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This is a prospective, randomized, single-center, non-inferiority interventional clinical trial comparing whole breast irradiation (WBI) to a total dose of 26 Gy in 5 fractions with simultaneous integrated boost (SIB) to the tumor bed to a total dose of 30 Gy, and WBI to a total dose of 40.05 Gy in 15 fractions with SIB to the tumor bed to a total dose of 48 Gy (standard treatment), for young or unfavorable breast cancer patients.
The project refers to a study on patients with T1-T3 Nx-N3 breast cancer, aged under 40 years or with unfavorable histology (lobular carcinoma, multifocal tumor, or histological subtypes Luminal B Her2 positive, Hormonal Receptors negative Her 2 positive, Triple Negative Breast Cancer-TNBC-) treated with breast-conserving surgery (BCS) and radiotherapy to the whole breast (+/- lymph node areas) to a total dose of 26 Gy in 5 fractions, with simultaneous boost (SIB) to the tumor bed to the total dose of 30 Gy, that will be compared with the current departmental standard of moderately hypofractionated radiotherapy to the whole breast, to 40.05 Gy in 15 fractions, with SIB to the tumor bed to a total dose of 48 Gy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1- Five fractions radiotherapy | Experimental | Patients in the study (randomized to arm 1) will be treated to the whole breast to a total dose (TD) of 26 Gy in 5 fractions, with simultaneous integrated boost (SIB) to a TD of 30 Gy to the tumor bed. For each patient, an IMRT (intensity modulated 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- Fifteen fractions radiotherapy | Active Comparator | Patients randomized to arm 2 will be treated according to the standard protocol of our department, delivering adjuvant whole breast irradiation (WBI) to a total dose (TD) of 40.05 Gy in 15 fractions, with simultaneous integrated boost (SIB) to the tumor bed to a TD of 48 Gy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Adjuvant 5 fractions whole breast irradiation with simultaneous integrated boost to the tumor bed | Radiation | Experimental arm (arm 1-five fractions WBI) patients will be treated to a total dose (TD) of 26 Gy in 5 fractions to whole breast, and a simultaneous integrated boost (SIB) to a TD of 30 Gy to the tumor bed, while arm 2-fifteen-fractions WBI patients with 40 Gy/15 fractions to PTV, and 48 Gy SIB to the tumor bed. |
| Measure | Description | Time Frame |
|---|---|---|
| Local Relapse Free Survival (LRFS) | o demonstrate the non-inferiority of local control (local relapse free survival - LRFS) of the study treatment (delivered in five fractions) compared to the department's standard WBI treatment (delivered in 15 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 RTOG/EORTC scale with 4 grades, from 0 no change to 4, worst toxicity | 1 month |
| Acute toxicity |
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Inclusion Criteria:
Exclusion Criteria:
Female patients with breast cancer and age <40 years regardless if histology, or 40-70 years old with unfavorable characteristics.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Andrei Fodor, MD | Contact | +390226437634 | fodor.andrei@hsr.it | |
| Roberta Tummineri, MD | Contact | +390226435452 | tummineri.roberta@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 |
|---|---|---|---|
| 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. | |
| 8931610 |
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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 458 patients are expected to be enrolled in this prospective, randomized study. A power of 80% and a significance level α of 5% are used to calculate the sample size. The hypothesis is that the proportion of patients free from local recurrence 5 years after the end of treatment is not less than 95.4%, with a margin of 5%. A total of 218 patients per arm are needed, and an additional 5% (22 patients) to compensate for dropouts.
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|
|
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 skin toxicity evaluated with RTOG/EORTC scale, with 4 grades, from 0 = no change, to 4 = maximum toxicity | 5 years |
| Late toxicity | Late toxicity evaluated with 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 |
| Ipsilateral Breast Tumor Recurrence (IBTR) | Ipsilateral breast tumor recurrence - IBTR- of the study treatment (delivered in 5 fractions WBI+SIB) compared to the department's standard WBI+SIB treatment (delivered in 15 fractions). | 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 200 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 200 patients | 42 months |
| Local relapse interim analysis | An interim analysis of local relapse rate will be performed for the first 200 patients | 42 months |
| 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 |
| Modeling of organ movement | Modeling of organ movement during treatment | 15 days |
| Radiomics | CT radiomic features predicting relapse or death will be extracted, acording to IBSI (Image Biomarker Standardisation Initiative), owning to the different families of features: Morphology, Statistical, Intensity Histogram, Grey Level Cooccurrence Matrix 3D-average, Grey Level Co-occurrence Matrix 3D-combined, Grey Level Run Lenght 3D-average. Grey Level Run Lenght 3D_combined, Grey Level Size Zone Matrix 3D, Neighbors Grey Tone Difference Matrix 3D, Grey Level Distance Zone Matrix 3D, standard convolutional filters within radiomic workflow (wavelets, Laplacian of Gaussian). Area Under Curve (AUC) will be taken as representative of the discriminative power for each of the significant RF. | 5 years |
| Predictive factors for toxicity | Identification of clinical, imaging, and laboratory prognostic factors for toxicity. Univariable and multivariable Cox analysis will be performed to identify factors associated with >/= G2 toxicity | 5 years |
| Predictive factors for disease progression | Identification of clinical, imaging, and laboratory prognostic factors for an aggressive phenotype of breast cancer. Univariable and multivariable analysis will be performed to identify factors associated with disease progression | 5 years |
| Predictive factors for death | Identification of clinical, imaging, and laboratory prognostic factors for an aggressive phenotype of breast cancer. Univariable and multivariable Cox analysis will be performed to identify factors associated with death. | 5 years |
| Result |
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| D017437 |
| Skin and Connective Tissue Diseases |