Single-fraction APBI for Early-stage Breast Cancer With Favorable Histological Subtypes (Breast-1F)

NCT06946238 | Recruiting DMC

• 1 other identifier: Breast-1F
• Study Type: interventional
• Target: 311
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Breast Cancer

Keywords

Breast Cancer; Accelerated Partial Breast Irradiation; Adjuvant Radiotherapy; Stereotactic Body Radiotherapy; Simultaneous Integrated Boost; Ultrahypofractionated Radiotherapy

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (14)

• Acute toxicity

  1 month

• Acute toxicity

  3 months

• Late toxicity

  5 years

• Local Control

  5 years

• Local Relapse-Free Survival (LRFS)

  From the date of radiotherapy end until the date of local relapse, assessed up to 5 years

Other Outcomes (4)

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

  5 years

• Modeling of organ movement

  5 days

• Radiomics

  5 years

Study Arms (2)

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.

Radiation: Adjuvant single-fraction accelerated partial breast irradiation

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.

Radiation: Adjuvant single-fraction accelerated partial breast irradiation

Interventions

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.

Also known as: Ultrahypofractionated Radiotherapy

Arm 1- Single-fraction APBI; Arm 2- Five-fractions APBI

Eligibility Criteria

• Age: 40 Years+
• Gender Eligibility Details: Female patients aged ≥40 years, with early-stage breast cancer and favorable histology will be enrolled
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histological diagnosis of breast cancer
• Patients aged ≥40 years
• Signed informed consent
• Stage pTis-T2, up to 3 cm in the greatest diameter
• Luminal A and Luminal B HER2-negative histological subtypes
• Negative surgical margins (≥ 0.2 cm)
• Negative lymph nodes at sentinel lymph node biopsy, or alternatively with imaging tests (Positron Emission Tomography (PET)/Computed Tomography (CT) and/or axillary ultrasound, and/or breast Magnetic Resonance Imaging (MRI) with and without contrast), or, in rare cases, where still performed, with axillary dissection
• Clinical M0 (PET/CT and/or bone scintigraphy and/or abdomen-pelvis CT with and without contrast in suspected patients), within the previous 3 months.
• Performance Status (PS) Eastern Cooperative Oncology Group (ECOG) ≤2
• No prior thoracic radiotherapy
• Fertile women using contraception methods initiated during oncological treatment.

You may not qualify if:

• Patients aged \< 40 years
• Tumors \> 3 cm
• Multicentric tumors
• Positive or close surgical margins (\<0.2 cm)
• Lobular carcinoma
• Negative hormone receptors
• HER2-positive
• BReast CAncer (BRCA) genes BRCA1 and/or BRCA2 positive (only if known)
• Severe systemic diseases
• Psychiatric or other disorders that may prevent the patient from signing informed consent
• Previous invasive cancer, except for skin cancer (excluding melanoma) unless the patient has been disease-free for at least 3 years (e.g., carcinoma in situ of the oral cavity or bladder)
• Collagen or autoimmune diseases (systemic lupus erythematosus, rheumatoid arthritis, scleroderma, Sjogren's syndrome)
• Lymph node disease (N1)
• Evidence of distant metastasis (M1)
• Contraindication to systemic treatment

Sponsors & Collaborators

• IRCCS San Raffaele: lead

Study Sites (1)

IRCCS San Raffaele Scientific Institute

Milan, 20132, Italy

RECRUITING

Related Publications (46)

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MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Andrei Fodor, MD

  IRCCS San Raffaele Scientific Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Andrei Fodor, MD

CONTACT

+390226437634; fodor.andrei@hsr.it

Nadia G Di Muzio, Prof

CONTACT

+390226437643; dimuzio.nadia@hsr.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: April 19, 2025
• First Posted: April 27, 2025
• Study Start: July 25, 2025
• Primary Completion (Estimated): June 30, 2029
• Study Completion (Estimated): June 30, 2035
• Last Updated: December 4, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR, ANALYTIC CODE
• Time Frame: for 5 years after the end of the study
• Access Criteria: request from the corresponding author approved by the Lombardy Territorial Ethics Committee

Locations

IT (1)