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NCT Number: NCT07020780

5 fr Ultrahypofractionated WBI and SIB for Breast Cancer With Unfavorable Characteristics

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Histological diagnosis of breast cancer
  • Patients younger than 40 years regardless of histological subtype, or patients between 40 and 70 years with lobular carcinoma, histological subtypes Luminal B Her2 positive, or with hormone receptors negative and Her2 positive (ErbB2), or triple negative (TNBC)
  • Signed informed consent
  • Clinical stage T1-T3, Nx-N3
  • Negative surgical margins (≥ 0.2 cm)
  • Clinical M0 in the previous 3 months
  • PS (ECOG) ≤2
  • No previous thoracic radiotherapy
  • Fertile women using contraceptive methods started during oncological treatment

Exclusion criteria

  • Patients with favorable characteristics (Luminal A, Luminal B Her2 negative, ≥ 40 years) undergoing partial irradiation
  • Patients who have undergone mastectomy
  • Multicentric tumors
  • Positive or close surgical margins (<0.2 cm)
  • BRCA1/2 positive (only if known)
  • Serious systemic diseases
  • Mental or other disorders that may prevent the patient from signing the informed consent
  • Previous invasive tumor, except skin cancer (excluding melanoma) unless the patient has been disease-free for at least 3 years (for example carcinoma in situ of the oral cavity or bladder)
  • Collagen or autoimmune diseases (systemic lupus erythematosus, rheumatoid arthritis, scleroderma, Sjogren's syndrome)
  • Evidence of distant metastases (M1)
  • Contraindication to treatment systemic
  • Pregnant women
  • Non-compliance with the dose limits established in the treatment plan

Treatment and study plan

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.

Other names: Ultrahypofractionated WBI with SIB

Primary outcomes

  1. Local Relapse Free Survival (LRFS)

    Time frame: 5 years

    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).

Secondary outcomes

  1. Acute toxicity

    Time frame: 1 month

    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

  2. Acute toxicity

    Time frame: 3 months

    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. Late toxicity

    Time frame: 5 years

    Late skin toxicity evaluated with RTOG/EORTC scale, with 4 grades, from 0 = no change, to 4 = maximum toxicity

  4. Late toxicity

    Time frame: 5 years

    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. Local Control

    Time frame: 5 years

    Local control of the treated site expressed in terms of local recurrence rate

  6. Ipsilateral Breast Tumor Recurrence (IBTR)

    Time frame: 5 years

    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).

  7. Regional Relapse-Free Survival (RRFS)

    Time frame: From the date of radiotherapy end until the date of regional relapse, assessed up to 5 years

    Time to regional (nodal) recurrence

  8. Distant Metastasis-Free Survival (DMFS)

    Time frame: From the date of radiotherapy end until the date of distant metasis diagnosis, assessed up to 5 years

    Time to distant (metastatic) relapse

  9. Disease-Free Survival (DFS)

    Time frame: From the date of radiotherapy end until the date of first, any ( local, regional, distant) relapse, assessed up to 5 years

    Time to first any relapse: local, regional or distant

  10. Breast Cancer Specific Survival (BCSS)

    Time frame: From the date of radiotherapy end until the date of death from breast cancer, assessed up to 5 years

    Time until death from breast cancer

  11. Overall Survival (OS)

    Time frame: From the date of radiotherapy end until the date of death from any cause, assessed up to 5 years

    Time until death from any cause

  12. Cosmesis

    Time frame: 5 years

    Cosmetic results evaluated with Harvard scale. It assesses the global esthetic appearance of the breast, categorized as Excellent, Good, Fair, or Poor

  13. Acute toxicity interim analysis

    Time frame: 3 months

    An interim analysis of acute toxicity (with RTOG/EORTC andf CTCAE v5.0 scales) will be performed for the first 200 patients

  14. Late toxicity interim analysis

    Time frame: 42 months

    An interim analysis of late toxicity (with RTOG/EORTC andf CTCAE v5.0 scales) will be performed for the first 200 patients

  15. Local relapse interim analysis

    Time frame: 42 months

    An interim analysis of local relapse rate will be performed for the first 200 patients

  16. Incidence of Treatment-Emergent Adverse Events as assessed with breast tumor specific quality of life questionnaires

    Time frame: 5 years

    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

  17. Modeling of organ movement

    Time frame: 15 days

    Modeling of organ movement during treatment

  18. Radiomics

    Time frame: 5 years

    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.

  19. Predictive factors for toxicity

    Time frame: 5 years

    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

  20. Predictive factors for disease progression

    Time frame: 5 years

    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

  21. Predictive factors for death

    Time frame: 5 years

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Andrei Fodor, MD

CONTACT

[email protected]

+390226437634

Roberta Tummineri, MD

CONTACT

[email protected]

+390226435452

Sponsors and collaborators

Lead sponsor

IRCCS San Raffaele

Other

Registry information

Official study title

Five Fractions Ultrahypofractionated Whole Breast Radiotherapy and Simultaneous Integrated Boost to the Tumor Bed, for Breast Cancer Patients With Unfavorable Characteristics

Important dates

Study start
2025
Primary completion
2029
Study completion
2035
First posted
Jun 13, 2025
Registry last updated
Jul 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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