rutgers E, Bartelink H, Elkhuizen PHM. Five-Year Results of the Preoperative Accelerated Partial Breast Irradiation (PAPBI) Trial. Int J Radiat Oncol Biol Phys. 2020 Apr 1;106(5):958-967. doi: 10.1016/j.ijrobp.2019.12.037. Epub 2020 Jan 25. |
| 25701298 | Result | van der Leij F, Bosma SC, van de Vijver MJ, Wesseling J, Vreeswijk S, Rivera S, Bourgier C, Garbay JR, Foukakis T, Lekberg T, van den Bongard DH, van Vliet-Vroegindeweij C, Bartelink H, Rutgers EJ, Elkhuizen PH. First results of the preoperative accelerated partial breast irradiation (PAPBI) trial. Radiother Oncol. 2015 Mar;114(3):322-7. doi: 10.1016/j.radonc.2015.02.002. Epub 2015 Feb 17. |
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| 35260319 | Result | Brand DH, Kirby AM, Yarnold JR, Somaiah N. How Low Can You Go? The Radiobiology of Hypofractionation. Clin Oncol (R Coll Radiol). 2022 May;34(5):280-287. doi: 10.1016/j.clon.2022.02.009. Epub 2022 Mar 5. |
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| D017437 |
| Skin and Connective Tissue Diseases |