Clinical trial NCT06946238: Single-fraction APBI for Early-stage Breast Cancer With Favorable Histological Subtypes (Breast-1F)
Official title: Accelerated Partial Breast Irradiation in One Fraction for Patients With Early-stage Disease and Favorable Histological Subtypes (Breast-1F).
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Breast Cancer
Keywords: Breast Cancer
Accelerated Partial Breast Irradiation
Adjuvant Radiotherapy
Stereotactic Body Radiotherapy
Simultaneous Integrated Boost
Ultrahypofractionated Radiotherapy
Lead sponsor: IRCCS San Raffaele
Sponsor class: OTHER
First posted: 2025-04-27
Enrollment: 311
Sex: FEMALE
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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).

Detailed description: 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).

Eligibility criteria: Inclusion Criteria:

1. Histological diagnosis of breast cancer
2. Patients aged ≥40 years
3. Signed informed consent
4. Stage pTis-T2, up to 3 cm in the greatest diameter
5. Luminal A and Luminal B HER2-negative histological subtypes
6. Negative surgical margins (≥ 0.2 cm)
7. 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
8. 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.
9. Performance Status (PS) Eastern Cooperative Oncology Group (ECOG) ≤2
10. No prior thoracic radiotherapy
11. Fertile women using contraception methods initiated during oncological treatment.

Exclusion Criteria:

1. Patients aged \< 40 years
2. Tumors \> 3 cm
3. Multicentric tumors
4. Positive or close surgical margins (\<0.2 cm)
5. Lobular carcinoma
6. Negative hormone receptors
7. HER2-positive
8. BReast CAncer (BRCA) genes BRCA1 and/or BRCA2 positive (only if known)
9. Severe systemic diseases
10. Psychiatric or other disorders that may prevent the patient from signing informed consent
11. 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)
12. Collagen or autoimmune diseases (systemic lupus erythematosus, rheumatoid arthritis, scleroderma, Sjogren's syndrome)
13. Lymph node disease (N1)
14. Evidence of distant metastasis (M1)
15. Contraindication to systemic treatment
16. Pregnant women
17. Non-compliance with the dose limits established in the treatment plan

Primary outcomes:
measure: Ipsilateral Breast Tumor Recurrence (IBTR)
timeFrame: 5 years
Secondary outcomes:
measure: Acute toxicity
timeFrame: 1 month
measure: Acute toxicity
timeFrame: 3 months
measure: Late toxicity
timeFrame: 5 years
measure: Local Control
timeFrame: 5 years
measure: Local Relapse-Free Survival (LRFS)
timeFrame: From the date of radiotherapy end until the date of local relapse, assessed up to 5 years
measure: Regional Relapse-Free Survival (RRFS)
timeFrame: From the date of radiotherapy end until the date of regional relapse, assessed up to 5 years
measure: Distant Metastasis-Free Survival (DMFS)
timeFrame: From the date of radiotherapy end until the date of distant metasis diagnosis, assessed up to 5 years
measure: Disease-Free Survival (DFS)
timeFrame: From the date of radiotherapy end until the date of first, any ( local, regional, distant) relapse, assessed up to 5 years
measure: Breast Cancer Specific Survival (BCSS)
timeFrame: From the date of radiotherapy end until the date of death from breast cancer, assessed up to 5 years
measure: Overall Survival (OS)
timeFrame: From the date of radiotherapy end until the date of death from any cause, assessed up to 5 years
measure: Cosmesis
timeFrame: 5 years
measure: Acute toxicity interim analysis
timeFrame: 3 months
measure: Late toxicity interim analysis
timeFrame: 42 months
measure: Local relapse interim analysis
timeFrame: 42 months
Other outcomes:
measure: Incidence of Treatment-Emergent Adverse Events as assessed with breast tumor specific quality of life questionnaires
timeFrame: 5 years
measure: Modeling of organ movement
timeFrame: 5 days
measure: Radiomics
timeFrame: 5 years
measure: Predictive factors for toxivity, disease progression and death
timeFrame: 5 years
Locations:
city: Milan
country: Italy
facility: IRCCS San Raffaele Scientific Institute
Study officials:
affiliation: IRCCS San Raffaele Scientific Institute
name: Andrei Fodor, MD
role: PRINCIPAL_INVESTIGATOR
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